Direct Links to important GMP API Guidelines

FDA Draft Guidance for Industry: Potency Assurance for Cellular and Gene Therapy Products

The scope of this guidance is limited to ensuring the effectiveness of CGT products regulated as biological products under Section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262). This guidance provides recommendations for ensuring the effectiveness of CGT products at all stages of their product life cycle. For investigational products, it explains how to implement a step-by-step strategy to ensure efficacy during product development. It also provides specific considerations for ensuring the efficacy of products undergoing rapid clinical development.

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.

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.

APIC - Statement on Good distribution practices

APIC - Quality Agreement for Laboratories; Guideline and Templates

Human Gene Therapy for Hemophilia - Guidance for Industry

Dieser Leitfaden enthält Empfehlungen für Sponsoren, die humane Gentherapie (GT)1-Produkte für die Behandlung von Hämophilie entwickeln, einschließlich des Designs klinischer Studien und der damit verbundenen Entwicklung von Gerinnungsfaktor VIII (Hämophilie A) und IX (Hämophilie B) Aktivitätsprüfungen, einschließlich der Frage, wie Diskrepanzen zwischen Faktor VIII und Faktor IX Aktivitätsprüfungen beseitigt werden können. Dieser Leitfaden enthält auch Empfehlungen zu präklinischen Überlegungen zur Unterstützung der Entwicklung von GT-Produkten zur Behandlung von Hämophilie.

Page 7 of 9