cGMP (Current Good Manufacturing Practices)

C-GMP

INTRODUCTION C-GMP means Current good manufacturing practices. What is CFR (Code of federal Regulations ), published by Federal government In CFR total 50 Chapters Chapter 3 : For US president Chapter 50: For Fisheries & Wild life preservation Chapter 21 : For Food & Drug manufacturing. The US GMP regulations are divided into two parts: 210 and 211, Title 21.• Part 210, “Current Good Manufacturing Practices in manufacturing, Processing.

Packing or Holding of Drugs “, basically it provides the framework for the regulation.

• Part 211, “ Current good manufacturing practices for finished pharmaceuticals.• The part 211 is further divided into 11 subparts ,Subpart A to Subpart K.

C-GMP Content of part 211 of US GMP regulation:• Subpart A : General Provision• Subpart B : Organization and personnel• Subpart C : Buildings and Facilities• Subpart D: Equipments.• Subpart E : Control of components and Drug product containers and closures• Subpart F : Production and process controls• Subpart G: Packaging and labeling Control.• Subpart H :Holdings and Distribution• Subpart I: Laboratory Control .• Subpart J: Records and reports• Subpart K: Returned and salvaged drug products.

C-GMP Principles of GMP• To harmonize the manufacturing procedures globally with a marked

standard, which assures that the product is been manufactures in a good facility and a quality product.

• It Provide the frame of SISPQ , i.e. Safety, Identity, Strength, quality, and Potency to a drug product.

• GMP is based on the controlled production of the drug products, under the federal Food , Drug and Cosmetic act, which states that , “ A drug products will be deemed to be adulterated unless the method used in or facilities or controls used for its manufacture, processing ,packaging, or holding conforms to or are operates or administered in conformity with current GMP.”

C-GMP

Role of GMP with respect to Quality Management .

To provide the better control on the manufacturing practices different QMS plan, i.e. Quality Management Systems. Are get introduces, which are as follows:

• Preparation of a effective operating procedure, i.e. An effective SOP for all the activities governing in the facilities.

• By taking proper Change control, Incidences, Deviations, with proper investigation report.

Contd…• By doing proper qualification of all the instruments and

equipments by performing all the qualification programs : • DQ (Design Qualification)• IQ (Installation Qualification)• OQ (Operational Qualification)• PQ (Performance Qualification)• FAT (Factory Acceptance Test)• SAT(Site Acceptance test).• By doing proper validation of all procedures and systems.

C-GMP Role of GMP with respect to Personnel:• Subpart B : Organization and personnel• Every person involve in the manufacturing, process, packaging, or holding of the

drug products must have education, training and proper experience to perform the activity in a proper and defined manner.

• Every employee should have a GMP training at least once in a year and also at the time of induction only.

• Proper strength of qualified persons should be there.• Proper Visit and Guidance of Consultant should be preferred.• Personnel responsibilities : 1. Should wear clean clothing, also should take daily bath and shave.2. Personnel shall practice good sanitization and health habits.3. Access control should be there in controlled areas.4. If you are ill or not healthy, plz take leave and come after complete fitness.

C-GMPSubpart C- Building and facilities: Design and construction features:• Building should be of suitable size, construction location to facilitate cleaning,

maintenance, and proper operation.• Space for all the equipments , instruments and also for storage of Raw material , in

process material and finished products.• Movement of component should be controlled to avoid contamination. Storage of release components, drug products containers, closures, and labeling. Holding of reject material and to be store them in lock and key. Storage of in process material. Manufacturing and processing operation. Packaging and labeling. Quarantine storage before release of drug products. Storage of drug products after release.

C-GMP Aseptic processing: Floor, walls, and ceilings of smooth and hard surface that is easily

cleanable like epoxy coating on floors. By avoiding corners and edges inside facility by doing cooing of corners. Temperature and humidity control by installing BMS (Bio maintenance

system) and by AHU (Air handling Units). By using HEPA filters under positive pressure. Adequate lighting should be provides in all areas. Heating, ventilation, and air conditioning (HVAC). Plumbing. Sewage and Sanitization.

C-GMP Subpart D: Equipment: Equipment should be appropriate design, adequate size, and suitably located to facilitate

operation for its intended use and for cleaning ad maintenance. Equipment should be constructed with such a material that does not contaminate the

material in touch and also should be inert in nature, should be corrosion free. Mainly stainless steel of desired grade is prefer, like SS 306 and SS 324 L (Used mainly in parental preparation manufacturing).

Equipment should be designed in such a way that’s its cleaning should be conducted easily , also proper sanitization schedule should be there for every equipment and instrument.

Calibration Schedule should be there at proper interval and also preventive maintenance.

For those equipment which are software controlled or computer controlled there should be a routinely calibration, inspection or checking program, with respect to the SOP should be governed.

Proper Installation and validation of equipment should be performed and documented.

C-GMP Subpart F : Production and process control Written procedures and procedure deviations. Preparation of master formula record. To follow the SOP during all process. Proper flow in of material by FIFO mechanism. Dispensing Shifting. Sampling and testing of in-process material and drug products Proper equipment identification Control of microbial contamination. Reprocessing.

C-GMP Subpart G: Packaging and Labeling control Material examination and usage criteria: Testing , issuance , handling,

sampling, examination and approval. Proper Issuance control. Execution of proper Batch packaging records Tamper evident packaging requirement for OTC human drug products. Proper Labeling. Proper container and closure selection. Drug product inspection. Expiration dating.

C-GMP

Quality Control ( Subpart I: Laboratory Control) Responsibilities of quality control unit: The QC unit must be given responsibility and authority to approve or reject all

components, drug products containers, closures, process material , Packaging material, labeling and drug products. And the authority to review production records.

Adequate laboratory facilities for testing and approval or rejection of the above listed materials must be available.

Establishment of scientifically sound and appropriate specification, standard test procedures, sampling plans, test procedures design to assure the material conforms to appropriate standards.

Testing and release for distribution. Stability testing Reserve samples. Animals used in testing components.

C-GMP Contract manufacturing When ever any organization is been having extra production requirement

and there facility is not been having that much capacity of production then at that time the concept of Contract manufacturing or Loan licensing is been introduces.

Criteria for contract manufacturing:• Facility audits.• Inspection program • Self inspection and quality audits.• Product audits• Method transfer and method verifications.etc.