Gmp Auditing And Active Pharmaceutical Ingredient Inspection

There are growing calls for stricter inspections and GMP auditing of active pharmaceutical

ingredient (API) facilities from manufacturers and public health organisations within the EU. At present, many producers of APIs go un-inspected and as such, pharmaceutical product manufacturers find it difficult to ensure that their products comply with GMP auditing standards of quality. They want the European Union's regulatory authorities and the European Medicines Agency (EMA) to carry out official audits on the facilities and manufacturers of APIs before they are used by medicine manufacturers.

GMP Auditing - Increasing the Safety of Pharmaceutical Products

Third party GMP auditing is offered by a number of pharmaceutical consultancy firms which have been recognised by the EU's regulatory authorities however the practise is not as widespread as manufacturers would like. The European Commission wants these third-part GMP audits to work alongside official inspections however the European Commission's Council of Ministers, the second arm of EU legislature representing the EU's 27 member states does not approve this method as it feels as though the responsibility of pharmaceutical companies will be diluted. However, critics of the Council's decision have stated that the pharmaceutical companies should not have the responsibility for setting standards and thus auditing their API suppliers, only a regulatory authority should have that power.

This issue is becoming even more serious as the number of counterfeit drugs flooding the EU increases. Ensuring the health of the public is the main concern of governing bodies such as the FDA - and this is something which they aim to achieve through undertakings such as GMP auditing inspections. However, it is also important that counterfeit and substandard APIs coming into the EU from foreign countries like China and India do not put too much competition on European produced ingredients. This is something which has the potential to hold back the pharmaceutical industry and, worse still, could pose potential health risks to consumers and patients.

Why GMP Auditing is so Important

With so many pharmaceutical products finding their way onto the market each year, it is easy to see why there is a need for stringent rules and regulations to be enforced by governing bodies such as the FDA. Training courses is an extremely prudent idea for pharmaceutical manufacturers as GMP auditing is something which is considerably easier to pass if all employees are fully aware of what to expect from auditors and, in turn, what is expected of them - as this form of training is something which will stand them in good stead when it comes to having the right manufacturing procedures in place. Unearthing a pharmaceutical consultancy firm who can provide this form of training and learning is likely to be a principal objective for a multitude of manufacturers across the EU and USA.

by: Mark Woodcock

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