GMP or Good Manufacturing Practice for injection ensures consistency and adherence to quality standards in the products. It minimizes the risks involved in pharmaceutical production.
What does it constitute? It is a core condition all across the globe, which includes the license to operate in the Pharma Injection manufacturing process. The rules and their interpretations differ from country to country, though. Also, the rules change frequently.
Hence, it requires a workforce of fully trained people to help with a flawless implementation of the rules while manufacturing injections. It is very much important.
GMP- the basic outline
There should be a minimum risk of quality in the production and distribution of the drugs. The manufacturing facilities should contain clean and hygienic areas, laboratories, and storage. To prevent cross-contamination of drug products, or contamination from labeled or non-labeled products, it is mandatory to keep operating principles and environmental conditions controlled.
The manufacturing process for injection has to be clearly defined, controlled, and validated to ensure compliance with specs and consistency. In the case of deviation, it has to be investigated and documented. Throughout the product life cycle process of injections, a state of control prevails. Improvements are made as and when required. The injection manufacturing company is responsible for keeping record of manufacture and distribution in an accessible and comprehensive format. It should contain the complete history of the batch.
There has to be a system for recalling products from the markets in case of any quality issue. When there is any complaint about marketed products, it has to be examined fully, and quality defects are supposed to removed immediately. All products of the defective lots need to be recalled from the market.
What is expected from a GMP approved manufacturer for injection?
GMP doesn’t give any prescriptive instructions about the manufacturing process. It is a series of general principles that are to be followed during the manufacturing of injections. When a company makes injections, it needs to fulfill GMP requirements. It is the responsibility of the company to implement the most effective and stringent quality process to meet these guidelines.
Inferior quality injections could cause havoc in the healthcare system and take many lives. To avoid such disasters, the government imposes standardization such as GMP. A GMP approved manufacturing unit churns out superior-quality drugs and medical instruments that are safe and reliable. It reduces risk and improves the faith in the system of providing healthcare to the people.