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TOP 5 GMP Downloads

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

 

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

 

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

 

4. Technical Agreement
and Delimination of Pharmaceutical Responsibilities.

 

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

 

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News about GMP/cGMP

2014-03-26

The EMA has published the final version of the long awaited Guideline on Process Validation “Guideline on process validation for finished products – information and data to be provided in regulatory submissions” on February 24, 2014. It will enter into force in August 2014.

 
2014-03-26

The FDA plans to reduce its number of routine GMP inspections in the U.S. by 40 % and thus to scale up its inspections overseas. This new strategy shall improve the quality of drugs imported into the U.S. and will bring the FDA closer to achieving its longtime goal of bringing parity to domestic and foreign inspections.

 
2014-03-04

The FDA has published a Draft Guideline for Industry entitled Analytical Procedures and Methods Validation for Drugs and Biologics. The revised document supersedes a draft of the year 2000 and – once finalized – will also replace the 1987 FDA Guidance on Submitting Samples and Analytical Data for Method Validation.

 
2014-03-04

The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set up a new 'cluster' on pharmacovigilance (medicine safety) topics.

 
2014-02-24

The FDA initiates the Secure Supply Chain Pilot Program to enhance the security of imported drugs. So far thirteen prequalified companies have been accepted for participation and will receive expedited entry for the importation of up to five selected drug products into the United States.

 
2014-02-24

The CFDA has announced the adoption of the draft amendment to the Regulations for the Supervision and Administration of Medical Devices at the executive meeting of the State Council on February 12, 2014. The regulations will be promulgated and implemented soon.

 
2014-02-20

As announced by the Swiss Regulatory Authority Swissmedic, a Memorandum of Understanding in the area of therapeutic products was signed with the Korean Ministry for Food and Drug Safety (MFDS). This was part of a state visit of the President of the Republic of Korea.

 
2014-02-12

The FDA has published its yearly guidance agenda including the new and revised draft guidances CDER is planning to publish during the calendar year 2014.

 
 
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