These guidelines interpret the requirements for good manufacturing practices (GMP) in Part C, Division 2 of the Regulations. They were developed by Health Canada in consultation with stakeholders. Guidance documents like this one are meant to help industry and health care professionals understand how to comply with regulations. They also provide guidance to Health Canada staff, so that the rules are enforced in a fair, consistent and effective way across Canada.
Health Canada inspects establishments to assess their compliance with the Food and Drugs Act (the Act) and associated regulations. When we conduct an inspection, we will use this document as a guide in assessing your compliance with GMP requirements. To better understand how risk ratings are assigned during inspections, see Risk classification guide for drug good manufacturing practices observations (GUI-0023). These guidelines are not the only way GMP regulations can be interpreted, and are not intended to cover every possible case. Other ways of complying with GMP regulations will be considered with proper scientific justification. Also, as new technologies emerge, different approaches may be called for. Guidance documents are administrative and do not have the force of law. Because of this, they allow for flexibility in approach. So use this guide to help you develop specific approaches that meet your unique needs.
The guidance in this document has been written with a view to harmonize with GMP standards from:
the World Health Organization (WHO)
the Pharmaceutical Inspection Cooperation/Scheme (PIC/S)
the International Council on Harmonisation (ICH)
the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)
other regulatory agencies in other countries
This document also takes into account current mutual recognition agreements (MRA) between Health Canada and other international regulatory authorities, as well as agreements with other parties.
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