Product and process
Dosage forms, formulations, potency, sensitization, microbial risk, batch sizes, process steps, yields, hold times and cleaning strategy.
Factory development guide · Africa and India
Facility, Utilities and Equipment Planning Guide
Turn the product and process strategy into premises, critical utilities and equipment that can be operated, cleaned, maintained, qualified and expanded without losing GMP control.
The central rule
Design from the process outward.
A pharmaceutical factory is not a conventional building filled with machines. It is a controlled process environment. Product risks, operating steps, flows, cleaning, data and maintenance must shape the rooms, utilities and equipment.
Current PIC/S PE 009-18 requires premises and equipment to suit their operations, minimize errors, and permit effective cleaning and maintenance. WHO guidance then provides more detailed lifecycle expectations for HVAC, water, validation and—where relevant—sterile manufacture. In India, the revised Schedule M is now the applicable design baseline; the eligible extension period ended on 31 December 2025.
Design input
Freeze six foundations before drawing rooms.
Each foundation should be written, reviewed and version-controlled. Unresolved assumptions become construction changes later.
Market and regulation
National licence, target export markets, procurement expectations, pharmacopoeial commitments, inspection pathway and planned future approvals.
Capacity and campaigns
Demand ranges, practical operating days, shifts, campaign lengths, changeovers, planned maintenance, rejects, growth and outsourcing assumptions.
Containment and segregation
Health-based exposure limits where applicable, dust and aerosol generation, product-contact risks, personnel protection and waste pathways.
Quality and data
Critical quality attributes, critical process parameters, sampling, monitoring, alarms, records, audit trails and release decisions.
Resilience and lifecycle
Power and water reliability, climate, vendor support, spares, maintainability, expansion, obsolescence and business-continuity requirements.
Integrated planning sequence
Move from design basis to qualified operation through eight controlled decisions.
Overlap work where it is efficient, but do not bypass the evidence needed to authorize the next capital commitment.
Step01
Write the design basis
What products, processes, capacities, markets and risks must the site support?
Controlled outputs
- Approved product and dosage-form scope
- Process maps and provisional batch sizes
- Containment and segregation assessment
- Demand, shift and campaign assumptions
- Applicable GMP and licensing basis
- Expansion and business-continuity philosophy
Decision evidence
Management, Quality, operations, engineering and regulatory teams approve one controlled basis before layouts or purchase specifications are frozen.
Step02
Map every flow
Can people, materials, samples, equipment, waste and records move without avoidable mix-up or contamination risk?
Controlled outputs
- Personnel and gowning flows
- Raw, packaging and finished-material routes
- Rejected, returned and recalled material routes
- Sampling and laboratory sample routes
- Movable-equipment and maintenance access
- Waste, laundry and cleaning-material routes
Decision evidence
The concept layout prevents uncontrolled crossing, backtracking and status ambiguity while remaining workable during routine operations.
Step03
Zone the facility
Which operations may share space or air systems, and which require physical or functional separation?
Controlled outputs
- Cleanliness and environmental zones
- Pressure and airflow philosophy
- Airlocks, pass boxes and transition points
- Dust-control and containment strategy
- Warehouse status and temperature zones
- Technical, service and maintenance corridors
Decision evidence
Zoning decisions are justified by product, process and patient risk—not copied from a generic room-classification drawing.
Step04
Create room data sheets
Does every room have a complete, coordinated set of process and engineering requirements?
Controlled outputs
- Room purpose, occupancy and activities
- Equipment envelopes and service clearances
- Finishes, cleaning and drainage requirements
- HVAC and environmental set points
- Utility outlets, loads and monitoring points
- Safety, access, data and communication needs
Decision evidence
Architectural, mechanical, electrical, process, automation and GMP requirements reconcile to one approved room-level record.
Step05
Build the utility balance
Can each utility meet peak demand, quality, pressure, temperature and recovery needs under realistic conditions?
Controlled outputs
- Connected and diversified loads
- Peak, average and future demand
- Quality specification at point of use
- Distribution, return and drainage design
- Alarm, monitoring and data requirements
- Redundancy, storage and failure response
Decision evidence
Utilities are sized from process demand and simultaneous-use scenarios, with critical failures and seasonal extremes tested on paper.
Step06
Specify equipment by intended use
Does the URS define what the equipment must achieve and demonstrate—not merely a preferred vendor model?
Controlled outputs
- Process performance and capacity ranges
- Product-contact materials and cleanability
- Containment, safety and ergonomics
- Controls, recipes, data and audit trails
- Utility, space and environmental interfaces
- Documentation, spares and service expectations
Decision evidence
Critical requirements are measurable, testable and traceable through design review, acceptance testing and qualification.
Step07
Integrate and construct
Are design changes, interfaces, installation quality and turnover records controlled as one project?
Controlled outputs
- Coordinated drawings and clash review
- Design qualification and risk register
- Construction quality and inspection plans
- Vendor FAT and site SAT plans
- Commissioning and turnover packages
- As-built, configuration and change records
Decision evidence
Installed assets match approved requirements and drawings, and discrepancies are resolved before formal qualification is used to discover basic construction defects.
Step08
Qualify and sustain
Can evidence demonstrate fitness for intended use and continued control throughout the asset lifecycle?
Controlled outputs
- IQ, OQ and PQ protocols and reports
- Traceability to requirements and risks
- Calibration and preventive maintenance
- SOPs, cleaning and operator training
- Monitoring, trending and periodic review
- Change control, requalification and retirement
Decision evidence
Quality releases each system for use only when evidence, deviations, training, maintenance and operating controls are complete and defensible.
Room data sheets
Make every room an auditable set of requirements.
A controlled room data sheet should connect process, architectural, mechanical, electrical, automation, cleaning and GMP needs before detailed design is approved.
Function
Process steps, materials, maximum occupancy, open or closed product exposure, cleaning method and operating sequence.
Space
Equipment footprint, charging and discharge, doors and hatches, operator movement, service clearances, maintenance removal path and future allowance.
Environment
Temperature, relative humidity, pressure relationship, airflow direction, filtration, recovery, dust extraction and monitoring locations.
Surfaces
Floors, walls, ceilings, coving, doors, glazing, penetrations, load capacity, chemical resistance, cleanability and drainage.
Services
Power, earthing, UPS, water grades, steam, gases, vacuum, compressed air, data, lighting, fire detection and emergency utilities.
Control
Access level, interlocks, alarms, BMS or EMS points, local displays, data retention, calibration, logbooks and room-status indication.
Critical utility planning matrix
Specify quality at the point of use—and capacity at the worst credible demand.
Utility qualification cannot rescue an unclear design. Define the intended use, required quality, operating range, monitoring and failure response before sizing generation and distribution.
| System | Design objective | Minimum planning evidence | Common trap |
|---|---|---|---|
| HVAC and dust control | Temperature, humidity, pressure, cleanliness, containment and occupant comfort appropriate to process risk. | Air quantity and quality, filtration, air-change and recovery performance, pressure relationships, alarms and seasonal load. | Shared returns spreading dust; inaccessible filters; no source extraction; cooling sized without latent load or future heat gains. |
| Water for pharmaceutical use | The correct water quality for formulation, cleaning, laboratory and other intended uses. | Feed variability, treatment, generation, storage, circulation, sanitization, sampling, online instruments and microbiological control. | Oversized stagnant loops; dead legs; poor drainability; no peak-demand analysis; sampling points that do not represent use. |
| Compressed air and gases | Reliable pressure, flow and quality at the actual point of use, especially where contact with product or critical surfaces occurs. | Oil, water, particles and—where risk requires—microbial quality; dryer, filtration, materials, condensate management and monitoring. | Testing only at the compressor; long wet branches; unidentified use points; no quality specification linked to product risk. |
| Steam and thermal systems | Process heat or clean steam of the defined quality, pressure and capacity for each application. | Boiler treatment, steam quality, traps, condensate, insulation, clean-steam generation, peak loads and safe shutdown. | Using plant steam for an application that needs clean steam; poorly drained lines; simultaneous loads not considered. |
| Electrical power | Safe, stable and sufficient power for production, laboratories, storage and critical environmental control. | Demand and diversity, starting current, harmonics, power quality, earthing, UPS, generator capacity, fuel endurance and load shedding. | A generator sized only by connected kW; critical loads undefined; no restart sequence; sensitive instruments exposed to poor power quality. |
| Vacuum and process gases | Capacity and quality appropriate to the process, with safe distribution and contamination protection. | Worst-case simultaneous demand, receiver size, backflow protection, filtration, leak testing, alarms and cylinder or bulk-gas safety. | Cross-connections; no reserve supply; inadequate ventilation; product ingress into common systems. |
| Drainage and effluent | Hygienic removal, segregation and treatment of liquid waste without backflow or contamination pathways. | Drain necessity, air breaks, traps, slopes, cleanability, process chemistry, hazardous streams, antimicrobial residues and treatment capacity. | Unnecessary drains in clean areas; open channels; reverse flow; incompatible streams combined; effluent obligations considered late. |
| BMS, EMS and monitoring | Timely, reliable evidence that critical facility and utility conditions remain controlled. | Critical parameters, sensor location, alarm limits, delay logic, audit trails, user access, backup, review and calibration. | Every available point treated as critical; nuisance alarms; sensors placed for convenience; data collected but not reviewed. |
Equipment user requirements
Choose equipment for controlled performance over its full lifecycle.
The URS should state what must be achieved and verified. A catalogue specification or copied URS usually misses the product, facility, cleaning, data and service interfaces that determine success.
Process capability
Operating range, accuracy, uniformity, endpoint control, scale-up basis and ability to meet product quality requirements.
Capacity fit
Minimum and maximum batch, campaign output, cycle time, changeover, yield, bottleneck impact and credible utilization.
Cleanability
Access, surface finish, seals, joints, drainability, dismantling, cleaning method, residue limits and inspection.
Containment
Closed transfer, local extraction, pressure control, dust capture, operator exposure and safe maintenance.
Materials
Product-contact construction, elastomers, lubricants, corrosion resistance, certificates and compatibility.
Controls and data
Recipes, access roles, audit trails, electronic records, interfaces, backup, time synchronization and cybersecurity.
Facility interface
Footprint, floor loading, headroom, access, utilities, exhaust, heat rejection, noise and maintenance withdrawal.
Lifecycle support
Manuals, drawings, software, training, critical spares, local service, warranty, obsolescence and lead times.
Testability
Measurable acceptance criteria that can be challenged during design review, FAT, SAT and qualification.
Evidence chain
Keep one traceable equipment lifecycle.
Requirements, risks, tests, deviations and operating controls should tell one consistent story from the first URS through routine use and retirement.
URS
State intended use, critical requirements, interfaces, data needs and acceptance criteria.
Risk + DQ
Challenge the proposed design against product, process, patient, operator and data risks.
Vendor selection
Compare technical compliance, lifecycle support, delivery risk and total cost—not purchase price alone.
FAT
Test critical functions, controls, alarms, documentation and known failure modes before shipment.
SAT + commissioning
Confirm installation condition, interfaces, utilities, safety and functional operation at site.
IQ/OQ/PQ
Establish installation, operating range and performance with traceability to requirements and risks.
Routine control
Operate through approved procedures, trained personnel, calibration, maintenance, cleaning and monitoring.
Change + retirement
Assess modifications, software, relocation and obsolescence; preserve data and controlled decommissioning evidence.
Dosage-form implications
The product family changes the factory.
This table is an early planning screen, not a complete design specification. Product-specific science and the competent authority determine the final controls.
| Product family | Typical process chain | Facility, utility and equipment focus |
|---|---|---|
| Non-sterile oral solids | Dispensing, granulation or direct compression, drying, blending, compression or encapsulation, coating and primary packaging. | Dust extraction, humidity where product/process requires it, contained transfer, cleaning access, tooling/change parts and metal detection. |
| Non-sterile liquids | Water preparation, charging, mixing, heating/cooling, bulk holding, transfer, filling, capping and cleaning. | Water-system capacity, microbial control, tank and pipe drainability, protected vents, transfer design, temperature and hold-time control. |
| Creams and ointments | Phase preparation, melting, emulsification, homogenization, vacuum, cooling, bulk holding and filling. | Jacket services, temperature profile, shear, deaeration, vessel geometry, cleanability, transfer losses and controlled bulk hold. |
| Highly sensitizing or potent products | Product-specific manufacture governed by applicable law and a formal cross-contamination and occupational-exposure assessment. | Dedicated or self-contained facilities where required, safe-change areas, contained charging, decontamination, waste and maintenance strategy. |
| Sterile products | Preparation, sterilization, aseptic processing or terminal sterilization, filling, inspection and controlled transfer. | Contamination Control Strategy, cleanroom and barrier design, sterilization, WFI/clean steam, environmental monitoring and Annex 1/WHO sterile GMP expertise. |
| Packaging operations | Primary and secondary packaging, coding, serialization where applicable, inspection, reconciliation and finished-goods transfer. | Line clearance, mix-up prevention, vision and coding controls, temperature-sensitive materials, reject handling and rapid changeover. |
Capacity logic
Size the production system—not individual machines.
A practical capacity model connects demand, batch size, complete cycle time, campaigns, bottlenecks, utilities, laboratories, maintenance and working capital.
Use practical time
Start with scheduled operating days and shifts, then deduct sanitation, setup, changeover, planned maintenance, breaks and realistic downtime.
Calculate the full cycle
Include staging, charging, processing, in-process testing, discharge, cleaning, drying, line clearance and release dependencies—not machine run time alone.
Find the bottleneck
Balance upstream, downstream, packaging, laboratory and utility capacity. The slowest constrained step defines practical throughput.
Test multiple products
Model worst-case batch size, longest cleaning, campaign mix, common equipment, seasonal demand and concurrent utility peaks.
Preserve operating range
Avoid equipment that meets the maximum forecast but cannot reliably process the smaller launch or low-dose batches.
Plan expansion deliberately
Reserve defined floor, utility, electrical, automation and material-flow capacity without creating oversized, hard-to-control systems today.
Capital and quality gates
Release the next project stage only against defined evidence.
| Gate | Evidence package | Decision rule |
|---|---|---|
| Concept freeze | Design basis, process maps, flows, zoning, room list, utility strategy, capacity model, site risks and expansion concept. | Proceed only when cross-functional reviewers agree that the concept can support the intended products and markets. |
| Basic design freeze | Approved layouts, room data sheets, equipment list, utility balances, control philosophy, EHS basis and preliminary qualification strategy. | Do not authorize major procurement while interfaces, loads or segregation decisions remain undefined. |
| Procurement release | Approved URSs, risk assessment, technical bid comparison, lifecycle support, vendor deliverables, FAT plan and commercial boundaries. | Record deviations from requirements and approve their impact before placing the order. |
| Mechanical completion | Construction checks, installation records, pressure and leak tests, flushing, balancing, calibration, as-builts and punch-list classification. | Separate commissioning defects from qualification; critical open items prevent formal acceptance. |
| Operational release | Qualification reports, approved deviations, maintenance and calibration, SOPs, training, spares, monitoring and change control. | Quality approval is based on complete evidence and controlled residual risk—not the pressure to start production. |
Africa and India implementation
Design to the operating environment without lowering the quality standard.
African operating reality
Design for the actual service environment: source-water variability, outages, voltage quality, heat, humidity, dust, long import lead times and limited specialist support may be normal project inputs—not rare emergencies.
- Separate critical and non-critical power loads
- Define generator, UPS, fuel and restart strategy
- Hold critical spares based on lead time and failure consequence
- Provide maintainable systems and structured local skills transfer
India compliance context
The revised Schedule M notified through G.S.R. 922(E) is the current GMP baseline. The time-limited extension route for eligible smaller manufacturers ran to 31 December 2025, so a 2026 project should design to the revised requirements from the outset.
- Map central, State and local approvals
- Include factory, fire, building and pollution-control permissions
- Separate domestic minimums from intended export-market requirements
- Control designers, fabricators and validation partners through approved scope
One GMP logic, local authorization
WHO and PIC/S guidance provide a strong technical baseline, but neither replaces the competent authority. Confirm national requirements, product-specific conditions and target-market commitments before design approval.
- Engage the regulator at defined project points
- Maintain a controlled legal and regulatory register
- Document justified differences between market requirements
- Design foreseeable upgrades before space and utilities are fixed
Avoidable project failures
Find interface mistakes before concrete, ductwork and purchase orders make them expensive.
| Failure pattern | What goes wrong | Better control |
|---|---|---|
| Buying machines before process design | Equipment sizes and utilities are fixed before batch strategy, flows and controls are agreed. | Approve the process and user-requirements basis before technical procurement. |
| Nameplate-capacity optimism | Quoted hourly output ignores setup, hold, cleaning, testing, failures and downstream constraints. | Model complete campaign cycles and test the bottleneck under realistic utilization. |
| Generic room classifications | Rooms are copied from another factory without linking environmental controls to process risk. | Use product and process risk to define zoning, pressure, filtration and monitoring. |
| Utilities sized in isolation | Equipment, HVAC, water and electrical designers use different load assumptions. | Maintain one controlled equipment list, utility matrix and simultaneous-use scenario. |
| No maintenance access | Plant works at handover but filters, motors, valves or large components cannot be safely reached or removed. | Review maintenance tasks and withdrawal routes in 3D before construction. |
| Qualification used as commissioning | IQ/OQ begins while wiring, balancing, controls and basic functions remain incomplete. | Commission and resolve construction defects before formal qualification. |
| Cheap vendor, expensive lifecycle | Limited documentation, proprietary controls, remote service and long spares lead times create chronic downtime. | Evaluate total lifecycle cost, supportability, obsolescence and documentation quality. |
| Resilience added after failure | Backup power, storage, redundancy and contingency procedures are improvised only after interruption. | Use a formal utility-failure assessment during concept design and test recovery before launch. |
Minimum planning package
Build a controlled handover—not scattered drawings and vendor files.
Design basis
Project brief; product/process matrix; capacity model; regulatory basis; contamination-control and segregation assessment.
Facility
Site and block plans; flow diagrams; zoning; room list; room data sheets; finishes schedule; layouts; area and expansion schedule.
Utilities
Load list; utility balance; P&IDs; system descriptions; point-of-use specifications; monitoring and alarm matrix; failure assessment.
Equipment
Equipment list; URSs; technical comparisons; design reviews; FAT/SAT plans; manuals; spares; calibration and maintenance strategy.
Project quality
Design qualification; quality plan; risk register; change control; commissioning plan; turnover index; qualification strategy and traceability.
Readiness
SOPs; training; maintenance; calibration; cleaning; monitoring; qualification reports; deviations; release-to-use and lifecycle review plan.
Primary regulatory and technical references
Accessed 20 October 2026. Always confirm current national law, product-specific requirements, licence conditions and target-market commitments before approving a design.
- PIC/S PE 009-18 (Part I), including Chapter 3: Premises and Equipment—effective 24 September 2026
- WHO TRS 986, Annex 2: GMP for pharmaceutical products—main principles
- WHO TRS 1010, Annex 8: HVAC systems for non-sterile pharmaceutical products—Part 1
- WHO TRS 1019, Annex 2: HVAC systems for non-sterile pharmaceutical products—Part 2
- WHO TRS 1033, Annex 3: Water for pharmaceutical use
- WHO TRS 1019, Annex 3: GMP guidelines on validation
- WHO TRS 1044, Annex 2: GMP for sterile pharmaceutical products
- WHO Africa: GMP inspection guidance with focus on antimicrobial-resistance controls
- Malawi PMRA: Business-premises licensing requirements
- India G.S.R. 922(E): Revised Schedule M, 28 December 2023
- India G.S.R. 127(E): Time-limited Schedule M compliance extension for eligible manufacturers
Educational notice: This guide provides general project and GMP education. Facility design, containment, environmental control, engineering calculations, qualification, EHS, licensing and construction require competent specialists and formal approval under applicable law and the manufacturer's pharmaceutical quality system.