Direct Links to important GMP API Guidelines

ICH E2A CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING

This document gives standard definitions and terminology for key aspects of clinical safety reporting. It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development.

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APIC - GUIDANCE ON ASPECTS OF CLEANING VALIDATION IN ACTIVE PHARMACEUTICAL INGREDIENT PLANTS

The document reflects the outcome of discussions between APIC member companies on how cleaning validation requirements could be fulfilled and implemented as part of routine operations.

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Auditing Guide - Annex 1 – Pre-Audit Questionnaire

The purpose of this questionnaire is to facilitate the preparation of the auditors for the audit at the API manufacturer's site.

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Auditing Guide - Annex 3 – Audit Report Template

This template provides a standard for reports fo audits conducted within the framework of the APIC Audit Program.

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ICH Q11 Guideline: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers

This document provides clarification to improve harmonisation of the considerations for the selection and justification of starting materials for API syntheses.

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APIC - Statement on Good distribution practices

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APIC - Quality Agreement for Laboratories; Guideline and Templates

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API-Mix (or mixtures) and CEPs

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APIC - Guideline for the Establishment of a Control Procedure for Technical Equipment, including related Utilities, Computerised Systems and Facilities used in the Manufacture of APIs and Intermediates (revised Nov.2018)

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APIC - GMPs for APIs: "How to do" Document - Interpretation of the ICH Q7 Guide Version 11

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GMP Conferences by Topics

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