Definition Of Pharmaceutical Product

Fda Product Complaints
Definition Of A Pharmaceutical Product

Definitions of Pharmaceutical terms as per WHO.

The definitions given below apply to the terms used in this guide. They may have different meanings in other contexts.

Search pharmaceutical product and thousands of other words in English definition and synonym dictionary from Reverso. You can complete the definition of pharmaceutical product given by the English Definition dictionary with other English dictionaries: Wikipedia, Lexilogos, Oxford, Cambridge, Chambers Harrap, Wordreference, Collins Lexibase dictionaries, Merriam Webster. Pharmaceutical definition: 1. Relating to the production of medicines: 2. Relating to the production of. The product has been reformulated with a view to improving its stability under tropical conditions; the product has been reformulated to exclude excipients not approved for use in pharmaceutical products in the country of import; the product has been reformulated to meet a different maximum dosage limit for an active ingredient. When you're sick, you might have to go to the doctor. That doctor may need to turn to pharmaceutical drugs to treat you and get you to feel better. Pharmaceutical drugs are chemicals that are.

Active Pharmaceutical Ingredient (API)

Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when so used, becomes an active ingredient of that pharmaceutical dosage form. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.

Airlock

An enclosed space with two or more doors, which is interposed between two or more rooms, e.g. of differing classes of cleanliness, for the purpose of controlling the airflow between those rooms when they need to be entered. An airlock is designed for use either by people or for goods and/or equipment. authorized person

The person recognized by the national regulatory authority as having the responsibility for ensuring that each batch of finished product has been manufactured, tested and approved for release in compliance with the laws and regulations in force in that country.

Batch (or lot)

A defined quantity of starting material, packaging material, or product processed in a single process or series of processes so that it is expected to be homogeneous. It may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to form a final homogeneous batch. In the case of terminal sterilization, the batch size is determined by the capacity of the autoclave. In continuous manufacture, the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity. The batch size can be defined either as a fixed quantity or as the amount produced in a fixed time interval.

Batch Number (Or Lot Number)

A distinctive combination of numbers and/or letters which uniquely identifies a batch on the labels, its batch records and corresponding certificates of analysis, etc.

Batch Records

All documents associated with the manufacture of a batch of bulk product or finished product. They provide a history of each batch of product and of all circumstances pertinent to the quality of the final product.

Bulk Product

Any product that has completed all processing stages up to, but not including, final packaging.

Calibration

The set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (especially weighing), recording, and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard. Limits for acceptance of the results of measuring should be established.

Clean Area

An area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce the introduction, generation, and retention of contaminants within the area. consignment (or delivery) The quantity of a pharmaceutical(s), made by one manufacturer and supplied at one time in response to a particular request or order. A consignment may comprise one or more packages or containers and may include material belonging to more than one batch.

Contamination

The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or on to a starting material or intermediate during production, sampling, packaging or repackaging, storage or transport.

Critical Operation

An operation in the manufacturing process that may cause variation in the quality of the pharmaceutical product.

Cross-Contamination

Contamination of a starting material, intermediate product or finished product with another starting material or product during production.

Finished Product

A finished dosage form that has undergone all stages of manufacture, including packaging in its final container and labelling.

In-Process Control

Checks performed during production in order to monitor and, if necessary, to adjust the process to ensure that the product conforms to its specifications. The control of the environment or equipment may also be regarded as a part of in process control.

Intermediate Product

Partly processed product that must undergo further manufacturing steps before it becomes a bulk product.

Large-Volume Parenterals

Sterile solutions intended for parenteral application with a volume of 100 ml or more in one container of the finished dosage form.

Manufacture

All operations of purchase of materials and products, production, quality control, release, storage and distribution of pharmaceutical products, and the related controls.

Manufacturer

A company that carries out operations such as production, packaging, repackaging, labelling and relabelling of pharmaceuticals.

Marketing Authorization (Product Licence, Registration Certificate)

Fda Product Complaints

A legal document issued by the competent drug regulatory authority that establishes the detailed composition and formulation of the product and the pharmacopoeial or other recognized specifications of its ingredients and of the final product itself, and includes details of packaging, labelling and shelf-life.

Master Formula

A document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a 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 Record

A document or set of documents that serve as a basis for the batch documentation (blank batch record).

Packaging

All operations, including filling and labelling, that a bulk product has to undergo in order to become a finished product. Filling of a sterile product under aseptic conditions or a product intended to be terminally sterilized, would not normally be regarded as part of packaging.

Packaging Material

Any material, including printed material, employed in the packaging of a pharmaceutical, but excluding any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.

Pharmaceutical Product

Definition Of A Pharmaceutical Product

Any material or product intended for human or veterinary use presented in its finished dosage form or as a starting material for use in such a dosage form, that is subject to control by pharmaceutical legislation in the exporting state and/or the importing state.

Production

All operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing, packaging and repackaging, labeling and relabelling, to completion of the finished product.

Qualification

Action of proving that any premises, systems and items of equipment work correctly and actually lead to the expected results. The meaning of the word “validation” is sometimes extended to incorporate the concept of qualification.

Quality Assurance

“Quality assurance” is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. Quality assurance therefore incorporates GMP and other factors, including those outside the scope of this guide such as product design and development.

Quality Control

The term quality control refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical. Such procedures may range from the performance of simple chemical experiments which determine the identity and screening for the presence of particular pharmaceutical substance (thin layer chromatography, infrared spectroscopy, etc.), to more complicated requirements of pharmacopoeial monographs. Activities extend to the area of quality control laboratories (good laboratory management practices, models, e.g. for certificate of analysis and lists of laboratory equipment, and an external assessment scheme.

Quarantine

The status of starting or packaging materials, intermediates, or bulk or finished products isolated physically or by other effective means while a decision is awaited on their release, rejection or reprocessing.

Reconciliation

A comparison between the theoretical quantity and the actual quantity.

Recovery

The introduction of all or part of previous batches (or of redistilled solvents and similar products) of the required quality into another batch at a defined stage of manufacture. It includes the removal of impurities from waste to obtain a pure substance or the recovery of used materials for a separate use.

Reprocessing

Subjecting all or part of a batch or lot of an in-process drug, bulk process intermediate (final biological bulk intermediate) or bulk product of a single batch/ lot to a previous step in the validated manufacturing process due to failure to meet predetermined specifications. Reprocessing procedures are foreseen as occasionally necessary for biological drugs and, in such cases, are validated and pre-approved as part of the marketing authorization.

Reworking

Subjecting an in-process or bulk process intermediate (final biological bulk intermediate) or final product of a single batch to an alternate manufacturing process due to a failure to meet predetermined specifications. Reworking is an unexpected occurrence and is not pre-approved as part of the marketing authorization.

Self-Contained Area

Premises which provide complete and total separation of all aspects of an operation, including personnel and equipment movement, with well established procedures, controls and monitoring. This includes physical barriers as well as separate air-handling systems, but does not necessarily imply two distinct and separate buildings.

Specification

A list of detailed requirements with which the products or materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation.

Standard Operating Procedure (SOP)

An authorized written procedure giving instructions for performing operations not necessarily specific to a given product or material (e.g. equipment operation, maintenance and cleaning; validation; cleaning of premises and environmental control; sampling and inspection). Certain SOPs may be used to supplement product-specific master and batch production documentation.

Starting Material

Any substance of a defined quality used in the production of a pharmaceutical product, but excluding packaging materials.

Validation

Action of proving, in accordance with the principles of GMP, that any procedure, process, equipment, material, activity or system actually leads to the expected results.

The information on this page is current as of April 1 2020.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

New Search

Help | More About 21CFR

[Code of Federal Regulations]

[Title 21, Volume 4]

[Revised as of April 1, 2020]

[CITE: 21CFR207.1]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER C - DRUGS: GENERAL

Subpart A - General

Sec. 207.1 What definitions and interpretations of terms apply to this part?

The definitions and interpretations of terms in sections 201 and 510 of the Federal Food, Drug, and Cosmetic Act apply to the terms used in this part, if not otherwise defined in this section. The following definitions apply to this part:

Active pharmaceutical ingredient means any substance that is intended for incorporation into a finished drug product and is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. Active pharmaceutical ingredient does not include intermediates used in the synthesis of the substance.

Bulk drug substance, as referenced in sections 503A(b)(1)(A) and 503B(a)(2) of the Federal Food, Drug, and Cosmetic Act, means the same as 'active pharmaceutical ingredient' as defined in § 207.1(b).

Commercial distribution means any distribution of a human drug, except for investigational use under part 312 of this chapter, and any distribution of an animal drug or an animal feed bearing or containing an animal drug, except for investigational use under part 511 of this chapter. The term does not include internal or interplant transfer between registered establishments under common ownership and control, including a parent, subsidiary, or affiliate company. For foreign establishments that manufacture, repack, relabel, or salvage, or for foreign private label distributors, the term 'commercial distribution' has the same meaning except the term does not include distribution of any drug that is neither imported nor offered for import into the United States.

Content of labeling means:

(1) For human prescription drugs that are subject to section 505 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act: The content of the prescription drug labeling (as specified in §§ 201.56, 201.57, and 201.80 of this chapter), including all text, tables, and figures.

(2) For human prescription drugs that are not subject to section 505 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act: The labeling equivalent to the content of the prescription drug labeling (as specified in §§ 201.56, 201.57, and 201.80 of this chapter), including all text, tables, and figures.

(3) For human over-the-counter (OTC) drugs: All text, tables, and figures including the drug facts labeling required by § 201.66 of this chapter.

(4) For animal drugs (including, but not limited to, drugs that are subject to section 512 of the Federal Food, Drug, and Cosmetic Act): The content of the labeling that accompanies the drug that is necessary to enable safe and proper administration of the drug (e.g., the labeling applicable to veterinary drugs specified in part 201 of this chapter), including all text, tables, and figures.

Domestic for purposes of registration and listing under this part, when used to modify the term 'registrant,' 'manufacturer,' 'repacker,' 'relabeler,' 'salvager,' 'private label distributor,' or 'establishment,' refers to a registrant, manufacturer, repacker, relabeler, salvager, private label distributor, or establishment within any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.

Drug, for the purposes of registration and listing under this part, has the meaning given in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Establishment means a place of business under one management at one general physical location. The term includes, among others, independent laboratories that engage in control activities for a registered drug establishment (e.g., consulting laboratories), manufacturers of medicated feeds and of vitamin products that are drugs in accordance with section 201(g) of the Federal Food, Drug, and Cosmetic Act, human blood donor centers, and animal facilities used for the production or control testing of licensed biologicals, and establishments engaged in salvaging.

Establishment registration number means the number assigned to the establishment, as identified by FDA, after the establishment registration required in this part.

Finished drug product means a finished dosage form (e.g., tablet, capsule, or solution) that contains at least one active pharmaceutical ingredient, generally, but not necessarily, in association with other ingredients in finished package form suitable for distribution to pharmacies, hospitals, or other sellers or dispensers of the drug product to patients or consumers.

Foreign for the purposes of registration and listing under this part:

(1) When used to modify the term 'manufacturer,' 'repacker,' 'relabeler,' or 'salvager,' refers to a manufacturer, repacker, relabeler, or salvager, who is located in a foreign country and who manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, that is imported or offered for import into the United States.

(2) When used to modify the term 'establishment' refers to an establishment that is located in a foreign country and is engaged in the manufacture, repackaging, relabeling, or salvaging of any drug, or any animal feed bearing or containing a new animal drug, that is imported or offered for import into the United States.

Importer means, for purposes of this part, a person in the United States that is an owner, consignee, or recipient, at the time of entry, of a foreign establishment's drug, or an animal feed bearing or containing a new animal drug, that is imported into the United States.

Manufacture means each step in the manufacture, preparation, propagation, compounding, or processing of a drug or an animal feed bearing or containing a new animal drug. Manufacture includes the making by chemical, physical, biological, or other procedures or manipulations of a drug, or an animal feed bearing or containing a new animal drug, including control procedures applied to the final product or to any part of the process. Manufacture includes manipulation, sampling, testing, or control procedures applied to the final product or to any part of the process, including, for example, analytical testing of drugs for another registered establishment's drug. For purposes of this part, and in order to clarify the responsibilities of the entities engaged in different operations, the term manufacture is defined and used separately from the terms relabel, repackage, and salvage, although the term 'manufacture, preparation, propagation, compounding, or processing,' as used in section 510 of the Federal Food, Drug, and Cosmetic Act, includes relabeling, repackaging, and salvaging activities.

Manufacturer means a person who owns or operates an establishment that manufactures a drug or an animal feed bearing or containing a new animal drug. This term includes, but is not limited to, control laboratories, contract laboratories, contract manufacturers, contract packers, contract labelers, and other entities that manufacture a drug, or an animal feed bearing or containing a new animal drug, as defined in this paragraph. For purposes of this part, and in order to clarify the responsibilities of the entities engaged in different operations, the term manufacturer is defined and used separately from the terms relabeler, repacker, and salvager, although the term 'manufacture, preparation, propagation, compounding, or processing,' as used in section 510 of the Federal Food, Drug, and Cosmetic Act, includes the activities of relabelers, repackers, and salvagers. Repackers, relabelers, and salvagers are subject to the provisions of this part that are applicable to repackers, relabelers, and salvagers, but are not subject to the provisions of this part that are applicable to manufacturers. When not modified by 'domestic' or 'foreign,' the term includes both domestic manufacturers and foreign manufacturers.

Material change means any change in any drug listing information, as required under §§ 207.49, 207.53, 207.54, 207.55, or 207.57 except changes in format of labeling, labeling changes of an editorial nature, or inclusion of a bar code or initial inclusion of an NDC on the label.

Outsourcing facility means a compounder that has elected to register with FDA under section 503B of the Federal Food, Drug, and Cosmetic Act and that meets all of the conditions of section 503B.

Person who imports or offers for import means, for purposes of this part, the owner or exporter of a drug who consigns and ships a drug from a foreign country to the United States. This includes persons who send a drug to the United States by international mail or other private delivery service, but it does not include carriers who merely transport the drug.

Private label distribution means commercial distribution of a drug under the label or trade name of a person who did not manufacture, repack, relabel, or salvage that drug.

Private label distributor means, with respect to a particular drug, a person who did not manufacture, repack, relabel, or salvage the drug but under whose label or trade name the drug is commercially distributed.

Registrant means any person that owns or operates an establishment that manufactures, repacks, relabels, or salvages a drug, and is not otherwise exempt from establishment registration requirements under section 510 of the Federal Food, Drug, and Cosmetic Act or this part.

Relabel means to change the existing label or labels on a drug or drug package, or change or alter the existing labeling for a drug or drug package, without repacking the drug or drug package. This term does not include the addition or modification of information affixed solely for purposes of delivery to a customer, customer identification, and/or inventory management.

Relabeler means a person who owns or operates an establishment that relabels a drug. When not modified by 'domestic' or 'foreign,' the term includes both domestic relabelers and foreign relabelers.

Repack or repackage means the act of taking a finished drug product or unfinished drug from the container in which it was placed in commercial distribution and placing it into a different container without manipulating, changing, or affecting the composition or formulation of the drug.

Repacker means a person who owns or operates an establishment that repacks a drug or drug package. When not modified by 'domestic' or 'foreign,' the term includes both domestic repackers and foreign repackers.

Representative sampling of advertisements means typical advertising material (including the promotional material described in § 202.1(l)(1) of this chapter, but excluding labeling as determined in § 202.1(l)(2) of this chapter), that gives a balanced picture of the promotional claims used for the drug.

Representative sampling of any other labeling means typical labeling material (including the labeling material described in § 202.1(l)(2) of this chapter, but excluding labels and package inserts) that gives a balanced picture of the promotional claims used for the drug.

Salvage means the act of segregating out those finished drug products that may have been subjected to improper storage conditions (such as extremes in temperature, humidity, smoke, fumes, pressure, age, or radiation) for the purpose of returning the products to the marketplace and includes applying manufacturing controls such as those required by current good manufacturing practice in parts 210 and 211 of this chapter.

Salvager means a person who owns or operates an establishment that engages in salvaging. When not modified by 'domestic' or 'foreign,' the term includes both domestic and foreign salvagers.

Unfinished drug means an active pharmaceutical ingredient either alone or together with one or more other ingredients but does not include finished drug products.