To Minimize the Risks
New GMP requirements to ensure the integrity of data obtained during clinical trias, production, packaging, distribution and control of medicinal drugs have been published. A Q&A document with guidelines have been developed by the European Medicines Agency (EMA) task force on GMP/GDP standards. The aim of the document is to ensure the integrity of data and minimize risks at all life cycle stages in pharmaceutical quality systems. The guidelines are valid both for paper and electronic systems. They concern risk assessment for data integrity for collection, processing and storage, risk management, draft and control of electronic and hard copy documentation systems, as well as measures to ensure data integrity for activities under contract with another company.
The document conforms to the current GMP guidelines, published by regulatory authorities, joined to the International pharmaceuticals inspection councils cooperation system. The document should be considered in conjunction with the national guidelines, legislation in the field of medicinal drug circulation and GMP standards.