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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

2010-03-11

FDA published a Draft Guidance on "Adaptive Design Clinical Trials for Drugs and Biologics" on Feburary 25, 2010.

This guidance provides sponsors and the review staff in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) with information regarding adaptive design clinical trials when used in drug development programs. This guidance gives advice on topics such as (1) what aspects of adaptive design trials (i.e., clinical, statistical, regulatory) call for special consideration, (2) when to interact with FDA while planning and conducting adaptive design studies, (3) what information to include in the adaptive design for FDA review, and (4) issues to consider in the evaluation of a completed adaptive design study. This guidance is intended to assist sponsors in planning and conducting adaptive design clinical studies, and to facilitate an efficient FDA review.

 
2010-03-10

FDA issued the final guidance to help manufacturers who are developing safe and effective cell-based viral vaccines to address emerging and pandemic threats. The guidance was published on March 2, 2010 by the FDA (U.S. Food and Drug Administration.

Titled “Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications,” the document will aid manufacturers who wish to use new cell substrates for vaccine production, such as for influenza vaccines. Currently, all licensed influenza vaccines are produced in chicken eggs.

 
2010-03-09

On February 25, 2010 FDA published a Guidance for Industry "Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes".

This guidance provides recommendations to applicants on information to include in support of parametric release for sterile products terminally sterilized by moist heat when submitting a new drug application (NDA), abbreviated new drug application (ANDA), new animal drug application (NADA), abbreviated new animal drug application (ANADA), biologics license application (BLA), or supplement or other postmarketing report.

 
2010-03-08

On Feburary 5, 2010 the FDA published a Warning Letter, adressed to a manufacturer of medical devices (automated external defibrillator devices). The staff failed to identify and initiate CAPA-measures.

 
2010-03-03

A linguistic review of product information in all EU languages is performed. This should ensure high quality and consistent product information of Centrally Authorised Products in all Member States.

 
2010-03-03

On February 26, 2010 EMA announced, that in recognition of World Rare Disease Day (the last day of February), the FDA and the EMA have agreed to accept the submission of a single annual report from sponsors of orphan products (drugs and biologics) designated for both the US and the EU.

 
2010-03-02

The EUs Comittee on Herbal Medicinal Products (HMPC) has established the ‘Community list of herbal substances , preparations and combinations thereof for use in traditional herbal medicinal products’. The list is being gradually developed through entries of structured information relating to individual herbal substances or preparations.

 
2010-03-01

The European Commissions 1997 publication on Radiation Protection, concerning Radiation Criteria for Acceptability of Medical Radiological Equipment Used in Diagnostic Radiology, Nuclear Medicine and Radiotherapy, is going to be updated this year. According to the Council Directive 97/43/EURATOM the EU Member States' competent authorities shall adopt specific criteria of acceptability for equipment in order to indicate when appropriate remedial action is necessary. This includes, if appropriate, taking the equipment out of service.

 

 
 
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