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ICH Quality Implementation Working Group POINTS TO CONSIDER ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation Document date: 16 June 2011 International Conference on Harmonization of Technical Requirements

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Date 14 December 1987 Revision Date 13 June 1987 Publishing License ICH Author ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) ISBN 0-06-131798-1 1.5.3.

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What is ich quality implementation working?

ICH Quality Implementation Working provides guidance on the development, registration, and post-approval changes of pharmaceutical products.

Who is required to file ich quality implementation working?

Pharmaceutical companies and manufacturers are required to file ICH Quality Implementation Working.

How to fill out ich quality implementation working?

ICH Quality Implementation Working can be filled out by following the guidelines provided by the International Council for Harmonisation (ICH) and submitting the required documentation and information.

What is the purpose of ich quality implementation working?

The purpose of ICH Quality Implementation Working is to ensure the quality, safety, and efficacy of pharmaceutical products by providing standardized guidelines for their development, registration, and post-approval changes.

What information must be reported on ich quality implementation working?

ICH Quality Implementation Working requires the reporting of various information, including but not limited to the manufacturing processes, quality control procedures, specifications, stability data, and any changes made to them.

When is the deadline to file ich quality implementation working in 2023?

The specific deadline to file ICH Quality Implementation Working in 2023 may vary depending on the jurisdiction and regulatory requirements. It is recommended to check with the appropriate regulatory authority for the exact deadline.

What is the penalty for the late filing of ich quality implementation working?

The penalties for the late filing of ICH Quality Implementation Working can also vary depending on the jurisdiction and regulatory authority. It is advisable to consult the applicable regulations and guidelines to determine the specific penalties.

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