Chapter 12

Global Quality

Jordi Botet

Abstract

Current pharmaceutical quality requires a global approach based on a quality system established on GMP and on risk analysis. Quality can be only ensured if hazards are identified and controlled to be kept at an acceptable risk level. Consequently, nowadays quality audits are not seen anymore as a simple compilation of checklist questions (yes/no/n. a.), but as an investigation to see if existing problems are detected and solved/controlled satisfactorily. This requires good knowledge and deep analysis on processes and products. As for the rest, it is also necessary to ensure that those pharmaceutical products which are dispatched from the warehouse, after being certified and released, maintain their quality when they reach their final consumers. Thus, it has been paid progressively attention to the hazards that waylay them in the often very complex distribution chain, including the risk of theft and counterfeiting. Taking into account the successful experience of GMP equivalent GDPs (good distribution practices) have been developed. It is also necessary to ensure the soundness of studies on drug products which are performed in different laboratories. And this requires a homogeneous quality approach. This is why, following again the same track, GLP (good laboratory practice) was prepared. And, finally, it is necessary to bear in mind that once a drug product has been licensed it is used by much more people than when it was tested during development, and this opens the door to unexpected reactions. Thus a pharmacovigilance system is necessary to keep updated its benefit-risk safety profile.

Total Pages: 441-484 (44)

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