ARCHIVED - Drug Establishments: Reviewing the Good Manufacturing Practices Inspection Program


The online consultation is now closed. The content found on this page is a snapshot of the online consultation as it was presented to the public and contains the content that was open for submissions during the consultation period. A summary report will be made available.

Consultation Workbook Introduction


Health Canada is reviewing its Good Manufacturing Practices (GMP) inspection program. Our goal is to make our inspections of drug establishments more risk-based. The review involves a detailed evaluation of all aspects of the GMP program, including such things as inspection scheduling and the conduct of inspections. Several factors highlighted the need for a review at this time, including the growing complexity of health products now available on the Canadian market and international trends related to GMP inspections.

We are exploring several changes and we would appreciate your input, as an industry stakeholder, on key concepts that we are considering.  Specifically, we welcome your input on (i) how we assess the risk of an establishment; (ii) appropriate inspection cycles for different levels of risk; and (iii) tools that can be developed to make the inspection program more risk focused.

The following suggestions may help you prepare your comments:

  • Please explain your views as clearly and concisely as possible.
  • Be sure to distinguish between what you support and what you object to in  this document.
  • Provide the rationale for your views, particularly your concerns, with facts,   data or specific examples.
  • Describe any assumptions that you made.
  • Please submit your comments by the deadline of November 30, 2009.

Please note that any information collected will only be used for input to this consultation. The information collected will be used to create a summary report and will guide recommendations made as part of the GMP Review. The summary report will be made available to stakeholders once consultations are complete.

About You

2. If an association:

3. If an establishment:


The Organization

The mandate of Health Canada's Health Products and Food Branch (HPFB) is to take an integrated approach to managing the risks and benefits of health products and food. HPFB administers its legislative and regulatory frameworks using risk management and scientific evidence to maximize the safety and quality of products available to Canadians.

The primary role of the Health Products and Food Inspectorate is to deliver a national approach to compliance and enforcement activities across regulated health products. The work of the Inspectorate is governed by the guiding principles of transparency, fairness, management of risk, commitment to quality and the hiring of qualified staff.

The Inspectorate meets its commitments, in part, by inspecting companies that fabricate, package/label, test, import, distribute and wholesale drugs.  The inspections verify compliance with the Good Manufacturing Practices (GMP) requirements set out in Part C, Division 2 of the Food and Drug Regulations.

GMP Review

The Inspectorate is reviewing the activities within the GMP Inspection Program, with a view to increasing the effectiveness of the program, and aligning it with international changes in the regulation of drug quality.

The Inspectorate has always adopted risk-based measures in conducting inspections. There are established criteria for risk rating observations made during an inspection. Establishments that fail to meet regulatory requirements must take corrective measures in a manner that is appropriate and proportionate to the risk associated with the inspection findings. The goal of the GMP Review is to enhance the role risk plays in inspection. The result will be a new inspection model that integrates

  • the effective, risk-based use of resources
  • the diversity of regulatory needs within the drug industry
  • the expectations of international regulators and partners in regulatory enforcement

Health Canada requires an inspection model that will allow it to equate oversight with the level of risk, is sustainable and allows for consistency and transparency.

Assessing the Risk of an Establishment

An overview

Establishments intending to fabricate, package/ label, test, import, distribute or wholesale drugs in Canada must apply for and hold an establishment licence (EL). Upon application for an EL, an establishment will receive an initial inspection and then a regular inspection within 12 months. From that point forward, establishments are subject to routine inspection at a frequency of

  • 2 years for fabricators, packagers / labellers and testing laboratories;
  • 3 years for importers, distributors and wholesalers.

Currently, risk does play a role in determining the length of inspection cycles. The activities an establishment performs determines if it is placed on a two- or three- year cycle. However, other potential risk factors, such as the risk associated with a specific drug product or the process used to make the product, the level of regulatory compliance, and product complaints and recalls do not factor into the determination.

The Inspectorate is considering a shift away from two pre-determined inspection cycles to a model where risk determines the cycle on a case-by-case basis. Under such a model, two establishments that perform similar activities may have different inspection cycles depending on an evaluation of risk. In addition, the inspection cycle for one establishment may change from one inspection to the next, if circumstances support such a change.

In adopting this new model, the Inspectorate has to identify the factors that should be used in assessing the risk of an establishment. The factors that are ultimately chosen need to be applicable and appropriate in almost all inspection situations, need to be reasonable in the Canadian context, and be dependent on information that is accessible and that inspectors are able to validate within a reasonable timeframe.


Below is a list of possible risk factors the Inspectorate could use in assessing the risk of an establishment.  Please indicate if you support each for the new model and explain why or why not.

Activities performed

Product range and complexity

Complexity of the process used to fabricate the drug

GMP compliance history

Recent changes at company

Site is sole or limited source of supply

Concerns raised by public/other regulatory authorities

Other enforcement measures taken and/or lack of cooperation

Significant concern over robustness of quality system

Significant nature of future changes on site

Significant failures to complete actions to close previous deficiencies

Site-based recalls since last inspection

Regulatory action related to the site

Inspection Cycles

An Overview

The Inspectorate would like move to a model where the inspection cycle is decided on a case-by-case basis depending on risk. Therefore, in addition to identifying the criteria that can be used to assess each establishment, the Inspectorate will also need to decide on new inspection cycles that are appropriate for various levels of risk.

The cycles will need to be inline with the obligations for inspection intervals set out by our international agreements. Canada has Mutual Recognition Agreements in place with a number of international partners. These require an effective inspection planning system.  Likewise, Canada exchanges Certificates of Compliance with other regulatory authorities as evidence of GMP compliance for fabricators, packagers/labellers and/or testers.  The certificates are issued to a recognized building located within the regulatory authority's jurisdiction for which the date of inspection indicated is no more than 3 years old.

Below are a variety of inspection periods for you to consider.

Option 1 Option 2 Option 3
More critical situations as soon as possible as soon as possible as soon as possible
Higher levels of risk 6 months 12 months 18 months
Medium levels of risk 12 months  18 months 24 months
Lower levels of risk 18 months 24 months 36 months


Developing New Tools

An Overview

In moving to a model where the date of an establishment's next inspection is dependent on the establishment's risk profile, the Inspectorate will require up-to-date information on the establishment, in order to make an accurate risk evaluation. Currently, the Inspectorate has no formal mechanism to obtain information from an establishment between inspections.

One option under consideration is to require establishments to provide a compliance report prior to an on-site inspection. A compliance report would include a summary of changes in site performance or activities, such as changes in key personnel or staff numbers, company ownership/ structure or status, processes/ products and facilities/ equipment. Such a report would help the inspector prepare for the inspection and define areas that need to become a priority during the inspection.


Appendix A


state of conformity of a regulated party (including a corporation, product with an institution, individual or other legal entity) to a legislative or regulatory requirement
Compliance Monitoring
actions planned to maintain regular surveillance in order to evaluate compliance with applicable requirements of the Food and Drugs Act (FDA) and its associated Regulations; includes a wide variety of fact gathering and assessment activities such as inspections, market surveys and a product sampling program
any substance or mixture of substances manufactured, sold or represented for use in:
  1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animal;
  2. restoring, correcting or modifying organic functions in human beings or animals;
  3. disinfection in premises in which food is manufactured, prepared or kept
on-site monitoring and assessment against the applicable requirements of the FDA and its associated Regulations; inspections are routinely conducted on a pre-determined cycle or as required to assess compliance
any person designated as an inspector for the purpose of the enforcement of the FDA under subsection 22(1)
the combination of the probability of occurrence of harm and the severity of that harm
Risk criteria
the factors considered in determining an establishment's risk level or rating
Risk assessment
a systematic process for organizing information to support a risk decision; for purposes of inspection scheduling culminates in determination of inspection frequency

Appendix B

The United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA)

The MHRA identifies a site's relative risk to determine appropriate inspection frequency:

  1. Prior to an inspection, a company is required to file a compliance report, which includes a list of the changes since the last inspection and a signed statement from the senior manager, who is accountable for performance, which serves as evidence of conformance to the requirements.
  2. The inspector reviews the compliance report, and the last inspection report, in preparation for the inspection.
  3. After the inspection, the inspector assigns a provisional risk rating based on the number and classification of observations.
  4. The inspector then looks at other risk factors that may affect the risk rating:
    • significant concern over robustness of quality system
    • significant failures to complete actions to close previous deficiencies
    • significant nature of future changes on site
    • complexity of site
    • site  recalls since last inspection
    • site  rapid alerts since last inspection
    • concern over batch specific variations submitted since the last inspection
    • regulatory action related to the site
    • other (for example, did establishment report all changes in Compliance Report)
  5. The inspector then assigns a final risk rating, which determines the general date of  the next inspection.
  6. Finally, the inspection report, with risk rating and commentary, is sent to the establishment.

The United States Food and Drug Administration (FDA)

The FDA's risk-based approach to inspection scheduling considers risk factors related to facility, product and process. The facility's size, type, products and date of last inspection are weighted numerically and combined to produce a site risk potential (SRP).

Under the model, the SRP determines how soon a site will be inspected, and a site's chance of being selected for inspection increases if it

  • has not been inspected recently
  • has a higher production volume
  • has a history of significant violations
  • makes products associated with a high frequency of recalls and/or serious defects, uses processes expected to have a greater potential for cross-contamination and/or loss of a state of control
  • makes sterile and/or prescription drugs

SRPs are then used to organize companies into tiers:

Table III. FDA Risk Tiers
Tier Description # of Sites Inspection Schedule
Tier 1 companies with highest SRP; includes newly registered sites and created since FY2006 400 sites must inspect in current year
Tier 2 includes companies whose last inspection resulted in official action (OAI) 400 sites must inspect 100, prefer to inspect all in current year
Tier 3 all other sites will not be inspected this year

An annual list of firms requiring priority inspection is compiled and district offices determine the depth of coverage of each inspection.

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