GMP glossary
The vocabulary inspectors use, defined the way it is used on site
100 terms grouped by EU GMP chapter. Search, or jump to a chapter.
100 terms
Regulations and frameworks
- Annex 1
- EU GMP annex on the manufacture of sterile medicinal products, including contamination control strategy and cleanroom classification.
- Annex 11
- EU GMP annex on computerised systems: validation, access control, audit trails, electronic signatures and data security.
- Annex 15
- EU GMP annex on qualification and validation, covering equipment, utilities, processes, cleaning and change control.
- Annex 16
- EU GMP annex on certification by a Qualified Person and batch release.
- Competent Authority
- The national or regional regulator responsible for licensing and inspecting manufacturers, for example HPRA, BfArM, AIFA or ANSM, coordinated through EMA.
- EudraGMDP
- The EU database of manufacturing and importation authorisations, GMP certificates and non-compliance statements issued by national competent authorities.
- EudraLex Volume 4
- The EU GMP guidelines. Part I covers medicinal products, Part II active substances, Part III GMP-related documents, plus the Annexes.
- GMP
- Good Manufacturing Practice. The part of quality assurance that ensures medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use.
- GxP
- Collective term for the good practice regulations: GMP, GDP (distribution), GCP (clinical), GLP (laboratory), GVP (pharmacovigilance).
- ICH Q10
- International guideline describing the Pharmaceutical Quality System model across the product lifecycle.
- ICH Q9
- International guideline on Quality Risk Management, defining a systematic process for assessing, controlling, communicating and reviewing risks to quality.
- Marketing Authorisation (MA)
- The licence granted by a competent authority to place a medicinal product on the market. Manufacturing must comply with it.
- PIC/S
- Pharmaceutical Inspection Co-operation Scheme. A cooperation between inspectorates that publishes a harmonised GMP guide and guidance such as PI 041 on data integrity.
Chapter 1: Pharmaceutical Quality System
Test this chapter- Batch disposition
- The decision to release, reject, rework or hold a batch, based on review of all records, results and deviations.
- CAPA
- Corrective and Preventive Action. Corrective action eliminates the cause of a detected problem; preventive action eliminates the cause of a potential problem.
- Change control
- A formal system for proposing, evaluating, approving, implementing and reviewing changes that could affect the validated state or product quality.
- Continual improvement
- Ongoing activity to enhance the ability to fulfil quality requirements, driven by PQR, CAPA, management review and knowledge management.
- Deviation
- A departure from an approved instruction, procedure, specification or established standard. Must be recorded, investigated and its impact assessed.
- Effectiveness check
- A pre-defined verification, after a CAPA or change is implemented, that it achieved its intended result and did not cause new problems.
- Impact assessment
- The documented evaluation of how a deviation or change affects product quality, patient safety, validation, regulatory filings and documentation.
- Management review
- Periodic review of the PQS by senior management to assess its effectiveness and the need for resources and improvement.
- Pharmaceutical Quality System (PQS)
- The management system that directs and controls a pharmaceutical company with regard to quality, encompassing GMP and quality risk management.
- Planned deviation
- A pre-approved, temporary departure from a procedure. Many inspectors consider this term a misuse; a planned change should go through change control.
- Product Quality Review (PQR)
- A periodic (usually annual) review of each product covering batches, deviations, changes, complaints, stability and trends, to verify process consistency.
- Quality Assurance (QA)
- The sum of the organised arrangements made to ensure medicinal products are of the quality required for their intended use.
- Quality Risk Management (QRM)
- A systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product across its lifecycle.
- Root cause
- The fundamental reason a failure occurred, which if removed would prevent recurrence. 'Human error' alone is rarely an acceptable root cause.
Chapter 2: Personnel
Test this chapter- Gowning
- The procedure for donning protective clothing before entering classified areas, designed to protect product from personnel-borne contamination.
- Hygiene programme
- Procedures covering health, hygiene practices and clothing for personnel, adapted to the activities performed.
- Key personnel
- The head of production, head of quality control and the QP, who must be full-time and, for production and QC, independent of each other.
- Qualified Person (QP)
- The person named on the manufacturing authorisation who is legally responsible for certifying that each batch complies with GMP and the marketing authorisation before release.
- Training effectiveness
- Evidence that training produced the required competence, for example through observed practice or assessment, not only attendance.
- Training matrix
- A record mapping each role to the procedures and training it requires, used to demonstrate that personnel are qualified for their tasks.
Chapter 3: Premises and Equipment
Test this chapter- Calibration
- Comparison of a measuring instrument against a traceable reference to establish its accuracy, with defined tolerance and interval.
- Cleanroom grade
- Classification of cleanrooms by permitted particle and microbial levels: Grades A, B, C and D in EU GMP Annex 1.
- Cross-contamination
- Contamination of a material or product with another material or product. Controlled by facility design, HVAC, cleaning, gowning and, where needed, dedication.
- Dedicated facility
- Premises and equipment used for a single product or product family where the risk of cross-contamination cannot be adequately controlled by other means.
- Health-Based Exposure Limit (HBEL)
- A toxicologically derived limit (such as PDE) used to justify cross-contamination controls and cleaning limits in shared facilities.
- HVAC
- Heating, Ventilation and Air Conditioning. Controls air quality, pressure differentials, temperature and humidity in manufacturing areas.
- IQ / OQ / PQ
- Installation, Operational and Performance Qualification: verifying equipment is installed as designed, operates across its ranges, and performs consistently under real conditions.
- Pressure differential
- The controlled difference in air pressure between adjacent rooms, used to direct airflow from cleaner to less clean areas.
- Preventive maintenance
- Scheduled maintenance carried out to keep equipment in its qualified state and prevent failures, recorded in the equipment log.
- Qualification
- Documented verification that premises, systems and equipment work correctly and lead to expected results. Stages: DQ, IQ, OQ, PQ.
- Validated state
- The condition in which a process, system or method has been shown to consistently do what it is intended to do, and is maintained through change control and periodic review.
Chapter 4: Documentation
Test this chapter- ALCOA+
- Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring and Available. The principles of data integrity.
- Audit trail
- A secure, computer-generated, time-stamped record that allows reconstruction of the creation, modification or deletion of an electronic record.
- Batch Manufacturing Record (BMR)
- The record of the manufacture of each batch, based on the approved master formula, capturing every step, parameter, material and signature.
- Batch Packaging Record (BPR)
- The record of the packaging of each batch, including line clearance, materials used, samples and reconciliation.
- Blank form control
- Issuing, numbering and reconciling blank templates so records cannot be recreated or replaced without trace.
- Controlled document
- A document managed under document control: versioned, approved, distributed and superseded through a defined process.
- Data integrity
- The degree to which data are complete, consistent, accurate, trustworthy and reliable throughout their lifecycle.
- Electronic signature
- A legally binding signature applied electronically, uniquely linked to an individual, meeting EU GMP Annex 11 and eIDAS (Regulation (EU) 910/2014) requirements.
- Good Documentation Practice (GDocP)
- The rules for creating, correcting, reviewing and retaining GMP records so that they are reliable evidence of what was done.
- Raw data
- The original record or certified true copy of the first capture of information, whether on paper or electronic, from which results are derived.
- Record retention
- The required period for keeping GMP records: batch documentation at least one year after expiry or five years after QP certification, whichever is longer.
- Second-person review
- Independent verification of a record or result by someone other than the person who generated it, including relevant audit trails.
- Standard Operating Procedure (SOP)
- An approved written instruction describing how to perform an operation consistently.
Chapter 5: Production
Test this chapter- Campaign manufacture
- Producing a series of batches of the same product in sequence before changing over, with cleaning and controls justified by risk assessment.
- Critical Process Parameter (CPP)
- A process parameter whose variability affects a critical quality attribute and must therefore be controlled within a defined range.
- Critical Quality Attribute (CQA)
- A physical, chemical, biological or microbiological property that must be within a limit to ensure the desired product quality.
- In-Process Control (IPC)
- Checks performed during production to monitor and, if necessary, adjust the process to ensure the product conforms to specification.
- Line clearance
- Documented verification that a production area and equipment are free of previous products, documents and materials before the next batch begins.
- Mix-up
- Confusion of one material, product, label or document with another. A primary risk that GMP controls in production are designed to prevent.
- Packaging material
- Any material used in packaging a medicinal product. Primary if in direct contact with the product, secondary otherwise, printed if it carries text.
- Process validation
- Documented evidence that a process, operated within established parameters, consistently produces product meeting its predetermined quality attributes.
- Quarantine
- The status of materials or products set apart while awaiting a decision on release or rejection.
- Reprocessing
- Reworking all or part of a batch by repeating one or more validated steps. Exceptional, and only under an approved procedure with QA authorisation.
- Starting material
- Any substance used in the production of a medicinal product, excluding packaging materials.
- Yield reconciliation
- Comparison of theoretical and actual quantities of product or printed materials at defined stages; discrepancies outside limits must be investigated.
Chapter 6: Quality Control
Test this chapter- Certificate of Analysis (CoA)
- A document stating the results of testing a batch against its specification, issued by the testing laboratory.
- Method transfer
- Documented process, with protocol and acceptance criteria, for qualifying a receiving laboratory to use an analytical method.
- Method validation
- Demonstration that an analytical procedure is suitable for its intended purpose, covering accuracy, precision, specificity, linearity, range and robustness.
- Out of Specification (OOS)
- A test result that falls outside the approved acceptance criteria. Requires a formal, phased investigation before any retesting.
- Out of Trend (OOT)
- A result within specification but inconsistent with previous results or expected trend, warranting investigation.
- Quality Control (QC)
- The part of GMP concerned with sampling, specifications and testing, and the organisation and documentation that ensure materials are not released until quality is judged satisfactory.
- Reference sample
- A sample of starting material, intermediate or finished product kept for future analysis if needed during the shelf life.
- Reference standard
- A highly characterised material used as a comparator in testing. Primary standards are officially recognised; secondary standards are qualified against them.
- Retention sample
- A sample of a fully packaged unit from each batch, kept for identification purposes for at least one year after expiry.
- Sampling plan
- A documented, justified scheme defining which containers to sample, how much, and how, to give a representative sample.
- Specification
- A list of tests, references to analytical procedures and acceptance criteria that a material or product must meet.
- Stability programme
- An on-going study of marketed product under defined storage conditions to monitor quality over its shelf life and detect adverse trends.
Chapter 7: Outsourced Activities
Test this chapter- Approved supplier list
- The controlled record of suppliers and contractors that QA has approved for specified materials or services.
- Contract acceptor
- The party performing an outsourced GMP activity under a written agreement, who must not subcontract without approval.
- Contract giver
- The party that outsources a GMP activity and retains ultimate responsibility for the quality of the product.
- Quality agreement
- A written contract defining each party's GMP responsibilities for an outsourced activity, including deviations, changes, complaints and record access.
- Supplier qualification
- The documented process of evaluating and approving a supplier, proportionate to the risk of the material or service, including audit where appropriate.
- Vendor audit
- An on-site or remote assessment of a supplier or contractor's compliance, used to support qualification and ongoing oversight.
Chapter 8: Complaints, Quality Defects and Recalls
Test this chapter- Complaint
- Any communication alleging a deficiency in the quality, safety or efficacy of a product. Must be recorded and investigated.
- Distribution record
- Records of where each batch was shipped, sufficient to trace and retrieve all product in a recall.
- Falsified medicine
- A product with a false representation of its identity, source or history. Suspected falsification must be reported to authorities.
- Mock recall
- A documented exercise testing the recall procedure, including traceability and reconciliation, without physically retrieving product.
- Quality defect
- An attribute of a product that does not conform to its specification or marketing authorisation, or that may affect safety or efficacy.
- Rapid Alert
- The system by which EU competent authorities notify each other of quality defects that may require recall, classified by urgency.
- Recall
- Removal of a batch or product from the market because of a confirmed or suspected quality defect or safety issue.
Chapter 9: Self-Inspection
Test this chapter- Audit finding
- A documented observation of non-compliance or improvement opportunity, usually classified critical, major or other.
- Audit independence
- The principle that auditors should not audit their own work or areas they are responsible for, to ensure objective findings.
- Critical / major / other deficiency
- The classification of inspection findings by severity: critical means significant risk of harm; major means a significant GMP departure; other means a minor departure.
- Inspection readiness
- The ongoing state in which a site can demonstrate compliance at any time, with records accessible and personnel able to explain their processes.
- Regulatory inspection
- An examination by a competent authority of a site's compliance with GMP, resulting in a report and, where compliant, a GMP certificate.
- Self-inspection
- An internal audit programme required by GMP to monitor implementation and compliance, and to propose corrective measures.