Direct Links to important GMP API Guidelines

APIC - Guidance on Handling of Insoluble Matter and Foreign Particles in APIs

This Guidance provides recommendations on GMP-compliant handling of foreign particles in active pharmaceutical ingredients.

2012/715/EU Commission implementing decision of 22 November 2012 establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities

list of third countries with a regulatory framework applicable to active substances like in the EU

APIC - eCTD How to do Document

This document provides guidance on how to document API quality in the eCTD.

APIC - GDP for APIs: "How to do" Document

This document provides guidance on how to implement the requirements of ICH Q7.

FDA Guidance for Industry: Completeness Assessments for Type II API DMFs under GDUFA

This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA), an amendment to an ANDA, a prior approval supplement (PAS) to an ANDA, or an amendment to a PAS (generic drug submissions).

Eudralex Volume 3 Quality Working Party questions and answers on API mix

This document provides information on how mixtures of active pharmaceutical ingredient and excipients (API mix) are considered in a marketing authorisation procedure.

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.

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.

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.

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.

Page 7 of 9