Current good manufacturing practice (cGMP) for finished pharmaceuticals falls under the schedule-M as per drug & cosmetic rule 1940 and refers to the Current Good Manufacturing Practice regulations enforced by the USFDA. cGMP provides for systems that assure proper design, monitoring and control of manufacturing processes and facilities in pharmaceutical industries. Following are the main components of cGMP for finished product.
Subpart A—General Provisions:
Subpart B—Organization and Personnel:
According to cGMP organization should play a vital role to provide adequate facility, quality system, organizational structure and resources. Adequate laboratory facilities for the testing and approval (or rejection) of drug product shall be available to the organization.
People in an organization are the main resource than other resources like facilities, equipment and materials. Every person involves in the manufacturing, 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 training. Training should be designed and continuous. Training records based on SOPs are a good means of evidencing that staff are able to perform tasks.
Subpart C—Buildings and Facilities:
Define the requirements for ensuring that buildings and facilities are in good condition. The facility shall be qualified by considering the following key points:
1. Design and construction features
2. Lighting: Adequate lighting shall be provided in all areas.
3. Proper ventilation and air conditioning system
4. Plumbing.
5. Sewage and refuse
6. Washing and toilet facilities.
7. Sanitation.
8. Maintenance.
Subpart D—Equipment
Equipment design, size, and location:
Equipment used in the manufacturing, packing and holding of a drug product shall be designed with adequate size and placed in a suitable location of the facility and qualified to enhance the smooth operations.
Equipment construction:
The MOC of product contact surface of the equipment shall be SS316 or SS316L, so that drug products shall not be reactive, additive or absorptive so as to alter the safety, identity, strength and quality. Any substances required for operation, such as lubricants or coolants, shall not come into contact with drug products. The lubricants should be food grade quality.
Equipment cleaning and maintenance:
Written procedures shall be established and followed for cleaning and maintenance of equipment used in the manufacturing of a drug product for smooth operation.
Filters:
Filters for liquid filtration used in the manufacture, processing or packing of injectable drug products intended for human use shall not release fibers into the products.
Subpart E—Control of Components and Drug Product Containers and Closures:
There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures to prevent contamination. The following key points are to be considered:
1. Supplier must be evaluated and approved before purchasing of any material.
2. Incoming material must be tested and should passed the quality test before use.
3. Material must be placed in stores or issued according to FIFO/FEFO.
4. Material must be stored very carefully so that they are not mixed up, damaged or contaminated.
Subpart F—Production and Process Controls:
Written procedures:
There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity as per requirement.
Calculation of yield:
At end of each manufacturing stage actual yields and theoretical yield shall be calculated and verified by a second person. If the yield is calculated by automated equipment than it may be verified by one person.
Equipment identification:
Major equipment shall be identified by equipment identification number and that shall be recorded in the batch production record to show the specific equipment used in the manufacture of each batch of a drug product.
Sampling and testing of in-process materials and drug products:
In-process materials shall be sampled and tested for identity, strength, quality, and purity by the quality control unit.
Time limitations on production:
There should be a pre-established time limits for the completion of each stage of manufacturing to assure the quality of the drug product. Deviation from predefined time limits may be acceptable if such deviation does not compromise the quality of the drug product.
Subpart H—Holding and Distribution:
Warehousing procedures:
There should be a written procedures describing the warehousing of drug. They shall include:
(a) Drug product shall be quarantined before release by the quality control unit.
(b) Drug products shall be stored in a prescribed environmental conditions like-temperature, humidity and light so that the identity, strength, quality, and purity of the drug products are not affected.
Distribution procedures:
Distribution of drug product shall follow the FIFO/FEFO. The oldest approved stock of a drug product is to be distributed first. Deviation from this temporary change control is required.
Subpart I—Laboratory Controls:
To ensure laboratory controls, the following procedure must be established and followed:
1. All action must be documented at the time of performance
2. Calculation needs to be recorded
3. Second person must be reviewing records
4. Data must be directly recorded in to appropriate records
5. Equipment software and method must be validated
6. And OOS results must be investigated.
Subpart J—Records and Reports:
1. Quality records are the critical component of cGMP and is the proof that the procedures were followed and they show traceability of product. (Eg-BMR, protocols, reports, logbooks, distribution records, complaint files).
2. Records are considered as legal documents and can be subpoenaed in a court of law as evidence.
3. Information must be recorded and signed at the time of performance on the original records.
4. Records shall be maintained for at least 1 year after the expiration date of all components, drug product containers, closures, and labeling.
Subpart K—Returned and Salvaged Drug Products:
Returned drug products:
Returned drug products shall be identified and hold as such. Procedures for the holding, testing and reprocessing of returned drug products shall be established and followed. Record of returned product shall be maintained.
Also read: Quality Management System (QMS)
Also read: Good Laboratory Practices
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