Direct Links to important GMP API Guidelines

APIC CEFIC Auditing Guide

This document aims to set standards for audits in API production sites and to provide guidance for the implementation and maintenance of an effective audit system.

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APIC - Parametric Release document, December 2002

This document provides guidance for applications that propose parametric release for Active Pharmaceutical Ingredients and isolated intermediates that are intended for commercial use.

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2014/1252/EU Commission delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use

GMP for active substances for medicinal

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FDA COMPLIANCE POLICY GUIDE Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval

This Compliance Policy Guide explains the enforcement policy on the timing of the completion of certain validation activities for drug manufacturing and API manufacturing.

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APIC - Qualification of existing equipment (November 2004)

This document provides guidance for the qualification of existing equipment and utilities in API facilities.

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APIC - Technical Change Control Guideline 2004 (October 2004)

This document provides guidance on change control procedures for equipment, utilities and computerised systems in API facilities.

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The APIC Audit Programme - Version 5, July 2017

The APIC Audit Programme describes a standardised Third Party Auditing process.

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WHO Guidelines on active pharmaceutical ingredient master file procedure

These guidelines are intended to assist applicants in the compilation of the information on APIs in their dossiers for prequalification or when submitting a variation to a dossier on a prequalifi ed product (named in the text from now on as product dossier) when the APIMF procedure is used. It is also intended to help APIMF holders in the compilation of their APIMFs.

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WHO Good trade and distribution practices for pharmaceutical starting materials

Guideline with requirements for QS-System, Documentation, Transport, Warehousing, Recalls, Labeling for the handling of pharmaceutical starting materials (API & Excipients)

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WHO Good Manufacturing Practices: water for pharmaceutical use

The guidance contained in this document is intended to provide information about the available specifications for water for pharmaceutical use (WPU), guidance about which quality of water to use for specific applications, such as the manufacture of active pharmaceutical ingredients (APIs) and dosage forms, and to provide guidance on the good manufacturing practice (GMP) regarding the design, installation and operation of pharmaceutical water systems.

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GMP Conferences by Topics

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