Direct Links to important GMP API Guidelines

WHO Supplementary guidelines on Good Manufacturing Practices: Validation

Guideline with focus on the overall concept of validation (API and Medicinal Products)

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WHO Good Distribution Practice for pharmaceutical products

WHO Guideline with requirements for distribution of pharmaceutical products (not API & Excipients)

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WHO Propasal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate release, solid oral dosage forms

This paper aims to give national authorities sufficient background information on the various orally administered active pharmaceutical ingredients (APIs) on the WHO Model List of Essential Medicines (EML), also taking into account local usage of the API, to enable them to make an informed decision as to whether generic formulations should be subjected to in vivo bioequivalence (BE) studies or whether a biowaiver can be granted.

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PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-14) Part II

Covers APIs used as starting materials

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APIC Qualification of existing equipment

However APIC recognized there is only limited guidance with respect to the qualification of existing equipment. Therefore APIC has prepared a document to reflect current thinking of the API manufacturing industry on this matter.

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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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GMP Conferences by Topics

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