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

Organization: Health Canada

Published: 2024-10-07

Specifications (section 44)

Product specifications for all products manufactured at the site
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 production, non-production, quarantine areas and so on
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

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
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

SOPs in place for material control, process control and product transportation, receiving and storage
Inspection program for contractors
Master production documents and batch records
Specifications, certificates of analysis (CoA) and release records for all raw materials (medicinal and non-medicinal ingredients)
Receiving and sampling records for raw materials
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) and suppliers
Water sample test results demonstrating that water used in manufacturing and for cleaning is of acceptable quality

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 sampling, inspecting and testing raw materials, packaging materials, and in-process and finished products
SOPs on releasing finished products, handling complaints, deviations, out-of-specification test results, and returned, rejected and expired goods

Stability testing protocol, 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 manufactured at the site
Relevant written procedures (SOPs) for the maintenance of records by manufacturers, 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
Records demonstrating that each lot or batch of the NHP was manufactured in accordance with the requirements of Part 3 of the regulations
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
Master production documents
Batch records
Raw material specifications
Records containing sufficient information to enable a recall, which includes product distribution records
CoA for all raw materials (medicinal and non-medicinal ingredients)
CoA for the finished product
Stability data and testing records for each product
Relevant records are maintained for a period of 1 year after the NHP has expired

Batch records
In-process and finished product testing results
Validation process
Sterilization and environmental monitoring records
QAP and product support staff qualifications
Records on specialized training in microbiology (applies only to supervisory staff)
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

Lists 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