Direkt Links to important GMP API Guidelines

PIC/S SOP - Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects (PI 010-4) Jan 2011

This procedure covers transmission of information by means of a Rapid Alert between the different parties relating to the recall of medicinal products which have quality defects, including counterfeit or tampered products, when urgent action is required to protect public health and animal health.

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APIC - List of Abbreviations & Acronyms

APIC List of Abbreviations & Acronyms

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APIC - Good manufacturing practices for Active ingredient manufacturers, with EFPIA, 1996

This joint CEFIC/EFPIA Guide describes the principles of GMP compliant manufacture of APIs.

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APIC - Quality Management System for Active pharmaceutical Ingredient manufacturers - Integrating GMP into ISO 9001, December 1997

This document gives detailed guidance for API manufacturers for implementing a Quality Management System.

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APIC - Manufacture of sterile active pharmaceutical ingredients - guidance 1999

This document provides guidance for the manufacture and handling of sterile APIs.

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APIC - Cleaning Validation in Active pharmaceutical Ingredient manufacturing plants - Policy, 1999

This document defines a comprehensive approach to the Validation of Cleaning procedures in Active Pharmaceutical Ingredient manufacturing facilities

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APIC - Good Manufacturing Practices in Active Pharmaceutical Ingredients Development, 1999

This document provides appropriate GMP requirements during APIs development from non-clinical studies to the submission of the Registration Dossier.

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APIC - Guidance on aspects of cleaning validation in active pharmaceutical ingredient plants, guidance 2000

This document is supposed to assist companies in the formulation of cleaning validation programmes

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APIC - GMPs for APIs: “How to do” Document - Interpretation of the ICH Q7 Guide - Version 8

This document provides an interpretation of “how to” implement the ICH Q7 Guide based on practical experience.

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APIC - Computer validation Guide, December 2002

This document provides guidance for the GMP-compliant use of computerised systems for the manufacture of an API or intermediate.

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GMP Conferences by Topics

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