GMP Consulting and the Pharmaceutical Industry

Many of the world’s leading manufacturing centres of pharmaceutical and medical products have legislated that every pharmaceutical company under their jurisdiction follow GMP procedures. The details of the guidelines vary from country to country although they all follow the same general principles. GMP compliance assures the quality of medical products by governing the production and distribution stages of manufacture. It does this by following a series of assurances which monitor the production process.

o The manufacturing processes are plainly defined and controlled. All critical stages are validated to guarantee consistency and compliance with specifications.

o If there are any changes to these stages, they are evaluated. Changes that have an impact on the quality of the products are validated as required.

o All the instructions associated with each stage are written clearly and explicitly.

o Operators are trained to carry out and document procedures to the exact specification determined during the validation process.

o Records are kept, manually or by computers during manufacture which exhibit that all the steps required by the defined validation instructions were taken and that the number and quality of the drug was as expected. Deviations should be investigated and documented.

o Records of manufacture (including distribution) that detail the complete history of any individual batch should be retained in a comprehensible and accessible form in case it needs to be traced at any time.

o The distribution of the medicines should not add any risk to their quality.

o It should be possible to recall any batch of the product from the market, even if the batch has been opened.

o Complaints about medicines on the market are investigated, the causes of quality defects are examined, and the correct measures are taken so that all faulty products are recalled and the problem will not arise again.

GMP consulting is available to help companies set up their manufacture processes and to evaluate their business before and after GMP audits. The pharmaceutical industry relies on GMP consulting as a way to keep up with the complex and often confusing amount of legislation that covers the medical sector. They are particularly important if a business is expanding its operations in to foreign premises. In the United States, GMPs are governed by the Food and Drug Administration (FDA), the World Health Organisation (WHO) have their own version of GMP guidelines that are used by the pharmaceutical industries in developing countries, members of the European Union have their own GMPs, as do countries including Australia, Japan and Canada, which have their own sophisticated guidelines. In the UK, the Medicines Act (1968) covers most aspects of GMP and is known as ‘The Rules and Guidance for Pharmaceutical Manufacturers and Distributors’, or the ‘Orange Guide’ due to the colour of the document. This makes it very complicated for pharmaceutical companies with offices on more than one continent as they may need different processes in each base of manufacture.

The regulatory authorities in each country have the power to make unannounced inspections of premises and products to ensure that patients are not put at risk from any bad practices. In the US, they have the power to bring legal action against any company they find to be violating GMPs and the FDA actually publishes a list of companies and individuals who have been prosecuted or disciplined by them.

Good Manufacturing Practices are implemented to ensure that patients are not put at risk from complications caused by medicines. The role of a GMP consultant can vary with every company they work with, but their role is vital as it protects the health and safety of the general public. Professionals from the pharmaceutical industry join GMP consulting firms to share their knowledge and expertise with other companies to make sure that they are manufacturing safe products whilst trying to maximise their profits.