GMP NEWS 2018

MHRA & FDA: First Joint Workshop on GCP in Washington

Data integrity plays an exceptional role in clinical studies. On 23-24 October, 2018, the US FDA and the British MHRA hosted a joint workshop on this topic. Learn more about the contents and results of the joint workshop "Good Clinical Practice: Data Integrity in Global Clinical Trials - Are we there yet?"

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Stability by Design - Guidelines for Assessing & Controlling Physical Stability

The USP Physical Stability Joint Subcommittee has published a Stimuli article regarding Guidelines For Assessing and Controlling the Physical Stability of Pharmaceutical Raw Materials, Intermediates, and Dosage Forms. 

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Valsartan: New Inspection reveals significant GMP Violations

An inspection by EU inspectorates in collaboration with EDQM has revealed significant GMP violations at a Valsartan manufacturer's site.

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USP article on pharmaceutical continuous manufacturing

In the latest edition of the Pharmacopoeial Forum 44(6), the US pharmacopoeia USP has published a so-called Stimuli Article on pharmaceutical continuous manufacturing. Apart from important definitions, the document contains further information on material properties and characteristics as well as risk management approaches for continuous manufacturing.

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Products with Genetically modified Cells - Draft Guideline

Due to the ongoing scientific development of laboratory methods, the EMA published a draft revision of their "Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells" for public consultation.

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False Positive HTLV Testing - Recommendations for Donor Requalification

In October 2018, the FDA published a new draft guidance with recommendations for a possible requalification of donors who had been deferred because of reactive test results for antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II). Read more about the requalification method under 21 CFR 610.41.

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ISO standard for packaging machines

A new international technical committee ISO/TC 313 Packaging Machinery has been founded, which will be responsible for establishing international standards for packaging equipment and systems.

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Current Questions on Validation of Blend Uniformity - Stratified Sampling

Validating blend uniformity is a decisive factor for the validation of solid dosage forms. In Europe, there are no regulatory provisions for this. This is different in the USA: the 21 Code of Federal Regulation (CFR) 211.110 requires the regular assessment of the adequacy of mixing.

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Supply Chain and Drug Shortages Problems

What are the supply chain and drug shortage problems often caused by GMP and quality related problems? To find out more about this issue and about the consequences of drug shortages on the key stakeholders - i.e. the patients, companies and the governments -  the ECA conducted a survey. It also addressed potential strategies industry and authorities can employ to minimise the risk of drug shortage or its impact. Find out what the ECA survey on drug shortage problems brought to light.

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New Timeline for USP Plastics Packaging Chapters

The USP posted a new timeline for the implementation of the plastics packaging chapters 661.1 and 661.2. So far, the new chapters were to become applicable on May 1, 2020. The implementation of the new requirements will now be delayed until December 1, 2025.

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New Top Lecture available - FDA´s Thinking about Modern Qualification and Validation

What is the FDA´s current thinking with regard to Modern Qualification and Validation? You will find out in a recent lecture from FDA Director Grace McNally.

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Management and control of biological raw materials - the EBE Concept Paper

Raw materials used in the manufacture of biopharmaceuticals may show highly different characteristics and risk potentials. Read here why and how risk assessments for raw materials must be performed and where practical advice therefore may be gained.

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FDA Warning Letter: Outlier Test inadequate for OOS Investigation

The API manufacture Zhuhai United Laboratories Co. Ltd. received a Warning Letter from the FDA in June 2018. The FDA criticized that the OOS results of assay determinations haven't been adequately investigated. According to the FDA, the sole use of outlier tests is not appropriate. Read more about FDA's Warning Letter to Zhuhai United Laboratories.

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Medical Device Warning Letters - Fiscal Year 2018 - CAPA no longer in 1st Place

You can regularly read about an evaluation of the deficiencies in FDA warning letters concerning medical devices. Find out what the past fiscal year looked like in terms of FDA Warning Letters regarding medical devices and what changed compared to fiscal year 2017.

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EU guidance for new Medical Device Regulation (MDR)

With the coming into force of the Medical Device Regulation (MDR) in 2020, the guidelines 93/42/EEC and 90/385/EEC, which have regulated the field of medical devices so far, will become invalid. Two EU documents define what is going to change and how the changes need to be implemented.

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Borderline questions on medical devices

At what point is a medical device considered a medical device in Europe? So-called borderline products sometimes cause problems regarding classification; a guideline on Borderline products by the European Union may be of help.

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Sponsor Oversight - Metrics & Case Studies

The overall responsibility for clinical trials lies with the sponsor. Whereas activities may be contracted or delegated, responsibility itself can not. Read more about metrics and case studies from GCP inspections with regard to sponsor oversight of clinical trials.

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What is required for electronic informed consent (eConsent)?

The MHRA released a joint statement setting out the legal and ethical requirements for documenting consent using electronic methods. Read more about the MHRA´s view of seeking consent electronically (eConsent).

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New defect Evaluation List for Moulded Glass out now

The brand-new 2018 edition of the Defect Evaluation List for Containers Made of Moulded Glass which includes an appendix with example pictures of specific defect characteristics is out now.

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EMA: Work on Annex 1 and Annex 21 will continue

Because of Brexit, the European Medicines Agency (EMA) further needs to reduce activities. However some EMA acitivities will continue as planned.

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