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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.

 
2014-02-10

Today the European Commission has launched the public consultation on the revision of Annex 15: Qualification and Validation.

 
2014-02-04

Shortly after the FDA notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products due to particularly serious GMP deficiencies, health agencies in Europe are evaluating the FDA inspection findings to assess if these deviations from GMP have any implication on medicines on the European market. Additional information requested from the marketing authorisation holders in the EU and from Ranbaxy itself will also be considered.

 
2014-02-04

According to the Pharmaceutical Inspection Co-operation Scheme PIC/S, the PIC/S Committee has adopted the revision of the PIC/S GMP Guide (PE 009-11). The document will enter into force on 1 March 2014.

 
2014-02-04

The PIC/S Committee has adopted the revision of the PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments (PE 010-4), which includes a new Annex 3 on radiopharmaceuticals.

This revised document will enter into force on 1 March 2014.

 
2014-01-27

The Health Ministry of India has constituted a sub-committee to prepare guidelines regulating the transportation of drugs in the country. This is a significant step as at present there are no rules or guidelines to be followed by transport agencies.

 
2014-01-21

Early this month, the China Food and Drug Administration (CFDA) issued an announcement on the implementation of the Good Manufacturing Practice for Drugs (2010 Revision) for sterile pharmaceutical products.

 
2014-01-14

As part of its transparency initiative the European Medicines Agency (EMA) has already published details of manufacturers who have violated GMP.

 
 
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