C
Calibration

The demonstration that a particular instrument or measuring device produces results within specified limits by comparison with those produced by a reference or traceable standard, over an appropriate range of measurements. [1, 2, 3]

CAS Number

Unique numerical identifiers assigned by Chemical Abstracts Service to every chemical substance described in the open scientific literature (currently including those described from at least 1957 through the present), including organic and inorganic compounds, minerals, isotopes, alloys and nonstructurable materials (UVCBs, of unknown, variable composition, or biological origin). [27]

CEFIC

The European Chemical Industry Council

CEP

Certificate of Suitability to the European Pharmacopoeia

Certificate

A document that affirms the applicant has met the requirements to be in substantial compliance with the standard or specification.

Certificate of Analysis (COA)

A document listing the test methods, specification and results of testing a representative sample from the batch to be delivered. [1, 3, 4, 8]

Certificate of Conformity (COC)

A document that confirms that the product shipped to the customer, complies with a specific set of requirements or specifications. It does not contain actual test results. [3]

Certificate of Suitability to the European Pharmacopoeia (CEP)

Certificate granted by the European Directorate for the Quality of Medicines (EDQM) to manufacturers of active ingredients or excipients confirming that the applicable Ph Eur monographs and general chapters are adequate to control the chemical purity of the material. Also a CEP can also be granted to confirm a material conforms to the European Pharmacopoeia general chapter 5.2.8 ‘Minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products', even if the material itself does not have a Ph.Eur monograph.

Certification

The process that leads to confirming the applicant meets the requirements of a Standard.

cGMP

Current Good Manufacturing Practice

Change Control

A process used for management review of proposed changes that may impact the quality or regulatory conformance of the excipient. [4]

Change Management

A systematic approach for proposing, evaluating, approving, implementing and reviewing changes. [11]

Chemical Abstracts Service Registry Number (CAS Number)

The CAS Registry is the largest substance identification system in existence. When a chemical substance, newly encountered in the literature, is processed by CAS, its molecular structure diagram, systematic chemical name, molecular formula, and other identifying information are added to the Registry and it is assigned a unique CAS Registry Number. [6]

Chemical Development Studies

Studies conducted to scale-up, optimise, and validate the manufacturing process for a new drug substance. [15]

Chemical Property

A quality parameter that is measured by chemical or physiochemical test methods. [5, 8]

Chemical Reference Substance

The term chemical reference substance, as used in this text, refers to an authenticated, uniform material that is intended for use in specified chemical and physical tests, in which its properties are compared with those of the product under examination, and which possesses a degree of purity adequate for its intended use. [21]

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. [20]

Cleaning Validation

Documented evidence to establish that cleaning procedures are removing residues to predetermined levels of acceptability, taking into consideration factors such as batch size, dosing, toxicology and equipment size. [23]

Co-processed Excipients

A co-processed excipient is a combination of two or more compendial or non compendial excipients designed to physically modify their properties in a manner not achievable by simple physical mixing, and without significant chemical change. However in some instances, formation of necessary components may occur, such as in situ salt formation.

Co-processing

The act of manufacturing a co-processed excipient. Several methods may be used, including standard unit operations such as granulation, spray drying, melt extrusion, milling, etc.

COA

Certificate of Analysis

COC

Certificate of Conformity

Combination Product

A drug product which contains more than one drug substance. [12]

Combined Sample

Sample resulting from combining all or parts of two or more samples of the material. [26]

Commingling

Unintended blending of traces of carryover material from one batch with another. [3]

Commissioning

Verification that the equipment is suitable for use in a controlled manner.

Commitment Batches

Production batches of a drug substance or drug product for which the stability studies are initiated or completed post approval through a commitment made in the registration application. [13]

Common Technical Document (CTD)

An internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration (FDA, US) and the Ministry of Health, Labour and Welfare (Japan). [28]

Comparator Product

The comparator product is a pharmaceutical product with which the multisource product is intended to be interchangeable in clinical practice. The comparator product will normally be the innovator product for which efficacy, safety and quality have been established. The selection of the comparator product is usually made at the national level by the drug regulatory authority. [24]

Competency

The demonstrated personal attributes and ability to apply knowledge and skills in the field of application.

Competitive Tender

A procedure for procuring pharmaceutical products which puts a number of suppliers into competition. Purchasing is done on the basis of quotations submitted by the suppliers in response to a public notice. [25]

Complaint

A request to investigate nonconformance with an aspect of the Excipient GMP Certification program. (SOP 16)

Component

Any material present in the excipient that arises as a consequence of the raw materials and/or manufacturing process. [4]

Composition Profile

A description of all of the components present in the excipient. [4]

Computer System

A group of hardware components and associated software, designed and assembled to perform a specific function or group of functions. [2]

Computer Validation

Documented evidence which provides a high degree of assurance that a computerized system analyses, controls and records data correctly and that data processing complies with predetermined specifications. [23]

Computerized System

A process or operation integrated with a computer system. [2]

Concomitant Component

A substance found in an excipient that is not the intended chemical entity, may be necessary for assuring the proper performance of the excipient in its intended use, and is not an impurity or a foreign substance. (Formerly referred to as minor component.

Concurrent Validation

Validation carried out during routine production of products intended for sale. [23]

Confidence Interval

A range, calculated from sample data, within which a population parameter, such as the population mean, is expected to lie, with a given level of confidence. [5]

Consignment (or delivery)

The quantity of a pharmaceutical starting material 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. [3, 18, 20]

Container

The material employed in the packaging of a pharmaceutical product. Containers include primary, secondary and transportation containers. Containers are referred to as primary if they are intended to be in direct contact with the product. Secondary containers are not intended to be in direct contact with the product. [17]

Container Closure System

The sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product. A packaging system is equivalent to a container closure system. Also includes use of tamper evident seals. [13]

Contaminant

An undesired material of a chemical or microbiological nature or foreign matter introduced from a raw material, intermediate, or excipient during production, sampling, packaging, storage or transport. [4]

Contamination

The undesired introduction of impurities of a chemical or microbiological nature or foreign matter into or onto a raw material, intermediate or excipient during production, sampling, packaging or repackaging, storage or transport. [1, 2, 3, 19, 20]

Continual Improvement

Recurring activity to increase the ability to fulfil requirements.

Continuous Process or Processing

A process that continually produces material from a continuing supply of raw material. [1, 3, 5, 8]

Continuous Process Verification

An alternative approach to process validation in which manufacturing process performance is continuously monitored and evaluated. [9]

Continuous Verification

Assuring that during routine production the process remains in a state of control. [29]

Contract

Business agreement for supply of goods or performance of work at a specified price. [3, 17, 18]

Contract Facility

An internal or external facility that provides services to the manufacturer and/or distributor of an excipient. These can include, but are not limited to: manufacturing facilities, laboratories, repackaging facilities (including labeling), warehouses, etc. [8]

Contract Manufacturer

A manufacturer performing some aspect of manufacturing on behalf of the original manufacturer. [2]

Control Strategy

A planned set of controls, derived from current product and process understanding, that assures process performance and product quality. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control. (ICH Q10) [11]

Controlled Document

Uniquely identified documents and records, e.g. SOPs, Work Instructions, training records, audit reports, etc., required to demonstrate conformance of the Quality System to established requirements. The issue, revision and withdawal of each version of the document is recorded.

Corrective Action

Action to eliminate the cause of a detected non-conformity or other undesirable situation.

Note: Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence.

Counterfeit

A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products and may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging. [17]

Cp

Process Capability Index

Critical

A process step, process condition, test requirement or other relevant parameter or item that must be controlled within predetermined criteria to ensure that the excipient meets its specification. [1, 2, 3]

Critical Material Attributes

The term critical material attributes is synonymous with critical quality attributes for the components (API and excipients).

Critical Operation

An operation in the manufacturing process that may cause variation in the quality of the excipient or pharmaceutical product or that may affect their regulatory status.

Critical Process Parameter

A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality. [30]

Critical Quality Attributes

A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality (ICH definition)

Cross-Contamination

Contamination of a material or product with another material or product. [1, 2, 3]

CTD

Common Technical Document

Current Good Manufacturing Practice (cGMP)

Requirements for the quality system under which drug products and their ingredients are manufactured. Current Good Manufacturing Practices (cGMP) is the applicable term in the United States. For the purposes of this guide, the terms GMP and cGMP are equivalent. [7]

Customer

The organization receiving the excipient once it has left the control of the excipient manufacturer; includes brokers, agents and users. [1, 3]

Customer Risk

The probability that a lot is released by the manufacturer although the product is nonconforming. [4]

Customs-Trade Partnership Against Terrorism (C-TPAT)

Joint government (US Customs)-business initiative to build cooperative relationships that strengthen overall supply chain and border security. [6]