Identify the material, receipt/lot, site and assessment date.
Assess each applicable control against current objective evidence. Record a reference, accountable owner and due date for any gap.
Justify every “Not applicable” decision and obtain appropriate review. Excluded controls reduce the score denominator.
Resolve relevant blockers before progression and record the authorized decision in your approved system.
Export your assessment for review. CSV and print use the currently visible controls; reset filters for a complete export.
Important: The percentage is a checklist completion indicator, not a GMP certificate, material release, electronic signature or risk-weighted compliance rating. Even 100% requires independent review of the evidence. Legal requirements and identity or Quality-release failures cannot be waived by this tool.
Progress is stored only in this browser and may be lost if browser data is cleared. This is not a validated GxP record system or secure document repository. Use non-confidential record references, keep controlled records in your approved system and retain an export. No registration is required.
Interactive material receipt, storage and dispensing assessment
Release and issue materials only when evidence supports the decision.
Define the assessment scope, assess each control, record the available evidence or next action, and use the gate view to expose what still prevents safe execution. Entries remain in this browser. “Ready” requires current, objective evidence—not an expected future action.
0%evidence ready
Assessed
0/40
Ready
0
In progress
0
Open gaps
0
Gate blockers unresolved
39
G1
Receive and quarantine0/8 ready
G2
Sample and release0/8 ready
G3
Store and protect0/8 ready
G4
Dispense and issue0/8 ready
G5
Reconcile and disposition0/8 ready
40 of 40 readiness controls shown
Framework reviewed 29 October 2026. Your context, notes and status remain only in this browser.
Control / gate
Readiness control
Owner / applicability
Criticality
Minimum evidence
Primary basis
Your assessment
REC-01Receipt and quarantineG1 · Receive and quarantine
Approved source and grade
Match actual manufacturer, supplier, grade and specification against current approval; escalate substitutions.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Approved-source record, purchase order and specification
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
REC-02Receipt and quarantineG1 · Receive and quarantine
Delivery identity and quantity
Reconcile material name, supplier lot, container count, quantity and delivery documents before acceptance.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Signed receipt and discrepancy record
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
REC-03Receipt and quarantineG1 · Receive and quarantine
Container and seal integrity
Inspect for damage, wetting, tampering, contamination and broken seals; segregate suspect containers.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Inspection record, photographs and affected-container list
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
REC-04Receipt and quarantineG1 · Receive and quarantine
Transport history
Review required condition records and transit delays; unresolved excursions remain on hold.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Logger data, route/delay record and Quality assessment
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
REC-05Receipt and quarantineG1 · Receive and quarantine
Internal lot and status
Assign a traceable internal receipt/lot reference; prevent use until authorized release.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Receipt labels, location and system quarantine block
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
REC-06Receipt and quarantineG1 · Receive and quarantine
Partial or mixed delivery
Distinguish supplier batches and multiple deliveries without losing container-level traceability.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Delivery-to-lot reconciliation
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
REC-07Receipt and quarantineG1 · Receive and quarantine
Controlled unloading
Protect goods from weather and pests; move temperature-sensitive consignments promptly to suitable storage.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Receipt timing and bay/storage check
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
REC-08Receipt and quarantineG1 · Receive and quarantine
Suspect material escalation
Prevent issue of potentially falsified or misidentified stock and escalate under approved procedures.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Hold record and escalation reference
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
REL-01Sampling and Quality releaseG2 · Sample and release
Approved sampling instruction
Use an approved material-specific plan, trained sampler and appropriate sampling environment.
QC / QAAssess against material, site and operation; justify every N/A
Gate blocker
Sampling instruction and training record
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
REL-02Sampling and Quality releaseG2 · Sample and release
Identity assurance
Apply required identity testing and justified container sampling; do not use an arbitrary square-root rule as universal policy.
QC / QAAssess against material, site and operation; justify every N/A
Gate blocker
Approved sampling rationale and identity results
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
REL-03Sampling and Quality releaseG2 · Sample and release
Contamination prevention
Confirm clean tools, booth status, containment and cleaning controls appropriate to material hazards.
QC / QAAssess against material, site and operation; justify every N/A
Gate blocker
Pre-use area and utensil checks
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
REL-04Sampling and Quality releaseG2 · Sample and release
Sample and container traceability
Link samples to supplier lot, internal lot and sampled containers; reseal and identify opened containers.
QC / QAAssess against material, site and operation; justify every N/A
Gate blocker
Sampling log and sample labels
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
REL-05Sampling and Quality releaseG2 · Sample and release
Testing and certificate review
Confirm required tests, specification version and supplier certificate authenticity; reduced testing needs justified authorization.
QC / QAAssess against material, site and operation; justify every N/A
Gate blocker
Laboratory results and certificate review
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
REL-06Sampling and Quality releaseG2 · Sample and release
Independent release authority
Only designated Quality personnel authorize status changes based on complete evidence.
QC / QAAssess against material, site and operation; justify every N/A
Gate blocker
Dated release decision and system audit record
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
REL-07Sampling and Quality releaseG2 · Sample and release
Expiry and retest decision
Confirm validity for intended use; an expired material is not automatically made usable by retesting.
QC / QAAssess against material, site and operation; justify every N/A
Gate blocker
Expiry/retest review and approved disposition
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
REL-08Sampling and Quality releaseG2 · Sample and release
Open investigation status
Resolve or formally assess relevant OOS, damage, temperature or supplier investigations before use.
QC / QAAssess against material, site and operation; justify every N/A
Gate blocker
Investigation impact assessment and disposition
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
STO-01Storage and inventory protectionG3 · Store and protect
Specified conditions
Use material-specific approved limits; do not assume one ambient limit applies to every material.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Storage specification and labelled conditions
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
STO-02Storage and inventory protectionG3 · Store and protect
Mapped storage locations
Use qualified/mapped areas and justified monitoring positions; assess seasonal and layout changes.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Mapping report and approved location plan
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
STO-03Storage and inventory protectionG3 · Store and protect
Monitoring and response
Use suitable calibrated monitoring with alarms or justified review frequency and accountable response.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Monitoring review and calibration records
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
STO-04Storage and inventory protectionG3 · Store and protect
Power failure response
Define alternate storage, transfer limits, backup power and escalation; test arrangements periodically.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Contingency plan and exercise/maintenance evidence
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
STO-05Storage and inventory protectionG3 · Store and protect
Segregation and access
Secure rejected, returned, recalled, hazardous and sensitive stock; enforce equivalent electronic segregation where used.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Location/status verification and access challenge
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
STO-06Storage and inventory protectionG3 · Store and protect
FEFO and reservations
Issue the earliest suitable expiry first while respecting release, retest, market and reservation constraints.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Pick list and justified FEFO exceptions
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
STO-07Storage and inventory protectionG3 · Store and protect
Cleanliness and pest prevention
Protect containers from water, dust and pests, maintain inspection access and investigate adverse trends.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Cleaning, pest and housekeeping records
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
STO-08Storage and inventory protectionG3 · Store and protect
Printed-component security
Restrict access and separate product, strength, market and artwork versions; block obsolete stock.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Artwork/version inventory and access record
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
DSP-01Dispensing and controlled issueG4 · Dispense and issue
Authorized batch requirement
Match current formula, batch size, material code and destination batch before picking.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Approved batch instruction and issue request
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
DSP-02Dispensing and controlled issueG4 · Dispense and issue
Current usable status
Verify release, remaining validity and any restrictions at the time of dispensing—not only when reserved.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Contemporaneous lot/status check
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
DSP-03Dispensing and controlled issueG4 · Dispense and issue
Line clearance
Remove prior materials, labels and records; verify clean area, booth, utensils and staging containers.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Executed clearance and cleaning status
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
DSP-04Dispensing and controlled issueG4 · Dispense and issue
Balance suitability
Confirm capacity, minimum usable weight, calibration and required pre-use checks for intended quantity.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Balance suitability and check record
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
DSP-05Dispensing and controlled issueG4 · Dispense and issue
Verified weights and calculations
Record gross, tare and net as applicable; independently check identity and quantity under the approved procedure.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Weighing printout and verification record
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
DSP-06Dispensing and controlled issueG4 · Dispense and issue
Container labelling
Identify material, source lot, quantity, destination batch and relevant conditions on every dispensed container.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Dispensing labels and container reconciliation
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
DSP-07Dispensing and controlled issueG4 · Dispense and issue
Exposure and hold limits
Control time out of storage, open-container exposure and staged hold time with justified limits.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Time records and approved hold/exposure limits
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
DSP-08Dispensing and controlled issueG4 · Dispense and issue
Production handover
Check container count, integrity and identity at transfer; retain linkage through addition to the batch.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Issue/receipt signatures and batch traceability
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
RECX-01Reconciliation and dispositionG5 · Reconcile and disposition
Quantity reconciliation
Reconcile opening, receipts, issues, returns, samples, destruction and closing stock using consistent units.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Lot-level reconciliation and count record
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
RECX-02Reconciliation and dispositionG5 · Reconcile and disposition
Discrepancy investigation
Hold affected stock when identity or quantity is uncertain; do not conceal differences through stock adjustments.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Deviation and authorized inventory adjustment
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
RECX-03Reconciliation and dispositionG5 · Reconcile and disposition
Return integrity
Re-establish identity, condition, exposure and custody before Quality-authorized return to usable inventory.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Return assessment and status decision
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
RECX-04Reconciliation and dispositionG5 · Reconcile and disposition
Rejected/expired disposal
Secure unusable stock pending authorized return or destruction; prevent re-entry into supply.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Disposition approval and destruction/return evidence
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
RECX-05Reconciliation and dispositionG5 · Reconcile and disposition
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Packaging reconciliation and destruction record
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
RECX-06Reconciliation and dispositionG5 · Reconcile and disposition
Traceability challenge
Demonstrate which finished batches used a selected material lot and locate remaining stock.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Traceability exercise and completeness check
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
RECX-07Reconciliation and dispositionG5 · Reconcile and disposition
Record integrity
Retain original observations, corrections and electronic history; prohibit retrospective reconstruction as original data.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Gate blocker
Reviewed records, access and audit-trail evidence
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
RECX-08Reconciliation and dispositionG5 · Reconcile and disposition
Recurring-risk review
Trend discrepancies, excursions, supplier defects and overdue quarantine; assign actions and effectiveness checks.
Warehouse / QA / responsible functionAssess against material, site and operation; justify every N/A
Major
Review minutes, CAPA owners and follow-up evidence
WHO GMP TRS 986 Annex 2; applicable national GMP; see guide references
Decision rule: an unresolved gate blocker normally prevents progression. If an authorized exception is permitted by the pharmaceutical quality system, record the risk, interim control, decision authority, expiry and closure condition. “Not applicable” also requires justification.