Ethics And Data Integrity Agreement

It is our duty to impose and strengthen the basic practices of CGMP and GDocP in our own laboratories and those of our suppliers through quality technical agreements, contractual obligations and periodic audits and evaluations of laboratory operations. While much can be done through legal and administrative diligence in contract negotiations, laboratory operations remain an area that must be respected to ensure compliance (i.e. review and evaluation). By examining these basic CGMP and GDocP practices, we can increase our likelihood of avoiding negative effects on the product, patients and business continuation. These observations should stop us from all those working in the life sciences sector when business models are in the direction of outsourcing and virtualization. Our industry is facing a serious problem with a lack of understanding and maturity of CGMP`s core practices and quality culture in laboratory operations, as evidenced by these violations and reinforced by the FDA now explicitly by referring to „Recommended CGMP Consultant“ in most warning letters issued since August 2017. A basic understanding of the CGMP can be found in Good Documentation Practices (GDocP). The WHO guidelines show that „the building blocks of good GXP data are to track GDocP and then manage risks for the accuracy, completeness, consistency and reliability of the data throughout their period of use, i.e. throughout the data lifecycle.“ 1 This article is part of a series to discuss specific opportunities to improve data integrity within individual quality systems (for example. B document control, data management, materials management) with specific examples of exploitation (for example.B.

database project, efficient verification of data sets of executed batches, improved timeline fidelity). FDA inspectors continue to monitor violations of CGMP with integrity in CGMP inspections of laboratory operations. At least 20% of the CDER Office of Manufacturing Quality`s warning letters in 2017 contained explicit observations from inspectors about gross data integrity violations in laboratories. While the number of warning letters to companies in China and India has increased due to gross data integrity violations, companies in the United States, Europe and Japan have also been cited for similar violations.

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