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News about GMP/cGMP

2015-04-01
 
2015-03-26

On 20 March 2015 the WHO has published a report on substandard/spurious/falsely-labelled/falsified/counterfeit medicinal products (SSFFCs). The report was developed during a Member State Meeting on SSFFC in October 2014 in Geneva, Switzerland. It includes recommendations for health authorities to detect and deal with actions, activities and behaviours that result in SSFFCs.

 
2015-03-13

In November 2014 the ICH Steering Committee endorsed an Implementation Working Group (IWG) tasked to develop a Questions and Answers document on ICH Q11 – Development and Manufacture of Drug Substances.

 
2015-03-06

The U.S. Food and Drug Administration (FDA) has published their yearly list of new and revised draft guidances CDER is planning to publish in 2015. The guidances are categorized in 14 different themes - from A (Advertising) to P (Procedural).

 
2015-03-06

EMA has published the work plan of the GMP/GDP Inspectors Working Group for 2015. The plan covers the different tasks of the group, e.g. harmonisation of inspections, mutual recognition agreements (MRAs) (maintenance, extension of scope) and GMP/GDP topics.
The list of GMP documents for revision contains the usual suspects – like Annex 15, but also the totally new Annex 21 on importation of medicinal products.

 
2015-02-25

The U.S. Food and Drug Administration (FDA) issued five draft documents related to drug compounding and repackaging to help entities in complying with important health provisions. The draft documents apply to outsourcing facilities, federal facilities, pharmacies and physicians. The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), enacted by Congress in November 2013.

 
2015-02-11

The European Medicines Agency (EMA) has released a Concept Paper on the Revision of Annex 1 of the Guidelines on Good Manufacturing Practice – Manufacture of Sterile Medicinal Products which addresses the need to update Annex 1 of the European GMP Guide. Annex 1 is common to the Member States of the European Union/European Economic Area as well as to the participating authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

 
2015-01-30

FDA has released a draft of the Guidance on cGMP requirements for combination products. The document is far more comprehensive than the actual version of 21 CFR 4 and consists of 46 pages.

 
2015-01-30

New versions of Chapter 3 (Premises and Equipment) and Chapter 5 (Production) have been published providing transitional arrangements for toxicological evaluation. The chapters are otherwise unchanged – apart from an editorial correction of footnote 2 in Chapter 5 – and become operational on 1 March 2015 for all other aspects.

 
2015-01-23

China’s Food and Drug Administration (CFDA) has issued the country’s first Good Supply Practices (GSP) regulations that apply to all Class 1, 2 and 3 medical device distributors, as well as third-party logistics service providers for medical devices.

 
2015-01-23

China’s Food and Drug Administration (CFDA) has revised the Good Manufacturing Practice for Medicinal Devices in accordance to the newly revised Regulations for the Supervision and Administration of Medical Devices and Administrative Measures for the Supervision of Medical Device Manufacturing.

 
2015-01-16

FDA Center for Drug Evaluation and Research (CDER) launched an Office of Pharmaceutical Quality (OPQ) as part of its ongoing Quality Initiative. This new office plans to create a drug quality program as the programs the agency already has in place for drug safety and efficacy.

 
2015-01-14

The ICH Q3D Guideline on Elemental Impurities reached Step 4 of the ICH Process in December 2014 and now enters the implementation period (Step 5). The new guidance has been developed to provide a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.

 
2015-01-09

The US Food and Drug Administration (FDA) has just released a list of all new and revised draft guidances it plans to release in 2015. The list is published on an annual basis by FDA's CDER.

 
2014-12-16

The ICH Steering Committee (SC) and its Expert Working Groups (EWGs) met in Lisbon, Portugal on November 8–13, 2014. The meeting was hosted by the European Commission and included over 300 participants.

 
 
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