PDA Glossary

The total number of microorganisms per unit of material prior to sterilization. (TR13)

Total number of viable microorganisms on or in a health care product prior to sterilization. (TR22)(TR61)(TR62)

A population of viable microorganisms in a fluid prior to sterilizing filtration. (TR26)

A measure of the contaminating organisms found in or on a given amount of material before it undergoes a sterilization process. (TR45) (TR70)

The number of detectable microorganisms (bacteria and fungi) with which an object is contaminated. It is measured in CFU (colony forming units). (TR47)

The number of viable, contaminating microorganisms present on a product immediately prior to decontamination. (TR51)

Viable microbial contaminants associated with personnel manufacturing environments (air and surfaces), equipment, product packaging, raw materials (including water), in-process materials, and finished products. (TR 67) (TR 69)

Personal care product formulations used to enhance an individual’s visual appearance or eliminate odor. This broad definition also applies to any material intended for use as a component of a cosmetic product. Note: The FDA specifically excludes soap from this category. (TR67)

A pharmaceutical product type that contains a drug substance, generally, in association with excipients. [Synonym: Dosage Form; Finished Product] (TR57)(TR14)(TR42)

A finished dosage form (e.g., tablet, capsule, or solution) that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients.(TR38) (TR67) (TR88)

The dosage form in the final immediate packaging intended for marketing.(TR60)(TR82)

The active ingredient that is subsequently formulated with excipients to produce the drug product. It can be composed of the desired product, product-related substances, and product- and process-related impurities. It may also contain excipients, including buffers and other components. [Synonyms: bulk drug substance, bulk material, active pharmaceutical ingredient (API)] (TR14) (TR57) (TR74) (TR60)

Active pharmaceutical ingredient in a drug product that is responsible for that product’s therapeutic activity.(TR67) (TR82) (TR88)

See Active Pharmaceutical Ingredient (API). (TR56)

A component of a drug formulation that has no active pharmacologic function. Excipients are commonly used in drug formulations as modulators of pH or osmolality for parenteral administration and as stabilizers for APIs. (TR54-4)

An ingredient added intentionally to the drug substance that should not have pharmacological properties in the quantity used. (TR57)

Inactive pharmaceutical ingredients in a product formulation that are responsible for the product’s manufacturability and physicochemical attributes. (TR67) (TR88)

Inspectional observation sheet used by FDA investigators to document their findings. (TR67)

A listing of the ingredients and composition of the dosage form. (TR38) The percent composition of ingredients in a product. (TR67)

Microorganisms responsible for infection in healthy individuals (i.e., individuals with normal operative and functional host defense mechanisms) that may be acquired from exposure to other infected people or animals, environmental reservoirs (exogenous) or the individual’s normal (endogenous) microbial flora. (TR67)

Compendial test for microbial counts using the plate-count, membrane-filtration or most probable number methods described in USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumerations Tests. (TR67)

The compendial tests for microbial enumeration and absence of specified microorganisms as found in USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumerations Tests and USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. (TR67)

A bacterium, yeast, or mold that, due to it prominence in product recalls, infection outbreaks, nosocomial infections, and the clinical literature, results in a multifactor risk assessment to determine whether the microorganism is objectionable if it is present in a specific nonsterile product. (TR67)

An infection acquired in a hospital or other healthcare institution that was not present at the time of admission; the most common sites of infection are the urinary tract, surgical wound and lower respiratory tract and bloodstream. The vast majority of nosocomial infections are associated with use of invasive medical devices (e.g., urinary tract catheters, ventilators and central venous catheters). (TR67)

According to 21 CFR 211.113 objectionable microorganisms can be: product related or recipient related. Please see glossary for "product related" or "recipient related" for additional information. (TR67)

Microorganisms responsible for infection in injured, invasively treated or immune-suppressed individuals that typically do not cause infection in healthy individuals, unlike frank pathogens. (TR67)

Drug products sold in drug stores directly to customers without a physician’s prescription. (TR67)

General classification of drug products based largely on their route of administration and presentation (e.g., compressed tablets, powder-filled capsules, topical creams and nasal sprays). (TR67)

Includes drug substances, excipients, processing aids and ingredient water. (TR67)

Utilities include pharmaceutical-grade water systems, compressed gases, pharmaceutical-grade air systems, heating, ventilation and air conditioning systems, and space pressurization. (TR67)

A complaint by a customer is any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a product on the market. Complaint Systems are used to collect and categorize information on the condition of regulated products on the market with which consumers are dissatisfied. (TR55) (TR67)

A microorganism that can adversely affect the appearance, physicochemical attributes or therapeutic effect of a nonsterile product. (TR67)

A systematic process for the assessment, control, communication, and review of risk to the quality of the drug product across the product lifecycle.(TR43)(TR54-2)(TR54-3)(TR57)(TR67)(TR68)

Documentation to prove that an installation/ equipment/process is designed and/or tested according to predefined specifications. Documentation may include Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).(TR58)

A systematic process for the assessment, control, communication, and review of risks to the quality of the drug (medicinal) product across the product lifecycle.(TR 54-5)(TR 76)(TR88)

Actions taken by a firm to remove a product from the marketplace; may be conducted on a firm’s own initiative or in response to an FDA request or order under the agency’s statutory authority. (TR67)(TR88)

A microorganism that, due to its numbers and pathogenicity, can cause infection, allergic response or toxemia in patients receiving the product. (TR67)

The combination of the probability of occurrence of harm and the severity of that harm.(TR30) (TR44) (TR54) (TR54-2) (TR54-4) (TR58) (TR67) (TR68) (TR88)

A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of identification of hazards and the analysis and evaluation of risk associated with exposure to those hazards. (TR30) (TR44) (TR54) (TR58) (TR55) (TR67) (TR57-2) (TR54-5) (TR88)

The systematic application of quality management policies, procedures and practices to the tasks of assessing, controlling, communicating and reviewing risk. (TR44) (TR54) (TR54-2) (TR55) (TR67) (TR54-5)

Active systematic steps taken to reduce or limit risk. (TR55) (TR67)

The way in which a drug product or medical device is delivered based on the dosage form and therapeutic use. (TR67)

Microorganisms with limit tests for absence in 1 or 10 g of a drug product, as described in USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms and USP <1111> Microbiological Quality of Nonsterile Pharmaceutical Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use. (TR67)

Type of correspondence that notifies a regulated industry about violations that FDA has documented during its inspections or investigations. (TR67)

Water Activity, A_w is the ratio of the vapor pressure of water in a product (P) to the vapor pressure of water in a product (P) to the vapor pressure of pure water (Po) at the same temperature. It is numerically equal to 1/100 of the RH generated by the product in a closed system. It is a measure of the free or available moisture in the material. Note: Water activity ≠ water content. RH can be calculated from direct measurements partial vapor pressure or dew point, or from indirect measurements by sensors whose physical or electric characteristics are altered by the RH to which they are exposed. Microorganisms need available water within a pharmaceutical product, as well as nutrients and minerals, to proliferate. Water activity, and not water content, is a better measure of the free water, in contrast to bound water that microbial cells require for metabolic activity and osmotic regulation. Effects of reduced A_w on microbial growth include a longer lag phase, slower growth rate, lower numbers of organisms in the stationary phase, and reduced microbial toxin production; below a specified A_w for an organism, microbial growth will not occur. (TR55) (TR67)