The European Medicines Agency (EMA) has released new good manufacturing practice (GMP) guidance to ensure the integrity of data that are generated in the process of testing, manufacturing, packaging, distribution, and monitoring of medicines.
EMA’s GMP / Good Distribution Practice (GDP) Inspectors Working Group has developed a set of questions and answers with advice for stakeholders on measures that ensure data integrity and minimize risks at all stages of the data lifecycle in pharmaceutical quality systems. The advice applies to both paper-based and electronic systems. It specifically addresses:assessment of risks to data integrity in the collection, processing and storage of data; risk-management measures at various stages of the data lifecycle; design and control of both electronic and paper-based documentation systems; measures to ensure data integrity for activities contracted out to another company.
The document is aligned with existing GMP guidance published by some regulatory authorities participating in the Pharmaceutical Inspection Co-operation Scheme (PIC/S). PIC/S is a non-binding, informal cooperative arrangement between regulatory authorities for GMPs of medicinal products for human or veterinary use. It is open to any authority having a comparable GMP inspection system. PIC/S presently consists of 48 participating authorities coming from all over the world (Europe, Africa, America, Asia and Australasia). PIC/S aims at harmonizing inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to inspectors. It also aims at facilitating cooperation and networking between competent authorities, regional and international organizations. The EMA guidance should be read in conjunction with national guidance, medicines legislation and the GMP standards published in Eudralex Volume 4.
The PIC/S has issued draft guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Draft 2)) developed by the PIC/S Working Group on Data Integrity. This draft guidance will be applied on a six-month trial basis by PIC/S Participating Authorities. This draft document results from the need among Inspectorates to have access to harmonized data-integrity guidance. The purpose of the trial-period is to learn from implementation. It is acknowledged that the guidance requires expanding in some areas; however, the document has value in describing foundational principles which can be enhanced in future revisions. This draft document is not open for comments by industry. Formal adoption of the guidance will proceed in accordance with PIC/S procedures, including a stakeholders’ consultation, on a revised version after completion of the trial-period.
In April 2016, the FDA issued draft guidance on data integrity in a question and answer format that addressed 18 questions relating to the subject.
Source: European Medicines Agency and PIC/S