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Applicants may submit a corporate or consultant audit report, using the Audit Report Form, as evidence to establish the compliance of a foreign site with Division 2 (GMP) of the Food and Drug Regulations (FDR), so long as the criteria outlined in the guidance "Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites" (GUI-0080) are met.
The audit must be conducted by an individual(s) that possesses sufficient knowledge of and experience with Good Manufacturing Practices (GMP) and is qualified according to section C.02.006 of the FDR.
Division 2 of the FDR sets out the Good Manufacturing Practices (GMP) that manufacturers, packagers, labellers, testers, importers, distributors and wholesalers must meet before an Establishment Licence (EL) will be issued.
The statements/questions in this report are divided into sections in accordance with those outlined in Division 2 of the FDR.
Check off the response to the statement/question as either Yes that the statement/question is correct or No that the statement/question is not correct. If the statement/question is unclear, refer to the appropriate section(s) in the GMP guidance document (GUI-0001) for assistance.
If the answer to the statement/question is yes, clearly describe, in the space provided, how the site complies with the referenced section of FDR.
If the answer is no, provide a clear rationale, in the space provided, as to why the statement/question is not applicable to the activities conducted at the site.
Note: Additional pages may be attached if the space provided is not sufficient. Identify the additional pages that have been attached under the Supporting Documentation section.
For each statement/question, list in the provided table all of the deviations from Division 2 of the FDR that were observed during the audit. Assess the risk associated with each observation, based on Health Canada's guide "Risk Classification of GMP Observations (GUI-0023)":
If deviation(s) were listed above, describe in the space provided the details of the corrective action(s) that were taken or will be taken, along with time lines, in addition to any preventive measures to avoid recurrence, as needed.
For each listed deviation(s), a corrective action plan may be attached and listed under the Supporting Documentation section.
List all supporting documentation as described above (SOP(s), corrective action plan(s), etc.), and attach the document(s) directly behind the statement/question page.
For each statement/question, the applicant is required to list the title(s) and the number(s) of the relevant standard operating procedure(s) that are in use at the site. However, the actual SOP(s) does not need to be attached, unless the applicant feels that the SOP(s) will help in the assessment of the site's compliance with Division 2 of the FDR. In addition, a copy of any SOP may be requested at any time during the assessment of the site's compliance with Division 2 of the FDR.
A judgement is required on the part of the auditor(s) as to the overall compliance, based on Health Canada's guide "Risk Classification of GMP Observations (GUI-0023)", of the site with Division 2 of the FDR.
If the answer to the statement/question is yes, clearly describe, in the space provided, how the site complies with Division 2 of the FDR.
If the answer is no, provide a clear rationale, in the space provided, as to why the site does not comply with Division 2 of the FDR.
The person(s) that conducted the audit, as identified in box #15, is(are) required to Print and Sign his/her name and Date this part of the Audit Report form.
In addition, if deviations were observed during the audit, it is requested that an official with signing authority, from the audited foreign site, Print and Sign his/her name and Date the second attestation.