Direct Links to important GMP API Guidelines

FDA Guidance for Industry: Cellular Therapy for Cardiac Disease

This guidance provides you, sponsors who are developing cellular therapies for the treatment of cardiac disease, with recommendations on the design of preclinical1 and clinical studies, and on the chemistry, manufacturing, and controls (CMC) information to include in an investigational new drug application (IND) for cardiac cellular therapy.

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Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Guidance for Industry

Empfehlungen bezüglich der Prüfung auf RCR bei der Herstellung von Produkten der retroviralen vektorbasierten Gentherapie und bei der Nachbeobachtung von Patienten, die retrovirale vektorbasierte Gentherapieprodukte erhalten haben.2 Die Empfehlungen umfassen die Identifizierung und die Menge des zu prüfenden Materials sowie allgemeine Testmethoden. Darüber hinaus werden Empfehlungen für die Überwachung von Patienten hinsichtlich des Nachweises einer retroviralen Infektion nach Verabreichung von retroviralen vektorbasierten Gentherapieprodukten gegeben.

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APIC CEFIC Auditing Guide

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APIC - Guide for auditing Registered Starting Material manufacturers

This document is intended to give guidance on auditing manufacturers of registered starting materials.

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Eudralex Volume 2C Guidance on elements required to support the significant benefit in comparison with existing therapies of a new therapeutic indication in order to benefit from an extended (11 years) marketing protection period (November 2007)

This guidance outlines the level of evidence required to support extended marketing protection period based on a new therapeutic indication.

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Eudralex Volume 3 NOTE FOR GUIDANCE ON Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

This document is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin (i.e. mammalian, avian, insect) and outlines data that should be submitted in the marketing application/registration package. For the purposes of this document the term virus excludes nonconventional transmissible agents like those associated with Bovine Spongiform Encephalopathy (BSE) and scrapie. Applicants are encouraged to discuss issues associated with BSE with the regulatory authorities.

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Eudralex Volume 3 Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems (non-polymeric surfactants)

Requirements on the development of insoluble APIs which are enhanced in solubilty by using surfactants

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Annex 1 - Contract between Auditor and the API Compliance Institute

Contract between Auditor and the API Compliance Institute.

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Annex 3 - Secrecy Agreement

Secrecy Agreement between customer, auditee, auditors and API Compliance Institute.

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Standardised Letters related to Shared 3rd Party Audits: Letter 1 - Letter to the Manufacturing Authorisation Holder, Letter 2 - Letter to the API Manufacturer, Letter 3 - Letterfrom the API Manufacturer to the customer

Standardised Letter to the Manufacturing Authorisation Holder

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GMP Conferences by Topics