FDA's Strategic Priorities 2011 - 2015 now available

The U.S. FDA released the final version of a strategic priorities document outlining the goals that will guide the agency through 2015. Read more.


EMA's answers to FAQ on Computerised Systems

The EMA (European Medicines Agency) has just published answers to questions on computerised systems under "Q&A: Good Manufacturing Practices (GMP)". Read more here.


New PIC/S Document on GMP for APIs

A new document created by a PIC/S team of APIs experts raises the central issue related to the production and distribution of APIs and provides essential answers and clarification on the topic. Read more about the interesting collection of Questions and Answers here. 


CAPA among the most frequent GMP Deviations cited in FDA Warning Letters

As indicated by ECA's current Warning Letter Report, Production Record Review and respective CAPA deviations are (again) the most frequent GMP observations made by the FDA. Read more.


Nuclear Load of pharmaceutical Products from Japan

Both ECA and Concept Heidelberg increasingly receive requests on whether a pharmaceutical manufacturer has to check substances and medicinal products from Japan for nuclear loads. Read more about the current situation.


Revision of Chapter 8 of the EC guide to GMP

EMA's GMDP Inspectors Working Group has agreed on a concept paper on revising chapter 8 'Complaints and Product Recall' of the EC guide. Chapter 8 should introduce Quality Risk Management principles and appropriate root cause analysis work when investigating quality defects/complaints for both marketed products and  IMPs. Read on here.


EDQM's Enquiry on the new Draft of a general Chapter on Uniformity of Dosage Units

EDQM has published an enquiry on the draft concerning a new general chapter 2.9.47 - Demonstrating Uniformity of Dosage Units using Large Sample Sizes and an article on the topic on behalf of the PAT Working Group of the European Pharmacopeia. Read more here.


Risk Management Principles used for WHO Inspections of API facilities

The new WHO Pharmaceutical Newsletter reports about the API inspection programme. This programme has been established by using risk management principles. Please read more here


EDQM requires more Information on the Manufacturer's Localisation (DUNS/GPS) for CEPs

From 15 April, the European Directorate for the Quality of Medicines and Health Care (EDQM) requires for applications or revisions of a Certification of Suitability (CEP) the indication of the manufacturing site localisation with GPS data or a DUNS number. This change is in line with the requirements laid down in the new EU Site Master File. Read more here


New Guidance on Investigational Medicinal Products (IMPs) and Non Investigational Medicinal products (NIMPs)

The EU Commission has published a revision of the Guidance on Investigational Medicinal Products (IMPs) and Non investigational Medicinal Products (NIMPs). Read more.


Note for Guidance on minimising the Risk of transmitting Animal Spongiform Encephalopathy Agents via human and veterinary Medicinal Products

Regarding the developments in research and sciences of TSE and the current data about BSE arround the world, the European Commission revised the "Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products". Read more here.


New Limit regarding unspecified Impurities for certain Substances - EDQM Updates respective CEPs

34 monographs of Ph. Eur 7.0 to 7.2 have been revised regarding the limit for unspecified impurities. Read more about the consequences for applicants of new CEPs.


New answers published about Variations: EMA's updated "Post-Authorisation" Guideline

The compilation of EMA's Questions & Answers on Variations has been recently updated. Additionally, a Procedural Guideline has been published. Read more about the new developments here.


Quality IWG Training Material on ICH Q8, Q9 and Q10

The Quality Implementation Working Group has developed a consolidated training package on ICH Q8, Q9 and Q10 that is now available on the ICH website. Read more.


May unvalidated Methods also be accepted to test Drug Products? - The FDA answers

The use of validated analytical test methods in GMP regulated laboratories is obligatory. Nevertheless, under certain circumstances exceptions may be allowed. Here you can read FDA's answer to the question asked in the title of this news.


New EMA Checklist should help Type IA Variation Submissions

The EMA has published a checklist which is supposed to help applicants to check the correctness and completeness of type IA variation notifications. This will be certainly a precious help for those who have to compile documents under time pressure. Read more here.


EMA and FDA announce Pilot Program for Assessment of QbD Applications

EMA and FDA are launching a three-year pilot program that will allow parallel evaluation of relevant quality data components, known as Quality by Design (QbD), of selected applications that are submitted to both agencies at the same time. Read more.


Annual Product Review (APR) as GMP Deviation in FDA Warning Letters

Reviewing FDA's Warning Letters of the last fiscal year reveals that the Annual Product Review (APR) is still a hot topic. The main reasons can be found in failing timely completion and in inadequate processes. Read more.


Video Presentation from FDA´s Dr Moheb Nasr available

A presentation from Dr Moheb Nasr about FDA´s Pharmaceutical Quality Initiatives was videotaped at the 13th European API Conference in Barcelona. Click here to read more.


Dedicated Facilities: FDA publishes Draft Guideline

In March 2011, the Food and Drug Administration (FDA) published a new draft guideline which extends the requirements on the separation of penicillin also on other beta lactam antibiotics. Read more here.


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