GMP News - Quality Assurance

05.06.12

FDA's new Guidance Documents for 2012

The  U.S. Food and Drug Administration FDA has issued its yearly list of planned draft and final guidance documents for 2012. There are about 50 such guidance documents planned. Read more.

more

16.05.12

Foundation of a new French Health Regulation Authority

The existing French health authority has been re-organised. The AFSSAPS has been replaced by the ANSM (Agence nationale de sécurité du médicament et des produits de santé). Read on.

more

09.05.12

FDA Update

The FDA has published a presentation on ongoing activities of the FDA. Read more.

more

11.04.12

FDA: Ensuring the Safety of Vaccines in the United States

The FDA published two documents on vaccines safety and the reporting of vaccine adverse events in the United States. More details can be found here.

more

14.03.12

PIC/S asks Inspectors to have a look at Job Cuts

In a new Recommendation on for Risk-Based Inspection Planning in the GMP Environment, the PIC/S asks Inspectors to have a look at job cuts. Read more.

more

07.03.12

EMA Reflection Paper on Sourcing Biological Starting Materials

According a new Reflection Paper, the European Medicines Agency (EMA) wants companies to trace their heparin supplies back to the slaughterhouse. Read more.

more

07.03.12

New Chinese GMP rules published in English

The Chinese Ministry of Health has published revised GMP rules for drugs in the beginning of 2011. March 1, 2011 was specified as date for the entry into force. Now, an English translation is available. Read more about the main differences between the Chinese GMP rules and EU GMP Guideline Part I.

more

29.02.12

FDA Draft Guidance: How to qualify Heparin Suppliers

The U.S. Food and Drug Administration (FDA) recently published a draft Guidance on Monitoring Crude Heparin for Quality. Read more.

more

18.01.12

Archiving of Paper and Electronic Data of great Concern for FDA and EU Authorities

Demonstrating the integrity and security of laboratory data, records, results and information is paramount for a successful audit or inspection for any GMP regulated quality control laboratory. Please read more here.

more

18.01.12

New ISPE Guide on Process Gases

The ISPE has published a detailed document on the GMP-compliant handling of gases for pharmaceutical and biopharmaceutical production processes. The main focus of this Guide is on the development, the establishment, the implementation and the qualification of process gas systems. Read more here.

more

12.01.12

ICH Q11 close to final Approval

The International Pharmaceutical Quality (IPQ) Journal - one of the most important Journals in the GMP and regulatory environment - reports in a very detailed article, that ICH's "Development and Manufacture of Drug Substances" Q11 Guideline is close to being cleared in Step 4 after some significant changes to the Step 2 draft by the Expert Working Group (EWG). Read more here.

more

14.12.11

ICH Publishes Additional Q8/Q9/Q10 Points to Consider

At its meeting in Seville in November 2011, the ICH Quality Implementation Working Group finalised three Points to Consider topics. Please find more about the new document which has been published on 6 December here.

more

14.12.11

Screening of Frequent Donors of Blood and Blood Components

The FDA published a Draft Guidance for Industry about the Implementation of Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components. Read more.

more

30.11.11

"Production Record Review" - The most frequently cited Paragraph in FDA Warning Letters

"Your firm has not thoroughly investigated the failure of a batch" - This is the most frequently cited criticism in the Warning Letters the US FDA issued to drug manufacturers in and outside the US in the Fiscal Year 2011. To get more information about the first results of the Warning Letters analysis that is annually published by Concept Heidelberg, please go here.

more

30.11.11

FDA wants to streamline the Classification of Blood and Plasma Recalls

To streamline the procedure for recall classifications and to save time and resources, FDA's CBER published the Direct Recall Classification Program for Blood and Plasma (DRC). More details can be found here.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics