Overview:

To ensure safety, effectiveness and maintain quality, Therapeutic Goods Administration (TGA) publishes the Good Manufacturing Practices (GMP) approach for oversees manufacturers to assist manufacturers who may undergo remote inspection.

General Expectations:

TGA’s general expectations are:

  • All manufacturing organization should comply with the GMP
  • Manufacturers should have Quality Management System (QMS) in place
  • QMS should be revised using the management principles and identify hazard and plan a risk management plan to minimize any risk

Responsible Person (Host):

While a remote inspection, a responsible person (host) should be nominated who should have the authority and IT support and who as a POC can be available anytime for communication to the remote inspection for the site.

TGA intends to send a checklist to the site which should be within 2 weeks and which will assist the manufacturing inspection site to prepare for inspection.

Preparing for a remote inspection:

To prepare for a remote inspection the manufacturer should:

  1. Have all pre-recorded videos of the site and operation which can be presented virtually
  2. It is suggested to organize guest remote only logins for the QMS inspectors at the time of inspection
  3. The host should be comfortable to communicate in English and should have technical knowledge about the inspection site
  4. In case of time zone differences, subject matter expert should be made available at pre-agreed real time
  5. Any information requested by the inspector should be provided by the host during or post-inspection within the requested timeframes.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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