GMP NEWS 2018

Warning letter: falsified batch records and missing certificates of analysis

The final release of drug products without the documented prove of compliance with the specifications is a criterion for exclusion, and not just during an FDA inspection. Find out, what other GMP violations regarding the manufacturing and testing FDA inspectors found during an inspection.

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More stringent FDA requirements for homeopathic medicinal products

In December 2017, the FDA published a new draft guideline for homeopathic products. There is to be a more stringent and risk-based approach by which all products are to be recorded. Find out more about the new FDA requirements for homeopathic products.

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New MHRA "GxP Data Integrity Guidance and Definitions" published

On 09 March, 2018, the British supervisory agency MHRA published the final version of its guideline on data integrity which has been available as a draft since July 2016. Find out more on a first analysis of the new document "GXP Data Integrity Guidance and Definitions" .

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FDA Warning Letter due to Faulty Sampling

Drug manufacturer Shanghai Weierya Daily Chemicals in China received an FDA Warning Letter in February 2018. During the inspection, the inadequate sampling when testing active pharmaceutical ingredients and excipients was criticised. Read more about the recent Shanghai Weierya FDA warning letter.

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Inspectors' Aide Memoire on Process Validation - a Detailed Analysis

With the Annex 15 revision, the issue of process validation became significantly more complicated. What is an authority's view on the topic of process validation?

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New Edition of VDI 6022 Part 1: Hygiene and Hygiene Inspections of HVAC Systems

In January, the VDI published a completely revised edition of part 1 of the VDI 6022 series. The guideline deals with hygiene for HVAC systems with the objective of preventing negative effects on room air.

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EMA releases Draft Guideline on Safety and Efficacy Follow-up and Risk Management of ATMPs

The European Medicines Agency (EMA) published the first revision on their Guideline on safety and efficacy follow-up and risk management of Advanced Therapy Medicinal Products, considering the experiences since the first adopted version.

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EMA Committee for Advanced Therapies (CAT) publishes 2018 Work Plan

Concerning their activities in the field of ATMP, the EMA Committee for ATMP (CAT) published their work plan for 2018 for the different areas of responsibility from pre-authorisation to used technologies.

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CAT and CHMP update their Procedural Advice on the Evaluation of ATMPs

Relating to the ongoing experiences in the marketing authorisation of ATMPs, the EMA published an updated version of their "Procedural advice on the evaluation of advanced therapy medicinal product in accordance with Article 8 of Regulation (EC) No 1394/2007".

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MRA with FDA: Four new States accepted

Four more EU Member States were evaluated and accepted by FDA and will now benefit from the EU-US Mutual Recognition Agreement for inspections.

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Measurement Uncertainty for the Pharmaceutical Industry

The USP recently published a stimuli article regarding the discussion of measurement uncertainty (MU) which is a component of the lifecycle approach to analytical procedures. Read more about the USE OF MEASUREMENT UNCERTAINTY IN THE PHARMACEUTICAL INDUSTRY.

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Impressive Non-Compliance Report for Romanian Drug Manufacturer

The European Health Agency EMA publishes Non-Compliance Reports by GMP inspectors in their EudraGMDP database. A report of impressive deficiencies at a pharmaceutical manufacturer's site in Romania based on an inspection in summer 2017 is available there, as well.

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Ph. Eur. Draft on PAT

Recently a draft monograph on PAT has been published for comment in Pharmeuropa. Read more about Ph. Eur. chapter 5.25. Process Analytical Technology.

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FDA Draft on Pediatric Rare Diseases

The FDA published a strategy paper covering extrapolation of efficacy from adults to children. Read more about the draft document Pediatric Rare Diseases — A Collaborative Approach for Drug Development Using Gaucher Disease as a Model.

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Revision of EU GMP Chapter 1 to enhance Quality Risk Management

The European Medicines Agency (EMA) is planning to revise Chapter 1 of the EU-GMP Guidelines. In the new document, risk-based approaches will be included to prevent drug shortages.

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Warning Letter due to Non-Compliance with Specifications

Drug manufacturer Shanwei Honghui Daily Appliance in China has received an FDA Warning Letter in December 2017. During the review, the FDA criticised the company's failure to check certificates of analysis for compliance with the specifications. Find more information in the recent FDA Warnig Letter to Shanwei.

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What plans does the FDA have for 2018?

What are the FDA's plans for 2018? The Center for Drug Evaluation and Research (CDER) has answered that question in their list of FDA guidelines in the planning or to be revised.

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Swissmedic's statement on how to handle discrepancies between EU and PIC/S GMP

In December, the Swissmedic - the Swiss Agency for Therapeutic Products, has published a short statement on how to handle differences between different GMP guidelines.

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EMA's GMP Plans for 2018

The European Medicines Agency has published the 2018 Work Plan. The EMA plans some new guidance and some revisions to existing requirements.

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Disregard of general GMP Principles at Indian API Facility

During the inspection of an Indian active pharmaceutical ingredient manufacturer, European GMP inspectors were met with severe deficiencies. Read here, which violations of GMP principles for production, laboratory and handling of reference samples led to a Non-Compliance Report. 

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