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News about GMP/cGMP

2016-12-05

The ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) regarding the selection and justification of starting materials, reached Step 2b of the ICH process and enters the consultation period.

 
2016-12-05

The ICH Q3C(R6) Guideline “Impurities: Guideline for Residual Solvents” reached Step 4 of the ICH Process in November 2016 and now enters into the implementation period (Step 5).

 
2016-11-29

On 22 November, 2016, the US Food and Drug Administration (FDA) finalized its long awaited Guidance on Contract Manufacturer Quality Agreements.

 
2016-11-25

On 23 November 2016, the US Food and Drug Administration (FDA) released a Revision 1 of the draft guidance to Quality Metrics which was initially published in July 2015. The revision with the new title “Submission of Quality Metrics Data” came on short notice and is open for comments and suggestions until 24 January 2017.

 
2016-11-18

On 5-10 November 2016, the International Council for Harmonisation (ICH) met in Osaka, Japan, for its assembly meeting and has now published a press release.

 
2016-11-03

In October, the 15th round of negotiations for TTIP (Transatlantic Trade and Investment Partnership) took place in New York. The European Commission has now published a report, which covers inter alia the mutual recognition of US/EU-GMP-inspections.

 
2016-10-21

Not only China and India are in the focus of the US FDA when it comes to GMP non-compliance. Recently the FDA has released warning letters for cGMP violations identified in Scotland, the Netherlands and Switzerland.

 
2016-10-21

According to RAPS, the CFDA (Chinese Food and Drug Administration) has released a draft guidance on drug data management practices. The paper is addressed to manufacturers, developers and distributors of pharmaceutical products and aims at an accurate, timely and traceable recording of data.

 
2016-10-10

On 4 October 2016, EMA published an interesting Concept Paper on Good Manufacturing Practice and Marketing Authorisation Holders (MAH). The document aims at giving clarity and a better understanding as to what the responsibilities of MAHs actually are in their  totality, and what they mean at a practical level.

 
2016-10-07

The European Directorate for the Quality of Medicines and Healthcare (EDQM) announced a new agreement with Japanese authorities. The intention is to share more information on the outcome of GMP inspections of manufacturing sites of active pharmaceutical ingredients (APIs) that are of interest to both Europe and Japan.

 
2016-10-04

FDA’s Center for Drug Evaluation and Research (CDER) published a comprehensive Report on the Drug Safety Priorities 2015-2016: Initiatives and Innovation. It highlights the key safety priorities and details FDA’s mission for ensuring drug safety and the protection of public health.

 
2016-09-18

The European Commission has published a revised Version 7 of its Question and Answers Document that sets out frequently asked questions on importation of active substances for medicinal products for human use. This document is continuously updated and further supplemented.

 
2016-09-13

Almost one year ago, on 15 September 2015, the European Commission published a comprehensive draft version of Annex 17: Real Time Release Testing (we reported). The seven-page document was open for public consultation until December 2015. All in all 12 responses were received which have now been published on the Commission's website.

 
2016-09-09

As previously announced, the International Council on Harmonization (ICH) has now published the additional two training modules to ICH Q3D Elemental Impurities on its website. The modules 8 (case studies) and 9 (FAQs) are part of a comprehensive training programme prepared by the ICH Implementation Working Group (our news of March 2016).

 
2016-09-02

According to pharmabiz.com, the Indian Central Drug Standards Control Organization (CDSCO) is planning to recruit 500 more drug inspectors by the end of 2017. Up to now 147 inspectors have already been trained to enhance inspections of manufacturing units in line with current Good Manufacturing Practices (cGMP).

 
 
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