Good manufacturing practices (GMP) are the practices required in order to conform to guidelines laid down by agencies which control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines are laid down with the intention of providing minimum requirements that a pharmaceutical or a food product manufacturer must meet while manufacturing drugs or food products ,which then assures that the products manufactured/produced are of high quality and do not pose any risk to the consumer or public. Good manufacturing practice guidelines provides guidance for manufacturing, testing, and quality assurance in order to ensure that drug product is safe for human consumption. Many countries have legislated that pharmaceutical and medical device manufacturer must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. Basic concepts of all of these guidelines remain more or less similar to the ultimate goals of safeguarding the health of patient as well as producing good quality medicine, medical devices or active pharmaceutical products. In the U.S.A a drug may be deemed adulterated even though it has passed all of the specifications tests and it is found to be manufactured in a facility or condition which violates or do not comply with current good manufacturing guideline. Therefore complying with GMP is a mandatory aspect in pharmaceutical manufacturing.
Although there are a number of them, all guidelines follow a few basic principles:
- Hygiene: Pharmaceutical manufacturing facility must maintain a clean and hygienic manufacturing area.
- Controlled environmental conditions in order to prevent cross contamination of drug product from other drug or extraneous particulate matter which may render the drug product unsafe for human consumption.
- Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
- Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
- Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
- Operators are trained to carry out and document procedures.
- Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.
- Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
The distribution of the drugs minimizes any risk to their quality.
A system is available for recalling any batch of drug from sale or supply.
Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.
GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process.
