Guidance for Industry on the Topic of Cross-Contamination
The topic cross-contamination is very important in the GMP environment. For example, Chapter 5 of the EU GMP Guide was adapted in this regard a few years ago. Annex 15 also paid more attention to the topic with the 2015 revision. However, the topic is also an issue in the USA.
FDA also does not accept creative Arguments for Lack of Validation
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?
Medical Device Information available on EMA's Website
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?
FDA draws consequences for poor quality of hand disinfectants and UV Wands
In the follow-up to the pandemic situation, the FDA is still reviewing the manufacture and importation of hand sanitizers and identifying potentially critical hand sanitizers. This is shown by the warning letter issued to Guangzhou Orchard Aromatherapy & Skin Care Co.
FDA Warning Letter: Testing, Stability Program and Quality Oversight
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.
In May, the Chinese National Medical Products Administration (NMPA) published their new Annex 13 "GMP for Investigational Medicinal Products (IMPs)", which was incorporated into the Chinese GMP guidelines on July 01, 2022.
Since the end of last year, the ICH Q9 document on quality risk management has been in stage 2 of the ICH process for publishing ICH documents as a draft revision 1. Now, the draft document has also been published by the FDA on its website and is available for comments.
Data Integrity Problems as Main Topic of an FDA Warning Letter
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.
The US American CGMP Rules 21 CFR 211 also contain requirements concerning training (21 CFR 211.25). An actual warning letter shows the current interpretation of this requirement by the FDA. How does the FDA interpret the chapter "Training" today?
FDA offers "Snapshot" Feature for Clinical and Development Guidelines
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?
New Ph. Eur. Chapter on Implementation of Pharmacopoeial Procedures
Ph. Eur. 11.0 has been published in July 2022. Amongst others, the 11th Edition contains the previously announced new general chapter 5.26. Implementation of Pharmacopoeial Procedures providing a 2-step approach.
New Edition of the Technical Guide for the Elaboration of Ph. Eur. Monographs
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.
The FDA would like to use so-called Remote Regulatory Assessments (RRAs) not only during the COVID-19 pandemic, but also beyond it for the asessments of establishments and applications and has published a Draft Guidance for Industry on this.