The container and its components that hold the excipient for storage and transport to the customer. [8, 5]

Packaging Material

A material intended to protect an intermediate or excipient during storage and transport. [1, 2 3, 4]

Packaging Operations

Those manufacturing processes which place the finished excipient into the container and its components designed to hold the excipient for storage and transport to the customers. [7]


Process Analytical Technology


Permissible Daily Exposure


Documentation that provides traceability of the material throughout the supply chain.

Performance Indicators

Measurable values used to quantify quality objectives to reflect the performance of an organisation, process or system, also known as ?performance metrics? in some regions. (ICH Q10) [11]

Performance Qualification (PQ)

Documented verification that the equipment or system consistently produces the intended output.

Periodic Testing Program

See "Skip-Lot Testing". [8]

Permissible Daily Exposure (PDE)

The maximum daily acceptable intake of a substance. [7]

Permitted Daily Exposure

The maximum acceptable intake per day of residual solvent in pharmaceutical products. [16]

Ph. Eur.

European Pharmacopoeia [6]

Pharmaceutical Alternatives

Products are pharmaceutical alternative(s) if they contain the same molar amount of the same active pharmaceutical moiety(s) but differ in dosage form (e.g. tablets versus capsules), and/or chemical form (e.g. different salts, different esters). Pharmaceutical alternatives deliver the same active moiety by the same route of administration but are otherwise not pharmaceutically equivalent. They may or may not be bioequivalent or therapeutically equivalent to the comparator product. [24]

Pharmaceutical Equivalence

Products are pharmaceutical equivalents if they contain the same molar amount of the same active pharmaceutical ingredient(s) in the same dosage form, if they meet comparable standards, and if they are intended to be administered by the same route. Pharmaceutical equivalence does not necessarily imply therapeutic equivalence, as differences in the excipients and/or the manufacturing process and some other variables can lead to differences in product performance. [24]

Pharmaceutical Excipient

Substances, other than the active ingredient, which have been appropriately evaluated for safety and are included in a drug delivery system to:
- Aid in the processing of the drug delivery system during its manufacture; 
- Assist in product identification; or
- Enhance any other attribute of the overall safety and effectiveness of the drug during storage or use. [22]

Pharmaceutical Quality System (PQS)

Management system to direct and control a pharmaceutical company with regard to quality. [11]

Pharmaceutical Starting Material

A pharmaceutical starting material is an active pharmaceutical ingredient (API) or an excipient intended or designated for use in the production of a pharmaceutical product. [3, 18]

Pharmacopoeial Reference Standards

The specificity of pharmacopoeial reference substances has been addressed in the introduction of ISO Guide: General requirements for the competence of reference material producers.

"Pharmacopoeial standards and substances are established and distributed by pharmacopoeial authorities following the general principles of this Guide. It should be noted, however, that a different approach is used by the pharmacopoeial authorities to give the user the information provided by certificate of analysis and expiration dates” [21]

Physical Form

The state, at ambient conditions, in which the excipient is found; solid, liquid or gas. [7]

Physical Property

A quality parameter that can be measured solely by physical means. [5, 8]

Physiological Effect

Any effect on the normal health of the human body. [5]

Pilot Scale Batch

A batch of a drug substance or drug product manufactured by a procedure fully representative of and simulating that to be applied to a full production scale batch. For solid oral dosage forms, a pilot scale is generally, at a minimum, onetenth that of a full production scale or 100,000 tablets or capsules, whichever is the larger. [13]

Pivotal Scale

A scale of cGMP pharmaceutical product manufacture less than full commercial scale but greater than 1/10th commercial scale. Studies using such manufacture (e.g. product stability) may be used to support the marketing application. [4]

Polymorphic Forms

Different crystalline forms of the same drug substance. These can include solvation or hydration products (also known as pseudo-polymorphs) and amorphous forms. [15]


The occurrence of different crystalline forms of the same drug substance. This may include solvation or hydration products (also known as pseudopolymorphs) and amorphous forms. [12]


Performance Qualification


Those studies preceding formal formulation design that are used to investigate the physical, chemical and biopharmaceutical properties of the API. [4]


The precision of an analytical procedure expresses the closeness of agreement (degree of scatter) between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions. Precision may be considered at three levels: repeatability, intermediate precision and reproducibility.


The activities undertaken in defining a product or service need, seeking expressions of interest from enterprises to supply the product or service, and examining the product or service offered against the specification and the facility where the product or service is prepared against common standards of good manufacturing practice (GP). The examination of the product or service and of the facility where it is manufactured is performed by trained and qualified inspectors against common standards. Once the product is approved, and the facility is approved for the delivery of the specified product or service, other procurement agencies are informed of the decision. Prequalification is required for all pharmaceutical products regardless of their composition and place of manufacture/registration, but the amount and type of information requested from the supplier for assessment by the procurement agency may differ. [25, 26]

Preventive Action

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

NOTE: Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence. (ISO 9000:2005) [11]

Primary Batch

A batch of a drug substance or drug product used in a formal stability study, from which stability data are submitted in a registration application for the purpose of establishing a re-test period or shelf life, respectively. A primary batch of a drug substance should be at least a pilot scale batch. For a drug product, two of the three batches should be at least pilot scale batch, and the third batch can be smaller if it is representative with regard to the critical manufacturing steps. However, a primary batch may be a production batch. [13]

Primary Chemical Reference Substance

A designated primary chemical reference substance is one that is widely acknowledged to have the appropriate qualities within a specified context, and whose assigned content when used as an assay standard is accepted without requiring comparison with another chemical substance. [21]

Primary Packaging Materials

Packaging materials which have direct contact with the excipient.

NOTE 1: Examples of primary packaging materials are glass, plastics, aluminium films, foils.
They may be combinations of different materials/components.

NOTE 2: Primary packaging materials may be directly printed or decorated.

Primary Reference Standard

A substance that has been shown by an extensive set of analytical tests to be authentic material that is of high purity and to which all like standards are traced and qualified or certified. This standard is preferably obtained from an officially recognized source. If no official recognized source is available, the reference standard selected shall be appropriately characterized.

A substance that has been shown by an extensive set of analytical tests to be of defined quality; generally of high purity and to which all like standards are traced and qualified or certified. This standard is preferably obtained from an officially recognized source. If no official recognized source is available, the reference standard selected shall be appropriately characterized.


Written, authorized instruction for performing specified operations. [3]


The combination of operating steps including synthesis, isolation, purification, packaging, etc. that produce the finished excipient. [4, 5, 8]

Process Aids

Materials, excluding solvents, used as an aid in the manufacture of an intermediate or API that do not themselves participate in a chemical or biological reaction (e.g. filter aid, activated carbon, etc). [2]

Process Analytical Technology (PAT)

A system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. [6, 9]

Process Capability

A statistic which describes the performance of the process with respect to the specification limits.

Process Capability Index (Cp)

A statistical measurement that can be used to assess whether or not the process is adequate to meet specifications. A ?State of Statistical Control? can be said to exist if the random variation in test results for a process parameter is such that the cal

Process Control

See "In-Process Control". [2]

Process Parameter

A measurable operating condition. [4, 5]

Process Robustness

Ability of a process to tolerate variability of materials and changes of the process and equipment without negative impact on quality. [9]

Process Step

A documented instruction to the pharmaceutical excipient manufacturing personnel directing that an operation be done. [4]

Process Validation

A documented program that provides a high degree of assurance that a specific process will consistently produce a result meeting predetermined acceptance criteria.


Operations to change product characteristics by mainly physical treatment through e.g. milling, sieving, distilling, filtration, blending. [3]

Processing Aid

A material added to a manufacturing step for the purpose of facilitating the completion of that step or subsequent step. [4]


The process of purchasing or otherwise acquiring any pharmaceutical product, vaccine, or dietary supplements or component of such productsfor human use.

Procurement Agency

Any organization purchasing or otherwise acquiring any pharmaceutical product, vaccine, dietary supplements or component of such products for human use.

Producer Risk

The probability that a lot is rejected by the manufacturer although the product is conforming. [4]

Product Information

In the context of this document, product information means information on pharmaceutical products submitted by manufacturers or suppliers in any of the formats specified in the procurement agency’s guidelines (including product dossiers, product questionnaires or other formats) to obtain prequalification for the products. [25]

Product Lifecycle

All phases in the life of the product from the initial development through marketing until the product?s discontinuation. [10]

Product of Biotechnology

A product derived from any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.

Product of Fermentation

A substance produced and secreted by living organisms, and harvested for use or subsequent processing.

Product Realization

Achievement of an excipient with the quality attributes appropriate to meet the needs of patients, health care professionals, regulatory authorities (including compliance with marketing authorisation) , and internal customers? requirements. [IPEC]

Product Recall

Product recall is a process for withdrawing or removing a pharmaceutical product from the pharmaceutical distribution chain because of defects in the product or complaints of serious adverse reactions to the product. The recall might be initiated by the manufacturer, importer, distributor or a responsible agency. [17]


Operations involved in the preparation of an excipient from receipt of materials operations through processing and packaging of the finished excipient. [1, 2, 3, 18, 19, 20, 26]

Production Batch

A batch of a drug substance or drug product manufactured at production scale by using production equipment in a production facility as specified in the application. [3]

Production Specification

A list of tests, references to analytical procedures, and appropriate criteria for a material as manufactured. [4]

Proposition 65

The California Safe Drinking Water and Toxic Enforcement Act of 1986, better known by its original name of Proposition 65, is “right to know” legislation regarding substances known to the State of California to cause cancer or birth defects or other reproductive harm. [6]

Prospective Validation

Validation that should be successfully completed before the product is offered for sale.


A detailed plan describing the conduct of a study.


The extent to which the excipient is free of foreign materials such as impurities and contaminants. [7]

Purity Tests

Test to ensure that all the analytical procedures performed allow an accurate statement of the content of impurities of an analyte, i.e. related substances test, heavy metals, residual solvents content, etc. [12]


A specification parameter that stipulates that the substance or product will not induce elevation in body temperature if administered to, or included in a product to be administered to, a patient.