GxP Document Templates
Practitioner-authored templates mapped to regulatory expectations across validation, QA, QC, manufacturing, lab systems, data integrity, and inspection readiness.
Each template is documented in full — open any one to see its complete section outline, a baseline you can adapt for your own site document.
Regulated Operating Model Establishment Plan
The sequencing plan a new regulated organisation builds its quality system against — scope and role determination, decision rights, the governing procedure set, the record model, qualification, and the operating history that has to exist before an inspection. Records decisions and owners, not compliance status.
Contamination Control Strategy (CCS) Framework
Comprehensive CCS document template mapped to EU GMP Annex 1 §4. Includes site risk register, facility controls, procedural controls, and monitoring program integration.
Environmental Monitoring Risk Assessment (EMRA)
Risk-based EM program design template. Identifies critical sampling locations, justifies frequencies, and documents alert/action level rationale per USP <1116>.
Quality Risk Assessment (QRA) — Type 1
Standard QRA template for process and change control risk assessment using FMEA methodology. Maps directly to ICH Q9(R1) formality guidance.
Aseptic Process Simulation (APS) Protocol
Full APS/media fill protocol template for liquid fill-finish operations. Covers pre-simulation activities, execution, acceptance criteria, and post-simulation reporting per Annex 1 §8.
Airflow Visualization Study (AVS) Report Template
Smoke study documentation template for critical zone airflow characterization. Includes test conditions, acceptance criteria, video reference index, and critical observation log.
Validation Master Plan (VMP) Shell
Site-level VMP structure covering validation strategy, scope, organization, and scheduling. Pre-populated with 21 CFR 211 and Annex 15 alignment sections.
Annual Product Review (APR) Framework
Structured APR/Annual Product Quality Review template aligned to ICH Q10 lifecycle management requirements. Includes data trending sections and CAPA integration fields.
SOP Development Template
Standardized SOP format with all required GMP elements: purpose, scope, responsibilities, definitions, procedure, related documents, and revision history. Built to 21 CFR 211.100 (written procedures).
Deviation & Nonconformance Report
Structured deviation/nonconformance record with risk classification, product impact assessment, root-cause analysis, and CAPA linkage. Built for a defensible quality-event system.
CAPA Plan & Effectiveness Review
Corrective and preventive action plan with owners, due dates, and a pre-defined effectiveness check — so the fix is verified, not assumed. Maps to 21 CFR 820.100 and ICH Q10.
Change Control Request Form
Change control request capturing description, quality/validation/regulatory impact, risk categorisation, and approval before implementation. Aligned to ICH Q10 and ICH Q12.
PACMP & Change-Classification Protocol
Post-Approval Change Management Protocol that pre-defines a change, its studies and pre-agreed acceptance criteria, and the resulting reporting category — the enhanced-approach mechanism for lowering a change from a prior-approval supplement to a notification. Aligned to ICH Q12, ICH Q10, and ICH Q9(R1).
Out-of-Specification (OOS) Investigation Report
Two-phase OOS investigation — Phase I laboratory assessment then Phase II manufacturing investigation — driving a scientifically sound result-validity and disposition decision.
Supplier Quality Agreement
Written quality agreement defining the GMP responsibility split between manufacturer and supplier/contract facility — responsibility matrix, notification duties, and audit rights.
Internal Audit Program & Checklist
Risk-based self-inspection program with an annual schedule, area-by-area checklists, and finding-to-CAPA tracking. Maps to ICH Q10 self-inspection and 21 CFR 820.22.
Quality Management Review Pack
Management review pack assembling PQS performance metrics, deviation/CAPA/change status, and audit outcomes for leadership decisions. Structures the ICH Q10 / 21 CFR 820.20 review.
Cleaning Validation Protocol
Cleaning validation protocol with worst-case grouping, HBEL/PDE-based residue limits, swab/rinse sampling and recovery, and acceptance criteria. Maps to EU GMP Annex 15 and 21 CFR 211.67.
Process Validation (PPQ) Protocol
Stage 2 Process Performance Qualification protocol with CQA/CPP linkage, enhanced sampling, per-attribute acceptance criteria, and statistical evaluation. Follows the FDA 2011 lifecycle and Annex 15.
Computer System Validation (CSV) Plan
CSV plan scoping a GxP computerised system by GAMP category and risk, defining IQ/OQ/PQ deliverables, Part 11 applicability, and requirements traceability. Maps to GAMP 5, Part 11, and Annex 11.
Data Integrity (ALCOA+) Assessment
System-and-record data integrity assessment against the ALCOA+ attributes, with audit-trail and access-control review and a risk-ranked remediation register. Maps to Part 11, MHRA DI (2018), and WHO TRS 996 Annex 5.
Clinical Monitoring Plan
Risk-based clinical monitoring plan identifying critical data and processes and setting the on-site/remote/centralised monitoring mix, visit scope, and escalation. Aligned to ICH E6(R3).
Trial Master File (TMF) Index
TMF index structuring essential documents by zone/section with an expected-document list and completeness tracking, so the TMF stays inspection-ready. Maps to ICH E6(R3) and the EMA TMF guideline.
GLP Study Plan
Nonclinical GLP study plan defining objective, test system, test/reference items, Study Director and QA responsibilities, procedures, and archiving. Maps to OECD GLP and 21 CFR Part 58.
Temperature Excursion Assessment
Cold-chain temperature excursion assessment evaluating product against stability data and mean kinetic temperature to reach a science-based disposition. Maps to EU GDP (2013/C 343/01) and WHO TRS 961 Annex 9.
Signal Management Procedure
Pharmacovigilance signal management SOP covering detection, validation, prioritisation, benefit-risk assessment, and action tracking across the product lifecycle. Maps to EU GVP Module IX and 21 CFR 314.80.
Commissioning & Qualification (C&Q) Plan
Risk- and science-based C&Q plan concentrating qualification effort on the aspects critical to product quality and patient safety. Maps to ASTM E2500, ISPE Baseline Guide Vol. 5, and EU GMP Annex 15.
User Requirements Specification (URS)
URS capturing testable functional, operational, data integrity, and regulatory requirements with unique IDs and traceability — the anchor for design, risk assessment, and qualification. Maps to ASTM E2500 and GAMP 5.
Project Quality Plan (PQP)
The single document that defines how quality is built into a regulated project — quality objectives, roles and responsibilities, deliverables and gates, risk-management approach, and the documentation strategy — from concept through commercial release. Maps to ICH Q10, ICH Q9(R1), and ISPE Good Practice Guide: Project Management.
Stage-Gate Quality Review Record
A gate-review record that fuses the project stage gate with the quality gate — capturing the quality acceptance criteria, evidence reviewed, open risks and actions, and the quality unit’s go / conditional-go / no-go decision at each phase boundary. Maps to ASTM E2500 and ICH Q9(R1).
Risk-Based Quality Management (RBQM) Plan
A clinical Risk-Based Quality Management plan aligned to ICH E6(R3) and E8(R1): identifies the factors critical to quality, defines the risks to them, and sets the risk-based monitoring, key risk indicators, and quality tolerance limits that focus oversight on what matters to subject safety and data reliability.
Nitrosamine Impurity Risk Assessment
A structured nitrosamine risk assessment covering the three-step process — risk evaluation, confirmatory testing, and risk control — for API and drug-product sources of N-nitrosamine and nitrosamine drug-substance-related impurities (NDSRIs), with acceptable-intake comparison and a control strategy. Aligned to the EMA and FDA nitrosamine guidance and ICH M7(R2).
Computer Software Assurance (CSA) Test Strategy
A CSA test strategy that assigns assurance effort to each software feature by its impact on product quality or the quality system, then matches the testing activity — unscripted, ad-hoc, or scripted — to that risk, leveraging supplier evidence to keep documentation least-burdensome. Aligned to the FDA CSA guidance (2025) and GAMP 5 (2nd ed.).
Audit Trail Review SOP
A procedure for routine, risk-based review of electronic audit trails: what to review, how often, who reviews it, and how audit-trail review is built into batch-record and data review rather than treated as a separate exercise. Aligned to MHRA GXP data-integrity guidance, EU GMP Annex 11, and 21 CFR Part 11.
Supplier Qualification Questionnaire
A risk-based supplier qualification questionnaire and evaluation record for API, excipient, packaging, and service suppliers — capturing quality-system, GMP status, change-notification, and regulatory information, with a scored disposition. Supports the supplier controls required by ICH Q7 and EU GMP Chapters 5 and 7.
Technology Transfer Protocol
A sending-unit to receiving-unit technology transfer protocol covering the transfer of product and process knowledge, analytical methods, and acceptance criteria, with a gap analysis and a transfer report structure. Aligned to WHO TRS 961 Annex 7 and the lifecycle knowledge-management expectations of ICH Q10 and Q12.
Stability Study Protocol
A stability study protocol defining storage conditions, orientation, time points, testing matrix, and acceptance criteria for long-term, intermediate, and accelerated studies, with a bracketing/matrixing rationale where used. Aligned to ICH Q1A(R2) and the evaluation approach of ICH Q1E.
Equipment Qualification Protocol (IQ/OQ/PQ)
A combined installation, operational, and performance qualification protocol with pre-approved acceptance criteria, a requirements-to-test traceability table, and a deviation-handling section — the URS→DQ→IQ→OQ→PQ flow expected by EU GMP Annex 15, sized to system impact per ASTM E2500.
Complaint Handling & Recall SOP
A procedure covering receipt, triage, investigation, and trending of product complaints, and the decision, classification, execution, and effectiveness check of a recall — including regulator notification. Aligned to 21 CFR 211.198, EU GMP Chapter 8, and the PQS expectations of ICH Q10.
CSV Requirements Traceability Matrix
A requirements traceability matrix linking each user and functional requirement to its risk assessment, design specification, and verification test with a result and status — the trace that demonstrates coverage in a GAMP 5 computerised-system validation. Rendered as an editable spreadsheet. Aligned to GAMP 5 (2nd ed.) and EU GMP Annex 11.
Quality & Regulatory Due-Diligence Checklist
A structured checklist for the quality and regulatory diligence stream in a transaction: regulatory standing and inspection history, quality-system health, data integrity, validation and facilities, supply chain and recalls, a findings/remediation summary, and post-close integration readiness. The quality practitioner’s contribution to a deal — not legal, financial, or transaction advice. Structured on ICH Q10, ICH Q9(R1), 21 CFR 211, and EU GMP Chapter 1.
Capital Project Charter & Business Case
Phase-0 charter template that captures the investment thesis, product and capacity basis, regulatory strategy, make-vs-buy decision, high-level quality criteria, and sponsor governance for a regulated capital project — the decision record every later phase traces back to.
Basis of Design (BoD)
Front-end-planning template that fixes the design basis — capacity, product mix, quality targets, regulatory and standards basis, process/utility basis, classification concept, contracting model, and cost/schedule class — so detailed design proceeds from an agreed, change-controlled baseline.
Site Selection & Feasibility Assessment
Structured comparison and decision-record template for choosing a manufacturing site: candidate matrix, regulatory jurisdiction and inspection-regime analysis, utilities and infrastructure feasibility, workforce and supply-chain factors, EHS/permitting, and a defensible recommendation.
Design Qualification (DQ) Protocol
DQ protocol template verifying that the detailed design meets the URS and the identified critical aspects — URS-to-design traceability matrix, critical-aspect verification, design-review record, acceptance criteria, and the documented DQ conclusion Annex 15 expects.
Factory Acceptance Test (FAT) Protocol
FAT protocol template for verifying equipment at the vendor works before shipment — prerequisites, functional and performance test matrix, the documentation-review checklist that makes FAT results leverageable in C&Q, punch-list disposition, and formal acceptance.
System Turnover Package (TOP)
Turnover package template for mechanical completion and handover — system boundary, mechanical-completion checklist, documentation manifest (drawings, certificates, records), punch-list register, and the care/custody/control transfer record that starts the qualification clock.
Commissioning Plan
System-level commissioning plan template applying good engineering practice per ASTM E2500 and the ISPE Baseline Guide Vol. 5. Covers the commissioning organisation, system-by-system scope, functional test matrix, documentation approach, evidence leverage into qualification, punch-list handling, and handover.
Operational Readiness Review (ORR)
Structured operational readiness review template for the transition from project to operations: readiness dimensions (SOPs, training, materials, maintenance and calibration, live quality system), a weighted scorecard, an open-gap register, and a documented go/no-go recommendation.
Inspection Readiness Plan
Pre-approval and routine inspection readiness plan template: submission-to-evidence traceability, site readiness assessment, mock-inspection programme, ALCOA+ data-integrity assurance of inspectable records, front-room/back-room logistics, and CAPA for readiness gaps.
Continued Process Verification (CPV) Plan
Stage 3 CPV plan template per the FDA Process Validation Guidance (2011) lifecycle: the CQAs and CPPs monitored, sampling plan and frequency, statistical control approach and signal rules, review cadence and roles, out-of-trend response, and linkage to periodic product review.
Project Close-Out Report
Capital-project close-out report template: open-action and punch-list closure status, documentation archival and retrievability record, benefits realisation against the business case, residual risks transferred to operations, a lessons-learned register, and formal close-out sign-off.
Risk Management Plan (RMP)
Risk management plan built around the safety specification: important identified risks, important potential risks and missing information, each carrying the pharmacovigilance activity that investigates it, the minimisation measure that contains it, and a pre-specified effectiveness indicator. Maps to EU GVP Module V and ICH E2E.
Pharmacovigilance System Master File (PSMF)
Standing description of the pharmacovigilance system a marketing authorisation holder operates: the QPPV role and its authority, delegated activities and the agreements governing them, the safety database, the quality system with its performance indicators, and the change logbook. Maps to EU GVP Module II and Reg. (EU) 520/2012.
Safety Data Exchange Agreement (SDEA)
Agreement defining how two organisations sharing a product exchange safety information: each party’s own obligations recorded first, the awareness definition and exchange clock with the receiving party’s remaining time made explicit, scope, periodic-report and signal responsibilities, reconciliation, and termination handling. Maps to ICH E2D(R1).
Periodic Benefit-Risk Evaluation Report (PBRER)
Periodic re-examination of whether a product’s benefits still outweigh its risks: data lock point and interval, regulatory and study developments, interval and cumulative datasets, signal evaluation with conclusions attached, and an integrated benefit-risk analysis naming the population it applies to. Maps to ICH E2C(R2).
Individual Case Safety Report Processing Record
Case-processing record built around the decision that actually gets cited in findings: day zero and how awareness is evidenced. Covers minimum criteria, seriousness and expectedness against a named labelling version, coding with dictionary versions, follow-up attempts, and per-authority submission with acknowledgements. Maps to ICH E2A, E2B(R3) and E2D(R1).
Safety Literature Monitoring Procedure
Literature-monitoring procedure and per-cycle search record, scoped by active substance rather than brand, with search strings captured verbatim so a reviewer can re-run them. Covers frequency and its justification, explicit screening criteria, the cycle log, and the cases arising. Maps to ICH E2D(R1) and EU GVP Module VI.
US Postmarketing Safety Report Decision Record
Decision record for US postmarketing safety reporting that starts where the errors start: which regime governs the product. Covers the drug and biological-product provisions, seriousness and expectedness against the approved labelling version, the awareness date and its evidence, submission, and reconciliation against the safety database. Maps to 21 CFR 314.80 and 21 CFR 600.80.
Medical Device Report Decision Record
Reportability decision record applying each limb of the Medical Device Reporting test explicitly, including the malfunction limb that turns on likely harm if the malfunction recurred rather than harm that occurred. Covers device preservation, failure-mode investigation, initial and supplemental filing, and feedback into complaint handling and CAPA. Maps to 21 CFR Part 803.
Pharmacovigilance Inspection Readiness Plan
Readiness plan built on the premise that an inspection tests whether the system on paper is the system in operation. Covers master-file reconciliation with a gap log, case-walkthrough rehearsal on adversely selected cases, compliance metrics with explanations prepared, evidenced oversight of delegated activities, and briefing. Maps to EU GVP Module III and Reg. (EU) 520/2012.
QPPV Appointment and Authority Record
Appointment record that makes the QPPV role real rather than nominal: qualifications with evidence, authority stated in terms exercisable against resistance, permanent availability and a deputy with equivalent standing and a recorded handover, and the information flows from functions that hold no pharmacovigilance role. Maps to EU GVP Module I and Reg. (EU) 520/2012.
Post-Authorisation Safety Study (PASS) Protocol
Protocol for a post-authorisation safety study, structured so the objective is specific enough that the design can be judged against it. Covers the safety question and what result would resolve it, design and population with justifications, an explicit test of whether the data source can observe the exposure and outcome, a pre-specified analysis plan, and dissemination including of an unfavourable result. Maps to EU GVP Module VIII.
Veterinary Adverse Event Report
Veterinary adverse event report using the veterinary framework rather than human pharmacovigilance by analogy. Captures species, weight and actual administered dose without which a case cannot be assessed, the full event categories including suspected lack of expected efficacy and human exposure, clinical course, and causality with the method named. Maps to VICH GL24.
Clinical Trial Protocol
Trial protocol structured so the document a site actually works from is unambiguous: eligibility with objective thresholds, a schedule of assessments carrying a visit window for every visit, critical-to-quality factors with the control built into the design, and a reconciliation table run against the consent form, case report form and analysis plan on every amendment. Maps to ICH E6(R3) and ICH E8(R1).
Informed Consent Process Record
Consent record covering what a monitor actually reconstructs: form version against its approval date, who conducted the discussion and whether they were delegated to, time allowed, an explicit sequence check that no trial procedure preceded the signature and that the participant dated it personally, the process note, and re-consent tracked with an outstanding column. Maps to 21 CFR Part 50 and ICH E6(R3).
IRB Submission Package
Submission inventory built to survive validation rather than stall on it: every document with a version and date including every recruitment item, the risk determination with its justification, a vulnerable-population table answered row by row including the exclusions, recruitment and compensation, and continuing-review obligations diarised with owners. Maps to 21 CFR Part 56.
IND Application Assembly Record
Assembly record for an investigational new drug application, checking the nonclinical package against the exposure the protocol actually proposes across route, duration, population and margin; deriving the starting dose from a stated point of departure and safety factor; and tracking the review period so dosing does not begin on the assumption that silence is approval. Maps to 21 CFR Part 312.
EU Clinical Trial Application Dossier Plan
Dossier plan for a single EU application assessed jointly by every concerned member state: the Part I / Part II split document by document, a validation gate treated as a gate rather than a formality, requests for information with owners and fixed windows, and the downstream modification and results obligations planned before authorisation starts their timetable. Maps to Regulation (EU) 536/2014.
Serious Adverse Event Report Form
Trial SAE form separating the axes that get conflated: seriousness criteria and severity recorded in different places, investigator and sponsor causality both retained rather than one overwriting the other, expectedness judged against the reference safety version in force at onset, and a clock table that distinguishes the shorter fatal or life-threatening window. Maps to 21 CFR Part 312 and ICH E6(R3).
Protocol Deviation Log
Deviation register recording date of occurrence and date of discovery separately so the duration of the condition is recoverable, classifying by impact on safety and data reliability rather than by inconvenience, escalating serious breaches on discovery, and carrying a pattern-analysis tab so corrective action is written against the systemic cause rather than the last occurrence. Maps to ICH E6(R3).
Source Data Verification Plan
Risk-based verification plan that defines what source is for each data point before the first visit, sets verification depth and sample size per variable by criticality, checks the attributes that make data trustworthy, treats a discrepancy as a question about the process, deliberately looks for data never reported, and records what was not checked as well as what was. Maps to ICH E6(R3).
Statistical Analysis Plan
Analysis plan built on the estimand rather than the method: treatment, population, variable, summary measure, and a strategy chosen for every enumerated intercurrent event; analysis populations defined so membership needs no judgement at analysis time; sensitivity analyses each naming the assumption they probe; and a version table recording whether each change preceded unblinding. Maps to ICH E9(R1).
Clinical Study Report
Study report following the expected structure, with an amendment table carrying the enrolment count at the time of each change, disposition that reconciles every participant enrolled, efficacy results labelled pre-specified or post-hoc, unfiltered safety, and a deviation section proportionate to the log it summarises. Maps to ICH E3.
Medical Device Clinical Investigation Plan
Investigation plan under the device good clinical practice standard, which is not the drug one: risk analysis documented before the design, the operator treated as part of the intervention with training and learning curve controlled, controls named where blinding is impossible, device version traceability with a documented poolability assessment, and device deficiencies reported on potential rather than actual harm. Maps to ISO 14155:2026.
Veterinary Clinical Study Protocol
Study protocol under veterinary good clinical practice, where the subject cannot consent and the owner or producer can: target species and husbandry matched to intended use, written owner consent covering withdrawal obligations, animal welfare and ethical review, evidenced food-chain protection rather than a withdrawal period merely stated, and safety recording that includes humans exposed during handling. Maps to VICH GL9.
Raw Data Definition Register
Per-system register answering which record is the raw data, because the answer differs between an instrument that writes a final value and one that acquires a signal then processes it. Covers acquisition versus processed output and whether a result can be regenerated, attributability and shared logins, the correction method per system, and archive format checked against the retention period. Maps to OECD GLP Advisory Documents No. 17 and No. 22.
Good Documentation Practice SOP
Procedure for handwritten GxP records built around the five requirements almost every finding in this area reduces to: contemporaneous, on the issued form, legible and permanent, attributable, nothing blank. Includes a signature register to resolve initials and a review section that distinguishes checking entries from signing them. Maps to WHO TRS 996 Annex 5 and the MHRA GxP data integrity guidance.
GxP Record Correction Log
Correction log built on the principle that the original entry stays readable, with a permitted-versus-never table, per-correction reasons, an escalation assessment for corrections that changed a decision, and an electronic section treating the audit trail as the digital strike-through. Maps to WHO TRS 996 Annex 5 and PIC/S PI 041-1.
Controlled Blank Form Issuance Log
Issuance and reconciliation register closing the gap that lets an unwanted result be repeated onto a fresh sheet: uniquely identified copies, issue recorded at the point it happens, every copy reconciled to a documented outcome, voided copies retained visibly, plus access control and the electronic templates usually left uncontrolled. Maps to WHO TRS 996 Annex 5 and the MHRA GxP data integrity guidance.
Data Criticality and Risk Assessment
Assessment separating the two questions regulators expect to be answered independently: how important the data is to a decision, and how vulnerable it is to alteration or loss. Includes a data map covering informal locations, criticality and vulnerability scored apart, combined control intensity, and audit trail review targeted by criticality rather than defined as comprehensive. Maps to the MHRA GxP data integrity guidance and PIC/S PI 041-1.
True Copy Verification Record
Record for producing a copy that can replace the original, and recognising when it cannot. Establishes what the original consists of including its metadata, records the reproduction method per component, verifies before the original is disposed of, labels the copy, and marks convenience copies as uncontrolled with a review date. Maps to WHO TRS 996 Annex 5 and the FDA data integrity and CGMP Q&A.
Hybrid Record Definition and Control
Definition and control for processes running on both paper and a system: which components together form one record, a two-way link between the halves, review that sees both, electronic controls for the electronic half regardless of the wet signature, matched retention archived linked, and a stated transition intention. Maps to the FDA data integrity and CGMP Q&A and PIC/S PI 041-1.
Controlled Substance Recordkeeping Procedure
Recordkeeping procedure for a regime aimed at diversion rather than product quality, which sits outside the GMP harmonisation architecture entirely. Covers registration scope, the initial and biennial inventories, separation of Schedule I and II records, readily-retrievable tested rather than asserted, unit-level accountability treating a discrepancy as a diversion signal, and physical security. Maps to 21 CFR Part 1304.
Data Integrity Breach Investigation Report
Investigation report for the case where the records themselves cannot be assumed true. Secures evidence before interviews, scopes by what the same person, system or practice could have touched rather than by what was found, determines error versus falsification rather than assuming, assesses impact on released product and submissions, and separates control causes from cultural ones. Maps to the MHRA GxP data integrity guidance and PIC/S PI 041-1.
GLP Study Director Appointment Record
Appointment record establishing the single point of study control good laboratory practice is built around: a named individual dated before study start, qualification evidenced against this study type, authority stated in exercisable terms including the authority to stop the study, the quality-assurance interface, and a replacement procedure documented before it is needed. Maps to 21 CFR Part 58 and the OECD GLP Principles.
GLP Quality Assurance Unit Charter
Charter for an inspection function whose independence is structural rather than declared: four independence tests with evidence, a master schedule maintained while studies run, an inspection programme stating what makes each interval adequate, escalation to management as well as the study director, and a final-report audit against raw data protected in the schedule. Maps to 21 CFR Part 58 and the OECD GLP Principles.
Test Item Characterisation Record
Characterisation record establishing what was actually administered: identity, strength, purity and composition determined before dosing, stability for the dosing formulation at the concentrations used rather than the neat substance, homogeneity verified with sampling positions named, the vehicle and control article characterised too, plus accountability and reserve samples. Maps to 21 CFR Part 58 and the OECD GLP Principles.
GLP Multi-Site Study Arrangement
Arrangement for a study split across sites without splitting responsibility for it: phases and sites named in the plan itself, a principal investigator per delegated phase reporting to the study director, quality-assurance coverage agreed rather than assumed, raw data ownership and transfer, deviations routed without delay, and one final report with signed contributing reports attached. Maps to the OECD GLP Principles.
GLP Final Study Report
Final report carrying the two elements that make it a GLP report rather than a scientific write-up: the study director dated compliance statement naming the deviations, and the quality assurance statement. Methods described as performed against as planned, every deviation with an impact assessment, a traceability table from each result to its raw data, signed contributing reports attached, and amendment control after signature. Maps to 21 CFR Part 58 and the OECD GLP Principles.
GLP Archive Index and Control Record
Archive index built for retrieval rather than storage: material indexed on deposit, per-study completeness across plan, raw data, report, specimens and samples, retention set from the longest applicable requirement with the basis recorded, a named archivist with controlled access, periodic electronic readability re-verification, and controlled transfer and destruction. Maps to 21 CFR Part 58 and the OECD GLP Principles.
GLP Monitoring Inspection Readiness Plan
Readiness plan for a compliance monitoring inspection, where the outcome is your standing in a system other countries rely on rather than one client confidence. Covers the authority and the scope actually inspected, master-schedule currency, a self-audit on a study that could fail, demonstrating the facility rather than paperwork about it, quality-assurance record consistency, and answering findings with cause, correction and prevention. Maps to the OECD GLP Principles and Directive 2004/10/EC.
EPA FIFRA GLP Compliance Record
Compliance record for pesticide registration studies, which fall under the EPA good laboratory practice standards rather than the FDA ones. Begins with an explicit regime determination, scopes which studies must comply in both directions, prepares the submission statements that have no counterpart in the pharmaceutical regime, and tracks international acceptance before the study runs rather than at submission. Maps to 40 CFR Part 160.
Bioanalytical Method Validation Protocol
Validation protocol proving a method quantifies an analyte in the matrix it will actually see, under expectations that apply equally to nonclinical and clinical work. Covers selectivity against real interference, calibration and quality controls with the lower limit demonstrated rather than asserted, accuracy, precision and matrix effect across multiple lots, stability under every condition a sample will meet, and run acceptance and reassay rules fixed before any result is seen. Maps to ICH M10.
ISO/IEC 17025 Accreditation Scope Plan
Accreditation plan built around the fact that competence is recognised method by method and matrix by matrix, never for a laboratory in general. Covers the applied-for scope, impartiality risks and their mitigation, method validation with measurement uncertainty, metrological traceability, proficiency testing with outliers investigated to a cause, and scope maintenance so a new method is never offered as accredited before the extension is granted. Maps to ISO/IEC 17025:2017.
Responsible Person Appointment Record
Appointment record for the named individual a wholesale dealer authorisation rests on: knowledge and experience evidenced, authority listed in exercisable terms including the authority to stop a shipment, three structural independence tests, a named deputy with equivalent standing, visibility in the quality system, and change notification to the authority. Maps to EU GDP 2013/C 343/01 and MHRA GDP expectations.
Supplier and Customer Qualification Register
Register verifying both ends of every transaction: authorisation confirmed against the issuing register rather than a supplied copy, entitlement checked for the specific product category transacted, a risk assessment capturing commercial red flags as signals rather than opportunities, written agreements, and re-verification on cycle and on trigger. Maps to EU GDP 2013/C 343/01 and MHRA GDP expectations.
Temperature Mapping Protocol
Mapping protocol that finds where a storage area is actually out of range: mapped loaded in the real pattern, sensors placed to find extremes rather than confirm the middle, duration covering real cycles and working activity, seasonal extremes and failure modes challenged, and permanent monitoring placed at the extremes the study found rather than where cabling is convenient. Maps to WHO TRS 957 Annex 5 and USP <1079>.
Cold Chain Lane Qualification Protocol
Lane qualification proving a packout holds range over a specific origin, destination, route and season rather than in a chamber. Covers route-specific ambient profiles instead of generic curves, qualification with margin beyond the expected transit, a packing instruction written to be followed exactly, shipment monitoring compared against the qualification, and an excursion decision rule set against stability data in advance. Maps to WHO TRS 961 Annex 9 and PDA Technical Report No. 39.
Wholesale Returns Assessment Record
Assessment record for the one routine transaction where product re-enters saleable stock from outside your control. Quarantine on receipt, positive evidence of storage conditions rather than the absence of a complaint, origin and entitlement checks, packaging and safety-feature inspection, a responsible-person decision against defined criteria, and returns analysed as data. Maps to EU GDP 2013/C 343/01 and WHO TRS 957 Annex 5.
Suspected Falsified Medicine Procedure
Procedure for containing a suspect pack without destroying the evidence that identifies it: a do-immediately versus never table, batch and consignment quarantine rather than the single pack, trace back and forward, notification to the authority and marketing authorisation holder, system alerts treated as suspicion until resolved, and an investigation of your own controls afterwards. Maps to Delegated Regulation (EU) 2016/161.
DSCSA Product Tracing Implementation Plan
Implementation plan for the US tracing regime, opening with a side-by-side comparison against the EU scheme because neither satisfies the other. Covers authorised trading partner status, the product identifier and where its syntax comes from, electronic exchange that is also interoperable, verification response as a system design requirement, suspect and illegitimate product handling, and exemption status re-checked against a current source. Maps to the DSCSA and the GS1 General Specifications.
Active Substance Distribution Procedure
Distribution procedure for bulk active substances under the guideline written for them, which is separate from the finished-product one. Begins by confirming the classification and that the finished-product guideline does not govern, then covers member-state registration, traceability to the original manufacturing site through any broker, control of repackaging and relabelling, certificates of analysis tied to the batch supplied, and storage and recall at bulk scale. Maps to EU GDP for Active Substances 2015/C 95/01.
Veterinary Active Substance Distribution Procedure
Distribution procedure under the veterinary instrument, which is separate from its human counterpart because the applicable law follows intended use rather than the molecule. Establishes intended use first, checks that registrations are veterinary-specific rather than inherited from a human-side authorisation, controls storage for the material actual risk profile, verifies customer entitlement, and plans recall with treated animals and the food chain in view. Maps to Implementing Regulation (EU) 2021/1280.
Foreign Supplier Verification Program
Programme for the US importer obligation to verify that each foreign supplier produces food meeting an equivalent level of public health protection. Determines who the FSVP importer actually is, analyses hazards per specific food rather than by category, establishes who controls each hazard and what documentation that assumption requires, evaluates the supplier alongside the food, and treats verification as an activity performed and evidenced rather than a certificate accepted. Maps to 21 CFR Part 1, Subpart L.
Clinical Trial Laboratory Setup Plan
Setup plan that begins by determining which standard actually governs, because good clinical laboratory practice exists in the gap between nonclinical GLP and the diagnostic standards and neither fits trial sample analysis. Covers a quality system built around the trial rather than the specimen, run acceptance criteria fixed before use, competence evidenced per method, equipment with its failure impact on results, and an end-to-end data path. Maps to WHO GCLP (2009) and EMA/INS/GCP/532137/2010.
Clinical Trial Laboratory Manual
The site-facing manual that acts at the moment the sample is taken, where most trial sample problems are created and become irreversible. Specifies tube, additive and order of draw per assessment, processing steps with permitted time windows, labelling that keeps blinding intact and survives storage temperature, storage and shipping with excursion handling, and an explicit statement of what is time-critical. Maps to WHO GCLP (2009).
Sample Chain of Custody Record
Custody record accounting for every sample from the participant to the result and its disposal. Unique identifiers never reused, every transfer recorded with person, time and condition, transit excursions assessed against analyte stability, receipt reconciled against expected, aliquots inheriting the parent chain, and a documented end state for each sample. Maps to WHO GCLP (2009) and EMA/INS/GCP/532137/2010.
Central Laboratory Qualification Record
Qualification record assessing a central laboratory against the trial you are running rather than its brochure: the specific assays and matrices in scope, accreditation verified against the schedule rather than the certificate, empirical cross-site comparability, logistics tested with real shipments before the trial, data transfer and reconciliation agreed in writing, and escalation with an audit before commitment. Maps to WHO GCLP (2009) and EMA/INS/GCP/532137/2010.
ISO 15189 Implementation Plan
Implementation plan for a medical laboratory system scoped across all three examination phases, since most diagnostic error happens outside the analysis. Risk assessed as harm to the patient rather than as a defect in the result, point-of-care testing brought inside the system as the current edition requires, competence per examination, commercial methods verified in your own population, and turnaround set from the clinical requirement. Maps to ISO 15189:2022.
CLIA Compliance Record
Compliance record for the US federal regime that attaches to the testing site rather than the organisation, so every location performing testing needs its own certificate. Determines test complexity, from which everything else follows; matches personnel criteria to that level as criteria rather than titles; enrols in proficiency testing per regulated specialty; and states the proficiency-sample prohibitions whose sanctions do not distinguish motive. Maps to 42 CFR Part 493.
Laboratory Proficiency Testing Programme
Programme using external comparison to find bias internal quality control cannot see, because a laboratory consistently wrong is consistently wrong against its own controls. Enrolment mapped from the live test menu, samples handled exactly as routine work, a results register, unacceptable results investigated to a cause with the already-reported results reviewed, and consistent bias inside the acceptable range treated as a trend rather than a pass. Maps to ISO 15189:2022 and 42 CFR Part 493.