The CFIA (Canadian Food Inspection Agency), Health Canada and the FDA can audit any facility at any time. Audits can be invasive and a highly disruptive experience - especially if you are not ready. Inspectors have the right to review any staff, procedures, product samples, documents and data in order to assess that (1) you are set up well for compliance, (2) you are adhering to your set up, and (3) the data you have collected can be trusted.
Process Manager EBR is digitization software that helps facilitate an efficient and smooth inspection process, which builds trust with inspectors that your organization takes food safety seriously.
What precipitates an inspection?
The CFIA, Health Canada and the FDA will inspect a facility more frequently if they have identified higher risks of contamination and other food safety issues relating to the facility, product or a process.
- Facility: An example of facilities risks could be related to an issue with CGMP (Current Good Manufacturing Practices) relating to your facility or product recalls.
- Product: Most product related risk that ring alarm bells for CFIA has to do with new applications, complaints or new product innovations (or breakthroughs).
- Process: Process risks are higher if the manufacturing process is unusually complicated or if the manufacturer has a history of not collecting batch information properly.
What does an inspection look like?
CFIA, Health Canada and the FDA inspectors can come to your facility unannounced and they have the authority to examine almost anything and order your staff to do almost anything as long as it is related to the safety of food. Their powers include:
- Examine, test, or take samples of anything in the facility
- Examine any document and make copies
- Order staff to move or not move anything in the production process
- Order staff to prove their identity
- Order staff to start, stop or complete any standard operating procedure relating to the production of the product
- Use your computers to analyze, print or save your data
Take photographs of anything
See comprehensive list of inspection powers here: https://laws-lois.justice.gc.ca/eng/acts/S-1.1/page-2.html#h-429522
What are inspectors looking to assess?
CFIA, Health Canada and the FDA will assess 3 main areas of batch record management:
- Readiness for commercial manufacturing - Determine whether the establishment(s) has a quality system that is designed to achieve sufficient control over the facility and commercial manufacturing operations. This relates to material handing, contamination, procedures and process feasibility.
- Conformation to Application - Verify that the formulation, manufacturing or processing methods, and analytical (or examination) methods are consistent with descriptions contained in the CMC section of the application for the biobatch (and other pivotal clinical batches, when applicable), the proposed commercial scale batch, and the API(s).
- Data Integrity Audit - CFIA, Health Canada and the FDA require that all data collected is complete, consistent, and accurate, aligned with the ALCOA principle:
- A - Attributable - able to be ascribed to a particular author
- L - Legible - clear enough to read and understand
- C - Contemporaneous - existing or occurring in the same period of time
- O - Original / True - present or existing from the beginning
- A - Accurate - correct in all details; exact
Are you ready for an inspection?
The CFIA, Health Canada and the FDA wants to ensure that you are your facility, products and processes are setup to ensure safe food practices, that you are executing your setup every time, and that the data has integrity - complete, consistent and accurate. Once you have set up your SOPs and manufacturing procedures to adhere to standards, Process Manager EBR can help to ensure your procedures are followed and the data your collect is true and accurate.
Process Manager EBR is designed to help you efficiently facilitate inspections:
- Ensure SOPs and schedules are followed to the letter - Repeated checks, automated calculations, double-blind fields, communications and real-time notifications ensure your compliance process can be dictated once and followed automatically every time.
- Enhance Data Integrity - Audit trails trace the entire batch process, including any changes that were made. This provides inspectors with transparency into the entire batch process. Enhance data accuracy, attribution and legibility makes the inspection process much more efficient for inspectors and enhances trust that your facility takes CGMP and safe food practices seriously.
- Accessible Reports - Inspectors review easily accessible and transparent data aligned with the spirit of the CFIA function.
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