Distribution Centre:Health Canada Audits & Inspections

Health Canada Audits & Inspections

Background

This information is recorded to assist with the preparation and conduct when faced with a Health Canada Inspection.

Types of Health Canada Inspections

• GMP (Good Manufacturing Practise)
• Narcotic & Controlled Substances
• Precursors
• Medical Devices
• Other not applicable to uniPHARM - GXP-Clinical, Pharmacovigilance and CFIA (Canadian Food Inspection Agency)

Challenges

• Data Integrity
• Good documentation practices for QA/QC
• Transportation/storage-temperature control/mapping studies/qualified pack out solutions/IQ/OQ or DQ/PQ (should be done at least every 5 years)
• Inspection program for active pharmaceutical ingredients (Human only)

Preparation

• Ensure good communication with all colleagues that could be involved in the audit and review "The Golden Rules" & topics that will typically be covered during the inspection

Golden Rules

Rule #1

1. Be well prepared - it's important to be knowledgeable of the HC regulations

• • Where possible - simulate inspection process in the organization
  • Test internal SOP (Standard Operating Procedures)
  • Test staff knowledge
  • How are questions answered

Inspection "Don'ts..."

• • Don't - Guess, lie or make misleading statements
  • Don't - Get uptight, overly anxious, or defensive
  • Don't - Volunteer more information than necessary to answer the question
  • Don't - Engage in unconstructive arguments

1. Ensure that documents are readily retrievable
2. Use relevant guidelines as resources
3. Important to have senior management support as preparation takes resources

Rule #2

1. Good documentation practices

• Accurate records
  • Record all necessary information immediately upon completion of a task
  • Never trust your memory or write results on loose pieces of paper or a post-it note
  • Write your name legibly in ink. Remember that by signing records you are certifying that the record is correct and that you have performed the task as per the defined procedure.
  • Draw a single line through any mistakes, and initial and date the correction. Include a reason for the correction at the bottom of the page.
  • Record details if you deviate from a procedure
  • Never assume that undocumentated work has been properly completed - if it's not written down then it didn't happen
  • Review SOP's and processes regularly to assure that they are up to date
  • Document changes (change control)

Rule #3

1. Write good procedures and follow them - "Walk the talk"

Rule #4

1. Train and develop staff
   1. Training should be documented on a training form

Rule #5

1. Perform regular audits

• • Self inspections - complete, update SOP's as needed

Rule #6

1. When the inspector requests a document

• • Provide the required document ONLY

1. When the inspector asks a question

• • Answer the question directly and honestly - DO NOT provide any further details or information if it's not necessary
  • If you don't know that answer - DON'T guess - state you will find out and come back with the information

Rule #7

1. Key people must be present on the day of the inspection - if this is not possible, then ensure a suitable back up or request a reschedule if possible
2. Important documents to be available

• • Organizational Chart
  • SOP's
  • Training records
  • Transactional details