GMP News

New ISO Standard for Tamper-Evident Packaging

The International Organization for Standardization has published the new ISO standard "Packaging - Tamper verification features for medicinal product packaging".

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News from the ICH on Continuous Manufacturing

In June 2018 already, the International Council for Harmonisation (ICH) announced the coming issuance of a new ICH Guideline on continuous manufacturing. Now, the ICH has released further news about the planned content of the new guideline ICH Q13.

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Clinical Trials if there is no Brexit Deal

To face the possibility of a Hard Brexit, the MHRA has issued updated guidance proposing some necessary arrangements in regard of Clinical Trials of IMPs.

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EMA Guideline on Content, Management and Archiving of the TMF

The EMA published a new guideline on the content, management and archiving of the TMF clinical trial master file (paper and/or electronic).

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Cleaning Validation of Medical Devices: What should it look like? An ASTM Guide provides Answers

There are regulations for cleaning validation in the pharmaceutical sector and in the manufacture of active ingredients. But what about the cleaning validation of medical devices?

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Things to Consider for Medical Device Manufacturers when Relocating

In December 2018, the FDA  published its finalised guideline entitled "Manufacturing Site Change Supplements: Content and Submission". The first draft dates back to October 2015. Now, who can use this document?

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Foreign FDA Inspections of Medical Device Manufacturers increase by 243% over the last 10 Years

In its "Medical Device Enforcement and Quality Report", the FDA has published current data on its monitoring activities with regard to medical device manufacturers. Find out what's new.

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Hard Brexit: MHRA proposes necessary Arrangements

To face the possibility of a Hard Brexit, the British MHRA has issued an updated guidance proposing some necessary arrangements.

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Cleaning Validation: What can a Quality Risk Management Approach Look Like?

With the implementation of the ICH Q9 document, risk management has become mandatory in virtually all GMP areas. This also applies to cleaning validation. But what can such a quality risk management approach look like for cleaning validation? The American Society of Testing and Material (ASTM) has recently issued a guideline on a Science-Based and Risk-Based Cleaning Processes Development and Validation. What does the Guide suggest?

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Will EMA Plans change the Landscape of GMP?

EMA has published a strategic reflection paper "EMA Regulatory Science to 2025". As a consequence, the regulatory landscape, including GMP requirements and standards, needs to be adapted.

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Process Validation: The Impact of Equipment Change

In a previous News you could already read about the cleaning issues at a US-American pharmaceutical company. Now, the Warning Letter issued provides much more information - also with regard to process validation.

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New VDI Guidelines for Clean Room Technology

The Association of German Engineers (VDI ="Verein Deutscher Ingenieure") has recently released two new draft guidelines from the area of clean room technology: one regarding central air handling systems, and the other one regarding air filter systems.

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FDA Data Integrity and Compliance with CGMP Guidance for Industry finalised

Data integrity is still topic number 1 for national and international authorities. In 2016, the US-FDA presented a draft guidance on that in form of a questions and answers document. Now, it was finalised on 12 December 2018. Read more about the Guidance for Industry "Data Integrity and Compliance with CGMP".

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British Regulatory Authority MHRA criticises Cross Contamination Issue

The publication of EMA's "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities" and the related Q&A documents have given the topic cross contamination a greater importance.

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Safety Features: EU Commission issues Version 12 of Q&As

The European Commission has reviewed their list of questions and answers regarding safety features and issued it as version 12. Find out what changed in the Q&As on safety features.

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Revision of EMA's Guideline on the Use of Pharmaceutical Water

In the course of the revision of the European Pharmacopoeia which allows the production of WFI with other methods than distillation, the revision of EMA's "Guideline on the quality of water for pharmaceutical use" has become necessary.

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Warning Letter for Korean Manufacturer due to Poor Sterile Practices

As a result of repeated deviations in the area of aseptic manufacturing, a Korean manufacturer has received a Warning Letter from the FDA.

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New Ph. Eur Monograph on PAT adopted

The European Pharmacopoeia (Ph. Eur.) Commission adopted 16 new texts including the general chapter on PAT - Process analytical technology (5.25).

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New Ph. Eur. Structure of Chapter 3 on Materials and Containers

The Ph. Eur. Commission decided to restructure Ph. Eur. Section 3 on materials and containers. A new Subsection 3.3. has been added to cover items that are classified as medical devices according to EU legislation. Read more about 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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Cross Contamination: One of FDA's Current Issues

In a current Warning Letter from November 2018, the FDA criticised insufficient cleaning validation and verification at a pharmaceutical manufacturer. They referred to 21 CFR 211.67 (a). What was the reason for this?

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Non-Compliance at Italian Sterile Manufacturer

In the course of an inspection conducted in October 2018, the Italian health authority discovered several GMP deviations in the areas of sterile manufacturing, packaging and QC testing at an Italian manufacturer. Read more details about the Non-Compliance Report which can now be found in EMA's inspection database.

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Gene Therapeutics - FDA updates Requirements for CMC Information

In recent months, the FDA has published a number of documents on gene therapy. With a draft guideline on "Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)", the next step in the update of the relevant guidelines has been taken.

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Transfusion Transfer of Babesiosis - FDA Draft: Recommendations for Risk Minimization

The FDA published a new Draft Guidance on Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis. The recommendations contained in this guidance apply to the collection of blood and blood components, except source plasma.

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FDA Draft Guidance on the risk of Bacterial Contamination of Blood Platelets

With a new draft guidance on the risk of bacterial contamination of blood platelets for transfusion purposes, the FDA wants to give updated recommendations on risk minimization to affected donor institutions and transfusion centers.

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GDP Association updates Code of Practice for the Responsible Person for GDP

The Code of Practice "The Responsible Person for GDP" has been revised. The new Version 2 has just beed issued for members of the European GDP Association.

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