Summary

Implementation of International Council for Harmonisation (ICH) of Technical Requirements of Pharmaceuticals for Human Use Guidance Q3C(R6): Impurities: Guideline for Residual Solvents

22 June 2018
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Summary

Annex 1 to the Good Manufacturing Practices Guide – Manufacture of Sterile Drugs (GUI-0119) – Summary – Canada.ca

1 May 2018
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Summary

MHRA ‘GXP’ Data Integrity Guidance and Definitions

25 April 2018
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Summary

GMP Guide for Drug Products GUI-001 Canada

27 March 2018
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Summary

Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry

26 March 2018
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Summary

EU SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE QUESTIONS AND ANSWERS – VERSION 9

23 March 2018
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Summary

Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry

19 March 2018
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Summary

FDA Unique Device Identification: Direct Marking of Devices

5 March 2018
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Summary

FDA Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

16 February 2018
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Summary

ICH Q12 on Pharmaceutical Product Lifecycle Management was issued for public consultation

12 February 2018
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