GMP NEWS 2021

Lack of Scientifically Sound Laboratory Controls often mentioned in FDA 483s Reports

Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. An evaluation of the last two fiscal years shows that a lack of scientifically sound laboratory controls and not following/documenting laboratory controls are often mentioned in such FDA 483s.

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Inadequate Sampling Plans lead to FDA 483 Inspection Report

Sampling of materials is one of the most important processes in pharmaceutical companies. An Indian company received a so-called 483 FDA report due to inadequate sampling plans for raw materials and intermediates. Furthermore, the FDA criticises that components used in manufacturing are not tested and released prior to use.

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FDA criticizes Manual Visual Inspection

In a recent Form 483 issued as part of an FDA inspection conducted at an Indian sterile manufacturer, the FDA criticized the manual visual inspection, among other things.

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Aide-Memoire from the PIC/S regarding the Inspection of Quality Risk Management

The PIC/S has developed a stand-alone Aide-Memoire (PI 038-2) on Quality Risk Management (QRM) for GMP inspectors. The aim of the document is to provide guidance to GMP inspectors on the inspection of QRM systems in the pursuit of harmonisation.

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New Updates of the Templates for Reporting Nitrosamine Contamination

Marketing authorisation holders of chemically-synthesized or biologic medicinal products are required to perform confirmatory testing after identifying a potential risk of nitrosamine contamination and report the results using specified templates. One of these reporting templates has been recently revised. Read more here about the updates to be considered in the nitrosamine contamination reporting template.

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New Limits for Heavy Metals in Food Supplements

The European Commission sets new limits for Cadmium and Lead in certain Foodstuffs and Food supplements. Products placed on the market before the entry into force of the new regulations and not complying with the new maximum levels should only be allowed to remain on the market for a limited period of time.

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Analytical Procedure Life Cycle - New USP Chapter <1220> published

More than a year after the publication of the draft of Chapter <1220> on Life Cycle Management of Analytical Procedures, the USP has announced the final version for 01 November.

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New FDA Draft Guidance - Microbiological Quality Control of Non-Sterile Medicinal Products

Based on the experience of the past years, the FDA has published a new draft guidance that deals with the microbiological control of non-sterile medicinal products and clarifies it by means of case studies.

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EU: further Extension of GMP and GDP Certificates

The EU will extend GMP and GDP certificates until the end of 2022 due to ongoing pandemic restrictions. The relevant document has been updated for this purpose.

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FDA Warning Letter Due to Lack of Stability Data and Specifications for APIs

FDA Warning Letters frequently cite fundamental GMP deficiencies in quality control. These include lack of testing of incoming material and components and stability testing, as described in a recent Warning Letter to a Honduran medicinal product manufacturer.

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Industry 4.0 Trends in the Laboratory

Industry 4.0 will open up new opportunities in the pharmaceutical industry. But what exactly is behind the term "Industry 4.0" and what solutions can be implemented in a laboratory?

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Important Change for Entries in EudraGMDP Database

The new regulatory framework for veterinary medicinal products requires several changes to the EudraGMDP database. One important change is the integration of EudraGMDP into the EMA's Organization Management Service (OMS).

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USP Chapter on Impurities in Food Supplements

USP´s Expert Committees for Non-Botanical & Botanical Dietary Supplements and Herbal Medicines propose the elaboration of a new USP general chapter <2760> on impurities in food supplements.

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Strategic Plan of "Access Consortium" published

The "Access Consortium", a consortium of the regulatory authorities from Australia (TGA), Canada (HBFB), Switzerland (Swissmedic), Singapore (HSA) and now also the United Kingdom (MHRA), published a three-year plan regarding planned common approaches and goals.

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FDA´s Q&As on Generic Drug Development during the COVID-19 Pandemic

What can be done when a test or reference product batch used in the conduct of a bioequivalence study expires while the study is interrupted due to the COVID-19 pandemic? Find out in FDA´s updated Q&As on Generic Drug Development.

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Clinical Trial Information System - EMA publishes Sponsor Handbook

The go-live date for the CTIS is 31 January 2022. The System will then become the single entry point for clinical trial application submission, authorization and supervision in the EU. In order to help sponsors prepare for using the CTIS, the EMA has now published a handbook.

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CDER published Q&A Catalogue for Generic Drug Authorisations

In September 2021, the CDER (Center for Drug Evaluation and Research) of the U.S. FDA published a so-called "Draft Guidance for Industry" for generic medicinal product authorisations in the form of a question and answer catalogue.

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EMA: Update of the Q&A Documents "Centralised Procedures"

In July and September 2021, the European Medicines Agency (EMA) published the updated and revised versions of the "Questions & Answers (Q&A)" documents on centralised procedures on their website.

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Updated Version of the Q&As regarding the Clinical Trials Regulation

The European Commission published a revised Version 4 of the Questions & Answers relating to the Clinical Trials Regulation. In particular, updates to Q&As in Chapter 11 "Arrangements for the transitional period" have been made.

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New JP Draft 2.28 Circular Dichroism Spectroscopy Published for Public Comments

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published a Japanese Pharmacopoeia (JP) draft of a New General Test 2.28 Circular Dichroism Spectroscopy. Comments can be submitted until September 30, 2021.

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