Good manufacturing practices and COVID-19
On this page
- What are good manufacturing practices
- Good manufacturing practices inspections during COVID-19
- Regulatory flexibility during COVID-19
- COVID-19 regulatory measures for Canadian drug establishments
What are good manufacturing practices
Good manufacturing practices (GMP) ensure that drugs meet the quality standards appropriate to their intended use before they are sold.
To ensure compliance with GMP regulations, Health Canada inspects establishments that fabricate, package or label, distribute, import, wholesale or test drugs. During these inspections, Health Canada verifies compliance with good manufacturing practices (Part C, Division 2 of the Food and Drug Regulations). This is a requirement for issuing a drug establishment licence.
To help industry comply with these requirements, we have developed guidelines on good manufacturing practices. We have also developed a series of guides and other helpful documents.
Good manufacturing practices inspections during COVID-19
Health Canada is working closely with the Public Health Agency of Canada, which is leading Canada’s COVID-19 public health response and pandemic planning. In addition, we are working with our provincial, territorial and international partners to monitor and respond to this evolving situation.
In response to travel restrictions put in place to limit the spread of COVID-19, we have changed the schedule for inspections related to drugs manufactured both in Canada and in other countries.
Our focus at this time is on the critical services related to protecting the health and safety of Canadians during the COVID-19 pandemic.
Over the course of the pandemic, we have modified our approach by conducting remote GMP inspections. This approach involves:
- using telecommunications (for example, videoconferencing)
- exchanging inspection-related documents online
- conducting remote reviews
For activities that require onsite evaluation, we have been conducting hybrid GMP inspections, which involves both an onsite (limited) and remote component. However, onsite inspections continue to be considered for establishments getting ready to manufacture:
- a medically necessary drug or
- a drug considered important in mitigating the risks of COVID-19
We continue to closely monitor public health guidelines. As a result, we have resumed onsite inspections in regions where provincial and territorial health authorities have indicated it’s safe to do so.
We continue to monitor the situation as it evolves, remain flexible and ready to adapt our approach to ensure the health and safety of Canadians.
We have resumed foreign onsite GMP inspections in the following situations:
- where it’s critical to do so in light of the COVID-19 pandemic
- to prevent a shortage of a medically necessary drug
Where it’s feasible, we are also considering remote foreign inspections.
When scheduling an inspection, we consider the following risk-based criteria:
- the nature of the product (for instance, if the product is urgently needed or is medically necessary)
- compliance history of the foreign building
- whether other trusted regulatory authorities are planning to inspect the foreign building
We continue to actively work with our international partners, including sharing inspection reports and keeping them informed of our current actions and approaches.
In the absence of acceptable GMP evidence, importers may submit a foreign building assessment request. We will review these requests on a case-by-case basis. Our review may take longer than the general timelines outlined in the How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080) guidance.
To submit a foreign building assessment request, send in a cover letter along with the Good Manufacturing Practices - Request for Inspection of a Foreign Site Form (FRM-0213). Email: firstname.lastname@example.org.
Drug and Health Products Inspections Database
Please continue to consult the Drug and Health Products Inspections Database for GMP inspection information. The database has the most up-to-date information for each type of drug and health product inspection conducted by Health Canada, within Canada and abroad.
For domestic GMP inspections, email: email@example.com
For foreign GMP inspections, email: firstname.lastname@example.org
Regulatory flexibility during COVID-19
As soon as it’s reasonably feasible, we will return to ‘regular’ operations. The regulatory flexibilities are not intended to be adopted as regular practice. They are an exception (for example, planned deviation) because of unique challenges presented by the COVID-19 pandemic.
The GMP and DEL regulatory flexibilities are currently under review by Health Canada. Our review process involves many considerations, including stakeholder feedback.
We have introduced interim measures that provide regulatory flexibility for drug establishment licensing (DEL) and good manufacturing practices (GMP). Our focus is on critical services for medically necessary drugs as well as drugs that are important in mitigating the risks of COVID-19. Our regulatory measures are:
- available should the Canadian drug establishment not be able meet certain requirements for DEL and GMP during the pandemic
- in effect until further notice
- constantly evaluated to ensure they allow for appropriate product quality oversight
Quality risk management
The COVID-19 pandemic has created a number of challenges for businesses. For example:
- limited availability of staff restricts the work that can be performed
- disruptions in supply chains and distribution chains
- limited availability of contract service providers affecting the ability to perform services related to tasks, such as external calibration and specialized equipment maintenance
We recognize the health product industry may need to adjust the way they operate temporarily. However, these changes must continue to comply with good manufacturing practices (GMP) requirements and good quality risk management (QRM) principles.
Examples of QRM changes include:
- adjusting equipment calibration, requalification or maintenance frequencies
- revising approaches to vendor audits or requalification (deferring on-site audits and replacing with desk-top approaches)
- deferring periodic confirmatory testing for raw materials or imported drugs
- deferring ongoing periodic training
- deferring annual product quality reviews
When making changes, remember to:
- document the changes in your Quality Management System
- apply sound decision-making based on QRM principles
- some adjustments may not be appropriate for every situation (for example, deferring equipment calibration or maintenance when there is a risk of failure or problems)
- consider risk mitigation options already available within GMP
- drug manufacturers may decide to validate a process concurrently (in other words, to release batches on their own merit before a study is completed)
- refer to the validation guidelines for pharmaceutical dosage forms (GUI-0029)
- consider the impact of your quality adjustments on a product's market authorization
- unless you are informed otherwise, the requirements outlined in the Food and Drugs Act and its Regulations and applicable guidance remain in effect
- report any drug shortages
Deferring low-risk investigations
It may not be practical or appropriate to hold batches of products with shortage concerns to allow for the completion of minor or low-risk investigations during the pandemic. However, it is critical that you:
- assess all incidents to determine any impact to product quality (these must be investigated)
- track and trace all incidents (all negative trends should be investigated and action taken in a timely manner)
Document approvals when working remotely
Due to the pandemic, you may have a significant number of staff working from home, and quality and service consultants may not be able to visit your sites. We understand that not all companies have the appropriate controls in place for electronic signatures, as per the Good manufacturing practices guide for drug products (GUI-0001). As soon as reasonably possible, qualify/validate your electronic signature systems to have appropriate security and safeguards in place to ensure authenticity.
For questions related to business impact mitigation, email: email@example.com.
New evidence required by date
The new evidence required by date (NERBY) is the date by which you must submit new evidence to Health Canada as part of your drug establishment licence (DEL) application to maintain a foreign building.
Due to travel restrictions and fewer onsite inspections taking place by other regulatory authorities around the world, we have extended the NERBY date of all foreign buildings until further notice. However, if you have full GMP evidence as per GUI-0080, you should submit it to us at any time before the existing NERBY on your DEL.
Evidence of foreign building GMP compliance
To add a foreign building on an importer's DEL, you must provide evidence of GMP compliance. This evidence must be in accordance with the Guidance document on how to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080).
Effective April 1, 2021, Health Canada and the equivalent EU regulatory authority are accepting certificates of GMP compliance for extra-jurisdictional inspections conducted on or after April 1, 2021, for finished dosage form products.
The certificate of GMP compliance must be within the period of validity issued by the EU regulatory authority. This notice was published in DEL bulletin No. 116.
During the pandemic, in the absence of a recent inspection by a regulatory or qualified authority, you may submit for Health Canada to consider:
- an inspection report issued within the last 5 years to demonstrate compliance of a foreign building on the foreign building annex
- a corporate/consultant audit report, where acceptable, to demonstrate GMP compliance of foreign buildings for all activities or product types (refer to the GMP audit report form)
- an updated Table A (foreign building API annex) that includes a foreign building supported by evidence of GMP compliance that is older than 3 years (evidence must meet the requirements of Canadian GMP standards, in which no risks to health and safety are identified)
Notwithstanding the above, importers may submit a foreign building assessment request. We will review these requests on a case-by-case basis. Our review may take longer than the general timelines outlined in the How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080) guidance.
To request a foreign building assessment, send in a cover letter and the Good Manufacturing Practices - Request for Inspection of a Foreign Site Form (FRM-0213). Email: firstname.lastname@example.org.
Interim testing measures for licensed importers
We have introduced interim measures to help expedite the importation of drugs into Canada. These measures will ensure Canadians have continued access to the medication they rely upon. Canadian importers must meet all product release requirements as outlined in the Food and Drug Regulations and our Good manufacturing practices guide for drug products (GUI-0001).
Due to COVID-19, should importers of drugs from non-MRA countries licensed under division 1A of the Regulations not be able to meet all the product release requirements outlined in GUI-0001, the following flexibility may be applied:
- modify current unique identifier principles to confirm the identity of the drugs being imported to include:
- a visual inspection of the labelling on samples of product taken from each batch received against approved product labelling
- a visual comparison of the drug in dosage form against that of previously retained samples or other comparative information
- an application of physical measurements (dimensions, volume) of a sample of the drug in dosage form.
- defer confirmatory testing requirements if unable to conduct such tests, provided all other product release requirements are met
The manufacturer of the drug and associated supply or transportation chain must be fully traceable. Companies conducting licensable activities for the product being released must:
- have a DEL or
- be listed on the foreign building annex of the importer's DEL
You are responsible for:
- ensuring your product complies with Canadian regulations and marketing authorizations
- maintaining appropriate oversight of your supplier and managing any identified risks
- including a review of the supplier history to demonstrate they can consistently supply a product that meets the requirements if they adopt the approaches outlined above
Additional flexibility for certain low-risk non-prescription drugs
We have introduced interim measures for importers of certain non-prescription drugs that are being fabricated, packaged or labelled, or tested in a building, subject to oversight by a foreign country’s regulatory authority. If you continue to face challenges with conducting identity or confirmatory testing, the requirements set out in subsections C.02.019 (1) and (2) of the Regulations may be temporarily waived.
Before the product can be released for sale, importers must ensure it meets specifications and was manufactured in accordance with the master production documents. However, should the importer of certain non-prescription drugs face drug storage challenges, we will not object to the product being shipped from a foreign manufacturer directly to a retailer if the importer will:
- release the drug before it is shipped by reviewing all applicable documentation and testing results
- will have measures in place to ensure all requirements of the regulations are met, which means:
- identifying roles and responsibilities
- having appropriate quality agreements between all parties, including the foreign manufacturer, importer and retailer receiving the product
Transportation and storage
Canadian importers, distributors and wholesalers must ensure that shipping conditions will not affect the safety, efficacy or quality of the drugs that Canadians rely upon. Additional information on shipping and storage requirements are found in our guidelines for temperature control of drug products during storage and transportation.
During the COVID-19 pandemic, Canadian suppliers may be required to use new shipping modes or routes to mitigate potential risks. Be sure to evaluate such changes in accordance with QRM principles. Consider the following:
- determine potential risks and potential extreme environmental conditions for the new shipping route
- review known information about the product, such as stability data including any freeze/thaw and high temperature cycling studies (you may need to ask for guidance or recommendations from your supplier)
- take steps to mitigate identified risks, such as increasing temperature monitoring points throughout the load to better assess transportation conditions
- review and update your risk evaluations regularly
Due to the pandemic, you may be experiencing additional challenges. These may include:
- unavailability of temperature-mapped vehicles and containers
- potential lack of warehouse space
- lack of qualified people to conduct required qualification and calibration activities
Consider the following measures to mitigate these challenges:
- increased temperature monitoring
- periodic calibration checks of devices to ensure they are working within established temperature and humidity limits
Where pandemic- related challenges continue to exist, we will not object to the product being shipped to Canada before all testing and fabricator release requirements (ship in quarantine) are met. However, Canadian importers are still expected to:
- quarantine all incoming shipments until released
- ensure all required testing is completed before the product is released to the Canadian market
- check that the product meets its release requirements, including test results
For questions about interim measures for testing, email: email@example.com.
For questions about foreign building evidence: email firstname.lastname@example.org.
For information on drug establishment licensing, email: email@example.com.
COVID-19 regulatory measures for Canadian drug establishments
Exceptional importation and sale of drugs in relation to COVID-19
The Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 was made on March 1, 2021, in order to extend, clarify and modify certain measures from a previous interim order made in March 2020.
This interim order (IO) helped to ensure that Canadians had access to the health products they needed during the pandemic. It specifically allowed the importation and sale of certain foreign-authorized drugs that may not fully meet Canadian regulatory requirements, but are manufactured according to comparable standards.
The IO provisions on the exceptional importation and sale of drugs have been transitioned into permanent amendments to the Food and Drug Regulations, with an entry into force date of March 2, 2022. The permanent regulations do not require a drug shortage to be related to the COVID-19 pandemic to be eligible for exceptional importation and sale.
For more information, visit the Overview of exceptional importation and sale of drugs page.
- Drug establishment licences and COVID-19
- Canada’s approach to onsite inspections during COVID-19: Notice
- Good manufacturing practices guide for drug products (GUI-0001)
- Good manufacturing practices guidelines for active pharmaceutical ingredients (GUI-0104)
- Q9: Quality Risk Management - International Council for Harmonisation
- Post-notice of compliance changes: Quality document
- Alternate sample retention site guidelines – guidance document (GUI-0014)
- Letter to stakeholders - Responsibilities and obligations with respect to good manufacturing practices
- Chemical entity products/quality
- Drug establishment good manufacturing practices - Pre-application package (importers, distributors and wholesalers)
- Notice - Submission filing requirements - good manufacturing practices/establishment licences
- Notice to stakeholders - Amended Food and Drugs Regulations for active ingredients
- Good manufacturing practices inspection summary reports
- Summary report of the drug good manufacturing practices inspection program - April 1, 2006, to March 31, 2011
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