GMP News

EMA: Another Update of the "IRIS" Documents

Since May 2022, the new version of the "IRIS guide for applicants" is available on the EMA website. Besides formal adaptations, version 2.10 contains additions in chapter 7 and updates in chapters 2 and 6.

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BfArM Adjusts Specification for Medical Cannabis

Growers and importers of cannabis flowers have reported to the German BfArM that the specification requirements of the DAB monograph Cannabis Flower cannot be met, especially for low cannabinoid contents. The BfArM has now worked out a compromise for cannabis used  for magistral preparations.

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New Pharmeuropa Bio & Scientific Notes Article on Weighing according to the European Pharmacopoeia

In the Pharmeuropa Bio & Scientific Notes, a free online journal of the EDQM, a new scientific article entitled "Weighing according to the European Pharmacopoeia: general considerations and new general chapter 2.1.7. Balances for analytical purposes" was published.

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MHRA (UK) now also a full ICH Member

The United Kingdom (UK) becomes a full member of three international associations, including the International Council for Harmonisation ICH.

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FDA Form 483 due to Insufficient Investigations after Out-of-Specification (OOS) Dissolution Results

The U.S. Food and Drug Administration (FDA) published a Form 483 after an inspection at an Indian drug manufacturing side. The lack of control over compression machines settings led to not meeting the dissolution specifications. As the investigations were limited to the directly affected batch only, it is not excluded that other products may be affected by the same problem. Furthermore, the stability program was not followed to complete the testing within the predefined time frame.

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CBD Novel Food Assessment Interrupted Due to Data Gaps

The EFSA can currently not establish the safety of cannabidiol (CBD) as a novel food due to lack of data and uncertainties about potential hazards related to CBD.

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EMA: Another Update of the Q&As on Parallel Distribution

Already in April 2022, the "Frequently asked questions about parallel distribution" were revised and published on the EMA website - as already reported recently. Now, the Q&As have been updated again and supplemented.

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Benefit-Risk Assessment for Product Quality Evaluation

Before approving an application, the FDA must determine whether the drug product is both safe and effective for use. A new draft guidance describes the FDA principles when conducting product quality-related assessments of CMC information.

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Draft on Labeling Requirements for IMPs Published

With the application of the EU Clinical Trials Regulation some labelling requirements for IMPs have changed, in particular regarding the expiry date. Now an initiative eliminates the obligation to include an expiry date on the immediate packaging of IMPs in specific circumstances.

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What is a Complex Clinical Trial?

In order to support sponsors, clinical investigators and applicants in planning and conducting complex clinical trials (CCTs), a new Q&A document covering this topic has now been published on the European Commission (EC) website. What is a complex clinical trial?

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New Guidance Documents for GCP Inspections

Following the previously published list of documents needed during GCP inspections, the EMA issued a set of updated documents on planning and conducting GCP inspections on its website. The annexes compile specific items that may be verified at the sponsor / CRO / investigator site and clinical laboratories.  

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Clinical Trials Regulation - Version 6.1 of the Q&As

The European Commission published an updated version of the Questions & Answers document relating to the EU Clinical Trials Regulation. What are the GMP consequences of switching the regulatory framework applicable to a clinical trial?

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Proposed Revision of USP Chapter <711> Dissolution Canceled

The Dosage Forms Expert Committee intends to revise USP General Chapter <711> Dissolution. Based on the comments received, the previously proposed revision, published in Pharmacopeial Forum 48(2) in March 2022, has been canceled. It is expected that a new proposed revision will be published as an Interim Revision Announcement in Pharmacopeial Forum 48(6) in November 2022.

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EFPIA Member Survey on Current Inspection Trends

The EFPIA has published its "Annual Regulatory GMP/GDP Inspection Survey 2021 Data". With some interesting results that perhaps not everyone would have expected.

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GMP Deficiencies in the Sterile Area

In a Warning Letter addressed to a US-American pharmaceutical manufacturer, the FDA points out various deficiencies in aseptic production. Among other things, deficiencies are described in the design of equipment and rooms, airflow and visual inspection.

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Interpretation of 21 CFR 211.67 Cleaning of Equipment

The US-American GMP regulations for medicinal products are laid down in 21 CFR 211. Section 21 CFR 211.67 requires the establishment of and adherence to written instructions regarding the cleaning and maintenance of equipment. What is exactly meant by this?

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Ph. Eur. Draft Monograph for CBD

Following the USP Draft Monograph for Cannabidiol (CBD) published earlier this year a draft Ph. Eur. Monograph for CBD has now been published in Pharmeuropa 34.3. The comment deadline is 30 September 2022.

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Comment Period Extended for the Proposed Rule for the Licensure of WDDs and 3PLs

The U.S. Food and Drug Administration (FDA) has extended the comment period for the proposed rule "National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs)" to September 6, 2022. The FDA believes that this extension allows adequate time for interested stakeholders to submit comments.

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GDP Non-Compliance Report: Failure to Meet the GDP Principles of Cold Chain Products

The competent authority of Portugal (National Authority of Medicines and Health Products, I.P.) has entered a new GPD Non-Compliance Report into the EudraGMDP database. According to the authority, the wholesaler concerned does not comply wth the GDP principles of cold chain products.

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Acting as a MHRA Approved Compliance Monitor for GDP

The Medicines and Healthcare products Regulatory Agency (MHRA) began a pilot programme for monitoring GMP and GDP activities, whereby approved consultants, so-called Compliance Monitors (CM), will supervise the completion of an agreed Compliance Protocol (CP). Consultants interested in being named as eligible to act as a CM for GDP (or GMP), have to fill out the MHRA "Compliance Monitor (CM) Application Form".

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Validation of Mixing Uniformity also required for Active Ingredients

The issue of mixing uniformity has been a validation-required topic in the field of solids for years. This is even explicitly required in the US regulations (21 CFR 211.110). In a recent Warning Letter, requirements for the mixing uniformity of an active ingredient were also addressed. What did the FDA criticise?

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USP publishes Draft Guideline on Analytical Methods for mRNA Vaccines

At a time of increased interest in mRNA-based medicinal products and vaccines, the USP has published for comment a draft guidance document on "Analytical Methods for the Quality of mRNA Vaccines".

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USP intends to revise the Chapters on Microbiological Control of Non-sterile Medicinal Products

In PF46(2), the United States Pharmacopoeia has published a Stimuli article addressing the planned revision of chapters relevant to microbiological control of non-sterile products.

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MHRA introduces external consultants as Compliance Monitors in Companies

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a pilot project for a new Compliance Monitor Process. External consultants are being used for this purpose.

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Several Revised Chapters on Chromatographic Methods Adopted

During its 172nd session in March 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted several new and revised texts and monographs for publication in Ph. Eur. Supplement 11.1, including several general chapters on chromatographic methods.

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