| Many of the world's leading manufacturing centres of | | | | defects are examined, and the correct measures are |
| pharmaceutical and medical products have legislated | | | | taken so that all faulty products are recalled and the |
| that every pharmaceutical company under their | | | | problem will not arise again. |
| jurisdiction follow GMP procedures. The details of the | | | | GMP consulting is available to help companies set up |
| guidelines vary from country to country although | | | | their manufacture processes and to evaluate their |
| they all follow the same general principles. GMP | | | | business before and after GMP audits. The |
| compliance assures the quality of medical products by | | | | pharmaceutical industry relies on GMP consulting as a |
| governing the production and distribution stages of | | | | way to keep up with the complex and often |
| manufacture. It does this by following a series of | | | | confusing amount of legislation that covers the |
| assurances which monitor the production process.o | | | | medical sector. They are particularly important if a |
| The manufacturing processes are plainly defined and | | | | business is expanding its operations in to foreign |
| controlled. All critical stages are validated to guarantee | | | | premises. In the United States, GMPs are governed |
| consistency and compliance with specifications.o If | | | | by the Food and Drug Administration (FDA), the |
| there are any changes to these stages, they are | | | | World Health Organisation (WHO) have their own |
| evaluated. Changes that have an impact on the | | | | version of GMP guidelines that are used by the |
| quality of the products are validated as required.o All | | | | pharmaceutical industries in developing countries, |
| the instructions associated with each stage are | | | | members of the European Union have their own |
| written clearly and explicitly.o Operators are trained | | | | GMPs, as do countries including Australia, Japan and |
| to carry out and document procedures to the exact | | | | Canada, which have their own sophisticated guidelines. |
| specification determined during the validation | | | | In the UK, the Medicines Act (1968) covers most |
| process.o Records are kept, manually or by | | | | aspects of GMP and is known as 'The Rules and |
| computers during manufacture which exhibit that all | | | | Guidance for Pharmaceutical Manufacturers and |
| the steps required by the defined validation | | | | Distributors', or the 'Orange Guide' due to the colour |
| instructions were taken and that the number and | | | | of the document. This makes it very complicated for |
| quality of the drug was as expected. Deviations | | | | pharmaceutical companies with offices on more than |
| should be investigated and documented.o Records of | | | | one continent as they may need different processes |
| manufacture (including distribution) that detail the | | | | in each base of manufacture. |
| complete history of any individual batch should be | | | | The regulatory authorities in each country have the |
| retained in a comprehensible and accessible form in | | | | power to make unannounced inspections of premises |
| case it needs to be traced at any time.o The | | | | and products to ensure that patients are not put at |
| distribution of the medicines should not add any risk | | | | risk from any bad practices. In the US, they have the |
| to their quality.o It should be possible to recall any | | | | power to bring legal action against any company they |
| batch of the product from the market, even if the | | | | find to be violating GMPs and the FDA actually |
| batch has been opened.o Complaints about medicines | | | | publishes a list of companies and individuals who have |
| on the market are investigated, the causes of quality | | | | been prosecuted or disciplined by them. |