Good manufacturing practices guide for natural health products (GUI-0158): Acronyms, glossary, references

Acronyms and abbreviations

CAPA: corrective and preventive action(s)
CC: change control
GLP: good laboratory practices
GMP: good manufacturing practices
ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
ISO: International Organization for Standardization
MRA: mutual recognition agreement
MSDS: material safety data sheet
NHP: natural health product
NPN: natural product number
OOS: out-of-specification
OOT: out-of-trend
PIC/S: Pharmaceutical Inspection Co-operation Scheme
PPE: personal protective equipment
QA: quality assurance
QAP: quality assurance person
QC: quality control
SOP: standard operating procedure
US FDA: United States Food and Drug Administration
USP: United States Pharmacopeia
WHMIS: Workplace Hazardous Materials Information System
WHO: World Health Organization

Glossary

The following definitions apply to the terms used in this guidance. Certain terms may have different meanings in other contexts. If there is a conflict between a definition in this section of the guide and a definition in the Food and Drugs Act or the Natural Health Products Regulations, the definition in the act or regulations prevails.

Acceptance criteria (tolerance limits): Numerical limits, ranges or other suitable measures for acceptance of the results of analytical procedures. (ICH Q7)

Batch: A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. For continuous production, a batch may correspond to a defined fraction of the production. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval. (ICH Q7)

Batch certificate: A certificate issued by the manufacturer of a lot or batch of a product imported from buildings inspected by a regulatory authority under a mutual recognition agreement (MRA) or under the Pharmaceutical Inspection Co-operation Scheme (PIC/S). For more information on the content of a batch certificate, refer to the International harmonized requirements for batch certification.

Batch number: A distinctive combination of numbers, letters or both that:

identifies a product batch and
appears on documents such as the batch record

Batch record: Production document that captures the quantity and lot number of all materials used, production steps and responsible persons involved in manufacturing a single batch of an natural health product in dosage form.

Bulk preparation: A homeopathic preparation not in its final packaging, usually in quantities larger than the largest commercially available package size.

Bulk product: A product in dosage form not in its final packaging, usually in quantities larger than the largest commercially available package size.

Certificate: A legally authenticated written declaration issued by a recognized institution to a person completing a course of study.

Certificate of analysis: A document containing the:

name and address of the lab performing the test(s)
name and specifications of the material(s)
test(s) performed
test method(s) used
actual numerical results
approval date(s)
signature of approver

Also contains other technical information deemed necessary for its proper use.

Certificate of manufacture: A document issued by a vendor to a distributor or importer attesting that a specific lot of product has been produced according to its master production document. Such certificates include a detailed summary of current batch documentation, with reference to respective dates of revision, manufacture and packaging, and are signed and dated by the vendor’s authorized quality assurance person.

Change control: A written procedure that describes the action to be taken if a change is proposed:

to facilities, materials, equipment or processes used to manufacture, package and test natural health products or
that may affect the operation of the quality or support system

Compliance: The state of conformity of a regulated party (including a corporation, institution, individual or other legal entity) or a product with a legislative or regulatory requirement, or a recognized standard.

Compositing: A process that involves:

taking multiple samples from a portion of units or containers
combining or blending the samples together to form a composite
taking a single sample from the composite and testing it once (composite testing)

Confirmatory testing: Tests done by a third-party laboratory to confirm results obtained from another facility. The goal is to confirm the validity of results already obtained for the same lot.

Contractor or contract manufacturer: A legal entity that carries out activities on behalf of a company according to a quality agreement (written agreement). This includes other sites within the same corporate structure. For example, a company that manufactures, packages or labels a natural health product (NHP) or performs any other activity or operation concerning an NHP, under the terms of an agreement with another party.

Conveyance: A vessel, aircraft, train, motor vehicle, trailer or other means of transportation, including a cargo container. (Safe Food for Canadians Act)

Corrective and preventive action (CAPA) plan: A set of actions that eliminate the cause of an identified non-conformity or other undesirable situation. Corrective actions are taken to control a current event. Preventive actions are taken to prevent them from occurring again.

Critical equipment: Equipment that if not properly controlled may cause significant variation in the quality of the finished product.

Critical process: A process that may cause significant variation in the quality of the finished product.

Data integrity: The extent to which all data are complete, consistent and accurate throughout the data lifecycle. (PIC/S)

Deviation: A departure from an established or approved procedure, process, work instruction, form, or accepted standard. Deviations can be planned (known in advance) or unplanned.

Diploma: A document issued by an educational institution, such as a university, college or technical institute, vouching that the recipient has earned a degree or successfully completed a particular course of study.

Distributor: A person who sells a natural health product to another person for the purpose of further sale by that other person.

Dosage form: The final physical form of the natural health product that may be used by the consumer without requiring any further manufacturing.

Education: The act or process of imparting or acquiring knowledge or skills. The learning of information by instruction, training or study can be testified to by a degree, certificate or diploma.

Experience: Knowledge or skills acquired by:

actively participating in events or activities
personally observing, encountering or undergoing something

Filling: Transferring and enclosing a bulk product into its final container.

Finished product: A product that has undergone all stages of production, including packaging into its final container and labelling.

Formulate: To prepare components and combine raw materials into a bulk natural health product.

Good documentation practices: Measures that collectively and individually ensure paper or electronic documentation is secure, attributable, legible, traceable, permanent, contemporaneously recorded, original and accurate. (WHO)

Health risk classification: A numerical designation that Health Canada may assign to a product to indicate the relative degree of risk to human health presented by the product:

Type I: A situation in which there is a reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death
Type II: A situation in which the use of or exposure to a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote
Type III: A situation in which the use of or exposure to a product is not likely to cause any adverse health consequences

Homeopathic medicine: Refer to the Supplementary GMP for homeopathic medicines for a description.

Import: To bring a natural health product into Canada, for the purpose of sale.

Importer: A person who imports a natural health product (NHP) into Canada, for the purpose of sale (includes bulk NHPs).

In-process control: Checks performed during production to monitor and, if necessary, adjust the process to ensure the finished product conforms to its specifications. The control of the production environment or equipment may also be considered part of in-process control.

In-process product: Any materials or mixture of materials that must undergo further processing to become a product in dosage form.

In-process tests: Tests performed during the manufacture of the natural health product, rather than as part of the finished product tests conducted before release. (ICH Q6A)

International Organization for Standardization, ISO: A worldwide non-governmental organization of national standards bodies that maintains a group of global standards.

Label (noun): Includes any legend, word or mark attached to, included in, belonging to or accompanying any food, drug, cosmetic, device or package. Natural health products are included.

Label (verb): To affix the inner or outer label of the natural health product.

Lot: A quantity of any natural health product in dosage form, a raw material or a packaging material, homogeneous within specified limits, constituting all or part of a single batch and identified by a distinctive lot number, which appears on its label.

Lot number: Any combination of letters, figures or both by which a natural health product can be traced in manufacture and identified in distribution.

Manufacture: To fabricate or process a product for the purpose of sale.

Manufacturer: A person who fabricates or processes a natural health product (NHP) for the purpose of sale, but does not include a pharmacist or other health care practitioner who, at the request of the patient, compounds an NHP for the purpose of sale to that patient.

Manufacturing order: Instructions that outline in detail the materials and procedures required to manufacture, prepare and preserve a single batch of a natural health product in dosage form.

Master formula: A document or set of documents specifying the raw materials with their quantities and the packaging materials, together with a detailed description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls.

Master production document: A document that includes:

specifications for raw materials, packaging materials and packaged dosage form
master formula
sampling procedures
critical processing related standard operating procedures
- whether or not these procedures are specifically referenced in the master formula

Also includes:

a complete list of raw materials used in the manufacture of the product, designated by names or codes
the amount of each raw material required for the product formulation
manufacturing and process control instructions

in-process testing requirements
a statement of the principal equipment to be used
a statement of the theoretical weight or measure of the manufactured product and the acceptable limits beyond which an investigation is required
a description of the finished product containers, closures and packaging labels
any special precautions to be observed
dates and times (if applicable) of commencement and completion of significant intermediate stages, such as blending or heating, and of completion of production

MRA country: A country that is a participant to a mutual recognition agreement (MRA) with Canada. (section C.01A.001(1), Food and Drug Regulations)

Mutual recognition agreement: An international agreement that provides for the mutual recognition of compliance certification for good manufacturing practices for drugs. (section C.01A.001(1), Food and Drug Regulations)

Natural health product: A substance set out in Schedule 1 (of the Natural Health Products Regulations) or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine, that is manufactured, sold or represented for use in:

the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans
restoring or correcting organic functions in humans or
modifying organic functions in humans

However, an NHP does not include a substance set out in Schedule 2 of the regulations or any combination of substances that includes a substance set out in Schedule 2.

Observation: A written or verbal comment used to identify a deviation or deficiency of good manufacturing practice (GMP). A GMP deviation or deficiency noted by an inspector during the inspection of a site, and confirmed in writing to the company in the inspection exit notice. Observations are assigned a risk classification ranging from 1 for "critical" to 2 for "major" to 3 for "other”.

Out-of-specification, OOS: A testing result that does not meet the approved specifications or established acceptance criteria.

Outsourced activity: Activities conducted by a contract acceptor under a written agreement with a contract giver. (ICH Q10)

Package: To put a product in its immediate container.

Package or packaging material: Includes:

immediate container
labels
printed packaging materials
any suitable material intended to protect the natural health product during storage and transport
those components in direct contact with the dosage form

Packaging order: Instructions that outline in detail the materials and special procedures required to package and label a single lot of a product in dosage form.

Pest: Any objectionable insect or other animal, including birds, rodents, flies, mites and larvae. (USP 2750)

Potency: The amount of the standardized components per dosage unit that further characterizes the quantity of the ingredient. It is necessary when a claim on the potency is required on the label or is required for a specific product (for example, when literature supports the product with that standardized component). In the Supplementary GMP for homeopathic medicines section of this guide, “potency” refers to the degree of dilution of a homeopathic medicine.

Preparatory (suitability) testing: A demonstration that the natural health product tested does not inhibit the assay or the recovery, multiplication or growth of microorganisms that may be present within it. Preparatory testing thus controls the risks of false negatives or lower-than-expected results.

Production: All operations involved in preparing a finished product, from materials received, through processing and packaging, to the finished product, including storage. (ICH Q7)

Product licence holder: An individual with legal ownership of and responsibility for the natural health product. The product licence holder may be located in or outside of Canada. Product licence holders who are located outside of Canada must identify a Canadian representative.

Purity: The extent to which a raw material or a product in dosage form is free from undesirable or adulterating chemical, biological or physical entities as defined by specification.

Qualification (personnel): To make competent or eligible for a job, position or task by having the proper or necessary skills, knowledge, credentials, accomplishments or qualities.

Quality assurance: Planned and systematic activities applied within the quality system give confidence that the predetermined standards for quality and safety will be met.

Quality assurance person: The person responsible for assuring the quality of the natural health product before it’s made available for sale. This person has the training, experience and technical knowledge related to manufacturing, packaging, labelling, importing and/or distributing. Also understands the good manufacturing practices requirements of Part 3 of the Natural Health Products Regulations.

Quantity: The amount of medicinal ingredient(s) per dosage unit.

Quarantine: Effective restriction of the availability of material or product for use (physically or by system), until released by the quality assurance person. The status of materials isolated physically or by other effective means pending a decision on their subsequent approval or rejection. (ICH Q7)

Raw material: Any substance, other than in-process product or packaging material, intended to be used in the manufacture of products. Includes those that appear in the master formula but that do not appear in the product such as solvents and processing aids.

Recall: A responsible party’s removal from further sale or use, or correction, of a distributed product that presents a risk to the health of consumers or violates the Food and Drugs Act or the Natural Health Products Regulations.

Recognized institution: A post-secondary educational facility (such as a university, college or professional institute) that has a solid reputation and is credible, reputable and authoritative.

Reconciliation: A comparison, making due allowance for normal variation, between the amount of product or materials theoretically produced or used and the amount actually produced or used.

Reprocessing: Subjecting all or part of a single batch of an in-process, bulk or finished natural health product to a previous step in the approved manufacturing process due to foreseen quality concerns with the batch. Reprocessing procedures are looked on as necessary from time to time. They are pre-approved by the quality control department and as part of the marketing authorization, where applicable.

Retention sample: A sample of a fully packaged unit from a lot or batch of finished product stored for identification purposes. For additional product testing, a sample is considered necessary to determine if the natural health product complies with its specifications. (European Commission Annex 19 Reference and retention samples)

Returned product: Bulk or finished product sent back to the manufacturer, packager, labeller, distributor or importer.

Reworking: Subjecting all or part of a single batch of an in-process, bulk or finished natural health product to an alternate manufacturing process due to a failure to meet predetermined specifications. Occurs unexpectedly and is not pre-approved as part of the marketing authorization.

Sale: See “Sell”.

Sampling: Collection of a number of units that makes up a representative sample from a designated lot or batch of product.

Scientific rationale: A justification that is in accordance with the principles and methods of science, and is systematic and exact. In the natural health product context, this justification should be supported by an acceptable pharmacopoeial reference or data to explain the underlying issues that led to the need of preparing such a rationale. When such acceptable references are not available or when such data is difficult to obtain, the justification must nevertheless be sound and reasonable.

Secondary package: A container in which a natural health product is wholly or partly contained without coming into direct contact with the dosage form.

Secondary packaging/labelling: To place a natural health product already in its immediate package or container into a secondary package or container.

Sell: Includes offer for sale, expose for sale, have in possession for sale, or distribute to 1 or more persons, whether or not the distribution is made for consideration for lease, offer for lease, expose for lease or have possession for lease. For clarity, the word “consideration” can take various forms, including:

monetary payment
promise to do something
promise to refrain from doing something

Shelf life: The time period during which a natural health product is expected to remain within the approved shelf-life specification, provided it’s stored under the conditions defined on the container label. (ICH Q1A)

Site: A place of or for an activity specified under the Natural Health Products Regulations.

Specifications: Quality standards include tests, references to test methods and appropriate acceptance criteria (tolerance limits), which are numerical limits, ranges or other criteria for the tests described. Specifications establish the criteria to which a finished product should conform to be considered acceptable for its intended use. (ICH Q6A)

Stability: The ability of a natural health product to keep its chemical, physical, microbiological and biopharmaceutical properties within specified limits throughout its shelf life. (adapted from the WHO definition)

Stability sample: A representative sample of a fully packaged unit from a lot or batch of finished product stored under controlled conditions for the stability tests to define its shelf life under specified packaging and storage conditions.

Stability tests: A series of tests done to obtain information on the stability of a natural health product in order to define its shelf life under specified packaging and storage conditions. (WHO)

Accelerated testing: Studies designed and performed according to an approved stability protocol, to increase the rate of chemical degradation or physical change of a product by using exaggerated storage conditions as part of the stability studies. Data from these studies, in addition to real-time (long-term) stability studies, can be used to assess longer-term chemical effects at non-accelerated conditions and to evaluate the effect of short-term excursions outside the label storage conditions such as might occur during shipping. Results from accelerated testing studies are not always predictive of physical changes. (adapted from the ICH Q1A description)
Real-time (long-term) stability studies: Stability studies, performed according to an approved stability protocol, under the recommended storage conditions for the shelf life proposed for labelling. The results are used to establish the shelf life, to confirm the projected shelf life, and to recommend storage conditions. (ICH Q1A)

Standard operating procedure, SOP: An authorized written procedure giving detailed instructions for performing operations consistently and in a repeatable way. They are not necessarily specific to a given product or material but are of a more general nature (for example, equipment operation, maintenance and cleaning, product release, training procedures). Certain standard operating procedures may be used to supplement product-specific master production documents.

Sterile: Free from viable microorganisms.

Sterile dosage form: A dosage form that is free from viable microorganisms.

Storage: A site, also called a warehouse, whose main purpose is to hold products, including natural health products.

References

Laws and regulations

Guidelines and other documents

Health Canada

Canadian Food Inspection Agency

Canada Organic Regime

European Union

Guidelines on good distribution practice of medicinal products for human use

United States

Homeopathic Pharmacopoeia of the United States
United States Pharmacopeia (USP) and National Formulary (USP–NF)

USP <51> Antimicrobial effectiveness testing
USP <71> Sterility tests
USP <1029> Good documentation guidelines
USP <1079> Risks and mitigation strategies for the storage and transportation of finished drug products
USP <1112> Application of water activity determination to nonsterile pharmaceutical products
USP <2091> Weight variation of dietary supplements
USP <2232> Elemental contaminants in dietary supplements
USP <2750> Manufacturing practices for dietary supplements

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

ICH guideline Q1D: Bracketing and matrixing designs for stability testing of new drug substances and products
ICH guideline Q7: Good manufacturing practices guide for active pharmaceutical ingredients
ICH guideline Q9: Quality risk management

International Organization for Standardization (ISO)

ISO 8601 Date and time format

Pharmaceutical Inspection Co-operation Scheme (PIC/S)

World Health Organization (WHO)

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2025-09-04

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