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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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Packaging Science

Aspect Ratio

The length of a particle or fiber divided by its width. (TR85)

Source: TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers

Manufacturing Inspections Packaging Science

Anaerobic Microorganism

A microorganism that does not utilize oxygen as the final electron acceptor during metabolism; microorganism that will grow only in the absence of oxygen. (TR62)(TR22)

Source: TR 22: Aseptic Process Simulation

Manufacturing Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Quality Risk Management/QRM

Attribute

A physical, chemical, or microbiological property or characteristic of an input or output material. (TR60)

Source: TR 60: Process Validation

Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Packaging Science Validation Quality Risk Management/QRM

Attribute Sampling

Inspection where either the unit of product is classified as conforming or non-conforming or the number of non-conformities in the unit of products is counted with respect to a given requirement of set of requirements. (TR43)

Source: TR 43: Glass Defects

Manufacturing Packaging Science Quality Risk Management/QRM Supply Chain Visual Inspection

Alert Limit

An established internal (in-house) data-based value giving early warning of potential drift of manufacturing process from normal operating conditions and triggers appropriate follow-up investigations. Alert limits are always lower than action limits. (TR69)

Source: TR 69: Bioburden/Biofilm Management

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

Aseptic Processing Area (APA)

Controlled environment, consisting of several zones, in which the air supply, facility, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels. (TR22) (TR28) (TR62) (TR70)

Source: TR 22: Aseptic Process Simulation

Biotechnology Manufacturing Combination Products Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Validation Sterile Processing

Assess the Effects of the Change

To evaluate the effects of a manufacturing change on the identity, strength, quality, purity, and potency of a drug product as those factors may relate to the safety or effectiveness of the drug product. (TR38)

Source: TR 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC)

Manufacturing GMP/Good Manufacturing Processes/cGMP Packaging Science Quality Risk Management/QRM

Attributes (Quality Attribute)

A molecular or product characteristic that is selected for its ability to indicate the quality of the product. Collectively, the quality attributes define identity, purity, potency and stability of the product, and safety with respect to adventitious agents. Specifications measure a selected subset of the quality attributes. (TR60)

Source: TR 60: Process Validation

Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Packaging Science Validation Quality Risk Management/QRM

Attachment (Adhesion)

Discrete association of a microorganism with an animate or inanimate surface. (TR69)

Source: TR 69: Bioburden/Biofilm Management

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

Aseptic Processing Simulation (APS)

A means for establishing the capability of an aseptic process as performed using a growth medium. (TR22) (TR62)

Source: TR 22: Aseptic Process Simulation

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

Attributes (Process Performance Attribute)

An output variable or outcome that cannot be directly controlled, but is an indicator that the process performed as expected.(Synonym - Process Performance Parameter) (TR60)

Source: TR 60: Process Validation

Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Packaging Science Validation Quality Risk Management/QRM

Autoclave

A chamber for steam sterilization. (TR45)

Source: TR 45: Depth Filtration

Biotechnology Manufacturing Filtration Packaging Science Sterile Processing Supply Chain

Aseptic Processing

Handling sterile materials in a controlled environment, in which the air supply, facility, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels. (TR28) (TR62) (TR69) Handling of sterile product, containers, and/ or devices in a controlled environment in which the air supply, materials, equipment, and personnel are regulated to maintain (product) sterility. (TR13)

Source: TR 13: Environmental Monitoring

Biotechnology Manufacturing Combination Products Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Validation Sterile Processing

Anaerobe

An organism that has the ability to grow in the absence of oxygen. (TR51)

Source: TR 51: Biological Indicators

Biotechnology Manufacturing Microbiology Packaging Science Validation Quality Risk Management/QRM Sterile Processing

Amplicon

A segment of double stranded DNA formed as the product of polymerase chain reaction or other amplification based techniques such as TMA or NASBA. (TR50)

Source: TR 50: Alt. Methods Mycoplasma Testing

Biotechnology Manufacturing Microbiology Packaging Science Validation Quality Risk Management/QRM Sterile Processing

Alternative or Rapid Microbiological Method (RMM)

A novel, modern and/or fast microbiological testing method that is different from a classical or traditional growth-based method, such as agar-plate counting or recovery in liquid broth media. The alternative or rapid method may utilize instrumentation and software to manage the testing and resulting data, and may provide quantitative, qualitative and/or microbial identification test results. Automated technologies that utilize classical growth-based methods may also be designated as being novel, modern or rapid, based on their scientific principle and approach to microbial detection. The terms alternative, rapid microbiological method, rapid method and the acronym RMM are used interchangeably within this technical report. (TR33)

Source: TR 33: Rapid Micro Methods

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

Alert Level

An established microbial or nonviable particle level giving early warning of potential drift from normal operating conditions; not necessarily grounds for definitive corrective action but typically requires follow-up investigation. (TR13) (TR22) (TR69) An established level that, when exceeded, is giving an early warning of a potential drift from normal operating conditions; while not necessarily grounds for definitive corrective action, it typically requires follow-up review. (TR 60) An established microbial or nonviable particle level giving early warning of potential drift from normal operating conditions; not necessarily grounds for definitive corrective action, but typically requires follow-up investigation (3, 4, 7). (TR88)

Source: TR 13: Environmental Monitoring

Biotechnology Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Sterile Processing

Aerobic Microorganism

A microorganism that utilizes oxygen as the final electron acceptor during metabolism; a microorganism that will grow primarily in the presence of oxygen. For the purpose of this report, this definition encompasses facultative anaerobes. (TR22) (TR62)

Source: TR 22: Aseptic Process Simulation

Biotechnology Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Sterile Processing

Action Plan

A written plan consisting of elements to be accomplished to achieve a specific result. The plan describes responsibility for each element and a target date for completion. (TR22)

Source: TR 22: Aseptic Process Simulation

Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science

Action Limit

An internal (in-house) value used to assess the consistency of the process. The cause of the excursion should be investigated and documented and corrective action is generally required. Action limits are not specifications. (TR42) An established internal (in-house) data-based value which is part of the control strategy and used to assess the consistency of the manufacturing process. An action limit excursion result in an investigation, identification of recovered isolates, root-cause analysis, assessment of a systemic failure and impact on product quality and patient safety. (TR69) An established internal (in-house) data-based value that is part of the control strategy and used to assess the consistency of the manufacturing process. An action limit excursion result in an investigation, identification of recovered isolates, root-cause analysis, assessment of a systemic failure and impact on product quality and patient safety. (TR74) A limit that, when exceeded, indicates a process is outside of its normal operating range. A response to such an excursion should involve a documented investigation and corrective actions based on the results of that investigation. (TR60)

Source: TR 42: Validation: Protein Manufacturing

Biotechnology Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Sterile Processing

Action Level (environmental monitoring)

An established microbial or non-viable particle level that, when exceeded, should trigger appropriate investigation and corrective action based on the investigation. (TR22)

Source: TR 22: Aseptic Process Simulation

Biotechnology Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Sterile Processing