Download - Features of Quality Assurance

8/11/2019 Features of Quality Assurance

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Salient Features of Quality Assurance


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30/02/2008 2

Quality Assurance

Quality assurance is a wide ranging conceptcovering all matters that individually or collectivelyinfluence the quality of a product.

It is the totality of the arrangements made withthe object of ensuring that pharmaceuticalproducts are of the quality required for theirintended use.

QA is the heart and soulof quality control

QA = QC + GMP


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The System of Quality Assurance

Pharmaceutical products are designed and

developed in a way that takes account of the

requirements of GMP and other associated

codes such as those of good laboratry practice(GLP) and good clinical practice (GCP)

Product and control operations are clearly

specified in a written form and GMP

requirements are adopted


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30/02/2008 Dept. of Pharmaceutics 4


Managerial responsibilities are clearly specifiedin job description

Arrangements are made for the manufacture,supply and use of the correct starting andpackaging materials.

All necessary controls on starting materials,

intermediate products, and bulk products andother in-process controls, calibrations, andvalidations are carried out.


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The finished products is correctly processed andchecked according to the defined procedures.

Pharmaceutical products are not sold orsupplied before the authorized persons havecertified that each production batch has beenproduced and controlled in accordance with the

requirements of the marketing authorization andany other regulations relevant to the production,control and release of pharmaceutical products


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Satisfactory arrangements exist to ensure, as faras possible, that the pharmaceutical productsare stored by the manufacturer, distributed andsubsequently handled so that quality ismaintained throughout their shelf-life.

There is a procedure for self-inspection and/or

quality audit that regularly appraises theeffectiveness and applicability of the qualityassurance system


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Deviation are reported, investigated andrecorded

There is a system for approving changes thatmay have an impact on product quality

Regular evaluations of the quality ofpharmaceutical products should be conducted

with the objective of verifying the consistency ofthe process and ensuring its continuousimprovement.


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Quality Assurance-Highlights

Quality assurance is independence ofmanufacturing

In process quality is checked duringmanufacturing

Validation of facilities, equipments,process, products and cleaning as permaster plan


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Quality Assurance-Highlights

Complaint handling

Storage of quality record and controlsamples

Stability studies

Registration of documents


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Activities of Quality Assurance Dept.

1.Technology transfer

2. Validation

3. Documentation

4. Assuring quality of products

5. Quality improvement plans


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1. Technology Transfer

Receipt of product design documents fromresearch centre

Distribution of documents received fromresearch centre

Checking and approval of documents generatedbased on research centre documents i.e. batch

manufacturing record

Scale-up and validation of product


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2. Validation

Preparation of validation plans for facility,

equipments/process including cleaning

Approval of protocol for validation of

facility/equipment/product/process

Team member for execution of validation

of facility/equipment/product/process


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3. Documentation Control

Controlled distribution and archiving of

documents

Control of changes made by proper

change control procedure

Approval of all documents


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4. Assuring Quality of Products

cGMP training SOP compliance

Audit of facility for compliance

Line clearance In-process counter checks

Critical sampling

Record verificationRelease of batch for marketing

Investigation of market complaints


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5. Quality Improvement Plans

Feedback received from the compliance team

Proposals for corrective and preventive actions

Annual Products review

Trend analysis of various quality parameters forproducts, environment and water


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Flow Chart RM/PM Inspection


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Flow Chart-Finished Product Inspections


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Flow Chart- In Process Check


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Download - Features of Quality Assurance

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