The speed with which GMP compliance guidelines are modified or changed completely often puts manufacturers in a difficult position but using expert consultants can prove highly beneficial in such circumstances. 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.

Most GMP compliance inspections will be split into a number of different stages in order to get a more comprehensive overview of the manufacturing process as a whole. Aspects such as manufacturing conditions and standard of employees will be the sorts of things that come under scrutiny during GMP auditing inspections.

GMP Compliance – Looking At The Different Inspections

The diversity of products produced in the pharmaceutical industry means that the sort of GMP compliance inspection that takes place will need to be tailored to the sort of manufacturing plant in question. The safety of the end user is the key concern for governing watchdogs and this is what will be the chief consideration of assessors as they run the rule over pharmaceutical manufacturing plants during a GMP auditing inspection.

Whilst most GMP compliance inspections will be agreed in advance, some manufacturers will be subjected to surprise inspections of their premises so as to ensure that they are compliant at all times and not just in and around the times of inspection. 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.

During an inspection, a GMP compliance assessor will want to see the requisite evidence and documentation that showcases that a manufacturer is adhering to the latest compliance regulations. 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.