Glossary44 terms
The pharma GMP glossary — in plain English.
Short, accurate definitions of the quality, laboratory, manufacturing and compliance terms you meet every day — and how each one shows up in Swat iQua Suite.
A to Z
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21 CFR Part 11 (Electronic Records; Electronic Signatures)
21 CFR Part 11 is the US FDA regulation that sets the criteria under which electronic records and electronic signatures are trustworthy and equivalent to paper.
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ALCOA+
ALCOA+ is the set of nine attributes regulators use to judge whether GMP data — paper or electronic — can be trusted.
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Annex 1 (EU GMP Annex 1: Manufacture of Sterile Medicinal Products)
EU GMP Annex 1 is the guideline for manufacturing sterile medicines, revised in 2022 with a contamination control strategy at its centre.
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Annex 11 (EU GMP Annex 11: Computerised Systems)
EU GMP Annex 11 sets out how computerised systems used in GMP activities must be validated, controlled and maintained in the EU, UK and PIC/S countries.
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Annex 22 (EU GMP Annex 22: Artificial Intelligence (draft))
EU GMP Annex 22 is a draft annex setting out how artificial intelligence models used in GMP activities should be selected, tested and overseen. It was published for consultation in July 2025 and is not yet in force.
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APQR (Annual Product Quality Review)
An APQR (or PQR) is a periodic review of all batches of a product that confirms the process is consistent and identifies improvements.
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Audit trail
An audit trail is a secure, computer-generated, time-stamped record of who created, changed or deleted GMP data, when, and why.
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Batch release
Batch release is the formal QA (or Qualified Person) decision that a manufactured batch meets all requirements and may be sold or supplied.
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CAPA (Corrective and Preventive Action)
CAPA is the GMP process for finding the root cause of a quality problem, fixing it, stopping it recurring and checking that the fix worked.
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CCIT (Container Closure Integrity Testing)
CCIT shows that a container and its closure keep a sterile product protected from microbial ingress and contamination throughout its shelf life.
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CCS (Contamination Control Strategy)
A contamination control strategy is the site-wide, documented plan required by EU GMP Annex 1 for preventing, detecting and controlling contamination.
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Change control
Change control is the formal GMP process for proposing, assessing, approving, implementing and reviewing any change that could affect product quality.
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CoA (Certificate of Analysis)
A certificate of analysis is the approved document that reports the test results for a batch against its specification, issued by the testing laboratory.
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CPV (Continued Process Verification)
Continued process verification is the ongoing monitoring of commercial batches to show that a validated process stays in a state of control.
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CSA (Computer Software Assurance)
Computer software assurance is a risk-based approach to validating software that focuses testing effort on the features that matter for quality and safety.
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CSV (Computer System Validation)
Computer system validation is documented evidence that a GMP computerised system does what it is intended to do, reliably and consistently, in your environment.
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Data integrity
Data integrity is the degree to which GMP data are complete, consistent, accurate and trustworthy throughout their lifecycle, from capture to archive.
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Deviation
A deviation is any departure from an approved instruction, procedure, specification or standard during GMP work, recorded and investigated by QA.
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eBMR (Electronic Batch Manufacturing Record)
An eBMR is the electronic record of how one batch was manufactured, captured step by step against the approved master instructions as the work happens.
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Electronic signature
An electronic signature is computer data that a person executes, adopts or authorises as the legally binding equivalent of their handwritten signature.
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Environmental monitoring
Environmental monitoring is routine sampling of cleanroom air, surfaces and personnel for viable and non-viable contamination against alert and action limits.
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eQMS (Electronic Quality Management System)
An eQMS is software that runs a pharma company’s quality processes — CAPA, deviations, change control, audits, documents and training — in one system.
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FMEA (Failure Mode and Effects Analysis)
FMEA is a structured risk tool that rates each way a process can fail by severity, occurrence and detection, to prioritise controls.
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GAMP 5 (Good Automated Manufacturing Practice)
GAMP 5 is ISPE’s guidance on a risk-based approach to compliant GxP computerised systems, widely used to plan and scale computer system validation.
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GMP (Good Manufacturing Practice)
GMP is the set of regulations and guidelines that make sure medicines are consistently produced and controlled to the quality standards for their intended use.
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Hybrid batch record
A hybrid batch record combines electronic and paper parts for one batch, which makes controlling the paper copies essential to data integrity.
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IQ, OQ, PQ (Installation, Operational and Performance Qualification)
IQ, OQ and PQ are the qualification stages showing equipment or a system is installed correctly, operates as specified and performs reliably in routine use.
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LIMS (Laboratory Information Management System)
A LIMS is software that manages QC laboratory samples, tests, results, specifications and certificates of analysis under GMP controls.
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MBR (Master Batch Record)
The master batch record is the approved template of formula, materials and instructions that every executed batch record of a product is created from.
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Media fill (Aseptic Process Simulation (APS))
A media fill, or aseptic process simulation, runs an aseptic process with sterile growth medium in place of product to prove it does not contaminate units.
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OOS (Out of Specification)
An OOS result is a test result that falls outside the approved specification or acceptance criteria, and it must be investigated before any decision.
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OOT (Out of Trend)
An OOT result is within specification but does not follow the expected trend over time, signalling a possible emerging problem worth investigating.
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Product recall
A product recall removes distributed batches from the market when they are, or may be, defective — relying on fast, complete batch traceability.
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QP (Qualified Person)
A Qualified Person is the legally named individual in the EU and UK who must certify that each batch was made and tested in line with GMP and its authorisation.
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QRM (Quality Risk Management)
Quality risk management is the systematic process of assessing, controlling, communicating and reviewing risks to product quality, described in ICH Q9.
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Quarantine
Quarantine is the status of materials or products held apart, physically or by system controls, while they await a release or rejection decision.
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Reconciliation
Reconciliation compares the quantities of materials or printed components issued, used, returned and destroyed, so any unexplained difference is investigated.
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Revised Schedule M
Revised Schedule M is India’s updated GMP requirement for pharmaceutical manufacturers, aligned with WHO and international GMP and now in force for all.
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Segregation of duties
Segregation of duties means no single person both performs and approves the same GMP activity, so every critical step gets an independent check.
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SOP (Standard Operating Procedure)
An SOP is an approved, controlled document that gives step-by-step instructions for performing a routine GMP activity consistently.
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Specification
A specification is the approved list of tests, analytical procedures and acceptance criteria that a material or product must meet to be acceptable.
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Stability study
A stability study tests a product at defined time points under controlled storage conditions to establish and confirm its shelf life and storage instructions.
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Supplier qualification
Supplier qualification is the documented process of evaluating and approving suppliers of GMP materials and services before use, and monitoring them afterwards.
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URS (User Requirements Specification)
A URS is the document in which a regulated company states what a system or piece of equipment must do for its intended GMP use.
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