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

Specifications (section 44, if applicable)

• In cases where there is a quality agreement in place indicating the packager is responsible for product release:
  • product specifications for all products packaged at the site
  • product specifications are approved by the quality assurance person (QAP)
• For liquid products:
  • microbiological test results obtained on the finished product after packaging or evidence of microbial controls used to mitigate the risk of contamination during the filling process
    • a certificate of analysis (CoA) is sufficient if a third-party laboratory conducts the testing

Premises (section 45)

• A detailed floor plan showing non-production, quarantine and packaging areas
• Standard operating procedures (SOPs) and associated records for:
  • prevention of contamination and cross-contamination of natural health products (NHPs)
  • storage conditions of packaging materials, bulk and finished products
  • pest control
  • janitorial duty schedule and cleaning completion
  • ventilation inspection and maintenance records (as applicable)
  • restricting access to storage areas for printed materials
  • water quality testing
  • facility inspection and maintenance

Equipment (section 46)

• Preventative maintenance schedule or program for equipment, which includes identification of equipment and instructions on how to maintain it
• Equipment usage, cleaning and maintenance logs
• Calibration program and records for equipment that requires it, including proof of the calibration standard or reference being used
• SOPs for the operation of equipment

Personnel (section 47)

• SOPs for the appropriate education, training or work experience for all personnel
• List of qualified QAP designate(s)
• Records of completed training relating to assigned duties and responsibilities (for example good manufacturing practices (GMP) training) of personnel
• Employee training schedule or attendance records that demonstrate initial and on-going relevant training
• Job descriptions that outline roles and responsibilities of positions
• Résumé or curriculum vitae that show the person meets their job description

Sanitation program (section 48)

• SOPs and associated records for a sanitation program that includes information on cleaning of premises, packaging and storage areas and equipment, such as:
  • storage and protection of equipment after cleaning
  • procedures for destroying and disposing of waste materials and debris
  • cleaning and sanitizing agents to be used
  • cleaning frequencies
  • facility cleaning schedule
  • cleaning completion
• SOPs and associated records for a health and hygiene program that includes:
  • personnel hygiene training
  • guidance related to personal hygiene

Operations (section 49)

• SOPs and associated records for:
  • transporting, receiving, handling, storing, and distributing packaging materials, bulk or finished products
  • packaging NHPs
  • sampling records for packaging components
  • product disposition, return and disposal
  • packaging material specifications, CoAs and release records for all packaging materials
  • out-of-specification (OOS) results related to packaging material, including investigations into root causes and resulting corrective and preventive actions
  • product complaints and resulting action
• Ensure polymer-based packaging material are acceptable (if used)
• Master production documents and batch records
• Quality agreements with contractors (for example, manufacturers, packagers, labellers, importers, warehouses, test labs, wholesalers, quality assurance consultants) and suppliers
• List of all contract manufacturers, packagers and labellers used domestically and in foreign countries, as applicable

Operations (section 50)

• SOPs and associated records for recalling a NHP and recall reporting
• Each lot of released finished product has distinct identification for traceability (for example, lot number)
• Distribution records for all products
• Signed quality agreement outlining recall responsibilities

Quality assurance (section 51)

• Organizational chart showing independence of QAP's function
• Identification of the QAP and delegate (where applicable)
• QAP's and delegate's (where applicable) résumé, including education
• QAP's training record demonstrating ongoing and relevant training
• SOPs and associated records for:
  • QAP job description that outlines roles and responsibilities, required training, experience and technical knowledge
  • approval of packaging materials and finished products
  • releasing packaging materials and finished products (if applicable)
  • investigation and resolution/corrective actions for complaints, deviations, OOS test results, and returned, rejected and expired products
  • disposition, distribution and disposal of products
  • review and approval of methods, procedures and systems used to package NHPs
• Approved finished product specifications, if applicable
• Approved finished product release records, if applicable

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

• List of all NHPs packaged at the site
• A copy of the sanitation program in use 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 or evaluation results and release records for packaging material
• Relevant records are maintained for a period of 1 year following the expiry date of the NHP to which the record relates
• Records containing sufficient information to enable a recall, which includes product distribution records
• 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:
  • information that supports the suitability and reliability of the system
  • documentation that outlines the development and maintenance of the system
• 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
• Packaging material specifications
• For packagers of liquid products:
  • documents demonstrating microbial controls to mitigate the risk of contamination during the filling process, or
  • microbiological test results obtained after packaging

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

• SOPs and associated records for:
  • packaging processes
  • environmental control of particulate and microbial contamination
  • clean room entry and exit process for personnel and materials
  • clean room maintenance
  • laminar flow maintenance
  • product sterilization
  • in-process and finished product testing
  • QAP and product support staff qualifications and specialized training in microbiology (applies only to staff supervising the sterile packaging)
• Detailed floor plan showing movement of personnel and materials during sterile packaging
• Product-specific process validation for all critical steps of the packaging process, requalification and controls of the sterilization process
• For more information, refer to Annex 1 to the Good manufacturing practices guide – Manufacture of sterile drugs (GUI-0119)