GMP News - Validation

During GMP inspections, inspectors should first look at critical (computerised) systems. Neither the EU GMP Guide nor Annex 11 or 15 give clear guidance on how to identify such critical systems. How can a system be established within the company to identify the criticality of computerised systems?

In the GMP environment one often talks about critical data. The term "critical data" only appears in a few places in the EU GMP Guidelines and their annexes and is also not clearly defined. How does one deal with this?

On 1 August 2023, the FDA issued a Warning Letter to the Indian company Intas Pharmaceuticals Limited, as a result of which an Import Alert was issued. What points were criticised with regard to computerised systems?

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter. During an inspection at an Indian company, the FDA investigators observed several GMP violations concerning inadequate investigation of humidity excursions, data integrity deficiencies, and inadequate testing of component lots used to manufacture the OTC drug products.

At the beginning of August, the U.S. Food and Drug Administration (FDA) has published a new Warning Letter. As in several cases in recent months, it is again about a US manufacturer who failed to conduct proper identity testing of glycerin and other high-risk components. In addition, a number of other CGMP violations are documented.

The US FDA recently published a discussion paper addressing artificial intelligence in the manufacturing of medicinal products. The FDA is considering the extent to which its risk-based regulation is applicable to AI technologies in the manufacturing of medicinal products.

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 11: How many days must be planned for the audit of a CSP? Is it also possible to carry out a remote audit?