Good Manufacturing Practices and COVID-19

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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, the Health Product Compliance Directorate (HPCD) inspects establishments that fabricate, package or label, distribute, import, wholesale or test drugs. During these inspections, HPCD verifies GMP compliance with Part C, Division 2 of the Food and Drug Regulations. This is a requirement for issuing an 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.

COVID-19 good manufacturing practices

Drug good manufacturing practices (GMP) inspections

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.  This necessary shift in priority is temporarily deferring some non-critical services, including the processing timelines of some drug establishment licence applications, and good manufacturing practices inspections.

Domestic inspections

As of March 2020 and until further notice, we have postponed on-site GMP inspections of Canadian drug establishments. However, to ensure compliance, we are implementing other ways of conducting inspections, such as using remote GMP evaluations. We are contacting applicants in advance and on an individual basis, before we conduct such a review of their establishment.

On-site inspections may be conducted on a case-by-case basis when we have identified a health risk. We may also conduct inspections when an establishment is getting ready to manufacture:

  • a medically necessary drug or
  • a drug considered important in mitigating COVID-19 risks

We will continue to monitor the situation as it evolves, remain flexible and ready to adapt our approach to ensure the health and safety of Canadians.

Foreign inspections

As of March 2020 and until further notice, we have postponed on-site GMP inspections of foreign establishments.

We will take into consideration the delay of planned inspections by qualified or regulatory authorities. Consideration will also be given if you are unable to find a qualified auditor to conduct a corporate or consultant audit because of COVID-19.

We are actively working with our international partners, including  sharing inspection reports and keeping them informed of our current actions and approaches.

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: hc.drug.gmp.questions-bpf.medicaments.sc@canada.ca

For foreign GMP inspections, email: hc.foreign.site-etranger.sc@canada.ca

COVID-19 business impact mitigation measures

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:

  • 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
  • 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). Electronic records and systems that do not fully meet these practices will be allowed as long as you take steps to ensure authenticity. This includes ensuring that:

  • electronic signatures are controlled and fully attributable to the person signing the record
  • staff understand the meaning of electronic signatures
  • electronic signatures are dated (time-stamped, where possible)

For questions related to business impact mitigation, email: hc.drug.gmp.questions-bpf.medicaments.sc@canada.ca

COVID-19 interim measures for Canadian drug establishments

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:

  • temporary
  • effective immediately and until further notice
  • constantly being evaluated to ensure they allow for appropriate product quality oversight

Exceptional importation and sale of drugs in relation to COVID-19

On March 30, 2020, the Minister of Health signed an interim order for drugs, medical devices and foods for a special dietary purpose in relation to COVID-19. This interim order (IO) ensures that Canadians have access to the health products they need during the pandemic. It specifically allows certain drugs that may not fully meet regulatory requirements, but are manufactured according to comparable standards, to be imported and sold in Canada.

The regulatory requirements for Canadian importers of designated drugs under this IO are found on the industry section of our page on the exceptional importation and sale of drugs.

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 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 may 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).

During the pandemic, in the absence of a recent inspection by a regulatory or qualified authority, you may submit:

  • 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)

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, all importers of drugs from non-MRA countries licensed under division 1A of the Regulations may:

  • 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 interim measures 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. The testing requirements set out in subsections C.02.019 (1) and (2) of the Regulations do not apply.

Under these temporary measures, we no longer require identity or confirmatory testing.

However, before the product can be released for sale, importers must ensure the product meets specifications, and was manufactured in accordance with the master production documents. 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

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: hc.drug.gmp.questions-bpf.medicaments.sc@canada.ca

For questions about foreign building evidence: email hc.foreign.site-etranger.sc@canada.ca

For information on drug establishment licensing, email: hc.del.questions-leppp.sc@canada.ca

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