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GMP Inspections in Europe: Proven Strategies on How to Prepare

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TOP 5 GMP Downloads

1. GMP Audit Checklist
The GMP Audit Checklist works great for both sides - the auditor and the inspected company.


2. GDP Audit Checklist
More than 700 questions with reference to regulations for preparing and carrying out GDP audits.


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


4. Creating a Master Plan for Drug Warehousing, Transportation and Distribution
Guide to preparing a company for compliance with Good Distribution Practice (GDP).


5. A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance


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News about GMP/cGMP


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(FDA) has announced an initiative in the Center for Drug Evaluation and Research (CDER) involving the review of draft guidance documents issued before 2010. The CDER plans to determine their status, and to decide whether those guidances should be withdrawn, revised, or finalized with only minor changes.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.


The U.S. Food and Drug Administration has announced that the USA is now a “listed country” with the European Commission (EC) so that U.S. companies need not obtain an export certificate form the FDA before shipping certain pharmaceutical products to Europe.


Japan has been added to the "list of third countries" as regards standards of manufacture and supervision of active pharmaceutical ingredients equivalent to those of the EU.


Following consultation with relevant industry groups, TGA, the Australian Therapeutic Goods Administration, has announced the adoption of a number of EU/ICH guidelines in Australia, effective 1 June 2013.

These include, inter alia:

  • Guideline on plasma-derived medicinal products (EMA)
  • Guideline on active substance master file procedure (EMA)
  • Guideline on bioanalytical method validation (EMA)
  • Impurities: Guideline for residual solvents ICHQ3C(R5)

TGA: Newsroom


On 24 May 2013, the FDA has published a draft guidance for industry entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements”. The guidance describes the current thinking of the government authority on defining, establishing and documenting the responsibilities of all parties involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP).


The Chinese Authorities have recently released a few newslets, one concerning the “Written Confirmation for active substances exported to the EU”, an omnipresent topic.

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