News about GMP/cGMP


PIC/S: Final guideline on Data Management and Integrity

PIC/S: Final guideline on Data Management and Integrity

After five years of drafting, PIC/S has now published the final version of a new guideline on data integrity, the PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1). The document has already been applied in practice on a trial basis during this time and has been modified twice.

The resulting feedback was incorporated in the final version. Although the document is primarily addressed to inspectors, it is of course of interest to all pharmaceutical manufacturers. The document came into force on 1 July 2021.

With its remarkable 63 pages, the document covers all aspects that are to be taken into account in the handling of data in the GMP/GDP field. From basic principles, such as the ALCOA principle, to considerations for paper-based or computerised systems or the handling of so-called "findings" and potential risks, all areas are covered.Outsourcing activities and resulting actions such as audits, secure supply chain considerations or document verifications are discussed in a separate section. This also applies to necessary regulatory interventions: Possible "deficiencies" in data management are categorised and suggestions are made on how to address them. A comprehensive glossary concludes the document.

PIC/S: Q&A on Data Management and Integrity