Direct Links to important GMP API Guidelines

Annex 2 - Agreement on Audit Execution

Agreement on audit execution between customer, auditee, auditors and 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 2 - Letter to the API Manufacturer

Standardised Letter to the API Manufacturer

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Standardised Letters related to Shared 3rd Party Audits: Letter 3 - Letter from the API Manufacturer to the customer

Standardised Letter from the API Manufacturer to his customer

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APIC - Quality Management System (QMS) for Active Pharmaceutical Ingredients (API) Manufacturers - Integrating GMP (ICH Q7a) into ISO (9001:2000), September 2005

This document gives detailed guidance for implementing a QMS and provides a standard for API manufacturers.

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FDA Guidance for Industry: Process Validation: General Principles and Practices

This guidance outlines the general principles and approaches that FDA considers to be 21 appropriate elements of process validation for the manufacture of human and animal drug and 22 biological products, including active pharmaceutical ingredients (API or drug substance),

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Eudralex Volume 3 Note for Guidance on Quality of Water for Pharmaceutical Use

Guidance on the pharmaceutical use of different grades of water in the manufacture of APIs and medicinal products

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APIC - Quick Guide for API Sourcing, 2008

This document focuses on the interaction between the API manufacturer and the medicinal product manufacturer and provides possible measures that may be taken by both partners in order to ensure only non-rogue APIs are used in the manufacture of medicinal products.

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PIC/S Aide Memoire on INSPECTION OF ACTIVE PHARMACEUTICAL INGREDIENTS (PI 030-1)

Guide for inspectors for preparing an inspection of an API facility and the API production.

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FDA Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 11: Capillary Electrophoresis General Chapter

This annex is the result of the Q4B process for the Capillary Electrophoresis General Chapter

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GMP Conferences by Topics

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