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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- TR 54: QRM:Manufacturing Operations (4)
- TR 54-2: QRM: Packaging Labeling (2)
- TR 54-3: QRM: Drug Products (2)
- TR 56: Phase Appropriate cGMP Application (2)
- TR 48: Moist Heat Sterilizer Systems (1)
- TR 52: Supply Chain GDP (1)
- TR 54-4: QRM: Biotech Drug Substance (1)
- TR 60: Process Validation (1)
- TR 3: Validation: Dry Heat (1)
- TR 60-3: Process Validation: A Lifecycle Approach: Bio Drug Sub Mfg (1)
- TR 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry (1)
- TR 81: Cell-Based Therapy Control Strategy (1)
- TR 60-2: Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Dosage/Semisolid Dosage Forms (1)
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Commissioning
A well planned, documented and managed engineering approach to the start-up and transfer of facilities, systems and equipment to the end-user that results in a safe and functional environment that meets established design and user requirement specifications. Commissioning precedes Qualification and includes three phases:
1. Inspection, testing, and regulation
2. Adjustment and setting of work
3. Functional testing (TR 3)
A prescribed number of activities designed to take equipment and systems from a static, substantially complete state to an operable state. (TR 48)
A well planned, documented, managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the end-user, that results in a safe and functional environment that meets established design requirements and stakeholder expectations.(TR 54) (TR 54-5)
Source:
Control Strategy
A planned set of controls, derived from current product and process understanding, which ensures process performance and product quality. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control. (TR 54) (TR 60) (TR 54-5) (TR56)
Source:
Corrective Action and Preventative Action (CAPA)
Action to eliminate the cause of a detected nonconformity or other undesirable situation. NOTE: Corrective action is taken to prevent recurrence, whereas preventive action is taken to prevent occurrence. (TR 52) (TR 54-2) (TR 54-3) (TR 54-5)
A subsystem used to collect and analyze information, identify and investigate product and quality problems, and take appropriate and effective measures to prevent recurrence of the identified problem (8). (TR88)
Source:
Critical Process Parameter (CPP) or Critical Operational Parameter
A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality. (TR54) (TR54-4) (TR56) (TR54-5) (TR60-2) (TR5 6) (TR 81)
An input process parameter that should be controlled within a meaningful operating range to ensure that drug substance critical quality attributes meet their specifications. Although parameters with wide operating ranges may also impact product quality, they are generally easily controlled and not as likely to result in excursions that impact quality and are therefore low risk of occurrence. (TR60-3)
Source:
Fault Tree Analysis (FTA)
A deductive technique used to analyze the causes of faults (defects). The technique visually models how logical relationships between failures, human errors, and external events can combine to cause specific faults. (TR54) (TR54-2) (TR54-3) (TR54-5)