Earlier I have shared you the GMP Requirement for Pharmaceutical plant premises, Equipment’s, Production, Training, personnel Hygiene, Self-Inspection, quality audits and suppliers’ audit and Personnel. There are various modules of GMP which I will share one after another & today’s module is Quality Control.
QC is the part of GMP concerned with sampling and testing of products and no materials should be used without testing or released. QC is not confined to laboratory operations, but may be involved in many decisions concerning the quality of the product.
Each manufacturer should have a QC function. The QC function should be independent of other departments and under the authority of a person with appropriate qualifications and experience. The basic requirements for QC are as follows: (a) adequate facilities, trained personnel and approved procedures must be available for sampling, inspecting, and testing starting materials, packaging materials, and intermediate, bulk, and finished products, and where appropriate for monitoring environmental conditions for GMP purposes; (b) To perform qualification and validation; (c) records must be made (manually and/or by recording instruments) demonstrating that all the required sampling, inspecting and testing procedures have actually been carried out and any deviations observed to be recorded and investigated; (d) records must be made of the results of inspecting and testing the materials and intermediate, bulk and finished products against specifications (e) sufficient samples of starting materials and products must be collected to permit future examination of the product if necessary.
Other Responsibilities of Quality Control :
Other QC responsibilities include: (a) establishing, validating and implementing all QC procedures; (b) evaluating, maintaining and storing reference standards for substances; (c) ensuring the correct labelling of containers of materials and products (d) ensuring that the stability of the active pharmaceutical ingredients and products is monitored; (e) participating in the investigation of complaints related to the quality of the product; (f) participating in environmental monitoring;
QC personnel must have access to production areas for sampling and investigation as or whwn ever required.
All tests should follow the instructions given in the relevant written test procedure for each material or product. The result should be checked by the supervisor before the material or product is released or rejected.
Sampling should be carried out so as to avoid contamination or other adverse effects on quality. The containers that have been sampled should be marked accordingly and carefully resealed after sampling.
Care should be taken during sampling to guard against contamination or mix up of, or by, the material being sampled. All sampling equipment that comes into contact with the material should be clean.
Sampling equipment should be cleaned and, if necessary, sterilized before and after each use and stored separately from other laboratory equipment.
Each sample container should bear a label indicating: (a) the name of the sampled material; (b) the batch or lot number; (c) the number of the container from which the sample has been taken; (d) the number of the sample; (e) the signature of the person who has taken the sample; (f) the date of sampling.
Out-of-specification results obtained during testing of materials or products should be investigated in accordance with an approved procedure. Records should be maintained.
Before releasing a starting or packaging material for use, the QC manager should ensure that the materials have been tested for conformity with specifications.
Each batch (lot) of printed packaging materials must be examined following receipt.
Finished products :
For each batch of medicines, there should be an appropriate laboratory determination of satisfactory conformity to its finished product specification prior to release. Products failing to meet the established specifications or any other relevant quality criteria should be rejected.
Quality Control Record Review :
QC records should be reviewed which is a part of the approval process of batch release before transfer to the authorized person. Any deviation or failure of a batch to meet its specifications should be thoroughly investigated. The investigation should, if necessary, extend to other batches of the same product and other products that may have been associated with the specific failure or discrepancy. A written record of the investigation should be made and should include the conclusion and follow-up action. Retention samples or Control Samples from each batch of finished product should be kept for at least one year after the expiry date. Finished products should usually be kept in their final packaging and stored under the recommended conditions. Samples of active starting materials should be retained for at least one year beyond the expiry date of the corresponding finished product. Other starting materials (other than solvents, gases and water) should be retained for a minimum of two years if their stability allows. Retention samples of materials and products should be collected in duplicate of double to perform reanalysis if required.
Stability studies :
QC should evaluate the quality and stability of finished pharmaceutical products and, when necessary, of starting materials and intermediate products.
A written programme for ongoing stability determination should be developed and implemented to include elements such as: (a) a complete description of the medicine involved in the study; (b) the complete set of testing parameters and methods, describing all tests for potency, purity, and physical characteristics and documented evidence that these tests indicate stability; (c) provision for the inclusion of a sufficient number of batches; (d) the testing schedule for each medicine; (e) provision for special storage conditions; (f) provision for adequate sample retention; (g) a summary of all the data generated, including the evaluation and the conclusions of the study. Stability should be determined prior to marketing and following any significant changes, for example, in processes, equipment or packaging materials.