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

Organization: Health Canada

Published: 2024-10-07

Specifications (section 44)

Product specifications for all imported products
Product specifications are approved by the quality assurance person (QAP)
Evidence that products are tested according to their finished product specifications, including testing methods and acceptance criteria as outlined in the Quality of natural health products guide

A detailed floor plan showing, for example, the warehouse, including quarantine area, release area and retain samples room
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

Calibration program and records for essential equipment, such as temperature and humidity monitoring devices

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

List of cleaning and sanitizing agents, if applicable
Facility cleaning schedule, including warehousing and storage areas, if applicable
Cleaning completion logs
Health and hygiene program
Personnel hygiene training

SOPs in place for product transportation, receiving and storage
Inspection program for contractors
Master production documents, master labels and batch records
Specifications and certificates of analysis (CoA) for all raw materials (medicinal and non-medicinal ingredients) and packaging material
Product disposition, distribution, return and disposal logs and records
Records for out-of-specification results, 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, warehouses, test labs, wholesalers, quality assurance consultants, importers) and suppliers

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

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 finished product was released by the QAP or delegate
Logs for complaints, returned products, product disposition, distribution and disposal
SOPs on releasing finished products, handling complaints, deviations, out-of-specification test results, and returned, rejected and expired goods

Stability testing protocol for imported products, including actions to be taken when a product fails stability, stability failure investigations and recalls, and details for establishing and extending product expiry dates
Stability report demonstrating that every product meets its specifications at expiry
- chemical contaminants such as heavy metals, pesticides and solvent residues do not need to be tested to support stability

List of all NHPs handled at the site
Records demonstrating that each lot or batch of the NHP was manufactured, packaged and labelled in accordance with the requirements of Part 3 of the regulations
Master production documents
Records containing sufficient information to enable a recall
Finished product specifications
CoA for the finished product
Access to the following records, if requested:
- batch records (when quantification by input is used)
- results of packaging material testing
- specification of raw materials and packaging materials
Stability data and testing records for each product
Relevant records are maintained for a period of 1 year after the product has expired
Relevant written procedures (SOPs) for the maintenance of records by importers, 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

Batch records
In-process and finished product testing results
Validation process
Sterilization and environmental monitoring records
QAP and product support staff qualifications
Records for specialized training in microbiology
SOPs and associated records for clean room maintenance, laminar flow maintenance and product sterilization

Retain an adequate number of samples of each lot of a finished product, to permit complete testing according to the specifications
Store samples in the environmental conditions listed on the label
Samples should be stored for 1 year after the product has expired
Samples should be stored in the same container closure system as the finished product
SOP for sample retention

List of all previous recalls and reasons for the recalls
Recall report
Product distribution records
Mock recall report
SOPs for notifying Health Canada's Regulatory Operations and Enforcement Branch of a recall