Materials & Lots
Know exactly what material is on site, what state it is in, and whether the quality unit has released it — so that nothing unreleased, expired or rejected can be dispensed into a batch.
Standards: ICH Q7 §6.3, §7.1–7.5; 21 CFR 211.84, 211.142; Schedule M Part I
What it includes (7 capabilities)
- Material master: raw, packaging, intermediate, finished product
- Shelf life, retest period, storage conditions and specification link
- Hazard, allergen, sensitiser and controlled-substance attributes
- Goods receipt against a supplier with COA capture
- Lot register with quarantine, released, rejected, on-hold and consumed states
- Quality-unit release or rejection of every received lot
- FEFO issue and lot balance tracking
Batch Manufacturing Records
Produce a complete, contemporaneous, attributable record of how one batch was actually made — the materials and lots consumed, the equipment used, who performed and who checked each critical step, every in-process result against its limit, and the quality unit's release decision.
Standards: ICH Q7 §6.4–6.7, §8; 21 CFR 211.186, 211.188, 211.192; 21 CFR Part 11; Schedule M Part I
What it includes (10 capabilities)
- Master Batch Record with revisions, approval and immutability once effective
- Bill of materials with overage and critical-dispensing flags
- Process steps with equipment, durations and line clearance
- In-process controls with enforced numeric limits
- Batch execution against the pinned MBR revision
- Material dispensing with lot genealogy and second-person verification
- In-process results judged against the limit in force at the time
- Yield reconciliation against the approved range
- Quality-unit batch record review and release, with electronic signature
- Printable batch manufacturing record and genealogy trace
Daily Production Checks
Record the routine, per-shift readiness check a supervisor runs before and during a run — is the line clear, is the equipment right and clean, are the safety controls in place — as a daily register that sits between the batch record it supports and the safety modules it draws on, so a shift cannot claim to be safe to proceed when a safety-critical check has failed.
Standards: ICH Q7 §6.5, §9.4; 21 CFR 211.67(b), 211.130; Schedule M Part I; ISO 45001 §8.1
What it includes (8 capabilities)
- One check per line per shift per day, enforced by a unique register key
- Standard line-readiness checklist pre-seeded: line clearance, equipment, area, safety, materials, documentation
- Each item recorded pass, fail or not applicable, with safety-critical and mandatory flags
- Linked to the batch (EBMR) being run and the instruction it was run against
- Linked to the permit to work authorising the shift's non-routine job
- Recorded "safe to proceed" decision derived from the items, not the form
- Supervisor submission and independent second-person verification (segregated)
- One-click escalation of a failed safety check into a linked OH&S incident
Deviations
Capture every departure from the approved instruction as a record in its own right, assess its impact on the batch it affected, and stop that batch being released until the deviation is closed.
Standards: ICH Q7 §2.16–2.18, §6.7; 21 CFR 211.192; Schedule M Part I
What it includes (6 capabilities)
- Planned and unplanned deviations raised against a batch, step or lot
- Immediate action and containment
- Quality-unit impact assessment on the affected batch
- Batch hold and release, exercisable independently of the deviation
- Disposition with justification
- Escalation into the existing RCA and CAPA engine
Recall & Traceability
Find every affected lot and every consignee holding it within the time a scheme or a regulator expects, prove recovery against a target, and rehearse the whole thing with a timed mock recall.
Standards: ICH Q7 §10.2, §15; 21 CFR 117.139; Codex CXC 1-1969 §7; FSSAI (Food Recall) Regulations 2017; ISO 22000 §8.9.5
What it includes (7 capabilities)
- Despatch register: which lot went to which consignee, and when
- Recall, market withdrawal and mock recall exercises in one record
- Affected lots resolved automatically by walking the genealogy chain
- Measured traceability time — the number a GFSI auditor asks for
- Consignee notification list built from despatch records, with responses
- Recovery reconciliation against a stated effectiveness target
- Regulator and public-notification tracking
Returned & Salvaged Product
Decide what happens to drug product coming back from the market with the same rigour applied to what leaves the site — held on arrival, examined against identity/strength/quality/purity, and only then returned to stock, reprocessed, salvaged or destroyed.
Standards: 21 CFR 211.204, 211.208
What it includes (5 capabilities)
- Inbound returns held, examined and dispositioned
- Return to stock refused unless examination confirms the product meets standards
- Reprocess, salvage and destroy dispositions
- Salvage requires an additional testing plan before it is final
- Closure with an optional Finding for a systemic pattern
Sanitation & Pest Control
Maintain the written sanitation programme 211.56 requires as a real register with a real clock, rather than an assumption that the plant is generally kept clean.
Standards: 21 CFR 211.56
What it includes (3 capabilities)
- Cleaning and pest-control schedules by location, method and frequency
- Dated execution history against each schedule
- Overdue schedules surfaced automatically from the execution clock