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To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system.
Supersedes: New document
Date issued: July 22, 2011
Date of implementation: July 22, 2011
This document does not constitute part of the Food and Drugs Act (Act) or its associated Regulations and in the event of any inconsistency or conflict between that Act or Regulations and this document, the Act or the Regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies. This document is not intended to provide legal advice regarding the interpretation of the Act or Regulations. If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel.
Health Canada is pleased to provide you with our new pre-application package to assist your organization in preparing for an initial drug GMP inspection by the Inspectorate.
This package is intended to be used prior to the submission of a Drug Establishment Licence Application for the activities of wholesaling, Importation and Distribution, in order to ensure that your establishment has the minimum requirements for GMP Compliance in place prior to an inspection.
In order to conduct activities relating to the fabrication, packaging/labelling, testing, distribution, importation or wholesaling of a category of drugs listed in Table II of Section C.01A.008 of the Food and Drug Regulations, you must comply with the requirements of Division 2 of the Food and Drug Regulations, which covers Good Manufacturing Practices (GMPs). As evidence of this compliance, an Establishment Licence is required. Division 1A of Part C of the Food and Drug Regulations outlines the requirements for Establishment Licences
These activities are defined as follows:
Wholesale - "To sell any of the following drugs, other than at retail sale, where the seller's name does not appear on the label of the drugs:
Import - "To import into Canada a drug for the purpose of sale." (C.01A.001)
Distributor or Manufacturer - "A person, including an association or partnership, who under their own name, or under a trade, design or word mark, trade name or other name, word, or mark controlled by them, sells a food or drug." (A.01.010)
Divisions 1A and 2 to 4 apply to the following distributors (C.01A.003):
(a) a distributor of a drug listed in Schedule C or D to the Act or in Schedule F to these Regulations, a controlled drug as defined in subsection G.01.001 (1) or a narcotic as defined in the Narcotic Control Regulations who does not hold the drug identification number for the drug or narcotic; and
(b) a distributor of a drug for which that distributor holds the drug identification number.
The following information is contained in this package:
The initial inspection of an establishment conducting licensable activities is triggered by the receipt of a Drug Establishment Licence Application. You are advised to submit your application once your establishment is ready to begin licensable activities for products subject to Division 1A of the Food and Drug Regulations or once you have received drug marketing authorization. The Drug Establishment Licence Application and Instructions can be found on Health Canada's website.
The Inspectorate endeavours to schedule an initial on-site inspection within 3 months of the date of the receipt of a complete Drug Establishment Licence Application by the Establishment Licensing Unit (ELU). Inspections are conducted to assess compliance with Division 2 Part C of the Food and Drug Regulations - with legislative authority for the regulations stemming from the Food and Drugs Act.
The scope of the inspection is dependent on the licensable activities being assessed. An on-site inspection could last anywhere from 1-5 days depending on the activity being conducted, as well as the category and dosage form class of products involved. It is important to note that it is expected that all documentation be available on site at your establishment.
To get a sense of which Division 2 regulations would apply to you, please refer to the GMP Regulations Applicable to Licensable Activities table included in this package. It is also recommended that you refer to Good Manufacturing Practices (GMP) Guidelines -2009 Edition (GUI-0001) version 2, applicable GMP Annexes and the Guidance on Drug Establishment Licences (GUI-0002)for further information.
An inspection will typically feature:
During an inspection, the inspector will record all deviations to Division 2 Part C of the Food and Drug Regulations as observations. You/Your establishment will be given the opportunity to correct observations as they are made during an inspection, where possible. Following the inspection, you/your establishment will be expected to submit a corrective action plan to address the observations noted. A defined timeframe for the submission of your establishment's response may be imposed and may vary according to the severity of the observations noted in the report.
For foreign market authorization holders, evidence that the Importer is a legal business entity in Canada (e.g. Business Registration) may be requested by Health Canada. It is important to note that under C01.004.1 the Importer assumes all regulatory responsibilities.
(MRA and non-MRAs)
|5. Raw Material Testing||C.02.009|
|6. Manufacturing Control||C.02.011||√||√|
|7. Quality Control||C.02.013||√||√||√|
|8. Packaging Material Testing||C.02.016|
|9. Finished Product Testing||C.02.018||√||√|
|13. Sterile Products||C.02.029|
For further information on Mutual Recognition Agreements, please refer to the International section on the Compliance and Enforcement Website.
For the extent to which these requirements apply to your products, please refer to the relevant guidance documents.
You/Your establishment should ensure that the following systems are in place prior to applying for an Establishment Licence. If, following an assessment of your Drug Establishment Licence Application, Health Canada determines that your site is not ready for an inspection, your Licence Application will be refused.
Following the implementation of the amendments to the User Fees Act, the refusal of a Drug Establishment Licence Application will result in the forfeiture of the Licence Application Fees. In addition, if the GMP compliance of an applicant's site cannot be assessed due to the site's lack of readiness or if the inspection results in a non-compliant rating, this will result in the refusal to issue the licence and a forfeiture of fees.
The assessment of your establishment's compliance may include, but may not be limited to, the requirements listed on the checklists, as applicable; however you should be aware that depending on the activities conducted or the products handled on site, other Regulations may apply.
The following Standard Operating Procedures (SOPs) must be in place:
In addition to the requirements for wholesalers, distributors are also required to have the following available for all products:
*Note: MPDs are defined in the Good Manufacturing Practices (GMP) Guidelines - 2009 Edition (GUI-0001) version 2 as documents that include specifications for raw material, for packaging material and for packaged dosage form; master formula (including composition and instructions as described in the definition above), sampling procedures, and critical processing related SOPs, whether or not these SOPs are specifically referenced in the master formula.
In addition to the requirements for wholesalers and distributors, importers are also required to have the following available for all products:
Note: It is expected that information demonstrating the GMP compliance of those foreign establishments conducting activities on your (your establishment's) behalf will be submitted with a Drug Establishment Licence Application. An outline of the types of information that should be submitted to demonstrate the GMP compliance of a foreign drug establishment can be found in the Inspectorate policy document entitled "Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080)", available on the Health Canada website.
The following Pre-inspection Information Request represents a sample of the information that you may be requested to provide the inspector in preparation for an inspection; however, depending on the licensable activity being evaluated, other information may be requested. An assessment of your firm's readiness for inspection could be evaluated by means of a phone interview.
In addition to the information provided in this package, we recommend that you review Health Canada's guidance and policy documents regarding good manufacturing practices and establishment licensing which can be found on the Good Manufacturing Practices and the Establishment Licences Website.
Acts and regulations of Canada are available on the Department of Justice Canada Website:
Good Manufacturing Practices
Guides (GUI), Policies (POL) and Forms (FRM) that relate to GMPs are available on Health Canada's Website in the Compliance and Enforcement Good Manufacturing Practices section.
Should this list not address your question, please forward your question via email to:
firstname.lastname@example.org, or by fax to 613 957-6709.
The Inspectorate is committed to continuous improvement in the delivery of its programs and services. Our new pre-application information package is just one way we are working towards helping the health products industry with information and guidance towards achieving world class excellence in safety and quality standards.
To help us develop better and more effective tools in support of our shared goals, please do not hesitate to tell us what you think.