Good manufacturing practice is something which is central to the pharmaceutical industry but many manufacturers may not be completely up to speed with the latest GMP compliance regulations. Needless to say, medical devices and supplements which are properly regulated during the manufacturing process may well be harmful to the end user and this is why GMP compliance guidelines are put in place to govern the industry.

When a pharmaceutical manufacturing plant is inspected to confirm GMP compliance, it is likely that the process will be broken into a number phases. Inspectors will be on the lookout for numerous different things during GMP auditing inspections but mainly will want to witness that good manufacturing practices are being followed and that no unsubstantiated claims are being made about pharmaceutical products.

GMP Compliance – Looking At The Different Inspections

The type of GMP compliance inspection that takes place will be largely dependent on the sort of product a manufacturer is producing as those who create medical devices may have a slightly different process to those who manufacture dietary supplements, for example. The main type of GMP auditing inspection will obviously centre around the conditions of the manufacturing plant itself and the safety of the ingredients used during the creation of the pharmaceutical goods or medical devices.

The vast majority of GMP compliance assessments will be carried out after consultation with manufacturers to arrange a date and so forth but there are occasions where surprise visits can occur in order to ensure ongoing compliance with regulations. Due to the fact that GMP compliance is such an important issue for pharmaceutical manufacturers, a large proportion of those responsible for creating medical devices or supplements will opt to employ the services of pharmaceutical consultancy firms to offer advice and guidance on how to stay compliant with the latest legislation.

GMP compliance assessment is not something that typically happens too often but it is certainly something that pharmaceutical manufacturers need to be fully prepared for. It is also the case that during inspections, GMP auditing assessors are likely to want to talk to the key personnel in the manufacturing plant to get a much greater understanding of the day to day operations.