GMP News - Quality Assurance

In the GMP rules there are many undefined terms, such as regular, adequate, etc. Inspection reports that interpret these undefined legal terms sometimes help here. In this case it is about insufficient process validation. What happened?

We have already reported about information regarding medical devices available on the EU Commission's website. Recently, a chapter on in vitro diagnostics (IVDs) was added. Also, the EMA website has a dedicated page for medical devices. What can be found there?

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an over-the-counter (OTC) drug product manufacturer in Los Angeles. Several GMP violations were identified in the area of laboratory testing, stability program, and quality oversight. In a previous inspection in 2018, similar observations were made. Therefore, the FDA considers the executive management oversight and control over the manufacture of drug products as inadequate.

Inspections are a regulatory requirement in the GMP environment. This also applies to the USA. But what happens if a manufacturer simply refuses to permit a GMP inspection?

Data integrity is still one of the major topics in FDA inspections. Missing controls to ensure the integrity of electronic data as well as inadequate access controls were some of the reasons why a Warning Letter to American company Vi-Jon was issued.

Documentation is an important element in the world of GMP. This applies to protocols as well as recording documents. For the field of development, the FDA is now offering a pilot program for a new function called "Snapshot" for their clinical and development guidelines. What's behind it?

The European Pharmacopoeia Commission published the 8th edition of the Technical Guide for the Elaboration of Monographs. The guide helps when drafting monographs and transferring analytical methods into a compendial procedure. The previous version of the guide dated back to 2015.