quality assurance and validation

8/2/2019 Quality Assurance and Validation

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Quality Assurance (QA) Management Procedures

In this episode you will find Standard Operating Procedures for establishing qualityassurance practices, such as preparation, maintenance, definition, classification and

change Control of Quality and Master file documentation necessary for your products;recording and reporting procedure for deviations management; quality concerninvestigation Process; customer complaint handling procedure; quality audit procedures;vendor assessment, evaluation and certification procedure; rework procedures for thedefective manufactured products; procedures on training for your staffs and many otherprocedures according to your need.All procedures have reference of prepared Forms and Templates for effective recordkeeping and reporting purposes. Forms are attached at the end of each procedure.Templates are listed separately.

SOP listWriting Standard Operating ProcedureThis SOP describes standard SOP format that you can create and use immediately foryour quality procedures. This SOP has instructions on how to write a formal OperatingProcedures for your systems which your people can follow everyday.GMP DocumentsIn this SOP you will find all type of quality and Technical/Master file documents to buildup a good quality management system for your manufacturing sites, definition ofdocuments, their classification, approval requirements and retention requirements. This

procedure has schematic diagrams for your understanding of how different types ofdocuments are prepared and stored in a typical documentation database.

Quality Documentation Change ControlThis SOP describes how to generate new quality documents or change control ofexisting documents, review of quality documents, satellite file management, role ofdocument author, approver, document control officer and satellite file administrator. Inthis SOP you will also find numbering systems of different quality documents like auditfiles, SOPs, forms, manuals, training files, QA agreements, project files etc and theireffective archiving system.Documentation RuleThis SOP describes the principles to be followed in GMP documents, entry of data andinformation, signature requirements and correction technique of incorrectly entered dataor information.

Document ControlIn this SOP you will find mainly the role of document control officer during the initiation,creation, circulation and approval of new quality related documents. It also describes
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the procedure of modification and review of existing document using a documentationdatabase. Management of existing and superseded documents is also a part of thisprocedure. You will see all the forms referred during the instruction are attached at theend of the procedure.Master GMP Documents

This SOP particularly focused on the management of master file documents likespecifications, control methods, raw materials, finished goods and packagingspecification and test reports, formulation, stability files etc required to generate duringthe product registration in the market. This SOP gives instruction on their creation,change control, numbering system, approval requirements and maintenance in a simplemaster file database. You will see all the forms referred during the instruction areattached at the end of the procedure.Deviation ReportingIt is a regulatory requirement to capture all sorts of deviations evolves in your systems

in order to maintain the continuous improvement of your processes and systems. ThisSOP describes how to categorize the deviations between production, audit, qualityimprovements, technical deviations, customer complaints and environmental, healthand safety deviations. It describes the management responsibilities of initiatingdeviation, capture data, analysis, investigation, determination of assignable causes,generation of management report and initiatives to be taken on corrective andpreventative actions.Product Shelf LifeThis simple SOP describes the meaning of shelf life and provides direction on how tointerpret shelf lives and storage conditions for your raw materials from the Certificate ofAnalysis, determining expiry date for your finished products by use of raw material dateof manufacturing and their shelf lives.

Vendor ManagementThis SOP describes the procedure to be followed during the vendor assessment andvendor evaluation for purchasing of raw materials, critical and non critical packagingcomponents, laboratory supplies, engineering supplies and imported finished goodsfrom the vendor. These instructions are essential for approving prospective vendor. Vendor CertificationThis procedure aims to describe the process by which a vendor may be certified tosupply materials or services. This procedure applies to vendors that supply a material orservice to be used at any stage of manufacture by operations. Here you will get theroles of each department in the process to certify an approved vendor.Product ComplaintThis procedure covers the receipt, logging, evaluation, investigation and reportingsystem of all complaints received from customers for the marketed products. This SOPcontains step by step instruction to be followed in the customer complaint management
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like numbering of complaint, registration, evaluation of complaints, determination ofassignable cause for the complaint deviation, implementation of corrective andpreventative actions, trending of complaints and handling of counterfeit products.Product ReviewThis procedure provides a guideline to annual product review which is required to beperformed for each product produced for the commercial market to evaluate data,trends and to identify any preventative or corrective action that would lead to productquality improvements and report them to management.ReworkThis SOP contains the step by step instruction to be followed when the rework of an in-process or completed finished good is required. This SOP covers the reworks of in-process manufactured goods where new batch number is introduced for the reworkedpart and rework of manufactured finished good keeping the same batch number. Thissop also describes how to create rework protocols for each individual case.Product Identification and TraceabilityThe purpose of this SOP is to define the method used for the identification of allcontributing materials that could affect product quality and to ensure their fulltraceability. Here you will find instruction on all the records and documents used for theidentification and traceability of incoming raw materials and out going finished goods. GMP AuditsThis SOP describes the process of planning, performing, reporting and follow-up ofdifferent audits for your systems like Internal Quality audit, Vendor audit, EnvironmentalHealth and Safety (EHS) audit, EHS workplace inspection, Housekeeping audit. ThisSOP also describes the process to be followed by manufacturing personnel during anaudit from a Regulatory authority.Batch DocumentationThis SOP describes the identification of all documentation relevant to a productionprocess in the form of Batch Documentation Checklists and to ensure their collectionby completion of the checklists by Authorized Persons. This procedure is based on anexample of tablet packaging process described in the Manufacturing category.Batch Document Evaluation for ReleaseThis procedure describes the process of collection, evaluation and record of batchrelated document generated during the production of a batch before an authorizedperson can release the batch for sale. This procedure is based on an example of tabletpackaging process described in the Manufacturing category.GMP TrainingThis SOP describes how to design and deliver GMP related trainings for yourmanufacturing staffs, training assessment design, recording of assessment andpreparation of training reports.
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GMP Training MaterialsThis simple SOP contains instructions on how to write training materials, identification oftraining requirements, available resources, preparation of training aid checklists for yourmanufacturing staffs.House Keeping AuditThis SOP describes the requirements, checklists and reporting procedure onhousekeeping audits. Individual checklist forms are attached at end of the procedure fordifferent areas like process, laboratory, engineering stores, warehouses. This procedurealso describes the handling of non-compliance found during the housekeeping audits.

Contract WorkThe procedure describes the management and control of contract work provided by thecontractors for packaging and finished products for your company as well as control ofcontract works done by your company on behalf of others.

Raw Material and Packaging Components SourcingThe purpose of this SOP is to describe the process for approval of an externalvendor/manufacturer supplying products to your company. It covers raw materials(including bulk products for subsidiaries and contract manufacturers), critical packagingcomponents in contact with product and imported finished goods. The SOP alsoreferences affiliated documentation detailing the scope of active materials used and theapproved manufacturers of these materials.Quality Investigation ProcessThis procedure contains instruction to be followed when conducting Investigations andto raise and assess Deviation Report when an Investigation or Incident Investigationoccurs. This procedure is to be used in conjunction with Deviation management, whichcovers the approval and follow-up activities associated with a Deviation Report. Hereyou will find collection of information for an incident or a deviation, steps to be followedfor a cross functional investigation, reporting and implementing of the outcomes ofinvestigation.Change Management SystemThis procedure provides a standardised procedure and framework for initiating,authorising, planning and implementing any change to a GMP system.

Product Change Management requires that all planned permanent changes that havethe potential to impact on regulatory filings or the quality of an active pharmaceuticalingredient or drug product must be evaluated, reviewed and approved. It also requiresthat the site procedure must include provision for effectively tracking all quality andregulatory changes and provide a mechanism for review and approval by the SiteQuality Team for all changesCross functional investigation
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This procedure describes the guidelines for initiating, communicating, conducting anddocumenting Cross-Functional Investigations (CFI) related to process, system, product,material, facility and laboratory deviations. A CrossFunctional Investigation is anextended investigation conducted in order to identify a Root Cause.
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Quality Control Laboratory ProceduresIn this episode you will find practical procedures on Retest Dating of Raw Materials;Calibration Policies for Laboratory Instruments; Archiving Laboratory Documentation;Management of Reference Substances; GLP requirements of Laboratory Workbook;

Creation of Certificate of Analysis; Managing Analytical Reagents; Laboratory WasteManagement; Managing of Retention Samples in Laboratory; Laboratory SupplierApproval; Laboratory Results-Out Of Specification Investigation; Raw Materials-Laboratory Testing and Documentation; Finished Goods-Laboratory Testing andDocumentation; Preparation and Maintenance of Stability Protocols (pharmaceuticals);Stability and Trial Testing Procedure (pharmaceuticals).SOP listsRetest DatingThe purpose of this procedure is to describe how to run the expired stock report; to

describe how to define the requirements for the retesting and assignment of storageperiods for active ingredients, excipients and raw materials; to instruct retestingprocedure and to determine the status of a finished goods batch with a shorter shelf life.Calibration of Laboratory InstrumentsThis SOP describes the calibration policies of laboratory instruments/ equipments. Itdescribes labeling and security requirements of laboratory instruments/ equipments.This SOP also describes the investigational steps to be required in the case of failedcalibration.

Archiving of Laboratory DocumentationThis procedure describes retention and disposal procedures of laboratorydocumentation, general laboratory documentation system that includes handling ofrejected raw material and finished product reports, finished goods certificate of analysis,finished goods register, raw material certificate of analysis, raw material register, trendcards, procedure for long term document retention.Reference SubstancesThis SOP describes the ordering, referencing, storing, coding, use and general registermaintenance of primary and impurity reference substances, primary reagent referencesolutions, secondary raw material reference substance, assay testing procedure ofsecondary raw material reference substance, use of secondary raw material referencesubstance in the laboratory routine analysis, determination of expiry date and re-testdate of reference substances.Laboratory WorkbookThis SOP describes types of laboratory workbooks, general and GMP requirements ofusing workbooks, analytical data entry in the workbook, formatting of laboratoryworkbooks for routine testing, experiments and trials, workbook retention policy,instruction on data entry for incomplete experiments and additional data.
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Certificate of AnalysisThe purpose of this procedure is to define the content and format of a Certificate ofAnalysis (C/A) and Certificate of Manufacture (C/C) and to provide guidance for issuinga Certificate of Analysis or Certificate of Manufacture and to locate the appropriate data

required for this task.

Analytical ReagentsThis procedure identifies the need for all analytical reagents and solutions preparedfrom the reagents, to have an assigned expiry date and storage conditions recorded onthe label. Here you will find the procedure for purchase and management of analyticalreagents and laboratory prepared reagents.Laboraotry Waste ManagementThis simple procedure describes how to dispose off laboratory generated wastes oftoxic, explosive, flammable, corrosive, oxidizing and biologically damaging natures. Laboratory Retention SamplesThe purpose of this SOP is to describe the finished good and raw material sampleretention procedures, products manufactured and/or received onsite and/or chemicallytested by the Laboratory.Laboratory Supplier ApprovalIn this simple SOP you will find the procedures for approving laboratory suppliers andcriteria for the purchase of equipment, instrumentation, consumables, durables andglassware for the laboratory.Laboratory Results Out Of Specification InvestigationThis procedure describes the actions to be taken by an analyst in the event the result ofa test does not conform to raw material/components or finished products specificationsfor physical and chemical tests. An out of specification (OOS) result does notnecessarily mean the batch under investigation fails and shall be rejected. The OOSresults shall be investigated and the findings of the investigation, including re-testresults shall be interpreted to evaluate the batch and reach a decision regarding releaseor rejection.

Laboratory Testing for Raw MaterialsThis SOP describes the procedure for sampling, location, pre-testing, testing anddocumentation of all raw materials and components subject to test, out of specificationresults, microbiological tests and release procedure for passed raw materials andcomponents.Laboratory Testing For Finished ProductsThis SOP describes the procedure for sampling, location, pre-testing, testing anddocumentation of all finished products subject to test, reagents and standards to be
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used for analysis, management of out of specification results, microbiological tests andrelease procedure for passed finished goods.Stability ProtocolsThis procedure describes the preparation and management of Stability Protocols for

marketed products. This procedure is applicable to all protocols for stability studies oncommercial products. The responsibility of the commercial Site Stability Manager forcreating and maintaining protocols that are required for studies that came as a result ofvalidation or process deviation.Trial TestingTo describe the steps necessary to ensure the effective control of stability and trialtesting programs of new and existing products. This procedure is focused on setting upof stability programs, testing, reporting, general sampling procedure for stabilityprograms, data generation and analysis, annual maintenance of stability, new productstability procedure, procedure for in-house trials, reporting and interpretation of trials

and conclusion of the trail program.

Preparation of Disinfactant Solution in the LabThis procedure describes the preparation and use of disinfectant solutions (70% IPA) inthe Sterile Area and also outlines the procedure for Integrity testing of the 70% IPAFilter.Laboratory Analytical DeterminationsThe purpose of this document is to describe the operational procedures to be followedwhen carrying out analytical analyses in the Quality Control Laboratory at a GMP site.This SOP outlines the system suitability (SST) and acceptance criteria for analysis byHPLC and UV-VIS Spectrophotometer; e.g. Composite Assay (Assay), DegradationProducts / Related Substances / Impurities (Degradation), Content Uniformity (CU), andDissolution tests for all Raw Materials, In-process, Finished Products and StabilitySamples in the QC Laboratory. This SOP also covers the number of standard andsamples to be weighed for HPLC and UV-VIS Spectrophotometers analyses.

HPLC Reproducibility, Column Performance and Testing GuidelinesThe purpose of this document is to describe the Reproducibility checks of the HighPerformance Liquid Chromatograph, Column Performance and guidelines for assaytesting on the HPLC.HPLC Method Development & Validation ProcedureThe validation of an analytical method is the process by which it is established that theperformance characteristics of the method, such as Precision, Accuracy, Specificity,Linearity, Limit of Detection (LOD), Limit of Quantitation (LOQ) and Robustness meetthe requirements for the intended applications. This SOP refers specifically toHPLC. However, the same principles may be applied to validations of other types ofanalytical procedures. Well-characterised reference materials with documented purityshould be used to perform the validation.
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The optimum wavelength for a method can be found by acquiring the chromatographicdata on a PDA detector over a large wavelength range, (e.g. 200-400nm). Theoptimum wavelength is the wavelength, which maximises the response for all thecomponents of interest, but is outside the absorbance for the mobile phase. Before

validating an HPLC method, its Specificity must be determined. If the method does notcomply with the Specificity requirements, the method must be modified until theacceptance criteria are met. Hence it is essential that the Specificity be adequate,before Precision, Linearity and Accuracy, etc. are performed. Laboratory In Process and Finished Product Quality ControlThis purpose of this document is to outline the procedure to be followed for thereceiving, scheduling, testing, reporting, reviewing, approval and release of In-processand Finished Products in the QC Laboratory at a GMP site.
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Microbiology (Sterility) Laboratory ProceduresIn this area you will find Standard Operating Procedures on Entry Procedure to SterileFilling Areas, Validation of Aseptic Gowning Procedures, Microbiological DataRecording Procedure, Destruction of Biological Waste in the Microbiology Laboratory,

Depyrogenation of Glassware In Micro. Lab. Oven, Media Preparation in MicrobiologyLaboratory, Aseptic Media Filling and Micro. Integrity Leak (Soup) Testing Procedure,Aseptic Media Filling and Soup Test Guideline, Environmental and Plant HygeneMonitoring Procedure, Microbial Limit Testing Procedure by Using Laminar FlowCabinets etc and many other procedures according to your need.All procedures have reference of prepared Forms and Templates for effective recordkeeping and reporting purposes. Forms are attached at the end of each procedure.Templates are listed separately.

SOP ListSterile EntryThis SOP outlines the gowning procedure that must be followed by each and everyperson who enters a Sterile Area. The procedure is designed to reduce the risk ofcontaminating product with bacteria and/or particlesAseptic Gowning ValidationAseptic gowning is the ability to complete the gowning procedure without compromisingthe sterility of the garment. This SOP outlines the sterile gowning validation procedureas required for the final sign off for the initial sterile training and the revalidation ofcurrently trained Operators, Fitters, Electricians and Cleaners and all organization staffwho are authorized to enter Sterile areas.Microbiological Data RecordingTo describe procedures for the recording of Microbiological data using the in-househard copy and computerized recording system. All documents containing test resultsare legal documents and therefore it is imperative that all the information required isrecorded accurately. Any changes/corrections to be made must be signed with thatpersons initials and dated.Biological Waste DestructionTo describe procedures for destroying all Laboratory Biological Waste to comply withQuarantine RegulationsDepyrogenation of GlasswareTo outline the procedure for the depyrogenation of glassware using the MicrobiologyLaboratory Qualtex Oven.Media Preparation
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To describe the procedures for the preparation of microbiological media for use in theMicrobiology Laboratory.Micro. Integrity Leak (Soup) TestingOne of the requirements of cGMP is a periodic evaluation of all aseptic processes by

filling media into the appropriate containers under normal production conditions. Themedia fill should reflect the sterility of the entire process from the Sterilizing filter to thefilled primary container and should include all subsequent manufacturing steps. ThisSOP outlines the procedures for both Media Fills and Microbiological Leak Tests. ForValidation purposes, a Microbiological Leak Test (Soup test) or a separate Protocol toverify the entire process from the Bioburden Reduction Filter to the primary containermay be required.Aseptic Media Filling and Soup TestMedia Fills are designed to verify the entire process, equipment and staff. This processsimulation should be performed as initial validation with three (3) consecutive

satisfactory simulation tests per shift and repeated at defined 6 monthly intervals (twiceper year per process per shift) and after any significant modification to the HVAC-system, equipment, process and number of shifts for aseptically filled process. Souptest has to be conducted at least once per year per shift for terminally sterilised linesand non-sterile process. Validation and re-validation media fills are to assure the sterilityof the entire process. This process simulation test should imitate as closely as possiblethe routine aseptic manufacturing process and include all the critical subsequentmanufacturing steps. The Media Fill should challenge the worst case situation andshould include all the possible interventions of a normal production run. The duration ofthe media run should be at least 4 hours or half a production shift to allow for all routineinterventions.Environmental and Plant Hygiene MonitoringDescription for Microbiological testing of areas of the environment which may influenceor affect product performance and/or quality-including, air, surfaces, personnel, clothingand disinfectants. Daily monitoring of sterile grade areas during production is to beconducted by trained production staff. The Microlab is to ensure that the necessaryplates are delivered on a daily basis so monitoring can take place. Once a test has beencompleted, the responsible operator is to initial the plate and make sure that the batchnumber of the batch running at the time of the test is written on the plate. Plates will belabeled with prompts to ensure this isnt forgotten. If no batch is running at the time ofthe test N/A should be put on the plate instead of a batch number. If an area of concernis noted during routine daily testing, inform Micro immediately so that further steps canbe taken.

Microbial Limit Testing Using Laminar Flow Cabinets.To describe the procedures to be followed in conducting Microbial Limit Tests in theLaminar flow Cabinets in the Microbiology Lab.Microbiological Monitoring of Plant Water Systems
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In this SOP you will find Sampling Procedure for Bioburden and Endotoxin Samples,Bioburden Test Method and Results, Endotoxin Testing of WFI (Distilled Water),Bioburden and Bacterial Endotoxin Alert and Action Levels, DiagrammaticRepresentations of a typical purified Water Systems, Bioburden Waste Tank WaterSampling, Clean Steam Sampling & Testing, OOL/OOS Result Actions etcSterility Testing ProcedureThis sop is to describe the procedure for sterility testing of aqueous, injectable andterminally sterilized non injectable products. To explain the correct interpretation ofsterility results and to outline Stasis requirements for used sterility canisters.Determination of Heat Resistance of Spore Forming OrganismsThis SOP describes the method for calculating the Heat Resistance Factor, (D-value),ofspore-forming organisms. D-Value is defined as the time required for a population of apure culture of microorganisms to be decreased by 90% when exposed to a fixedtemperature, e.g. 121C (+1C).Identification of Microorganisms to Genus and Species LevelTo describe the procedures for the preliminary identification of bacteria isolated fromPlant Water, Environmental, Personnel, Product and Raw Material sources. Bacteriathat will require identification (ID) to at least genus level include organisms isolated fromthe manufacturing environment, personnel, in-process and finished products, plantwater and other miscellaneous sources. SOPs detailing the microbiological testingprocedures for each of these samples will indicate the required level of ID of recoveredorganisms. The following sections detail the procedures for the preliminary ID of micro-organisms. Further ID to species level is to be conducted for conformation.Micro Evaluation on Bioburden, Non sterile and Raw MaterialsThis SOP describes the procedures for Microbiological Evaluation of Bioburdens, non-sterile Products & raw materials. Bioburdens includes: Batches prior to membranefiltration, i.e. solutions; Batches prior to sterilization i.e. filled containers; Face masks;IPA. This procedure includes Equipment preperation for Non-sterile testing, BulkSolution Bioburden (BSB) Sampling; Filled Container Bioburdens (FCB); Raw MaterialBioburdens (RMB); Surgical Face Masks; Isopropyl Alcohol (70% IPA); SpeciationProcedures for Organisms found in Non Sterile Products and Raw Materials; Out-of-Specification Procedures for Non Sterile Products and Raw Materials; Retest andRepeat Procedures for Non-Sterile Products and Raw Materials.Bacterial Endo Toxin Testing (LAL) - Gel Clot MethodTo describe the procedure for conducting a Bacterial Endotoxin Test by the LAL Gel-Clot method. The gel-clot method for bacterial endotoxin testing described in this SOPis based on the fact that Limulus Amoebocyte Lysate (LAL) will form a firm gel in thepresence of bacterial endotoxin.Bacterial Endo Toxin Testing kCA Method
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The purpose of this SOP is to outline the theory of Bacterial Endotoxin testing usingKinetic Chromogenic Analysis (KCA). And to outline the procedure for routine producttesting, operator / reagent verification and product validation by KCA using theBioWhittaker KQCL (brand) reader. This Procedure also describes the routinemaintenance procedures for the BioWhittaker KQCL (brand) reader. Stock Suspension of Micro OrganismThe objective of this SOP is: To describe the method for preparing and maintainingstock suspensions of vegetative microorganisms and spores used within theMicrobiology Laborator;. To explain the procedure for growth promotion and mediaverification requirements for all media used within the Laboratory; To outlinerequirements for Stasis testing on sterility canisters after sterility testing has beencompleted.Sterile Sampling Procedure for Microbiology LaboratoryTo detail the procedure for taking Microbiological samples for Sterility testing, Bacterial

Endotoxin testing, Bioassay testing, Microbial Limit test and Micro status testingthroughout Production. This procedure includes sterilization charts, Settle plates (Falloutplates) and Personnel monitoring.Gel Clot Validation MethodThe gel clot validation method for Bacterial Endotoxin testing described in this SOP, isto determine the level of Inhibition/Enhancement of products on the LAL test forendotoxins within the allowable Maximum Valid Dilution (MVD) for each type of product.The Gel-Clot techniques detect or quantify endotoxins based on clotting of the LALreagent in the presence of endotoxin. To be determined for each type of product, usingthe highest and lowest concentration of active. If either concentration shows inhibitionor enhancement, then each remaining concentration must be tested. At least three (3)Production batches of each finished product should be tested for inhibition andenhancement.Laboratory Investigation for Atypical and OOS ResultsThe purpose of this procedure is to provide guidance when investigating microbiologylaboratory out of specification (OOS) results associated with raw material samples, in-process samples and finished product samples. This procedure describes the actionstaken by Microbiology Laboratory staff in the event the result of a test does not conformto company specifications for microbiological release. This procedure will also provideguidance for re-testing raw material samples, in-process samples and finished productsamples when it has been decided through a laboratory investigation that retesting is

justified. Retesting should be viewed as an investigational tool to aid in determination ofthe root cause of the discrepant laboratory result.IPA Contamination Testing ProcedureTo describe the test sometimes used to check the purity of the IPA used in the factoryas a disinfectant.
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Control of Microbiology Test MethodsThis document details the writing, control, and distribution of Microbiological TestMethods (MTM) for use in the GMP Microbiology Lab. This procedure applies toMicrobiological Test Methods that are controlled from beginning to end by theMicrobiology Lab Manager.

Handling of Test Sample in Microbiology LaboratoryThis document details the handling of test samples (raw materials, bulk product andstability samples) processed for Microbial Limits Testing (MLT) in the MicrobiologyLaboratory. This procedure applies to samples tested for Microbial Limits within theQuality Control Microbiology Laboratory.

Documentation Requirement For Micro Test Method ValidationThe procedure describes the process for accessing and using protocol templates fordocumentation of test method validation activities in the Microbiology laboratories. Thisprocedure applies to Microbiology personnel responsible for the validation or verification

of microbiological test methods. The procedure outlines the requirements for approval ofmethod development protocols, validation/verification protocols and final validationsummary reports
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Process, Cleaning and Methodology Validation ProceduresIn this area you will find procedures on validation-concept and procedure, revalidationprocedure, method validation procedure, procedure for cleaning validation, validation oflaboratory instruments, equipment specification and qualification and in-house trial

procedure.

All procedures have reference of prepared Forms and Templates for effective recordkeeping and reporting purposes. Forms are attached at the end of each procedure.Templates are listed separately.

SOP listConcept and Procedure of ValidationThis procedure describes general validation concepts and practices, the way processesand systems must be qualified/validated and the confirmatory documentation required.

Here you will find the philosophy of validation, responsibilities, validation approaches ofdesign qualification, installation qualification, operational qualification, performancequalification, cleaning validation, method validation, computer validation, general andspecific criteria of validation, validation documentation and change control, validationreporting, guidelines of validation acceptance criteria.RevalidationThis procedure contains step by step instruction on initiation of revalidation categories,changes that warrant revalidation programs, basic steps of revalidation procedure,revalidation activities and specific responsibilities, revalidation protocols, revalidationtiming, equipment checklist, revalidation discrepancy procedure, release of revalidatedequipment, preparation of the revalidation reporting file.Method ValidationThis procedure provides a guideline for a validation Technician on the characteristicsthat must be considered during the validation of an analytical testing procedure. Theprocedures set out in this SOP apply to qualitative and quantitative analytical methodswhich are used to test finished goods, in-process material, excipients and raw materialsin support of registration documentation and cleaning validations and managementresponsibilities towards completing those method validation tasks.Cleaning ValidationThis SOP describes the types of cleaning process and cleaning agents of processequipments and their validation, complete instruction on cleaning validation procedure,calculation of acceptance limits for rinse and swab samples, calculation of acceptancelimits for swabs, analytical method validation for cleaning, cleaning validation testprotocols and change control for revalidation.Validation of Laboratory Instruments
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This procedure describes the validation practices for laboratory instrument/equipment tobe validated or calibrated and the confirmatory documentation required showing that theinstrument/equipment is capable and operating effectively for its intended purpose. Thisprocedure has practical instruction on Installation Qualification (IQ), OperationalQualification (OQ) and Performance Qualification (PQ) to be performed by the qualified

equipment service technician in the presence of the laboratory staff with reference tothe instrument/equipment manual.Equipment Specification and QualificationThis procedure describes in detail the procedures for the procurement of equipment,incorporating standardized demand specifications and Installation Qualificationdocumentation, to ensure that equipment procured complies with in-house requirementsand standards and conform to Good Engineering Practice, to detail the generalprocedure to be followed regarding the reporting of Factory and Site Acceptance Tests,to detail the manner by which the equipment Installation Qualification is documented.In-House Trial

The purpose of this SOP is to define common procedures to follow when organizingTrials/Evaluation Studies for the purpose of process improvement, equipment capabilityand validation studies. It defines the responsibilities within the trial process anddocuments that need to be considered when preparing the Trial documentation toensure that the trial meets GMP and where applicable validation requirements. ThisSOP defines the procedures for conducting in house stand-alone trials on systems,processes and equipment. There can be an overlap between a trial and validation inthat Trial documentation may form part of a latter process validation, (i.e. concurrentand prospective validation) and qualifications (OQ, PQ).Computerized Systems ValidationTo overview the procedure to be followed for the Qualification/Validation ofcomputerized systems. This procedure applies to all computer systems (includingembedded systems) directly associated with, or supporting, regulatory compliancerequirements for the development, testing, manufacture and distribution of medicinalproducts.

Impact Assessment for Computerized SystemsThe purpose of this SOP is to provide a method of assessing and determining thevalidation requirements for computerized systems and controllers. The SOP identifiesthe typical qualification activities required for those systems having a Direct or Indirectimpact on product/process quality and data integrity, should the system fail ormalfunction. These activities are in addition to Good Engineering Practice (GEP), whichis appropriate for all systems, and is also outlinedFunctional Testing Guide for Computerized SystemThis SOP provides guidance on functional testing during the development or change ofcomputerized systems which have GxP impact at a GMP manufacturing site. What
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constitutes a change to a computerized system is described in manufacturing changecontrol procedure.Design Qualification GuidelinesThe purpose of this document is to provide guidelines on conducting Design

Qualification (DQ) during the conceptual and detail design phase for the implementationof a GMP facility, process and equipment (including computerized systems) to ensureconformance to operational and regulatory expectations. The guideline will provide thebasis for conducting and documenting Design Qualification to all projects involving theintroduction of, or significant change to, any facility, system or equipment that potentiallyimpacts on product quality and is suitable for its intended purpose.Protecting the Reliability of Electronic GMP RecordsThis SOP applies to records created, processed, used or stored by (or for) the GMPManufacturing site, that are the output of a computerized system. It is of particularrelevance to records that have a GMP role, i.e. supporting product quality, patient safety

or regulatory compliance. The guideline may also be used for other computerizedsystems that are classified as business critical.
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GMP | Manufacturing ProceduresIn this area you will find exciting procedures on Clothing Requirements Inside theFactory Area, Cleaning Responsibilities and Methods for Employees, Factory CleaningProcedure, Manufacturing Pest Control, Tours of Factory, Requirements of Production

Logbook, Packaging Configuration for Production Line, Checking of Components Priorto Use, Tag Out Procedure, Procedures for Line Clearance, Line Opening and LineCleaning, Reconciliation of Component and Product, Operation of Barcode Reader asan example, Intermediate Bulk Container (IBC) Operation and Cleaning, Tablet PackingMachine and Cartoner-construction, operation and cleaning as an example,Manufacturing Instruction for Tablet Packing as an example, Mop Cleaning Procedure,Scheduling Production Lines, Vacuum Leak Testing Procedure, Weighing Equipment -Checking and Calibration, Operation of Checkweigher as an example, Tablet Packing-Start up and In-process Testing as an example, Packed Tablet Sampling by ProductionPersonnel for Testing as an exampleAll procedures have reference of prepared Forms and Visual Displays for effectiverecord keeping and reporting purposes. Forms are attached at the end of eachprocedure.

SOP listClothing RequirementsThis SOP covers the clothing requirements needed in all Factory areas for yourmanufacturing site. The different levels of cleanliness must be maintained to minimizemicrobial and particle contamination. This procedure contains general rules andrestriction to be followed by your manufacturing employees, defining differentenvironmentally graded areas and entry requirements for those areas.Cleaning Responsibilities and MethodsThis SOP describes the cleaning procedures to be followed by all employees working inthe manufacturing area in order to prevent contamination of product by foreign materialsfrom another batch, or by dirty parts, which may contain bacteria. This SOP containsinstruction on responsibility of cleaning, degree of cleaning to be done, popular cleaningaids and solutions permitted to use for cleaning, rubbish removal and outline of cleaningmethods for different environmentally graded areas.Factory CleaningThis SOP defines the methods, frequency and the intensity of Factory Cleaning. Thepurpose of cleaning is to remove debris from within the plant in a sanitary and effectivemanner and to avoid contamination from dust or foreign materials. This proceduredescribes which popular cleaning aids and solutions are to be used to clean the floors,walls, sinks and windows in the Production areas, office areas, change rooms,workshops, laboratories, stores, canteens, plus the toilet facilities. This procedure alsodescribes the scope and responsibility of contract cleaners.
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Manufacturing Pest ControlThis SOP describes the responsibilities of all employees and pest control services,classification of pests, frequency of the pest control service and effective treatmentsagainst all types of pest.

Production Logbook

This procedure outlines the generation, maintenance and filing of Production logbooks.Production logbooks form part of the documentation system required by the Code ofGMP to provide complete and up-to-date histories of all batches of product. Thelogbook provides a key link in the process of traceability.Packaging Configuration for Production LineThis SOP provides an alphabetically indexed diagram of shipper packing and palletpacking configurations for any packaging process. This procedure contains schematicdiagrams of different packaging configurations and calculations of total unit to bepacked per container which can be useable into your packing lines.Checking of Components before UseThis SOP sets out a procedure to ensure that only components of correct code andbatch number are issued for a batch and only issued components will be used in afinished product batch. This SOP also describes the procedure to be followed duringreturning of components to warehouse from the production lines.Tag Out ProcedureThis SOP describes how to prevent the risk of personal injury or damage to equipmentlikely to be caused by operating or attempting to operate machinery or equipmentdiagnosed as being unsafe, in need of repair or maintenance or formally removed fromservice. The SOP covers all isolation, condemning, repair or maintenance work thatnecessitates a device or machine to be taken out of service. This SOP applies to anysituation where energy (either supplied to equipment, or stored within it) needs to beisolated to ensure the safety of any person working on or near equipment, processes orservices - for any reason whatsoever.Line Clearance, Line Opening and Line CleaningThis SOP describes the procedure and order to be followed when performing a Lineclearance, Line opening and Line cleaning for a batch production. The procedure hasbeen established to prevent mix-ups of products, containers, components, labels andmistakes in documentations. Mix-ups and mistakes can occur when correct procedureand GMP are not followed. Particular care should be taken when starting a newoperation, at the change of shift and when additional components are needed. In thisprocedure you will find example of line clearance, opening and cleaning checklist basedon an example of tablet packing line.Reconciliation of Component and Product
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This simple SOP describes the concept of reconciliation, how to reconcile finishedgoods and determine the allowable discrepancies of components and products whenreconciled.Construction, Operation and Cleaning of Tablet Packing MachineThis procedure describes the machine construction and operation, machine start up andcleaning of a typical tablet Blistering machine and the Cartoner for tablet packing. Youwill be able to create a new procedure for your packing line based on the format of thisSOP.Manufacturing Instruction for PackingThis procedure describes how to create a complete manufacturing instruction for yourprocess line to be followed by your manufacturing employees. To make the instructionmore practical and easy to understand, a sample instruction is added in the form of aprotocol for a typical tablet packing process. All the related blank forms are attached atthe end of the procedure for a better understanding.Mop CleaningThis simple procedure outlines the operation of the factory laundry in a safe and hazard-free manner. This procedure can be used in any manufacturing site for the purpose ofmop cleaning.Scheduling of Production LinesThis procedure describes how to produce a monthly manufacturing schedule followingan agreed 12 months plan, to provide a sequence of work that will enable thescheduling of support groups (i.e. Quality, Technical and Warehousing), incorporate anyplanned engineering down time (i.e. project work, calibration and preventativemaintenance), create and release batches according to the agreed weekly schedule,provide key dates for product supply to support Customer Service.Vacuum Leak Testing ProcedureThis SOP describes the set up and operation of a standard vacuum Leak Tester for thevery popular vacuum leak testing used in a typical packing line.Tablet Packing-Start up and In-process TestingThis procedure contains instructions that enable the production operators working in atypical packing line to carry out Start-Up and In-Process Tests required in order toproduce quality products and to ensure in-process controls. A typical tablet packingprocess is used here as an example.Finished Product Sampling for TestingThis procedure describes the process of sampling manufactured finished good requiredto be taken by production personnel for the laboratory testing. A typical tablet packingprocess is used here as an example.Returning Components from Packaging Floor
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This procedure describes the steps to be followed when there are packagingcomponents to be returned to the warehouse after the packaging operation has beencompleted.
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Warehouse Management ProceduresIn this area you will find procedures on Receipt of Incoming Goods, Raw Material andComponents-Incoming-Handling by Sampler, procedure for Warehouse to ProcessingIssues, Returns and Rejects, Dispatch of Goods from Warehouse, Warehouse

Inventory Management, Warehouse Locations and Storage Area, Finished GoodsTransfer to Quarantine and Distribution Warehouse, Sampling of Raw Materials,Sampling of Components and Printed Materials, Work in Progress Area, SafetyProcedure of Warehouse Racking, Forklift Operation in Warehouse, Tablet DispensaryProcedure as an example, Raw Material Tablet Sampling by Dispensary as an example,Material Purchasing Information Record and Source List, Generation of Purchase OrderFor Inventory and ConsumablesSOP List

Incoming GoodsThis SOP contains step by step instruction on condition of accepting incoming goods inthe warehouse, booking In procedure of component and non component goods, how tocomplete movements of incoming goods into different storage locations within thewarehouse maintaining full traceability. Here you will find generation and filing ofdocuments related to receipt of incoming goods.In-coming Raw Material and Components HandlingThis procedure describes quarantining, sampling, testing and releasing of incoming rawmaterials to Production. Here you will find the labeling requirement for component to besampled, checking requirements of components, sampling and re-sampling of incominggoods for laboratory testing, generation of documentation during the movement ofcomponents in order to maintain complete traceability.Processing Issues Return and RejectsThis SOP contains step by step instruction on issue of tested and QC releasedcomponents for batch production, documentation needed for capturing identification andtraceability information during the picking, assembling and transferring of thosecomponents from warehouse to production. This procedure also has instruction to followduring the return and reject processing of raw materials and components fromproduction to warehouse.Dispatch of Goods from WarehouseThis SOP contains instruction and documentation on movement of finished goods toquarantine until release for sale, dispatching procedure and documentation needed fortransferring of finished goods from quarantine to warehouse store and subsequently toout side the manufacturing site maintaining a complete traceability of finished goods. Inventory ManagementIn this procedure you will find a complete inventory management system by stockcounting instruction, stock classification and reconciliation programs. Here you will find
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instruction on cycle counting by material code, counting by bin sheet information andreconciling/cross checking of those counts by physical counting of the stock,determination of material gain or loss and filing instruction.Warehouse Locations and Storage AreaThis SOP is designed to understand and draw an schematic diagram of idealwarehouse and production areas, identifying in-coming goods storage unit types andstorage bin types, quarantines, reject cage, cool room, flammable storage, dispensarybooths, production area, finished goods quarantine area and finished goods storageareas. This procedure defines how storage unit types and storage bins are numbered.This SOP is to be used as a guide to define the types of storage units and bins,movement direction within the warehouse and production areas.

Finished Goods Transfers to areasThis simple SOP contains instruction and documentation on movement of finishedgoods from production to warehouse finished goods quarantine location until the

samples are tested and released by the authorized persons.

Sampling of Raw MaterialsThis procedure primarily concerned with risk associated with sampling, precaution to befollowed when sampling, general sampling procedures for raw materials, critical andnon critical components, chemicals and secondary reference standards for laboratory. Sampling of Components and Printed MaterialsThis procedure is an elaboration of SOP WAR-045 and mainly concerned with samplingplans and instructions of components and printed materials for quality testing beforerelease for production use.Work in ProgressThis simple procedure describes the construction and locations of different work inprogress areas between production and warehouse for temporary storage of rawmaterials, component and finished goods.Warehouse RackingThis SOP outlines the measures to be taken to ensure the safety of all goods andpersonnel when using the storage racking system in order to avoid injury to staff ordamage to property. This procedure concerned with the handling and storage ofmaterials or products and to report any damage which may be occurred. This SOPparticularly relates to the activities of the staff of the receiving and distributionwarehouse.Forklift Operation in WarehouseThis SOP gives instructions on operation requirements and maintenance of forkliftsused in the warehouse, safety precaution to be taken during the operation of forkliftunder load.
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Dispensary ProcedureThis procedure is mainly concerned with dispensing plans and instructions of releasedraw materials for production use. An example of tablet dispensary procedure isprepared for better explanation and understandings of dispensing. You will be able tofollow the instruction for dispensing of any raw materials in your facility. Material Purchasing Information RecordThis simple procedure describes how to keep purchasing information for approvedmaterials, vendors, manufacturers, standard and current pricing and third partyagreements.Generation of Purchase OrderThis procedure describes the steps to be followed by planning and procurementdepartment to create purchase order for inventory items to be purchased from overseasand local suppliers.
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Quality GuidanceValidation of Analytical Test MethodsThis guideline provides guidance for the validation of analytical test methods. Theseanalytical test methods include those tests which evaluate API, Raw Materials, InProcess samples (e.g. reaction monitoring) and early intermediate materials (prior to the

introduction of the first critical intermediate). This also include Risk Assessment andPrioritization, System Suitability, Precision and Accuracy, Quantitation and DetectionLimitLinearity, Range and Specificity, Robustness,

Calculations of Residue Limits for Drug Product for Equipment CleaningThis guideline provides equations and examples for calculating the Maximum AllowableResidue and Residue Acceptability Limits for Drug Products and Non-Therapeutics.Examples are provided for determining the acceptable equipment cleaning residuelimits for therapeutic drug products and for non-therapeutic ingredients.Swab Sampling for API EquipmentThis guidance provides recommendations related to the selection and application ofswab sampling and visual inspection for various types of API equipment.

Product and Equipment Grouping and Worst - Case Product SelectionThis procedure defines the criteria that should be considered when grouping ActivePharmaceutical Ingredient (API) and Drug Product (DP) equipment or product for thepurposes of cleaning validation.

Validation of Test Method for Rinsate and Swab SampleThe guidance describes recommended approaches to develop and validate samplingand test methods for cleaning verification using rinse and swab samples.

Visual Inspection and Quantitation in Equipment CleaningVisual inspection is the minimum requirement for all clean and test regimes required forCleaning and Cleaning Validation. Five aspects of visual inspection discussed in thisguidance. Which are visual inspection following or during manual cleaning; visualinspection of dedicated equipment; routine visual inspection of multi-purposeequipment; visual inspection during validation and Visual QuantitationDocumentation and Instruction in Cleaning ValidationThis guidance addresses recommendations for developing and documenting therationale to support the product contact equipment cleaning program and to justify thevalidation strategy. This documentation may be described as a Cleaning EvaluationReport.

Critical Process Parameters for Drug ProductThis guidance provides recommendations and examples for evaluating a process toidentify and define the critical process parameters.
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Identification of the Critical Steps for Drug Manufacturing ProcessThis guidance provides recommendations for selecting critical process parameters andcritical process steps based on the understanding of a drug product process.

Equipment Cleaning Validation for APIThis procedure provides guidance in the validation of cleaning processes for equipmentused in the manufacture of Active Pharmaceutical Ingredients (API).

Equivalence Criteria of Impurities in API Process ValidationThis guidance provides recommendations for demonstrating equivalence of impurities tohistoric batches during validation of API processes for small molecules.

Equivalency Comparison of Drug ProductThis guidance addresses the equivalency comparison of manufacturing process datafrom drug product (DP) validation batches to previous batches (called referencebatches), when applicable.

Calculation of Clean Equipment Hold TimesThis guidance describes considerations and risks for determining if the establishment ofclean equipment hold times for equipment producing drug product and ActivePharmaceutical Ingredients (API) are requiredEvaluation of Non-cleaned Equipment Hold TimeThis guidance outlines considerations and risks associated with hold times betweenequipment use and cleaning. The recommendations to evaluate if the time betweenequipment use and cleaning needs to be established and controlled are described forActive Pharmaceutical Ingredients (APIs) and Drug Products. When they aredetermined to be critical, recommendations on how to establish and extend existinghold times are also described.Potential Impact of Changes in Process ValidationThis guidance provides recommendations and examples for evaluating the processvalidation impact of changes to manufacturing processes used for manufacture of API,Drug Products and packaging processes.

Process Validation SamplingThis guidance addresses recommendations for good sampling practices. Validationsampling plans must be specified or referenced in the protocol.

Determination of Swab & Visual Inspection Sampling LocationsThis guidance provides recommendations related to the selection and application ofswab sampling and visual inspection for various types of Drug Product equipment.

Bulk Drug Product Holding TimesThis Guidance sets out guidelines for the determination and validation of in-process andbulk product holding times.
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Demonstration of Active Pharmaceutical Ingredient (API) Batch HomogeneityThis guidance provides information on demonstrating batch homogeneity of final APIs(small and large molecules) and critical intermediates.This procedure provides guidancefor performing a homogeneity evaluation in support of API process validation. The

following components of the evaluation are described: Materials to be tested, Selectionof test methods for examining homogeneity, Sampling plan when to collect samples,from what locations, and the number of samples, Selecting acceptance criteria forevaluating homogeneity test results.

Continuous Quality VerificationThis guidance provides an example of documentation to support the use of ContinuousQuality Verification for demonstrating that a manufacturing process is in a validatedstate.Supporting Documentation for Continuous Quality VerificationThis guidance describes the documentation needed to support the use of ContinuousQuality Verification to demonstrate that a drug product or active pharmaceuticalingredient process is in a validated state. It also describes some similarities anddifferences between Continuous Quality Verification and traditional process validationusing three discrete lots.

Dose & Toxicity Data for Cleaning Limit CalculationThis guidance provides points to consider when selecting Dosage and Toxicity data foruse in the Cleaning Limits calculations.

Inspection Attributes in Non Sterile Packaging ValidationThis procedure provides examples and guidance on classification of defects forpackaged non-sterile drug products.Laboratory Instrument QualificationThis procedure provides guidance in the qualification of simple, moderate, and complexlaboratory equipment that is used in an analytical laboratory in a Good ManufacturingPractices (GMP) environment associated with products in or intended for the marketplace.

Matrices and Bracketing in Process ValidationBracketing and matrixing allow a most appropriate challenge condition to be defined fora process or drug product family (the same drug product with different dosagestrengths). This risk-based approach can allow the validation to be focused on the mostchallenging circumstances, or worst cases. Use of this approach can provide asignificant benefit to reduce the overall validation effort.Considerations for Selecting Packaging Lot Sizes During PackagingExamples of primary and secondary packaging validation, both manual and automatedoperations are provided in this guidance. This also provides guidance on aspects to
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consider for packaging validation. Explanations of factors to consider for acceptablepackaging validation and lot size are provided with various practical examples.

Non-Sterile Active Pharmaceutical Ingredient (API) Manufacturing AreaThis guidance is to address environmental control for existing, new, and modified non-

sterile API processing areas used for the manufacture of commercial materials. Thisincludes non-sterile API manufacturing areas where the API will subsequently be usedto produce sterile Drug Product.

Potential Critical Process Parameters and Validation PracticesThis Guidance provides a tabulation of potential critical process parameters and qualityattributes of typical steps of primary solid drug product (i.e. dry products) packagingprocesses. It also includes packaging validation items such as evaluation of equipment,protocol and report contents, amount of data (e.g. number of runs) and if warranted,microbiological studies.

Process Validation Sampling for Non-Sterile Liquid Semi Solid Drug Products

This guidance provides Process Validation Sampling guidelines for non-sterile liquid(solutions and suspensions) and semi-solid (ointments, creams, pastes, gels andlotions) drug product dosage forms.

Process Validation Sampling for Non-Sterile Solid Dose Drug ProductsThis guidance provides Process Validation Sampling guidelines for non-sterile soliddose drug product dosage forms. The purpose of this guidance is to provide the generalprinciples and approaches that should be considered for sampling non-sterile soliddosage forms.Performance Qualification Versus Process ValidationThis guidance compares and contrasts Performance Qualification (PQ) to ProcessValidation (PV). This guidance describes the differences between PQ and PV. It clarifieshow the PQ term is applied to systems and to processes. As applied to processes, PQbatches are used to demonstrate the robustness of a process and PV batches areintended to demonstrate the reproducibility of the process. As applied to systems, PQtesting is intended to verify that integrated systems function together as required Periodic Review of Processes and SystemsThis guidance addresses the application of a risk-based approach to: Prioritize thesystems and processes for periodic review (PR); Justify frequency and schedule of PR(if applicable); Routine revalidation of processes.Release of Drug Product and API Pre-Validation and Validation Batches ForCommercial UseThis guidance addresses considerations for commercial release of batches of productmanufactured prior to completion of proc