Glossary

A medicinal drug, or relating to or engaged in pharmacy or the manufacture and sale of pharmaceuticals. A pharmaceutical product is generally one that is made up using available chemical compounds.

A general manufacturing area classification designated by the need for a change of clothing (e.g., Packing Hall).

Products are pharmaceutical equivalents if they contain the same amount of the same active substance(s) in the same dosage form; if they meet the same or 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 can lead to differences in product performance.

Substances, other than the active ingredient, which have been appropriately evaluated for safety and are included in a drug delivery system to:a)Aid in the processing of the drug delivery system during its manufacture (diluent or vehicle).b)Protect, support or enhance stability, Bioavailability, or patient acceptability.c)Assist in product identification.d)Enhance any other attribute of the overall safety and effectiveness of the drug during storage or use.Simple syrup, aromatic powder, honey, and various elixirs are examples of excipients.

For the purpose of this Guide (ISPE GPG Assessing the Particulate Containment Performance of Pharmaceutical Equipment) the term “pharmaceutical ingredient” refers to the active pharmaceutical ingredient (API), synthetic intermediate, or pharmaceutical formulation for which the surrogate material is being substituted.

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (jointly referred as PIC/S) are two international instruments between countries and pharmaceutical inspection authorities, which provide together an active and constructive cooperation in the field of GMP.

Substance or combination of APIs and excipients, or preservatives which has a therapeutic, prophylactic, or diagnostic purpose, or is intended to modify physiological functions, and is presented in a dosage form suitable for administration to the patient.

Any substance or combination of substances which has a therapeutic, prophylactic or diagnostic purpose, or is intended to modify physiological functions, and is presented in a dosage form suitable for administration to humans.

(ICH Q10) Management system to direct and control a pharmaceutical company with regard to quality. (ICH Q10 based upon ISO 9000:2005)

The study of the interaction of an individual’s genetic makeup and response to a drug.

(ICH Q4B) The pharmacopeial monographs, general test chapters, and analytical methods emanating from the three regional pharmacopeias.

Detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effect, or medicines.

Drugs authorized to be sold only in licensed pharmacies under the supervision of licensed and registered pharmacists; they may be sold without a prescription.

Within the hierarchy of tasks an operator can start, the phase is the most elementary, in the sense of the low number of devices which it operates. Typical phases involve parameter regulation, such as temperature, pressure, pH, and stirring. A phase often matches an operation unit in the common sense of chemical engineering. It also may be a preparation phase, e.g., zeroing a scale and visually checking equipment are considered as phases.

Phase 1,2,3,4 Drug Trials

An organism whose phenotype (but not genotype) has been changed by the environment to resemble the phenotype usually associated with a mutant organism.

An organic acid often used as a disinfectant. Proper strength for a bacteriocidal preparation is 5%. Sometimes dispersed as an aerosol “fog” in manufacturing rooms.

The part of an organism’s genotype that is expressed, and thus is generally apparent by observation.

The physical manifestation of a gene function.

Protected Health information

PHI (Personally Identifiable Health)

Individually identifiable health information transmitted or maintained in any form.

A bond in which a phosphate group joins adjacent carbons through ester linkages. A condensation reaction between adjacent nucleotides results in a phospho-diester bond between 3’ and 5’ carbons in DNA and RNA.

The mechanism by which ultraviolet light reduces Total Organic Carbon (TOC) to CarbonDioxide. If halogenated organics are present, both CO2 and mineral acids can be formed.

Facultative autotrophs that obtain their energy from light.