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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

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.

 
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.

 
 
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