Archived Notice to stakeholders - Release of draft guidance document for consultation: Guidelines for environmental control of drugs during storage and transportation (GUI-0069)

December 20, 2018

Health Canada is pleased to announce the release of this draft guidance document for a 90 day stakeholder consultation from December 20, 2018 to March 20, 2019:

• Guidelines for environmental control of drugs during storage and transportation (GUI-0069)

This revised guidance document contains new information. Plain language principles to make the document easier to read and understand have been considered in rewriting and formatting the document. It will continue to support compliance with Good Manufacturing Practice requirements prescribed in Part C, Division 2 of the Food and Drug Regulations (FDR).

The key changes are listed below.

How to participate

1. Obtain documents

Please email hc.hpil.consultation-ipsop.sc@canada.ca to receive copy of:

• The draft guidance document, and
• The comment form for your submission of comments by section number and line number.

2. Submit Comments

Please email your comments to hc.hpil.consultation-ipsop.sc@canada.ca using the comment form. All comments will be considered in the finalization of the document. The 90-day consultation period is from December 20, 2018 to March 20, 2019 inclusively.

Comments can also be mailed to:
Health Product Inspection and Licensing Division
Health Product Compliance Directorate
Address Locator # 1913D

Overview of Key Changes

This Health Canada guidance document has been rewritten and formatted using plain language principles to make the document easier to read and understand. This is in conformance with requirements for migration of documents to the Canada.ca website.

GUI-0069:  Guidelines for environmental control of drugs during storage and transportation is applicable to all persons (individuals and companies) involved in the storage and transportation of drugs for human use, drugs for veterinary use, clinical trial drugs for human use, Active Pharmaceutical Ingredients (APIs) and samples distributed to professionals. Changes include:

• Updates to warehousing and storage including training requirements for personnel and Mean Kinetic Temperature (MKT) information added;
• Updates to transportation section including expanded contingency plans, written documentation and procedure requirements and expanded temperature mapping requirements and exemptions;
• Updates to containers and labelling section with provisions for labelling of small shipping containers and appropriate language to be used;
• Updates to the documentation section with expanded requirements and details for written agreements including contracted third parties.