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TOP 5 GMP Downloads

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

 

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

 

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

 

4. Risk Management
Apart from factual content you will find many tables, examples, forms, which can be used in daily practice.

 

5. Documenting Process Validation – A Drugmaker’s Guide
Document process validation in a way that’s sure to satisfy – and impress – regulators.

 

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News about GMP/cGMP

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.

 
2014-12-16

Before the end of the year the European Commission has published the “Commission Delegated Regulation (EU) No. 1252/2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use”. The regulation was issued on 25 November 2014 in the Official Journal of the European Union and has entered into force on 15 December 2014.

The regulation is binding in its entirety and directly applicable in all Member States of the European Union.

 
2014-12-09

The EMA has published the final version of the „Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”. The document was long expected and aims to recommend an approach for deriving a scientifically based threshold value for individual active substances to be applied for risk identification.

 
2014-12-03

A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product (reference medicinal product) in the EEA. The EMA has published a revised version of the guideline "Guideline on similar biological medicinal products". It outlines the general principles to be applied for similar biological medicinal products (also known as biosimilars) as referred to in Directive 2001/83/EC and includes the following categories:

 
2014-11-21

Officials of Australia and New Zealand have confirmed the plan to stop the development of the joint regulatory authority ANZTPA. The decision was taken following a comprehensive review of progress and assessment of the costs and benefits to each country.

 
2014-11-21

This month representatives of the FDA have met with their cross-agency team from the EMA, the European Commission and GMP experts form European Union Member States in London, in order to make progress on mutual reliance on GMP inspections. The event was the first face-to-face meeting of both complete teams to discuss how EMA and FDA can collaborate in the field of inspections.

 
2014-11-14

The FDA has published the following two updated lists of guidelines:

 
2014-11-11

ISPE released its Drug Shortages Prevention Plan during the 2014 Annual Meeting in Las Vegas, Nevada. ISPE developed the plan in response to global regulatory interest in preventing drug shortages due to manufacturing and quality issues. The plan addresses shortages at both the product and process levels. It lays out how industry can best prevent drug shortages by identifying the root causes of supply disruptions and creating a quality culture that will ensure a robust, resilient and reliable supply of medications to patients worldwide.

 
 
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