Letter - Guidance on Evidence to Demonstrate Drug Good Manufacturing Practices (GMP) Compliance of Foreign Sites (GUI-0080) - Current Practices

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Contact Information

Health Products and Food Branch Inspectorate
Graham Spry Building, 2nd Floor
250 Lanark Avenue
Address Locator #2002A
OTTAWA, Ontario
K1A 0K9

July 29, 2011

To: Establishment Licence Holders

Re: Guidance on Evidence to Demonstrate Drug Good Manufacturing Practices (GMP) Compliance of Foreign Sites (GUI-0080) Current Practices.

This letter is intended to clarify Health Canada's position on the regulatory requirements for companies submitting evidence to demonstrate drug GMP compliance of foreign sites. Further clarification is being provided at this time while GUI-0080 is being revised.

The following documents are requested in Section 3.2.1.2 A to F of the "Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080):

1. most recent (within the last 3 years) signed inspection report issued by:
   1. Regulatory Authority for a site outside of its jurisdiction, or
      e.g.:
      • Medicines and Healthcare Regulatory Agency (MHRA) (UK) inspection report for a site in India
   2. Qualified Authority for a site within its jurisdiction, or
      e.g.:
      • Food Drug Administration (FDA) (US) Establishment Inspection Report for a site located inside the US
      • Medicine Control Council (MCC) (South Africa) inspection report for a site in South Africa
   3. Qualified Authority for a site outside of its jurisdiction
      e.g.:
      • Food Drug Administration FDA (US) Establishment Inspection Report (EIR) for a site located outside the US
      • Health Science Authority (HSA) (Singapore) inspection report for a site in China
2. corrective actions taken, signed by a responsible official of the foreign site
3. copy of the Site Master File (for additional guidance, refer to the document entitled "Explanatory Notes for Industry on the Preparation of a Site Master File")
4. copy of the site's procedures for handling deviations and out of specification test results
5. copy of the site's procedure for finished product release
6. copy of the quality agreement between the foreign site and the Canadian site, including a list of the specific products for supply in Canada

The following table indicates the minimum documents to be submitted for each activity performed at the foreign site:

Section 3.2.1.2	Applicable Activities	Requirements (outlined in GUI-0080)
A	F	P/L	T	the most recent (within the last 3 years) signed inspection report
B	F	P/L	T	the corrective actions taken, signed by a responsible official of the foreign site
C	F		T	a copy of the Site Master File
D	F		T	a copy of the site's procedures for handling deviations and out of specification test results
E	F		T	a copy of the site's procedure for finished product release
F	F	P/L	T	a copy of the quality agreement between the foreign site and the Canadian site, including a list of the specific products for supply in Canada

(F: Fabricator, P/L: Packager/Labeller, T: Testing)

Please note that for foreign sites located in a country with which Canada has a Mutual Recognition Agreement (MRA), if the activities or dosage forms are not covered by the MRA (e.g. products not considered a drug in the country of origin, active pharmaceutical ingredients (API)), the importer must submit all GMP evidence in accordance with GUI-0080.

Submission of GMP evidence as soon as a complete package is available is encouraged. GMP evidence can be submitted independently of the DEL renewal. Please do not submit partial packages.

Please refer to Section 3.2.1.2 and 3.2.1.3 for information if the requested documents are not available. Alternative documents, such as inspection plans, corporate audits or consultant audits, may be acceptable, on a case by case basis. The alternative documents must clearly provide the same information required in the original, unavailable document (e.g. scope of inspection, regulatory standard against which the inspection was conducted, etc.)

Further guidance regarding the information required for foreign sites can be found in the guidance document "Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080) ", which can be found on the Health Canada website.

Failure to comply with the  Food and Drugs Act and its associated Regulations may necessitate compliance and enforcement action in accordance with Health Canada's "Compliance and Enforcement Policy (POL-0001)" as well as the "Good Manufacturing Practices and EL Enforcement Directive (POL-0004) " which are available on the Health Canada website.

Should you have any questions regarding EL renewal and GMP, please do not hesitate to contact us at the DEL_questions_LEPPP@hc-sc.gc.ca and foreign_site_etranger@hc-sc.gc.ca, respectively. We thank you for your cooperation.

Yours truly,

Original signed by

Diana Dowthwaite
Director General