Skip to main content Skip to search Skip to main navigation
News: Europe

PDA: New Publications and Formation of the D/A/CH Chapter

During the press conference of the PDA/FDA Joint Regulatory Conference 2024, PDA (Parenteral Drug Association) announced interesting new publications and the formation of the new D/A/CH Chapter to support local members.

New publications include:

  • Updated Technical Report 68 “Risk-Based Approach for Prevention and Management of Drug Shortages“
    Based on the impact this issue has to the pharmaceutical companies and the patients they supply, PDA provides this updated report free of charge globally.
  • In October the book “Global Sterile Manufacturing – Regulatory Guidance Comparison & Assessment Tools“ will be published.
    The book compares guidances from the FDA, EU, WHO, PIC/S, Canada, China and Japan. It simplyfies the challenging task of looking across regulatory guidances to ensure global compliance. It comes with explanations and Excel® files to work with.

PDA formed the new D/A/CH Chapter. The chapter region consists of Germany, Austria and German-speaking Switzerland. The chapter is led by Richard Denk of SKAN AG, Switzerland.


Source:

PDA Press Conference, 9 September 2024, Washington, DC

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

News: EMA

EMA Clarifies Batch Numbering for Parallel-Traded Medicines

EMA updated its GMP/GDP Q&A collection by revising the answer to Question 4 concerning Chapter 5 of the EU GMP Guide. It explains which batch numbers should appear on the packaging of parallel-traded medicines.

Read more
Question of the Week | GMP-Verlag

Why is it Important to use Consistent Microbiological Air Monitoring Methods in Pharmaceutical Cleanrooms?

Here's the answer:
Read more
Cleaning Validation: When PDE Reports and the Worst-Case Selection do not Align

Cleaning Validation: When PDE Reports and the Worst-Case Selection do not Align

Robust PDE reports form the basis of risk-based cleaning validation. This article highlights common deficiencies identified during GMP inspections and explains how they can be avoided.

Read more
News: Europe

EDQM: New Working Party on 3D-printed Medicinal Products

The European Pharmacopoeia Commission (EPC) approved the creation of a working party on 3D-printed medicinal products. Its aim is to support the development of appropriate quality standards in the European Pharmacopoeia (Ph. Eur.).
Read more
EMA: 14 New Nitrosamines for Appendix 1

EMA: 14 New Nitrosamines for Appendix 1

Appendix 1 of EMA’s Questions and Answers on nitrosamine impurities has been updated. This appendix contains acceptable intakes (AIs) established for N-nitrosamines.
Read more
WHO: Draft Revision of its Guidelines on Quality Risk Management

WHO: Draft Revision of its Guidelines on Quality Risk Management

WHO published a revised draft of its “WHO guidelines on quality risk management”. Working document QAS/26.994 is open for public comment until 15 November 2026.
Read more
Previous
Next