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PDA Technical Glossary

PDA Technical Reports are highly valued membership benefits because they offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world. These reports include terms which explain the material and enhance the reader’s understanding.

The database presented here includes the glossary terms from all current technical reports. The database is searchable by keyword, topic, or by technical report. Each definition provided includes a link to the source technical report within the PDA Technical Report Portal.

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Displaying results 1 - 50 of 201

Invalid Test

Laboratory test that, as a result of the laboratory (Phase I) investigation, did not meet the test method requirements and whose results would not be deemed valid. This may also apply to a test which was aborted (e.g. breakdown of isolator during sterility testing). (TR88)

Source: TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry

Microbiology Validation Sterile Processing

Critical Process (CP)

A process that impacts a critical quality attribute of the intermediate, drug substance or drug product being manufactured and therefore should have established critical process parameters that can be monitored or controlled to ensure that the process produces the desired quality.

Source: TR 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations

Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Prefilled Syringes/PFS Validation Quality Risk Management/QRM Sterile Processing Supply Chain Technology Transfer Vaccines Visual Inspection

Technically Unavoidable Particles (TUPs)

Particles that are visibly different from the bulk of the material when viewed with the naked eye within the container or against a suitable background (e.g., size, shape, color, number, texture) and are inherent to the manufacturer’s process, product, or raw materials. The unintended presence of a small quantity of particles, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, or migration from packaging that is technically unavoidable in good manufacturing practice, and do not pose a risk to patient safety. (TR78)

Source: TR 78: Particulate Matter in Oral Dosage Forms

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Quality Risk Management/QRM Sterile Processing

Intrinsic Particles

Those particles that arise from sources related to the formulation, packaging, or assembly processes. In each of these cases, the particle material (e.g., glass, stainless steel, rubber, or gasket material) could be identified as a known product-contact material. (TR78) A particle that comes from within the primary process. These are qualified product contact materials and are often associated with the primary packaging components. They are unplanned but not unexpected.(TR85)

Source: TR 78: Particulate Matter in Oral Dosage Forms

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Quality Risk Management/QRM Sterile Processing

Zone of Protection/Machine Shroud

A system fitted to a BFS machine to direct a flow of HEPA-filtered air over the Critical Processing Zone of the machine. (TR77)

Source: TR 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology

Biotechnology GMP/Good Manufacturing Processes/cGMP Microbiology Prefilled Syringes/PFS Quality Risk Management/QRM Sterile Processing

Mandrel

Specialized filling needles on certain BFS machines which also act to form the container. (TR77)

Source: TR 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology

Biotechnology Manufacturing Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Prefilled Syringes/PFS Quality Risk Management/QRM Sterile Processing

Advanced Aseptic Process

A process in which direct intervention with open product containers or exposed product contact surfaces by operators wearing conventional cleanroom garments is not required and never permitted. (TR77)

Source: TR 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology

Biotechnology GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing

Probability of a Non-Sterile Unit (PNSU)

The number that expresses the probability of occurrence of a non-sterile unit after exposure to a sterilization process. Within the pharmaceutical industry, a design end point better than or equal to the probability of one non-sterile unit in a million units is expected, i.e., PNSU ≤ 10–6. [Synonym: Steriliy Assurance Level (SAL)] (TR01)

Source: TR 1: Validation: Moist Heat

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing

Primary Contact Surfaces

All process surfaces that have a direct influence on the quality of the drug substance being manufactured, including surfaces processing equipment, storage containers, and of processing aids during manufacturing operations. (TR54-4)

Source: TR 54-4: QRM: Biotech Drug Substance

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Quality Risk Management/QRM Sterile Processing

Water for Injection (WFI)

Water purified by distillation or a purification process that is equivalent or superior to distillation in the removal of chemicals and microorganisms and contains no added substances. (TR45)

Source: TR 45: Depth Filtration

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing

Water for Bacterial Endotoxin Test (BET)

Sterile Water for Injection or other water that shows no reaction with the specific bacterial endotoxin test reagent with which it is to be used, at the limit of sensitivity of such reagent. (TR3)

Source: TR 3: Validation: Dry Heat

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing

Viable

Alive and able to be cultured in the laboratory. (TR69)

Source: TR 69: Bioburden/Biofilm Management

Microbiology Sterile Processing

Titer Reduction (TR)

A measure of the degree to which a particular filter removes a microorganism under specified test conditions. Calculated as the ratio of the total number of microorganisms used to challenge the filter divided by the total number of microorganisms that passed through the filter. (TR75)

Source: TR 75: Mycoplasma Filter Rating Method

Filtration Microbiology Sterile Processing

Unidirectional Air Flow Hood (UAFH)

A cabinet designed to protect materials from operator and environmental contamination. Also referred to as laminar air flow hood. (TR62)

Source: TR 62: Manual Aseptic Processes

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing

Vapor Phase Hydrogen Peroxide (VPHP)

A disinfection system in which 35% hydrogen peroxide is changed to a vapor phase and used for bioburden reduction of a chamber or items in a chamber. (TR70)

Source: TR 70: Cleaning/Disinfection Programs

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing

Upstream

The influent side of the filter. (TR45) (TR26)

Source: TR 26: Sterilizing Filtration of Liquids

Manufacturing Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing

Targeted Species

The range of species for which detection or analysis is aimed for by an assay method. (TR50)

Source: TR 50: Alt. Methods Mycoplasma Testing

Microbiology Validation Quality Risk Management/QRM Sterile Processing

TCld50 Assay

Quantal assays for determining the titer of a virus. The 50% tissue culture infective does (TCID50) is the dilution of virus that results in the infection of 50% of cell cultures that have been infected with the same dilution of the virus sample. (TR47)

Source: TR 47: Virus Spikes/Virus Clearance

Virus Biotechnology Microbiology Validation Quality Risk Management/QRM Sterile Processing

Spore

A bacterial dormant form that is highly resistant to adverse conditions. Fungal spores are not highly resistant; their susceptibilities are closer to vegetative microorganisms. (TR13)

Source: TR 13: Environmental Monitoring

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing

Specified Microorganisms

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)

Source: TR 67: Objectionable Microorganisms

GMP/Good Manufacturing Processes/cGMP Microbiology Quality Risk Management/QRM Sterile Processing

Sporicidal Vapor Phase Decontamination

The destruction of inactivation of microbial spores using a vapor or gaseous agent. (TR51)

Source: TR 51: Biological Indicators

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing

Spore Log Reduction (SLR)

The number of log reductions (10-fold changes) of spores from the initial population. For the overkill sterilization method, one targets a spore log reduction of 12 to achieve 1 x 10-6 probability of a survivor when using a biological indicator having a population of 1 x 106. (TR61)

Source: TR 61: Steam in Place

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing

Sporicide

A compound that destroys all vegetative microorganisms and bacterial and fungal spores. (TR70)

Source: TR 70: Cleaning/Disinfection Programs

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing

Static Monitoring

Monitoring of the environment in the absence of normal operations. This includes having the equipment installed and operational when no personnel are present. Per the EU and ISO standards, this is synonymous with “at rest.” (TR13)

Source: TR 13: Environmental Monitoring

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing

Soil

The chemical or microbiological materials left on process equipment after completion of process manufacturing, but before initiation of the cleaning process. (TR29)

Source: TR 29: Validation: Cleaning

Biotechnology Manufacturing Microbiology Sterile Processing

Sporulation

The formation of a spore. (TR51)

Source: TR 51: Biological Indicators

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing

Substrate

Primary construction material of a surface to be cleaned or disinfected. (TR70)

Source: TR 70: Cleaning/Disinfection Programs

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing

Strain

A specific isolate of a species that is maintained in pure culture and is serotypically, genotypically, or chemotaxonomically characterized to differentiate it from other strains of the same species. The strain is representative of the species and provides a reference for the species based on its historic isolation, characterization, and deposition in recognized culture collections. (TR13)

Source: TR 13: Environmental Monitoring

GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing

Saturated Steam Process

A sterilization process, typically used for porous/hard goods loads, where the sterilizing medium is saturated steam. (TR01)

Source: TR 1: Validation: Moist Heat

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing

Screening Studies

Studies used to select a particular type and grade of filter media. (TR45)

Source: TR 45: Depth Filtration

Manufacturing Filtration Microbiology Validation Quality Risk Management/QRM Sterile Processing Technology Transfer

Sanitizer

A compound that will reduce the number of vegetative microorganisms to a safe level as determined by public health requirements. Normally a reduction of 103 in vegetative microorganisms is obtained. (TR70)

Source: TR 70: Cleaning/Disinfection Programs

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing

Saturated Steam

Steam that is at a temperature and pressure that corresponds to the vaporization curve of water. It is in a state of equilibrium between being a liquid and a gas, with no entrained liquid water. [Synonym: Dry Saturated Steam] (TR01) (TR48) (TR61)

Source: TR 1: Validation: Moist Heat

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing

Sanitization

Reduction of microbial contaminants to safe levels as judged by public health requirements for the specific country. (TR13) A significant reduction in bioburden, achieved in chromatography by the use of bactericidal agents, such as sodium hydroxide (NaOH), hydrochloric acid (HCl), ethanol (EtOH), and isopropanol (IPA). (TR14) The process of reducing microbial levels by treatment at less than defined sterilizing conditions. Typically water at 80 °C or a chemical treatment is used to perform sanitization of process components. (TR45) A process that reduces the number of viable microorganisms to a defined level. (TR61) (TR69)

Source: TR 13: Environmental Monitoring

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing

Pyrogen

Any substance capable of eliciting a febrile (or fever) response upon injection or infection (as in endotoxin released in vivo by Gram-negative bacteria. (TR3) Fever-producing substance (TR69) A material that elicits a pyrogenic response (fever). (TR70)

Source: TR 3: Validation: Dry Heat

Virus Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Quality Risk Management/QRM Sterile Processing

Product Changeover

Procedural steps taken for switching from the manufacturing of one product to another product. (TR29)

Source: TR 29: Validation: Cleaning

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing Technology Transfer

Q-PCR Probe

A synthetic, chemically-labeled single-stranded nucleic acid complementary to a selected sequence within a DNA sequence to be amplified using forward and reverse primers in a Q-PCR reaction. A probe is typically labeled with both a fluorophor and quencher. The latter inhibits fluorescence until the quencher and fluorophore are separated by the exonuclease activity of DNA polymerase. (TR50)

Source: TR 50: Alt. Methods Mycoplasma Testing

Virus Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing

Rapid Microbiological Methods (RMMs; Alternative Microbiological Methods)

Technologies that allow users to obtain microbiology test results more quickly than traditional microbiological methods, which are usually culture/ growth based. (TR69)

Source: TR 69: Bioburden/Biofilm Management

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Quality Risk Management/QRM Sterile Processing

Positive Control Filter Membrane (Penetration Control)

A control filter membrane with a larger pore size rating than the test filter and used to demonstrate the penetrative ability of the test microorganism. Penetration of this filter by at least one CFU is required to validate a test. (TR75)

Source: TR 75: Mycoplasma Filter Rating Method

Manufacturing Filtration Microbiology Sterile Processing

Polymerase Chain Reaction (PCR)

A technique widely used in molecular biology in which a DNA polymerase is used to amplify a piece of DNA by in vitro enzymatic replication. As PCR progresses, the DNA thus generated is itself used as a template for replication. This sets in motion a chain reaction in which the DNA template is exponentially amplified. This technique may be used to quantify virus. (TR41) (TR47)

Source: TR 41: Virus Filtration

Virus Biotechnology Manufacturing Microbiology Quality Risk Management/QRM Sterile Processing Technology Transfer

Overkill Design Approach

A sterilization design approach where minimal information is required about the product bioburden. A worst-case bioburden assumption is used to determine the delivered lethality needed to achieve a PNSU of 10-6 on or in the items being sterilized. When using this approach, the qualification program must demonstrate that both the FBIO and FPHYS are greater than 12 minutes. The required lethality may vary regionally. (Note: For typical SIP systems, the FPHYS will need to be greater than the FBIO.) (TR01) (TR3) (TR30) (TR61)

Source: TR 1: Validation: Moist Heat

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing

Opportunistic Pathogens

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)

Source: TR 67: Objectionable Microorganisms

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing Vaccines

Pathogen

Any microorganism which by direct interaction with (i.e., infection of) another organism causes disease in the organism (by convention, a multi-cellular organism). (TR51)

Source: TR 51: Biological Indicators

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Quality Risk Management/QRM Sterile Processing Vaccines

Plasmid

An extra-chromosomal DNA molecule in bacteria which is capable of replicating independently of the host chromosomal DNA. Plasmids are often used as positive controls for NAT assays. (TR50)

Source: TR 50: Alt. Methods Mycoplasma Testing

Virus Biotechnology Manufacturing Microbiology Validation Sterile Processing

Plaque Forming Unit (PFU)

A measure of virus infectively based on formation of a region, or “plaque” of lysed cells within a monolayer culture caused by viruses that kill and disrupt their host cell. The number of plaques is directly correlated to the number of infectious virus particles. (TR47)

Source: TR 47: Virus Spikes/Virus Clearance

Virus Biotechnology Manufacturing Microbiology Validation Sterile Processing

Penicylinder

A small, ceramic carrier surface used to hold cultures of microorganisms. Used in antimicrobial effectiveness testing procedures. (TR70)

Source: TR 70: Cleaning/Disinfection Programs

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Sterile Processing

Parametric Release

A sterility release system based upon effective control, monitoring, documentation, and batch records review of a validated sterilization process cycle in lieu of release procedures based upon end-product sterility testing. (TR01) (TR3) (TR13) A sterility release program based on effective control, monitoring and documentation of a validated sterile-product manufacturing process where sterility release is based on demonstrated achievement of critical operational parameters and performance attributes in lieu of end-product sterility testing. (TR30)

Source: TR 1: Validation: Moist Heat

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing

Penetration Probe

A probe placed in contact with the load item or inside a container of liquid to measure the temperature of the load item or liquid. (TR01) A thermocouple placed in contact with the load item to measure the temperature of the load item. (TR3)

Source: TR 1: Validation: Moist Heat

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Sterile Processing

Microorganism

A microbe; a free-living organism too small to be seen by the naked eye. (TR45) (TR26)

Source: TR 26: Sterilizing Filtration of Liquids

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing

Microbial Count Determination

A test performed to quantify the number of microorganisms present in a sample of material. Standard microbial methods are utilized to estimate the number of colony forming units (CFU) per unit mass or volume. (TR28)

Source: TR 28: Process Simulation for Bulk API

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing

Microbial Classification

The arrangement of microorganisms into taxonomic groups based on their similarities and relationships. (TR13)

Source: TR 13: Environmental Monitoring

GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing

Displaying results 1 - 50 of 201