GMP News - Validation

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 10: Which persons (functions) should participate in the audit of a CSP and which topics should (must) be addressed?

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 9: The multi-tenant provision of SAAS is accompanied by a source code basis for all customers. This implies that all customers must have the same software version irrespective of whether or not a customer accepts a certain change. Is this compatible with GxP?

In April 2023, the Data Integrity Task Force of the APIC Quality Group, which is a sector group of the European Chemical Industry Council (CEFIC), published the document "Data Integrity Frequently Asked Questions (FAQ)" on its website. This document providees numerous questions and answers on the topic data integrity that were submitted to the Task Force by the pharmaceutical industry.

Since 2005, the ICH Q9 Guideline on Quality Risk Management has represented the state of the art. A revision was announced at the end of 2020. In January, this revision has reached stage 4 and is now moving into implementation.

In addition to guidelines, interpretations of the FDA's CGMP rules can often be found in Warning Letters. A current Warning Letter describes the FDA's expectations of the Quality Control Unit for validations, among other things.

At the end of July 2022 ISPE published an updated version of the widely accepted GAMP®5 guidance on 'A Risk-Based Approach to Compliant GxP Computerised Systems'. Read a first short review about the content of the revised version here.

In a recent FDA Warning Letter, the FDA criticizes inadequate process validation for a semi-solid dosage form. What exactly did the FDA find inadequate?