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Publications

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23/04/2022

Practical Risk-based Guide for Managing Data Integrity

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14/03/2022

How to do – Interpretation of ICH Q7 Guide

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15/02/2022

Guidance on aspects of cleaning validation in active pharmaceutical ingredient plants

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17/06/2021

The APIC Audit Program

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23/03/2020

Nitrosamines

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31/10/2019

Supplier Management

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23/03/2019

GDP

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23/11/2018

Guideline Technical Change Control revised

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23/10/2018

Audits of RSM Suppliers

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23/10/2017

APIC Brochure

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23/10/2016

APIC Auditing Guide

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23/06/2015

Guidance on Handling of Insoluble Matters and Foreign Particles in APIs

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23/10/2014

Qualification of existing equipment

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23/07/2014

eCTD How to do Document

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23/10/2012

APIC Quick Guide for API Sourcing

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23/10/2012

Guideline for Qualification & Management of Contract Quality Control Laboratories

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23/10/2012

Quality Agreements

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23/10/2005

Quality Management System (QMS) for APIs

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23/10/2002

Computer Validation Guide

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