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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


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.


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.


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.


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.


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


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.


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.


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.

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