GMP NEWS 2009

EMEA Draft Guideline on Quality, Non Clinical and Clincal Aspects of Live Recombinant Viral vectored Vaccines

The European Medicines Agency (EMEA) posted the new Draft Guideline on Quality, Non-clinical and Clinical Aspects of Live Recombinant Viral vectored Vaccines for comments. Read the details here.

More

EudraGMP 2.0 gives public access to information about GMP certificates

Press Release: EudraGMP 2.0 gives public access to information about good manufacturing practice (GMP). Read more.

More

EFPIA Criticises Increasing Number of Inspections

Based on a survey, the EFPIA has published a highly interesting position paper. It describes the problem represented by the continually increasing number of international authority inspections. Read more about the possibilities for improving the situation.

More

Quality by Design (QbD) - Contribution by Excipients Manufacturers

Quality by Design can be of relevance to manufacturers of pharmaceutical excipients, since excipients can have an important influence on the properties of the product and on the production processes. The IPEC Europe has issued a Q&A document on this topic. Read more here.

More

FAQ: Which Test for Evaluation of Activity of chemical Disinfections are relevant for the Pharmaceutical Industry?

The responsible personnel for disinfection management is often uncertain whether national or international standards of disinfection testing will be the rigth base to evaluate the capability of chemical disinfectants. Read more.

More

Joint GCP Initiative Launched by EMEA and FDA

With the key target of ensuring appropriate clinical trials, EMEA and FDA have launched a joint initiative. What is to be ensured among other things is the further harmonisation of clinical trials for obtaining marketing authorisations in Europe and the USA. Read more here.

More

ICH Q4B Annex 8 now in Step4

"ICH Q4B Annex 8 to Note for evaluation and recommendation of pharmacopoeial texts for use in ICH regions on sterility test general chapter" is in Step 4 now, and the proposed text has been submitted to the Pharmacopoeial Discussion Group (PDG). Find out more.

More

FDA limits Timeframe for Responding to a 483

In a new programme starting on 15 September 2009, the FDA intends to set the timeframe for statements and responses to a 483 to a maximum of 15 business days. Read more about the new programme.

More

New ICH Q4B Documents issued for Europe

Decay period and abration, sterility testing and Polyacrylamide Gel Electrophoresis are the topics of four new ICH Q4B Annexes the European Medicines Agency (EMEA) issued end of June. Read the details here.

More

Internet presentations regarding Cleaning Validation

Cleaning validation has been a very important topic for the pharmaceutical industry since the 1980s. On the Internet portal Scribd, a presentation on this subject has been published that illustrates the topic quite clearly. Read more.

More

FDA: cGMP expectations in Pharmaceutical Development

In their CFR the FDA has not defined special GMP-requirements for so called investigational drugs (INDs). And only for Phase 1 INDs dedicated Guidance is available. Read more about the background.

More

Update of the PIC/S Recommendation PI 007-4 Validation of Aseptic Processes

The PIC/S recommendations PI 007-5 "Validation of Aseptic Processes" were updated with regard to the "interpretation of data" in media fills on 1 July 2009. More details can be found here.

More

EMEA Database on GMP Inspections now publicly available (EudraGMP)

Following the launch of a new version the EudraGMP database is now providing public access to information about manufacturing, importation authorisations and Good Manufacturing Practice (GMP) certificates. Find more information here.

More

Revised Q&A Document available in EudraLex Volume 10 - Clinical Trials

The "Questions and Answers document" in the EudraLex volume 10 on clinical trials has been revised. Read more.

More

ICH Topic E16 Genomic Biomarkers Related to Drug Response - Deadline for Comments in September 2009

The European Medicines Agency (EMEA) published a note for guidance about ICH Topic E16 Genomic Biomarkers Related to Drug Response, open for comment until September 2009. To find out more please read here.

More

FDA Opens 3 Offices in Europe

The FDA will open as many as three offices in Europe. Through this, the FDA reacts to the challenge of a global supply chain. Details of the measures can be found here.

More

The New FDA Guideline on Impurities in Generics

The FDA publishes the revision of a guideline on impurities in generic medicinal products. The document calls for the indication of detailed information on impurities stemming from the active pharmaceutical ingredient (API) when a new application for a marketing authorisation for a generic is submitted or when a supplement is submitted because of changes to the API manufacturing process. The provisions of the guideline also apply to Type II Drug Master Files. Read the details here.

More

European Commission Publishes Comments on the Variations Guidelines

A large number of comments on the two detailed guidelines about the different variations categories and procedural questions regarding variations to the terms of marketing authorisations were submitted by industrial associations, authorities of EU member states, and companies. The European Commission has published all these statements as well as a summary and evaluation on its website. Here you can read more.

More

Danish Medicines Agency - Questions and Answers on GMP for APIs

The Danish Medicines Agency offers a list of questions and answers dealing with the GMP requirements on active pharmaceutical ingredients (APIs). You will find more here.

More

FDA Publishes Guideline to Fight Counterfeit Medicines

The FDA has published a new draft guidance describing the use of physical-chemical identifiers (PCIDs) in order to impede the counterfeiting of medicinal products. Details can be found here.

More

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK