The components of cGMP are as the following-
1. Quality management in the drug industry.
2. Good manufacturing practices for pharmaceutical products.
3. Quality control.
4. Sanitation and Hygiene.
7. Self-inspection and Quality audit.
Quality management in the drug industry:
Quality management is defined as the overall intentions and directions of an organization regarding quality regarding quality as formally expressed and authorized by the top management. The basic elements of quality management are an appropriate infrastructure or quality system. The concepts of quality assurance, cGMP and Quality control are inter related aspects of quality management.
Good manufacturing practices for pharmaceutical products:
Good manufacturing practice is that part of quality assurance, which ensures that the products are consistently produced and controlled to the quality standards. Good manufacturing practice directly diminishes the risks inherent in any pharmaceutical production that cannot be prevented completely through testing of final products. Such risks are essentially of two types, viz.: cross contamination and mix ups caused by false labels being put on containers.
Validation studies are an essential part of cGMP and should be conducted in accordance with the predefined products. Critical processes should be validated prospectively and retrospectively.
Sanitation and Hygiene:
A high level of sanitation and hygiene should be practiced in every aspect of the manufacture of drug products. The scope of sanitation and hygiene covers personnel, premises, equipment, apparatus, production materials and containers. Potential source of contamination should be eliminated through an integrated comprehensive programme of sanitation and hygiene.
Quality control is that part GMP concerned with sampling, specifications, testing and with organization, documentation and release procedure, which ensure that the relevant and necessary tests are released for sale or supply until their quality, has been judged to be satisfactory. The quality control department should be independent of other departments. The basic requirements for quality control should be adequate facilities, trained personnel and approved procedure should be available for sampling, inspecting and testing starting materials, packaging materials, intermediate bulk and finished products. Test method must be validated. Record must be made demonstrating that all the required sampling, inspecting and testing procedures have actually been carried out and deviations have been fully recorded and investigated. Sufficient samples of starting materials and products must be retained to permit future examination of the product if necessary; the retained sample must be kept in its pack.
All complaints and other information concerning potentially defective products must be carefully reviewed according to written procedures. Any complaint concerning a product defect should be recorded with all the original details and thoroughly investigated reports. The person responsible for quality control should normally be involved in the study of such problems.
Self-inspection and Quality audits:
The purpose of self-inspection is to evaluate the manufacturerâ€™s compliance with GMP in all aspects of production and quality control. Self-inspection should be performed routinely. The procedure for self-inspection should be documented and there should be an effective programme. A quality audit is usually conducted by outside or independent specialists or a team designated by the management for this purpose.
The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experiences. All personnel should be aware of the principles GMP. All the personnel should be motivated to support the establishment and maintenance of high quality standards. Key personnel include the head of production, the head of quality control, and the head of sales distribution. Their study should include the study of an appropriate combination of a) Chemistry-analytical, organic or bio-chemistry; b) Chemical engineering; c) Microbiology; d) Pharmaceutical sciences and technology; e) Pharmacology and technology; f) Physiology or g) Other related sciences. They should have adequate practical experiences in the manufacture and quality assurance of pharmaceutical products.
Starting materials should be purchased only from suppliers named in relevant specification and where possible directly from the producer. All incoming materials should be checked to ensure that the consignment corresponds to order. All materials and products should be stored under appropriate condition, temperature, light and segregation and guarantee as and when required.
Premises must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their lay out and design must aim to minimize the risk of error and permit effective cleaning maintenance in order to avoid cross contamination, build up of dust or dirt, and in general any adverse effect on the quality of products. Electrical supply, lighting, temperature, humidity and ventilation should be appropriate and as such they do not adverse effect directly or indirectly the pharmaceutical products during manufacture or storage or the accurate of the functioning of equipment. Premises should be designed and equipped so as to afford maximum protection against entry of insects or other animals.
Equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. The lay out and design of equipment must aim to minimize the risk of error and permit effective cleaning and maintains.
Good documentation is an essential part of the QA system as such related to all aspects of GMP. Its aim is to define the specifications for all materials and methods of manufacture and control. Documentation ensures that the authorized person have all the information necessary to decide to release a batch of drug or sale. Documentation should be regularly reviewed and kept up to date.