GMP NEWS 2013

Rapid Micro Methods Database updated with new systems

The Rapid Microbiological Methods database in the member area of our working group was updated with 3 new systems. For more information please see this news.

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EMA publishes ICH Q4B Annex 14 - Bacterial Endotoxin Tests

The European Medicines Agency (EMA) published ICH guideline Q4B Annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bacterial endotoxins tests". Read more.

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Use of Nucleic Acid Tests

With this guidance, the FDA addresses blood establishments that collect Whole Blood and blood components for transfusion or for further manufacture. Read on.

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FDA publishes current list of Drug Master Files (Type II)

Since the introduction of the Generic Drug User Fee Act (GDUFA) all Drug Master File (DMF) holders are required to pay a fee and the DMFs have to undergo a completeness assessment. The FDA has now published a list with all DMFs which meet these criteria. Read more.

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New MHRA's Webpage on the Falsified Medicines Directive

The United Kingdom has established a webpage about the Directive on the prevention from falsified medicines ("Falsified Medicines Directive"). Read more here about the information contained on this page and learn why it is important to visit it.

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Qualification, Requalification - frequent Obscurities

The terms qualification, requalification and monitoring are often mixed up, especially if the somewhat different language from ISO standards is used in the GMP environment. This can lead to misunderstandings that may result in problems. Read more.

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Cleaning Validation Requirements in Asia

Since the nineties, cleaning validation has been one of the main validation topics discussed by the pharmaceutical industry and API manufacturers. Because of growing globalisation, countries in East Asia (Tiger States and Panther States) have also become interesting as consumer countries of APIs and/ or medicinal products. What about requirements on cleaning validation there? Read more here.

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FDA publishes revised Guidance for Applicants of Marketing Authorisations for Generics

What do applicants for marketing authorisations of generic products absolutely have to observe is laid down in a FDA Guidance on fees and procedural issues within the framework of the Generic Drug User Fee Act (GDUFA). Read more on the topic.

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EMA gives Clarification to the Variations Guideline in a Q&A Document

The EMA has published a Q&A document to clarify the questions still open with regard to the "detailed guidelines on procedure issues and the classification of variations" associated to the Variations Regulation. Read more here in the News.

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Revision of USP Chapter on IR Spectroscopy

The revision of Chapter <854> on IR Spectroscopy proposed by the USP contains new provisions on the acceptance criteria for the validation of this method. Moreover, a new Chapter <1854> will provide theory and practice of Mid Infrared Spectroscopy. Read more in the News.

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FDA publishes Guideline Draft on the Registration of Production Sites

In our News from 11 September 2013, we reported about FDA's initiative to identify production sites according to a  uniform system. The topic seems to be crucial for the FDA as it has now released the draft of a "Guidance for Industry" entitled ... Read on.

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EMA QA Document for the Implementation of the Variations Guidelines

The European Medicines Agency (EMA) has published a document with practical questions and answers to support the implementation of the variations guidelines. Read more.

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European Pharmacopoeia Chapter 5.20 "Metal Catalysts or Metal Reagent Residues": Implementation Delayed Until Further Notice!

Ph. Eur. Chapter 5.20 on metallic impurities won't become legally binding until further notice. Read more about the background and the connection with the new ICH Q3D Guideline.

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EMA publishes Concept Paper on the Revision of the Finished Dosage Form Guideline

The EMA has recently published a concept paper on its website that initiates the revision of EMA's Guideline "Note for Guidance on Manufacture of the finished dosage form". Read more here.

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"Sister File Procedure": New Fast-Track Procedure for the Application of Further CEPs for the Same API

How to apply for a second or third additional Certificate of Suitability for the same API? The EDQM has released a guideline on the topic. Read more about how the so-called "Sister File" procedure works.

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Authorisation of Generic Drugs in the USA: Requirements on APIs Stability Data for US Drug Master Files

Which APIs stability information is required for a US Drug Master File within the marketing authorisation application of generic product? Read more about what DMF holders and applicants have to take into consideration in this context.

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Stability Testing of Generics: FDA publishes Q&A Document

The FDA has published a document with 30 questions and answers to clarify some issues regarding the stability testing of generic products. Read more here about the stability data required for ANDAs.

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World Health Organisation (WHO) continues successful collaboration with Paul-Ehrlich-Institut

WHO and PEI - eight years of successful cooperation for Quality Assurance of Blood Products and in vitro Diagnostic Devices. Read more here.

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EMA Guideline on Quality of biological active Substances produced by transgene Expression in Animals

In May, the Committee for Medicinal Products for Human Use (CHMP) adopted the Guideline on Quality of biological active substances produced by transgene expression in animals. Read more.

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Draft Guidance with Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products

Referring to the increasing need of Cellular and Gene Therapy products, the FDA published a daft guideline "Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products". More details can be found here.

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