Everything you need to know about GMP (Good Manufacturing Practice)
In the quality control world, Good Manufacturing Practice (GMP) is only just a part of the quality control systems that govern the guidelines recommended by agencies that control the authorization and licensing for the manufacture and sale of food, drug products, and active pharmaceuticals products. A product that is according to the guidelines is considered to be of high quality and will pose no risk to the consumers or the general public. No specific guidelines or instructions are laid down by GMP for how to manufacture a product but lays down general principles that must be observed during the manufacturing process. The manufacturer has to decide how to set up the manufacturing system to best follow the guidelines.
Good Manufacturing Practice has specified guidelines concerned with how various testing and production procedures influence the quality of the final manufactured product. In most countries, the guidelines are legislated through customized to suit their particular industries. GMP guidelines guide testing, manufacturing, and quality assurance to ensure that a food or drug product is safe for human consumption. Some countries have legislated that food; pharmaceutical and medical device manufacturers should follow GMP procedures and should create their own GMP guidelines that correspond with their legislation.
A few basic principles are followed by all guidelines. Some of them are mentioned below:-
- A clean and hygienic manufacturing area must be maintained by manufacturing facilities.
- To Prevent cross-contamination of food or drug products from adulterants environmental conditions are controlled that, may render the product unsafe for human consumption.
- Control is done on the manufacturing processes and any changes made are evaluated. As needed the changes that affect the quality of the drug are validated.
- In clear language, the instructions and procedures are written.
- Training is given to operators to carry out and follow document procedures.
- There is a clearly defined and controlled manufacturing process. To ensure consistency and compliance with specifications all critical processes are validated.
- Preventive measures are taken against cross-contamination with unlabelled major allergies.
- During manufacture records are made manually or by instruments to state that all needed steps were taken and that the quality and quantity of the drug was as expected. Any changes are investigated thoroughly and documented.
- Any risk to the quality is minimized by the distribution of food or drugs.
- There is a system for recalling any batch from sale or supply.
- Proper examination is done about the marketed products, and the causes of quality defects are investigated.
- Preventive measures are taken regarding the defective products and seen that such defects do not occur in the future.
Recommendations are given to various practices to guard the health of consumers and patients and also on the quality of food produced. In some countries, it has become mandatory to comply with GMP in all pharmaceutical manufacturing and food processing.
There is no specific instruction in GMP guidelines on how to manufacture a product. During manufacturing, there are a series of general principles that must be observed. There are many ways in which a company can fulfill GMP requirements by easily setting up a quality program. It is the responsibility of the company to determine the most effective and efficient quality process.
The product has a good quality and to ensure the product quality GMP plays an essential part. To show consistency with specifications the manufacturing processes must be fully documented and evaluated to determine the efficiency. Investigation and validation can be done to have an impact on the quality of the drug.
All the instructions must be written clearly as per good documentation practices. Training should be given and proper documentation of the actions of the operators should be maintained. Records must be kept manually or by automated testing during manufacturing to demonstrate all needed manufacturing procedures are carried out efficiently and the quality of the final product is received as expected.
Complete records of the distribution and manufacturing chain must be maintained and batches of products must be traceable to every step or location to ensure accountability. The process of distribution should also reduce the risk of damaging the quality. A comprehensive system should be in place for rapidly recalling a product from sale and supply. Feedback given by customers is important and complaints must be fully investigated. Appropriate steps should be taken to prevent occurrences of a defect in the future.
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