GMP News - Quality Assurance

11.05.11

EMA: Monitoring of Products originating from Japan for the Possibility of Radioactivity

EMA is working with its European and international regulatory partners to monitor and evaluate the possible risk of radioactive contamination of medicines manufactured in Japan. Read more.

11.05.11

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.

04.05.11

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.

28.04.11

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.

28.04.11

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.

13.04.11

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.

13.04.11

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.

06.04.11

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.

25.03.11

Results of Survey on EU GMP Guide Revisions of Chapter 5 (Production) and 7 (Contract Manufacture and Analysis)

At the end of last year, drafts about the changes of Chapter 7 (Contract Manufacture and Analysis) and Chapter 5 (Production) of the EU GMP Guide have been published. With regard of these changes, the European Compliance Academy (ECA) conducted a survey. The results were sent to the EMA too and - maybe - influence the final versions. Read more about the results of the survey here

25.03.11

Surveillance of Medicinal Products- Annual Report of the German Federal States

In February, the German Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) published its annual report on inspections. Read more here.

16.03.11

China's new GMP Regulation effective since March 1, 2011

The State Food and Drug Administration of China (SFDA) published a revised version of the GMP regulation. This new version came into force just recently, on 1st March 2011. Read more here.

16.03.11

FDA focuses more on Supplier Qualification

Compliance of suppliers and the challenges in all stages of purchasing, manufacturing and distribution is getting more and more in the focus of inspectorates. Read more.

09.03.11

New FDA Guidance Documents in Calendar Year 2011

On January 26, 2011 the FDA issued the Guidance Agenda: New & Revised Draft Guidances CDER plans on publishing during the calendar year 2011. Click here to read more.

09.03.11

Evaluation of the Warning Letters issued by the FDA for the Fiscal Year 2010 with regard to Risk Management

What do inspectors have to object to in regard to Quality Risk Management? Read more here.

09.03.11

Quality Agreement templates for every Participant of the 4th European GMP-Conference

All delegates of the 4th European GMP Conference on 19/20 May 2011 in Heidelberg will receive sample contracts on quality agreements for contract manufacturing, for contract analytics, for... Read more here.

Page 60 of 62

Combination Products - Live Online Training

Recommended Event

6/7 February 2024

GMP News - Quality Assurance

EMA: Monitoring of Products originating from Japan for the Possibility of Radioactivity

FDA's Strategic Priorities 2011 - 2015 now available

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

Nuclear Load of pharmaceutical Products from Japan

Revision of Chapter 8 of the EC guide to GMP

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

Quality IWG Training Material on ICH Q8, Q9 and Q10

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

Results of Survey on EU GMP Guide Revisions of Chapter 5 (Production) and 7 (Contract Manufacture and Analysis)

Surveillance of Medicinal Products- Annual Report of the German Federal States

China's new GMP Regulation effective since March 1, 2011

FDA focuses more on Supplier Qualification

New FDA Guidance Documents in Calendar Year 2011

Evaluation of the Warning Letters issued by the FDA for the Fiscal Year 2010 with regard to Risk Management

Quality Agreement templates for every Participant of the 4th European GMP-Conference

Recommended Event

Combination Products - Live Online Training

GMP Newsletter

GMP Conferences by Topics