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Controls and validation

Company controls, mapped to the regulations they satisfy.

Every assessment is graded against the company's own controls, and every control is tied to the regulations it exists to meet. Where a regulation has no control, that is shown as a gap, not hidden.

2 regulations have no company control mapped: EU GMP Annex 22 Artificial Intelligence (draft); EU GMP Annex 16 Certification by a Qualified Person and Batch Release.

Regulation coverage

Regulation or guideline	Company controls that satisfy it	Live assessments	Need a person
ICH Q9(R1) Quality Risk Management ICH	SOP-QC-021 Environmental Monitoring §5 SOP-PUR-006 Supplier Qualification §5 SOP-DIST-002 Cold Chain Distribution §5 VMP-001 Validation Master Plan §5 SOP-MFG-031 Aseptic Filling §5	6	5
ICH Q10 Pharmaceutical Quality System ICH	SOP-QA-007 Deviation Management §3.2 SOP-QA-012 Corrective and Preventive Action (CAPA) §3.2.2 SOP-QA-015 Change Control §3.2.4	4	2
ICH Q1A(R2) Stability Testing ICH	SOP-QC-009 Stability Program §2.2	1	0
21 CFR Part 211 Current Good Manufacturing Practice FDA	SOP-QA-012 Corrective and Preventive Action (CAPA) §211.192 SOP-QA-001 Document Control §211.100 SOP-MFG-014 Batch Record Review §211.188 SOP-QC-003 Laboratory Testing §211.194 SOP-QC-009 Stability Program §211.166 SOP-HR-004 GMP Training §211.25 SOP-PKG-005 Labelling Reconciliation §211.125	8	2
21 CFR Part 11 Electronic Records and Signatures FDA	SOP-QA-030 Data Integrity §11.10	1	1
EU GMP Chapter 1 Pharmaceutical Quality System EMA / EC	SOP-QA-007 Deviation Management §1.4 SOP-QA-015 Change Control §1.8	3	2
EU GMP Chapter 2 Personnel EMA / EC	SOP-HR-004 GMP Training §2.12	2	0
EU GMP Chapter 4 Documentation EMA / EC	SOP-QA-001 Document Control §4.1 SOP-MFG-014 Batch Record Review §4.20	2	1
EU GMP Chapter 5 Production EMA / EC	SOP-PKG-005 Labelling Reconciliation §5.61	1	1
EU GMP Chapter 6 Quality Control EMA / EC	SOP-QC-003 Laboratory Testing §6.15	1	0
EU GMP Chapter 7 Outsourced Activities and Suppliers EMA / EC	SOP-PUR-006 Supplier Qualification §7.5	1	1
EU GMP Annex 1 Sterile Medicinal Products EMA / EC	SOP-QC-021 Environmental Monitoring §9 SOP-MFG-031 Aseptic Filling §8	2	1
EU GMP Annex 11 Computerised Systems EMA / EC	SOP-QA-030 Data Integrity §7	1	1
EU GMP Annex 15 Qualification and Validation EMA / EC	VMP-001 Validation Master Plan §4	1	1
EU GDP Chapter 9 Transportation EMA / EC	SOP-DIST-002 Cold Chain Distribution §9.2	2	2
EU GMP Annex 22 Artificial Intelligence (draft) EMA / EC	Gap: no control mapped	0	0
EU GMP Annex 16 Certification by a Qualified Person and Batch Release EMA / EC	Gap: no control mapped	0	0

Qualification status: IQ, OQ and PQ

Equipment and systems are qualified in three stages: installation (IQ), operational (OQ) and performance (PQ). Where an assessment bears on a stage, it is linked, so a deviation found in the AI's review shows up against the equipment it affects.

Equipment or system	IQ	OQ	PQ
Autoclave A-12 Equipment · Manufacturing	Complete, deviation Executed; one probe calibration certificate was out of date ASM-0010 Needs review	Planned Starts once the IQ deviation is dispositioned	Not started After OQ
Purified water system PW-03 Utility · Manufacturing	Complete Approved 2026-01	Complete Approved 2026-03	Complete Three-phase sampling
Filling line FL-01 Equipment · Manufacturing	Complete Approved 2025-11	Complete Approved 2026-02	In progress Fill-weight trend under watch
Cold storage room 3 Equipment · Distribution	Complete Approved 2025-06	Complete Approved 2025-08	Complete Temperature excursion under review ASM-0001 Needs review
Chromatography data system CDS-02 Computerised system · Quality System	Complete Approved 2026-04	In progress Audit-trail and access-control tests running	Not started After OQ