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Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.


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News about GMP/cGMP


On 24 September 2013, the European Commission adopted two measures to improve the safety of medical devices. The new rules are:

  • A Commission Implementation Regulation clarifying the criteria to be met by notified bodies, which are responsible for inspecting manufacturers of medical devices, and
  • A Recommendation clarifying the tasks these bodies have to undertake when they perform audits and assessments in the medical devices sector.

The European Commission has published the final version of the revised Chapter 2 on Personnel. Changes have been made in order to integrate the principles of “Pharmaceutical Quality System” as described in the ICH Q10 tripartite guideline. Furthermore, a section on consultants has been added.


The number of PIC/S members is constantly growing. According to PIC/S, Hong Kong SAR’s Pharmacy and Poison Board has applied for PIC/S membership. Rapporteurs for this accession will be appointed at the next PIC/S Committee Meeting in Ottawa in October.


The Falsified Medicines Directive (FMD) has now been transposed into UK legislation and came into force on August 20, 2013. The FMD (Directive 2011/62/EU) introduces a series of measures to prevent the entry of falsified medicines and substandard raw materials into the legal supply chain, including stricter rules on the controls and inspections of producers of active pharmaceutical ingredients (APIs), intensified record-keeping requirements for wholesale distributors, and a common EU-wide logo to identify legal online pharmacies.


FDA is announcing the start of the Secure Supply Chain Pilot Program (SSCPP) in order to assist the Agency in its effort to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the FDA to focus its resources on imported drugs that fall outside the program and may pose risks.


The World Health Organization - supported by the IPEC Federation Member Groups - is currently in the process of revising and updating the „Good Trade and Distribution Practices for Pharmaceutical Starting Materials“ – WHO GTDP guide -  which is open for comments for a restricted audience only until September 2013.

The draft is not to be displayed on any web site and will be presented to the WHO Expert Committee during the 48th meeting in October 2013. Following adoption, the IPEC Federation will update its own guide in line with that of WHO.


WHO: Current Projects


The ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in July 2013 and now enters the consultation period (Step 3).


The US Food and Drug Administration's (FDA) has announced an initiative in the Center for Drug Evaluation and Research (CDER) involving the review of draft guidance documents issued before 2010. The CDER plans to determine their status, and to decide whether those guidances should be withdrawn, revised, or finalized with only minor changes. The new initiative was published in the latest edition of the Federal Register.


The FDA has issued a new guidance for "Safety Labeling Changes — Implementation of Section 505(o)(4) of the FD&C Act”. This section authorizes the FDA to require certain drug and biological product application holders to make safety-related labeling changes based on new safety information that becomes available after approval of the drug or biological product.


The Australian Therapeutic Goods Administration (TGA), part of the Department of Health and Ageing, has published an outline of its international engagement strategy for the next three years. It links current Australian government priorities for international engagement that are necessary to support effective therapeutic goods regulation with the TGA's business-as-usual activities and sets clear goals for international engagement activities.


The FDA published a draft on “Cosmetic Good Manufacturing Practices” in order to assist industry and stakeholders to identify the standards and issues that can affect the quality of cosmetic products. The document revises the “Cosmetic Good Manufacturing (GMP) Guidelines/Inspection Checklist” by updating it to set forth current practice and clarify certain topic areas based on recent experience.


The European Commission has published a draft of Annex 16 “Certification by a Qualified Person and Batch Release” of the EU GMP Guidelines. The Annex has been revised to reflect the globalisation of the pharmaceutical supply chains and the introduction of new quality control strategies. Furthermore, the ICH documents Q8, Q9 and Q10 were implemented.


FDA is announcing the availability of a guidance for industry entitled Heparin for Drug and Medical Device Use Monitoring Crude Heparin for Quality“. The need for the guidance can be traced back to 2007 and 2008, when heparin sourced from Chinese manufacturers killed 149 US citizens.


COFEPRIS, Mexico’s Ministry of Health, through the Federal Commission for Protection against Health Risks has updated the requirements on GMP for active pharmaceutical ingredients comparable to those of the European Union. The new GMP requirements enter into force immediately and are mandatory for all establishments engaged in the manufacture and distribution of APIs.

With this standard, Mexico believes to have met the requirement for API exports to the EU under the EU Falsified Medicines Directive, which came into force on 2 July 2013.

So far, COFEPRIS has published a Spanish version of the document..


RAPS: News


The WHO Expert Committee on Specifications for Pharmaceutical Preparations has published the Technical Report 981 which includes Annex 2, the WHO guidelines on quality risk management. QRM is the overall and continuing process of appropriately managing risks to product quality throughout the product's life-cycle in order to optimize its benefit–risk balance. It is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively.

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