GMP News - Quality Assurance

The European Commission finally adopted the revised Annex VI to the CTR as regards labelling requirements for IMPs. The amendment eliminates the obligation to include an expiry date on the primary packaging of IMPs in specific circumstances.

The FDA has published a report on the state of drug quality - and the results are mixed. However, if one takes a closer look, the reasons can be quickly identified.

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.