In March 2022, the U.S. Food and Drug Administration (FDA) sent a Form 483 to Cadila Healthcare’s sterile injectable manufacturing site in Jarod, India. Among other observations, it came out that the stability program is not followed to complete the testing within the predefined time frame. Some tests were even delayed by more than 120 days.
In March 2022, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to an American over-the-counter (OTC) drug product manufacturer due to significant violations of Current Good Manufacturing Practice (CGMP). The violations were related to identity testing, training, calibration, qualification and quality unit oversight.
In our News on FDA Warning Letter Statistics for the fiscal year 2021 (October 2020 - September 2021) you could read that deficiencies for process validation are on place 5. But what deficiencies did the FDA find in process validation?
On March 24, the drafting process of the new ICH Guideline Q14 Analytical Procedure Development and the revised Guideline Q2(R2) Validation of Analytical Procedures reached Step 2, and both were published for consultation by ICH members.
Due to the Corona pandemic and the resulting changes in working conditions, a new type of inspection was needed in addition to classical on site inspections of API manufacturing facilities and paper-based GMP assessments. For this purpose, the pilot project for so-called "Real-Time Remote Inspections (RTEMIS)" was created.
The MHRA GCP Inspectors provided insight in their experience during the COVID-19 Pandemic. Although they have their limitations, remote GCP inspections have proven to be very effective and critical findings have been identified.
The EMA published the Annual report of the Good Clinical Practice Inspectors’ Working Group (GCP IWG) containing examples of findings observed during recent GCP inspections. In addition, the 3-year work plan for the GCP IWG has been released.
What is the final deadline for submission of a clinical trial according to the former CTD rules? The European Commission published an updated Version 5 of the Questions & Answers relating to the CTR which came into application on 31 January 2022. The revision includes new Q&As regarding arrangements for the transitional period.
In March 2022, the European Medicines Agency (EMA) published on its website the updated and revised version of the "Questions & Answers (Q&A)" document "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure" regarding centralised procedures.
During an FDA inspection, the area of quality control is always closely investigated. This is reflected in the citations in the Warning Letters of the past fiscal year. Find out where the most frequent GMP violations occurred and what the FDA inspectors had to complain about with regard to stability tests on active ingredients and finished medicinal products.
In December 2021, the FDA published its long-awaited Draft Guideline on 100% Visual Inspection of Parenterals. Comments were accepted until mid-February 2022. Members of the Advisory Board of the ECA Visual Inspection Group took advantage of this opportunity and submitted numerous comments.
The European Commission published a new version of the Questions & Answers (Q&As) regarding the safety features for medicinal products for human use. Do the UIs of reference and retention samples taken from stock have to be decommissioned?
The European Medicines Agency (EMA) has updated its list of questions and answers on the GMP/GDP guidelines. The newly added chapter deals with the requirements for active substances used as starting materials in veterinary medicinal products. Among other things, it is clarified that the Veterinary Medicines Regulation requires manufacturers and importers of veterinary medicinal products to perform audits based on a risk-assessment on the manufacturers, distributors and importers from whom they source the active substances.