cGMP compliance is a requirement for all areas of the pharmaceutical industry, from the bulk ingredients to the finished product. Validation is the essential practical activity needed to prove the purity, safety and efficacy of these products.
A validation programme that is properly designed and executed will accomplish much more than just satisfying regulatory obligations. Considerable benefits will accrue as the result of process optimisation, improvement in yields, reductions in routine sampling and more reliable maintenance.
Aker Kvaerner is ideally qualified to provide the total validation expertise needed to maximise these benefits. Since the inception of validation by the Pharmaceutical industry, we have been involved in the validation of equipment, systems and entire facilities. Our high standing and reputation in this area has led to our playing a leading role, alongside executives from the major pharmaceutical companies and the FDA, in the development of the ISPE Baseline Guide on Commissioning and Validation.
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