Natural health products good manufacturing practices pre-inspection package: Checklist for packagers

Specifications (section 44, if applicable)

• In cases where there is a quality technical agreement in place indicating the packager is responsible for the product release:
  • product specifications for all products packaged at the site
  • product specifications are approved by the quality assurance person (QAP)

Premises (section 45)

• A detailed floor plan showing non-production, quarantine and packaging areas
• Daily temperature, relative humidity and light (as required) control records
• Facility maintenance records
• Pest control program
• Standard operating procedures (SOPs) on temperature and pest control
• Printed materials must be stored in an area with restricted access

Equipment (section 46)

• Preventative maintenance schedule for equipment
• Equipment usage, cleaning, sanitation and maintenance logs
• Calibration program and records for essential equipment
• SOPs on operating, maintaining and cleaning equipment

Personnel (section 47)

• Records that NHP GMP and relevant SOP training has been provided to all personnel involved in GMP activities
• Training program (for example, employee training schedule)
• Job descriptions that outline roles and responsibilities of positions
• Résumé or curriculum vitae and copy of educational degrees that show the person meets their job description

Sanitation program (section 48)

• List of cleaning and sanitizing agents
• Facility cleaning schedule
• Cleaning completion logs
• Health and hygiene program
• Personnel hygiene training
• SOPs on facility and processing equipment cleaning, storing cleaned equipment to avoid recontamination, and destroying and disposing of waste materials

Operations (section 49)

• SOPs in place for material control, process control, and product transportation, receiving and storage
• Inspection program for contractors
• Packaging material specifications, certificates of analysis (CoA) and release records for all packaging materials
• Receiving and sampling records for packaging components
• Product disposition, distribution, return and disposal logs and records
• Records for out-of-specification results related to packaging material, including investigations into root causes and corrective and preventive actions to address root causes and prevent recurrences
• Quality technical agreements with contractors (for example, manufacturers, packagers, labellers, importers, warehouses, test labs, wholesalers, quality assurance consultants) and suppliers

Operations (section 50)

• SOPs on conducting a recall of an NHP
• Each lot of packaging material has distinct identification for traceability (for example, lot number)
• Distribution records for all products
• Signed quality technical agreement outlining recall responsibilities

Quality assurance (section 51)

• Organizational chart showing independence of function
• Identification of the QAP and delegate (where applicable)
• Qualifications of the QAP and delegate (where applicable)
• Records showing that packaging material was released by the QAP or delegate
• Logs for complaints, returned products, product disposition, distribution and disposal
• SOPs on sampling, inspecting and testing packaging materials
• SOPs on releasing packaging materials, handling complaints, deviations, out-of-specification test results, and returned, rejected and expired goods

Records (section 54) and record maintenance (section 58)

• List of all NHPs packaged at the site
• Records demonstrating that each lot or batch of the NHP was packaged in accordance with the requirements of Part 3 of the regulations
• Packaging order
• Test results and release records for packaging material
• Relevant records are maintained for a period of 1 year after the NHP has expired
• Records containing sufficient information to enable a recall
• Relevant written procedures (SOPs) for the maintenance of records by packagers, including the following:
  • change control
  • record control and retention
  • control of electronic records
  • use of electronic signatures
  • good documentation practices
  • document translation
  • review and approval of GMP documents
  • SOP creation and maintenance
• When an electronic document management system is in place:
  • validation information for the system
  • electronic records are backed up
• When electronic signatures are in use:
  • documentation detailing the development and maintenance of the electronic signature identification system
  • they must be tested and evaluated for security, validity and reliability

Sterile natural health products (section 59) and ophthalmic use (section 60)

• Batch records
• Validation process
• Sterilization and environmental monitoring records
• QAP and product support staff qualifications
• Records for specialized training in microbiology (applicable to supervisory staff only)
• SOPs and associated records for clean room maintenance, laminar flow maintenance and product sterilization