ICH Q7 clause 10: Storage and distribution
The 7 audit questions covering clause 10, each with the objective evidence to request, the nonconformities most often raised against it and what to sample. Part of the free ICH Q7 API GMP audit checklist, which holds 350 items across 18 clauses.
All 7 questions for clause 10
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§10 Storage and distribution
10.10 Are storage facilities suitable to maintain API quality (controlled conditions, security)?
- Storage facility specifications
- Environmental monitoring records
- Access control records
- Security system documentation
- Storage area layout
- Pest control program
- Storage capacity vs inventory
- Facility maintenance records
- Storage conditions not matching material requirements
- Environmental monitoring absent or unreliable
- Security inadequate
- Pest control gaps
- Overcrowded storage making rotation difficult
- Warehouse alarm limits not defined for temperature and humidity excursions
Storage facilities protect the API from degradation and loss. Requirements include: controlled environment matching label conditions (typically ambient for most APIs, refrigerated or frozen for sensitive materials), physical security (locks, access control, surveillance), adequate space for orderly placement, segregation of different status materials, pest control. Monitoring demonstrates ongoing compliance.
10.11 Are materials identified by status and segregated to prevent mix-ups in storage?
- Segregation areas for each status
- Status labeling on stored materials
- ERP-based status control
- Status change authorization
- Audit trail of status changes
- Physical barriers where appropriate
- Status identification SOPs
- Periodic segregation audits
- Mixed-status materials in same location
- Released and rejected materials adjacent
- No clear status labeling
- Electronic status bypassed during warehouse operations
- Returned materials co-located with fresh stock
- Recalled material not physically isolated from approved inventory
Materials in different statuses must be segregated to prevent mix-ups. Physical segregation (separate areas, rooms, or zones) is preferred. Electronic systems with effective access controls may substitute. Status categories include: quarantine (pending release), released (approved for use), rejected (awaiting disposition), returned (from customer, under investigation), recalled (pulled from market). Each requires clear labeling and access control.
10.20 Is quality-unit release obtained before any API is distributed?
- QU release procedures
- Release certificates or records
- Release authorization workflow
- Contract manufacturer release procedures
- Physical or electronic release hold
- Released material inventory
- Release vs distribution audit trail
- QA release training
- Materials distributed before QU release
- Release based on production approval rather than QA
- No release documentation
- Contract manufacturers shipping without release
- Released materials commingled with unreleased
- Batch record review incomplete at time of distribution authorization
The QU release gate is the absolute requirement before distribution. Release occurs after batch record review, testing completion, and deviation resolution. Materials not yet released should be physically or electronically prevented from distribution. Contract manufacturers must hold released materials appropriately until pickup or shipment per quality agreement provisions.
10.21 Are special storage or transport conditions identified on the label or shipping documents?
- Transport condition labels
- Cold chain qualification records
- Transport provider qualifications
- Shipping document requirements
- Transport validation for sensitive materials
- Temperature monitoring during shipment
- Transport incident investigation records
- Shipping SOPs
- Transport conditions not on labels
- Provider not qualified for material type
- No temperature monitoring for cold chain
- Shipping documents lacking conditions
- Transport incidents not investigated
- Special handling instructions not communicated to freight forwarders
Transport can expose materials to temperature extremes, humidity, vibration, and delays. Materials requiring special conditions (cold chain, protection from light, orientation constraints) must have clear labels communicating these requirements. Transport providers must be qualified for the transport requirements. Shipping documents should reinforce the requirements.
10.22 Are special transport conditions (e.g., cold chain) contractually specified and controlled?
- Transport contracts with special conditions
- Temperature loggers in shipments
- Shipment monitoring data review
- Excursion investigation records
- Transport qualification for special conditions
- Provider performance tracking
- Excursion impact assessments
- Transport SOP for special conditions
- Special conditions not in contracts
- No monitoring for cold chain shipments
- Excursions not investigated
- Transport providers not qualified for special needs
- No receiver verification of conditions
- Calibration records missing for temperature data loggers used during shipment monitoring
Special transport requirements (refrigerated, frozen, temperature range, humidity control, orientation, vibration limits) must be contractually specified with transport providers. Monitoring during transport (temperature loggers, data loggers) provides evidence of compliance. Excursions trigger investigation similar to storage excursions, with potential impact on the shipped material.
10.23 Is the distribution system designed and controlled so it does not adversely affect API quality?
- Distribution system documentation
- Distribution quality risk assessment
- Distribution issue log
- Distribution incident investigations
- CAPA from distribution issues
- Distribution KPIs and metrics
- Customer complaint correlation with distribution
- Distribution qualification where applicable
- Distribution issues not tracked
- No investigation of recurring problems
- Quality impact assessment missing for distribution incidents
- No metrics on distribution performance
- Customer complaints not correlated with distribution
- No FIFO or FEFO rotation enforced — expired or oldest stock bypassed in favor of newer inventory
Distribution is an extension of manufacturing quality. The distribution system includes: warehouse storage (covered by 10.1), transport (10.21-10.22), intermediate handling points, and customer receipt. Quality issues at any point can compromise the product. Investigation of distribution problems (temperature excursions, damage, delays, losses) with CAPA prevents recurrence.
10.24 Do distribution records enable rapid identification of every customer who received a batch (recall capability)?
- Distribution records by batch
- Customer lists for each batch
- Distribution record retention per record retention SOP
- Recall capability demonstration (mock recalls)
- Distribution record retrieval time metrics
- ERP-based distribution tracking
- Customer master list maintenance
- Distribution record accuracy audits
- Distribution records incomplete or lost
- Unable to identify all customers of a specific batch
- Slow retrieval times for recall scenarios
- Customer data not maintained
- No recall capability testing
- Carrier information and special transport conditions not recorded in distribution records
Distribution records are recall capability infrastructure. Required content: every customer receiving any portion of a batch, quantities, dates, shipping details. Records must be readily retrievable — typically within hours for emergency recalls. For each batch, reverse traceability must be possible: 'Who received batch X and how much did each customer get?' Electronic systems greatly facilitate this.
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