What Is Wrong with APIs from China and India?

API manufacturers from India and China have more and more explaining to do. How is it possible that almost all of the CEPs withdrawn by the EDQM due to GMP inspections come from Asia, especially from India and China? Read more here.


Free Access to WHO GMP Inspection Reports

On the web page of the WHO Prequalification of Medicines programme, public inspection reports (WHOPIR) are published. A WHOPIR reflects the inspection report and gives a summary of the observations and findings made during the inspection, mainly at sites in India and China. Read more.


Shared Audit at Pfizer's Manufacturing Site in the US

On 15-16 March 2010, a regular re-audit was performed at Pfizer Global Manufacturing in Kalamazoo, USA. Click here to read more.


European Commission Will Revise IVD Guideline

The European Commission has recognised the need to update the IVD Directive to the state of the art. A questionnaire hints at the possible changes. Read more here…


Stability of Pharmaceutical Bulk Products - Which Data Are Dossier-Relevant?

The relevant guidelines on stability testing of active pharmaceutical ingredients and finished medicinal products provide hardly any information on the stability data of pharmaceutical bulk products that have to be included in the dossier for a marketing authorisation. Now the EMA gives answers to the most important questions in its Q-and-A section. Read more here.


Changes in the Pharmacopoeia: how to submit a Variation?

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human, CMD(h) has published an updated version of its Q&As on Variations according to Commission Regulation (EC) 1234/2008. In the latest revision, a question regarding pharmacopoeial updates was added. Read more.


WHO revises Good Distribution Practices for Pharmaceutical Products

With the revision of the WHO Technical Report Series No. 957 in June 2010, the WHO has also updated Annex 5 "WHO good distribution practices for pharmaceutical products". Read more about the changes.


FDA includes Remanufacturers of Medical Single-Use Devices in cGMP Rules

In Vol. 75, No. 121 of the Federal Register, the FDA announces the inclusion of remanufacturers of hospital single-use devices in the cGMP/QS rules (21 CFR 820). The FDA intends to bind the remanufacturers fully to the requirements. Read more here.


MHRA publishes new Enforcement Strategy

A new enforcement strategy has been published by the Inspection, Enforcement and Standards Division of the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA). Read more.


New draft of ISO 14644-9 - Classification of Surface Cleanlinesss

The Institute of Environmental Sciences and Technology announced that the Part 9 of ISO 14644 is now a Final Draft International Standard (FDIS). Read more here.


How to Facilitate the Transition between Process Validation and Continuous Verification

Jean-Marie Geoffroy, PhD, from Takeda Global Research & Development, USA, explains which factors are important in order to achieve modern concepts of process validation or even continuous verification instead of traditional process validation. You'll find further information here.


FDA Proposes to Publish More Information about Inspection Planning and Outcomes

The FDA has established an FDA Transparency Task Force. Among many other topics inspection-relevant information may also be published in much more detail in the future. Click here to read more.


WHO publishes new Guideline for the preparation of a CRO Master File

With the revision of the WHO Technical Report Series No. 957 in June 2010, the WHO has also published a new Annex 7 "Guidelines for the preparation of a contract research organization master file". Read more.


FDA Videos on Quality by Design Initiatives

Some presentations by FDA representatives are available on the Web. These presentations are helpful to understand the new approach. Go here to read more.


WHO Adopts GMP for APIs from the ICH Q7 Guideline - additional explanations added

In the recently published Technical Report Series No. 957, the WHO revised a number of annexes. For Annex 2 the wording of the ICH Q7 Guideline was adopted as a whole. The appendices that have been added to this annex in order to clarify some important GMP issues are highly interesting. Read more.


FDA publishes Draft Guidance on CMC Postapproval Changes (Annual Reports)

The US Food and Drug Administration, FDA issued a draft guidance for industry, CMC Postapproval Manufacturing Changes Reportable in Annual Reports, providing recommendations to drug applicants about the types of changes that may be included in annual reports. Read more.


WHO Publishes Guide on the Handling of Highly-Active Substances

In June 2010, with Annex 3 to TRS 957, the WHO published a new guide on the handling of hazardous or highly-active substances. Read more.


Guidance for the use of UK Stand Alone Contract Laboratories published

The Guidance on the use of UK stand alone contract laboratories has been updated to provide clarification on the use of UK contract laboratories. Read more.


USP 1050 Viral Safety of Biotechnology Products Derived from Cell Lines of Human or Animal Origin - proposed Revision

The USP General Chapter 1050 - "Viral Safety Evaluation of  Biotechnological Products Derived from Cell Lines of Human or Animal Origin" is under revision.  After 10 years, the document will be updated now with respect to the developments in the field of viral clearance. Read more here.


Authority Statement on Validation in Pharmaceutical Development

The Danish Medicines Agency (DKMA) is running a web page on FAQs on Annex 13 of the EU GMP Guide (Manufacture of investigational medicinal products). One interesting Q&A is dealing with validation of critical manufacturing processes. Read more.


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