New Method to Directly Sequence Small Genomes Without Library Preparation

For the first time, researchers sequenced DNA molecules without the need for the standard pre-sequencing workflow known as library preparation. Read more here.


New USP Publication: Monitoring Humidity during Transportation?

What are the risks of humidity excursions during transportation of products (medicinal products, APIs, intermediates)? A current publication in the USP Pharmacopeial Forum has examined the question. Read more here about the USP article.


PIC/S issues Update of GMP Guide

Mid of December 2012 the PIC/S (Pharmaceutical Inspection Co-Operation Scheme) issued an update of their GMP Guide. Particularly Part 1 (medicinal products) and the annexes were updated. Read more.


Swiss GMP standards and inspection equivalent to EU

The EU Commission has announced on 22 November 2012 that Switzerland has been listed as the first country with equivalent standards in the manufacture of active pharmaceutical ingedients (APIs) to those of the EU. Click here to read more


FDA provides information about influence of wheather conditions on biological products

The FDA's CBER provides information on the impact of severe weather conditions on biological products, e.g. Vaccines, blood and plasma. More details can be found here.


USP Postpones the Publication of General Chapters <232> and <233> on Metallic Impurities

The introduction of the USP chapters in metallic impurities originally planned for 1st December 2012 has been postponed. Read more here about USP's reasons for that decision.


EMA publishes Concept Paper on the Revision of Annex 15

In November 2012, the EMA released a Concept Paper of 3 pages on the revision of Annex 15. The introduction presents the reasons why the EMA has planned the revision, Read more here.


New Concept Paper on Annex 17 of the EU GMP Guide

The European Medicines Agency EMA has published a draft concept paper on the revision of Annex 17 (Parametric Release). Read more.


Pharmaceutical Standards in Israel and EU Equivalents

The European Parliament accepted the so called ACAA agreement between the European Union and Israel on October 23, 2013. Click here to read more


ECA publishes Good Practice Guide on Process Validation

An ECA Working Group has developed a Version 1 of a Good Practice Guide on Validation. This document is intended to provide support to both regulators and industry. Go here to read more.


How to Manage Efficiently Annual GMP Trainings?

Chapter 2 Personnel of the EU GMP Guide lays down that employees must be instructed on GMP regularly. The challenge raised is how to manage efficiently annual GMP trainings? Read more in the News.


FDA-approval for Roche’s nucleic acid based (PCR) Rapid Mycoplasma Test (MycoTOOL® PCR Mycoplasma Detection Kit)

On November 1st, 2012, the MycoTOOL® PCR Mycoplasma Detection Kit-based test from Roche Applied Science was approved by the U.S. Food and Drug Administration (FDA) for release testing of a  Roche biopharmaceutical product. More details here.


ICH plans Q&A on ICH Q7

The International Committee for Harmonisation (ICH) has published a concept paper on 17 October 2012. According to the announcement the ICH Implementation Working Group (Q7 IWG) is currently working on a Q7 Question and Answer document. Go here to read more.


New guideline for DNA Sequences could prevent erroneous Data

A international team of researchers, with it’s core at the University of Gothenburg, Sweden, has prepared a guide to assist the scientific community in the quality control process. Find out more.


News from the PIC/S

The Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S) has published a press release about the PIC/S’s meetings held in Ukraine from 30 September to 5 October 2012. What's new in the PIC/S?


Revision of USP 1223 - current Status

The Vice-Chair of the USP General Chapters – Microbiology Expert Committee, Tony Cundell, recently provided an update to the chapter’s revision process and what we should see when the draft is published in a future issue of the Pharmacopeial Forum. Read more.


Rapid Micro Biosystems announces Availability of Growth Direct System

New applications should improve the efficiency of microbial quality control processes while significantly reducing the time-to-result. More details can be found here.


EMA announces streamlining of activities of Committee for Advanced Therapies

To optimise the efficiency of EMA and the Committee for Advanced Therapies' in the field of ATMP, EMA has streamlined the activities of the CAT. More details here.


Commitee for Advanced Therapy Medicinal Products (CAT) - Public Call for Expression of Interest

For membership in the Committee for Advanced Therapy Medicinal Products (CAT), the European Commisiion published a public call for interested representatives of patients' associates and clinicians. Read more here.


New EMA Q&As on Genotoxic Impurities

In June 2012 the EMA posted a new question in the Q&A part on quality of medicines regarding how to set specifications for genotoxic and potentially genotoxic impurities. Read more.


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