Annex 7 to the Good manufacturing practices guide - Selected non-prescription drugs (GUI-0066): Definitions

The following definitions explain how terms are used in this document. They supplement the definitions provided in the Good manufacturing practices guide for drug products (GUI-0001).

If there is a conflict with a definition in the Food and Drugs Act or theFood and Drug Regulations, the definition in the Act or Regulations prevails.

Active ingredient:

A drug that, when used as a raw material in the fabrication of a drug in dosage form, provides its intended effect. (FDR, C.01A.001(1)) (ingrédient actif)

Active pharmaceutical ingredient:

An active ingredient used in the fabrication of a pharmaceutical. (FDR, C.01A.001 (1)) (ingrédient actif pharmaceutique)

Note: This definition also includes an active ingredient used in the fabrication of a drug that is of non-biological origin and is listed in Schedule C to the Act.

Batch (or lot):

A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In the case of 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) (lot de fabrication (ou lot))

Batch certificate:

A certificate issued by the fabricator of a lot or batch of a drug that is either imported within the framework of a mutual recognition agreement or referred to in the List of non-prescription drugs not subject to certain testing requirements and in which the fabricator:

1. identifies the master production document for the drug and certifies that the lot or batch has been fabricated, packaged/labelled and tested in accordance with the procedures described in that document
2. provides a detailed description of the drug, including
   
   1. a statement of all properties and qualities of the drug, including the identity, potency and purity of the drug and
   2. a statement of tolerances for the properties and qualities of the drug
3. identifies the analytical methods used in testing the lot or batch and provides details of the analytical results obtained
4. sets out the addresses of the buildings at which the lot or batch was fabricated, packaged/labelled and tested
5. certifies that the lot or batch was fabricated, packaged/labelled and tested
   
   1. in the case of a drug that is imported within the framework of a mutual recognition agreement, in accordance with the good manufacturing practices of the regulatory authority that has recognized those buildings as meeting its good manufacturing practices standards or
   2. in the case of a drug that is not imported within the framework of a mutual recognition agreement and that is referred to on the List of non-prescription drugs not subject to certain testing requirements, in accordance with the requirements of Division 2

(FDR, C.01A.001(1)) (certificate de lot)

Note: An example of a batch certificate's content is also described in Health Canada's International Harmonized Requirements for Batch Certification. This document was developed with our mutual recognition agreement (MRA) partners but is still relevant for products covered in Annex 7.

Batch number:

(See lot number) (numéro de lot de fabrication)

Bracketing:

The design of a stability schedule such that only samples on the extremes of certain design factors (for example, strength, package size) are tested at all-time points as in a full design. The design assumes that the stability of any intermediate levels is represented by the stability of the extremes tested. Where a range of strengths is to be tested, bracketing applies if the strengths are identical or very closely related in composition. Examples:

• a tablet range made with different compression weights of a similar basic granulation
• a capsule range made by filling different plug fill weights of the same basic composition into different sized capsule shells

Bracketing can be applied to different container sizes or to different fills in the same container closure system. (ICH Q1A) (méthode de la matrice)

Certificate of analysis (CoA):

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, and any other technical information deemed necessary for its proper use. (certificat d'analyse (CA))

Certificate of manufacture:

A document issued by a vendor to a distributor or importer attesting that a specific lot or batch of drug has been produced in accordance with its master production documents. 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 quality control department. For drugs that are fabricated, packaged/labelled and tested in MRA countries, the batch certificate is equivalent. (certificat de fabrication)

Change control:

A written procedure describing the action taken if a change is proposed:

• to facilities, materials, equipment and/or processes used in to fabricate, package and test drugs or
• that may affect the operation of the quality or support system

(contrôle des changements)

Changeover procedure:

A logical series of validated steps that ensure the proper cleaning of suites and equipment before the processing of a different product begins. (procédure de conversion)

Critical process:

A process that if not properly controlled may cause significant variation in the quality of the finished product. (procédé critique)

Data:

All original records and certified true copies of original records (includes source data, metadata and all subsequent transformations and reports of the data), that are recorded at the time of the activity and allow full and complete reconstruction and evaluation of the activity. (Adapted from WHO draft) (données)

Distributor or manufacturer:

A person, including an association or partnership, who under their own name or under a trade, design or word mark, trade name or other name, word or mark controlled by them, sells a food or drug. (A.01.010) (distributeur ou fabricant)

Divisions 1A and 2 to 4 apply to the following distributors:

• a distributor of an active ingredient or a drug in dosage form that is listed in Schedule C to the Act
• a distributor of a drug for which that distributor holds the drug identification number

(C.01A.003)

Dosage form:

A drug product that has been processed to the point where it is now in a form that may be administered in individual doses, unless otherwise defined in the Food and Drug Regulations. (forme posologique)

Drug:

Includes any substance or mixture of substances manufactured, sold or represented for use in:

• diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals
• restoring, correcting or modifying organic functions in human beings or animals or
• disinfecting in premises where food is manufactured, prepared or kept

(Food and Drugs Act, section 2)

In Division 1A and Division 2 of the Food and Drug Regulations, "drug" does not include:

• a dilute drug premix
• a medicated feed as defined in subsection 2(1) of the Feeds Regulations, 1983
• an active ingredient that is for veterinary use and is not an active pharmaceutical ingredient
• an active pharmaceutical ingredient for veterinary use that is not required to be sold pursuant to a prescription and is also a natural health product as defined in subsection 1(1) of the Natural Health Products Regulations
• a drug that is used only for an experimental study in accordance with a certificate issued under section C.08.015

(FDR, C.01A.001 (2)) (drogue)

Drug establishment licence:

A licence issued to a person in Canada to conduct licensable activities in a building that has been inspected and assessed as being in compliance with the requirements of Divisions 2 to 4 of the Food and Drug Regulations. (Licence d'établissement pour les produits pharmaceutiques (LEPP))

Drug identification number (DIN):

An 8-digit numerical code assigned by Health Canada to each drug product marketed under the Food and Drugs Act and Regulations. A DIN uniquely identifies the following product characteristics:

• manufacturer
• brand name
• medicinal ingredient(s)
• strength of medicinal ingredients(s)
• pharmaceutical form
• route of administration

(Numéro d'identification d'une drogue)

Fabricate:

To prepare and preserve a drug for the purpose of sale. (C.01A.001(1)) (manufacturer)

Finished product:

A product that has undergone all stages of production, including packaging in its final container and labelling. (produit fini)

Import:

To import into Canada a drug for the purpose of sale. (C.01A.001(1)) (importer)

Label:

Includes any legend, word or mark attached to, included in, belonging to or accompanying any food, drug, cosmetic, device or package (section 2 of the Act). As described in package/label, the action of labelling refers to affixing the inner or outer label to the drug. (C.01A.001) (étiquette)

List of non-prescription drugs not subject to certain testing requirements:

Refers to the List of non-prescription drugs for which the testing requirements set out in subsections C.02.019(1) and (2)of the Food and Drug Regulations do not apply. The list is published by the Government of Canada on its website and is amended from time to time. (C.01A.001(1)) (Liste de drogues vendues sans ordonnance et non soumises à certaines analyses)

Lot:

See Batch. (lot)

Lot number:

Any combination of letters, figures or both by which a food or drug can be traced in manufacture and identified in distribution. (A.01.010) (numéro de lot)

Manufacturing batch record:

Records demonstrating that the batch of a drug was fabricated in accordance with the approved master production documents. (fiche de lot de fabrication)

Marketing authorization:

A legal document issued by Health Canada authorizing the sale of a drug or a device based on the health and safety requirements of the Food and Drugs Act and its Regulations. The marketing authorization may be in the form of a:

• notice of compliance (NOC)
• drug identification number (DIN)
• device licence for classes II, III and IV medical devices
• natural product number (NPN) or
• homeopathic DIN-HM (DIN-HM)

(autorisation de mise en marché)

Master production documents (MPD):

Documents that include specifications for the:

• raw material, packaging material and packaged dosage form
• master formula, sampling procedures and critical processing-related standard operating procedures (SOPs)
  • these SOPs may not be specifically referenced in the master formula

(document type de production)

Matrixing:

The design of a stability schedule such that a selected subset of the total number of possible samples for all factor combinations is tested at a specified time point. At a subsequent time point, another subset of samples for all factor combinations is tested. The design assumes that the stability of each subset of samples tested represents the stability of all samples at a given time point. The differences in the samples for the same drug product should be identified as, for example, covering different batches, different strengths, different sizes of the same container closure system, and possibly in some cases, different container closure systems. (ICH Q1A) The concept of matrixing may also apply in other areas such as validation. (méthode de la matrice)

Medicinal ingredient:

See active pharmaceutical ingredient. (ingrédient médicinal)

MRA country:

A country that has a mutual recognition agreement with Canada. (C.01A.001(1)) (pays participant à un ARM)

Mutual recognition agreement (MRA):

An international agreement that provides for the mutual recognition of compliance certification for good manufacturing practices for drugs. (C.01A.001) (accord de reconnaissance mutuelle)

Original record:

Data as the file or format in which it was generated originally, which preserves the record's integrity (accuracy, completeness, content and meaning). Examples include an original paper record of manual observation or an electronic raw data file from a computerized system. (MHRA GMP Data Integrity Definitions and Guidance for Industry, March 2015) (données brutes)

Package:

As described in 'package/label,' the action of packaging refers to putting a drug in its immediate container. (Adapted from C.01A.001(1)) (emballer)

Package/label:

To put a drug in its immediate container or to affix the inner or outer label to the drug (C.01.A.001(1)). This includes repackaging and relabelling previously packaged and labelled drugs. (emballer-étiqueter)

Personal care products:

A substance or mixture of substances used in daily cleansing or grooming. Personal care products may fall into 1 of 3 regulatory categories in Canada: cosmetics, drugs or natural health products. (produits de soins personnels)

Person:

Anyone other than an importer (for example, a retailer). (personne)

Quarantine:

The status of materials isolated physically or by other effective means pending a decision on their subsequent approval or rejection. (ICH Q7) (quarantaine)

Recognized country or region:

A country on the List of foreign countries and their regulatory authorities for the application of subsection C.02.019(5) of the Food and Drug Regulations. The list is published by the Government of Canada on its website and is amended from time to time. (pays ou régions reconnus)

Raw material:

Any substance other than packaging material or an in-process drug that is used to manufacture a drug. Includes substances that appear in the master formula but not in the drug, such as solvents and processing aids. (matière première)

Sell:

Offer for sale, expose for sale or have in possession for sale, or distribute to one or more persons, whether or not the distribution is made for consideration. (section 2, Food and Drugs Act) (vendre)

Shelf life:

The time interval during which a drug product is expected to remain within the approved specification, provided it is stored according to the conditions noted on the label and in the proposed containers and closure. (durée de conservation)

Specifications:

A detailed description of a drug, the raw material used in a drug or the packaging material for a drug. Examples:

• a statement of all properties and qualities of the drug, raw material or packaging material that are relevant to the manufacture, packaging and use of the drug, including its identity, potency and purity, as well as raw material or packaging material
• a detailed description of the methods used for testing and examining the drug, raw material or packaging material
• a statement of tolerances for the properties and qualities of the drug, raw material or packaging material

(C.02.002) (spécifications)

Standard operating procedure (SOP):

A written procedure giving instructions for performing operations not necessarily specific to a given product or material but of a more general nature. Examples of operations where a SOP would apply include: equipment operation, maintenance and cleaning, validation, environmental control and cleaning of premises, sampling and inspection.

Certain SOPs may be used to supplement product-specific master and batch production documents. (procédure opératoire normalisée (PON))

Test:

To perform the tests, including any examinations, evaluations and assessments, as specified in Division 2 of the Food and Drug Regulations. (analyser)

Validation:

A documented program that provides a high degree of assurance that a specific process, method or system will consistently produce a result that meets pre-determined acceptance criteria. (ICH Q7) (validation)

Wholesaler:

A person who is not a distributor described in section C.01A.003 and who sells any of the following drugs other than at retail sale:

• a drug in dosage form that is listed in Schedule C or D to the Act, a drug that is a prescription drug or a controlled drug as defined in section G.01.001
• an active ingredient
• a narcotic as defined in the Narcotic Control Regulations or
• a drug containing cannabis as defined in subsection 2(1) of the Cannabis Act

(C.01A.001 (1)) (grossiste)