GMP News

Update of the borderline guideline on medical devices

At what point is a medical device to be considered a medical device in Europe? The classification of so-called borderline products is sometimes difficult. An updated EU guideline may be able to help.

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Track & Trace in Russia - One More Standard in Place?

The introduction of a Europe-wide serialization system (often simplified to "Track & Trace") has brought great challenges to pharmaceutical manufacturing companies. In addition, many countries outside Europe are preparing serialization systems. Internationally speaking, Russia is already very far advanced. Read more about the new requirements for Track&Trace in Russia.

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New Zealand proposes new legislation for medical cannabis

New Zealand released a proposed regulatory approach for medical cannabis. The implementation of the medical cannabis program is anticipated to start in the first quarter of 2020. In addition, the document proposes two options for GMP.

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Do liquid, sterile medicinal products have to be particle-free?

According to the pharmacopoeias, parenteralia, i.e. sterile medicinal products for injection purposes, must be 100% visually inspected. In addition to damages to the primary container, the absence of particles has also to be checked. But do these medicinal products also have to be 100% free of particles? Read more here.

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New structure of Ph. Eur.´s packaging section

The numbering of the Ph. Eur. packaging section 3 has been changed for the 10th Edition following the creation of the new chapter 3.3. Containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes.

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Updated Version of the Clinical Trials Regulation Questions & Answers Paper

The European Commission (EC) published an updated Version 2 of the Questions & Answers relating to the Clinical Trials Regulation. In particular, 47 Q&As on safety have been included.

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News from the clinical trial portal and database

The new CTR becomes applicable six months after the notice of the full functionality of the CTIS. The EMA informed that the CTIS now enters a phase of agile, iterative delivery, to prepare the system for audit.

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New Warning Letters - Quality Units in the Focus

"Your firm's quality systems are inadequate". A sentence in a Warning Letter you would not like to read. Some companies now had to.

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Creams, Gels & Pastes redefined

A revised version of the Ph. Eur. Monograph Semi-solid preparations for cutaneous application has been published in Pharmeuropa.

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Canada´s New Regulatory Approach for Cannabis Products

Health Canada proposes a regulatory pathway for a new class of cannabis products referred to as Cannabis Health Products that would not require practitioner oversight.

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How to deal with Indefinite Legal Terms in GMP Regulations?

The GMP regulations contain many indefinite legal terms. Procedures and processes should be appropriate, regularly repeated, or sufficient. Now, the question is how to concretise appropriate, regularly repeat and sufficient?

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FDA keeps an eye on use and marketing of cell and tissue products

The FDA publishes an Untitled Letter to a manufacturer of stem cell products that are used to treat various diseases and are not expected to meet regulatory requirements.

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ATMPs in combination with a medical device - QP task on release

With the coming into force of the Advanced Therapy Medicinal Products (ATMPs) GMP rules as Part IV of the EU GMP Guidelines, a new chapter has been opened on the manufacture and quality control of ATMPs. Special requirements are placed on the QP when an ATMP is combined with a medical device.

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How to handle possibly lifesaving OOS batches of ATMP - A question that concerns manufacturers and authorities

In the context of a Q&A document, the European Medicines Agency (EMA) offers assistance and information on when an Advanced Therapy Medicinal Product (ATMP) can be approved for treatment even in the case of an out-of-specification batch.

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Transmission of multiresistant microorganisms during transplantation

Following incidents involving the transmission of multi-resistant germs during the use of faecel microorganisms for transplantation, the FDA has established additional measures to minimise the risk of transmission.

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Serialisation: New Guidance for EU Inspectors

The European Commission has published an Aide-Memoire to help both manufacturers and inspectors to verify compliance with the safety features regulation.

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10th Edition of the Ph. Eur.

The 10th edition of the Ph. Eur. will be released in July 2019. The new and revised texts will become official on 1 January 2020.

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All Things come to Those who wait ... Germany approved by MRA EU-USA

Two weeks ago, we pointed out in our News entitled MRA Countdown: 10, 6, 4, 2 that the Mutual Recognition Agreement (MRA) with the USA was on track. The News concluded with the statement that Germany and Slovakia were missing. Meanwhile, things have changed!

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Deletion of Data: Does it have to be regulated in a SOP?

The data integrity topic raises a number of questions. Current questions are addressed in a loose sequence of News. Question 4: Does the deletion of data have to be regulated in a SOP?

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How to prepare for Russian Inspections

Quite a few authorities in the health care sector come for GMP inspections also to foreign countries. Here you can read what Russian inspectors will expect.

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Warning Letter for US Pharmaceutical Manufacturer: Container/Closure Issues and Other Deficiencies

The US FDA has recently published a Warning Letter describing the deficiencies observed during an inspection performed in September 2018 at a US pharmaceutical manufacturer. One serious deficiency concerns leaking product containers. Furthermore, defects in the stability programme, in the CAPA system and in data integrity have also been reported.

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MHRA reports serious GCP breaches including Data Integrity

The British Medicines and HealthCare Regulatory Agency (MHRA) recently published the 2018 metrics report for serious GCP breaches reported to the agency.

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The ICH publishes E8(R1) Draft Guideline for comment

The ICH E8(R1) draft Guideline on General Considerations for Clinical Trials reached Step 2b of the ICH Process in May 2019 and has entered the public consultation period.

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MRA Countdown: 10, 6, 4, 2, ...

The FDA has confirmed two other EU Member States to carry out GMP inspections at a level equivalent to that of the US. Only two states are still missing to implement the Mutual Recognition Agreement (MRA) between the FDA and the EU.

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Revised USP Elastomeric Components Chapters

The previous draft chapters were canceled. Therefore, USP´s General Chapters–Packaging and Distribution Expert Committee has published new proposals on elastomeric components.

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