What we build, and what it is built against
Six areas of work, scoped to the situation in front of them — a single audit response, a Revised Schedule M transition, a new block taken from drawing to qualification, or continuing quality oversight.
Plant layout, projects & regulatory approvals
A layout decides how much compliance will cost for the next twenty years. Rooms in the wrong sequence, a corridor doing two jobs, or a utility routed through a clean area cannot be corrected later by procedure — they are paid for in every batch, every deviation and every inspection that follows. We design layouts against the regulation that will judge them, for new facilities and for plants being reworked inside walls that already exist.
- Greenfield plant, block and production line layout design
- Brownfield restructuring within an existing building envelope
- Man, material, waste and personnel flow design
- Area classification, pressure cascade and airlock strategy
- Segregation, containment and cross-contamination control
- Utility routing and capacity planning — HVAC, water, gases
- Drawings and submission support for FDCA layout approval
- Project risk assessment and mitigation planning
- Equipment selection, user requirements and vendor evaluation
- Installation, commissioning and qualification coordination
- Technology transfer between sites and to contract manufacturers
- New-product project coordination for regulated markets
Total quality management system
A quality system is not a shelf of files. It is a small number of apex documents stating what the organisation stands for, and a set of working procedures that make those statements true every day. We build both — beginning with the Quality Policy, Quality Manual, Site Master File and Validation Master Plan, then the operating elements beneath them, then the SOP architecture and the training that puts it into the hands of the people who run the plant.
- Apex documents — Quality Policy, Quality Manual, Site Master File, Validation Master Plan
- Change control and change management
- Deviation and incident management
- OOS and OOT investigation with structured root cause analysis
- CAPA management and effectiveness verification
- Market complaint, product return and recall procedure
- Quality risk management and site risk registers (ICH Q9)
- Self-inspection and internal audit programme
- Product Quality Review / APQR and management review
- Vendor qualification and approved vendor management
- Batch record review, release and retained sample control
- SOP architecture — hierarchy, drafting, roll-out and revision
- Training and competency development, delivered on the floor
- Data integrity governance (ALCOA+) and audit trail review
Qualification & validation
Most sites are found wanting here not because the work was never done, but because the file does not prove it. We take the lifecycle from user requirement to periodic review, writing protocols that can be executed by the people who have to execute them, and reports that stand on their own when an inspector reads them three years later.
- URS, DQ, FAT, SAT, IQ, OQ and PQ across the equipment lifecycle
- Facility and cleanroom qualification
- Utility qualification — HVAC, purified water, WFI, pure steam, compressed gases
- Process validation and continued process verification
- Cleaning validation, MACO rationale, recovery and hold-time studies
- Analytical method validation, verification and transfer
- Stability programme design, protocols, chambers and trend evaluation
- Computerised system validation and electronic record controls
- Environmental monitoring programme and qualification of clean areas
- Media fill / aseptic process simulation for sterile operations
- Re-qualification, periodic review and validation status maintenance
- Validation Master Plan ownership and schedule governance
GMP documentation — the complete library
An inspector does not assess intention; he reads documents. The documentation below is what we develop, restructure or independently review — written to be consistent with one another, so that a single set satisfies the State licensing authority, a WHO or EU inspector and an export customer, rather than three parallel sets being maintained by a team that has no time to maintain even one.
Audit, compliance & regulatory support
Audit readiness is a condition, not a project undertaken three weeks before a visit. The objective is a site where the answer to an inspector’s question is already on the shelf, and where the people who must speak to it have done so before.
- Pre-audit gap assessment against the applicable standard
- Mock inspection with front-room and back-room discipline
- Preparation and rehearsal of subject-matter experts
- Document and data readiness review ahead of inspection
- Observation response drafting, CAPA and closure to the agency
- Hosting of regulatory, customer and third-party audits
- Vendor qualification audits and supplier assessment
- Contract manufacturer and loan-licence site audits
- Technical and quality agreements with contract sites
- Oversight of outsourced product quality and release
- Quality inputs for CTD Module 3 and dossier submission
- Support for WHO-GMP, COPP and market registration needs
Performance, MIS & digital systems
Most plants discover their condition only after something has gone wrong. Defined indicators, honestly reported, turn quality from an argument into a measurement — and give management a view of the plant while there is still time to influence it.
- Quality indicator definition, baselines and review cadence
- Deviation, OOS, complaint and recall trend analysis
- Batch right-first-time, rejection and rework monitoring
- CAPA ageing and effectiveness tracking
- Training compliance and competency measurement
- Management information system for plant-health reporting
- Dashboards for management and board-level review
- Electronic QMS selection, roll-out and migration from manual systems
- Computerised system validation of implemented software
- Customised software developed for organisation-specific needs
- Process improvement and productivity initiatives
- Automation and digital transformation of routine documentation
Tell us what is due, and by when.
Most engagements begin with one of four situations: an inspection is scheduled, an observation has landed, a new line or block is being built, or the standard has moved and the current system no longer meets it. Say which one applies and you will get a direct answer on scope, sequence and effort.