Good Manufacturing Practice , known as GMP in the world of quality control, is just one part of the quality control systems that govern the production and testing of medicines and pharmaceutical ingredients, as well as some foods and medical devices for them. Checkout QA Labels.
Good industrial technique, is at core, a series of rules about how various testing and industrial practices can affect the consistency of the finished product. In fact, the guidelines are legislated in most countries, though they are tailored to suit their own particular industries.
The GMP guidelines can be broken down into the following basic concepts though they differ by country:
The manufacturing processes used should be specifically described and regulated, and tested to show compliance with the requirements.
Any modifications to the manufacturing processes must be fully documented and assessed to determine their effectiveness. These will all be tested and checked if they are to have an effect on the safety of medicines.
The guidelines should be published simply and unambiguously, in line with sound management standards.
Participating operators must be properly trained to execute and document their actions.
During production, records must be maintained either manually or through automatic monitoring that shows that the appropriate manufacturing processes have been completed and that the final product output has been as anticipated.
When research shows anomalies from what is anticipated, therefore it is important to thoroughly analyze the anomalies and determine the source.
Clear records of the chain of production and produce must be maintained, and drug samples must be traceable to each phase or venue, guaranteeing transparency.
The distribution process should be such that the risk of adverse effects on the quality of the product is minimised.
A robust program will be in effect to easily remove a drug from sale and distribution should it be considered appropriate.
Customer input is crucial-grievances should be reviewed in detail and the triggers should be reported. The appropriate steps to prevent future occurrences of the defect should be taken, if necessary.
It is up to the firms to decide exactly whether to enforce the aforementioned requirements, while the legislation merely demands that they show that they are doing so through whichever manner they find to be most cost- and quality-effective.