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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


EMA published some days ago the Concept Paper on the Revision of the Guideline on Process Validation. This concept paper aims to update the guideline on Process Validation; due to the development of new ICH guidelines Q8, Q9 and Q10, this guideline is being reviewed in order to implement the concepts highlighted in the ICH guidelines.


EMAs Committee for Medicinal Products for Human Use (CHMP) has published the Draft "Guideline on Real Time Release Testing (formerly Guideline on Parametric Release)".


The GMP Experts of Maas & Peither have published an Online GMP Glossary free of charge.


As the requirements for related substances in Ph. Eur. monographs have been adapted in accordance with the principles of ICH Guideline Q3A(R2), there is a need for more appropriate format for quantitative purposes. The Chairs of EDQM's Chemical Groups have developed a model text to which new or revised monographs would be adapted.


What kinds of products and facilities does the Food and Drug Administration (FDA) inspect? Who conducts these inspections? What do they look for?

On Thursday, March 25th, at 2 p.m. ET, the FDA will host a webinar that answers these questions and more. The featured speaker, Michael Rogers, Deputy Director, Office of Regional Operations, will discuss how FDA staff inspect domestic and foreign establishments, check shipments of imported product, and collect and test samples for signs of contamination.


FDA published a Draft Guidance on "Adaptive Design Clinical Trials for Drugs and Biologics" on Feburary 25, 2010.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


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.


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.

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