The User Requirements Specification describes the business needs for what users require from the system. User Requirements Specifications are written early in the validation process, typically before the system is created. They are written by the system owner and end-users, with input from Quality Assurance.
- URS for Autoclave Cum Bung process
- URS for Automatic High Speed Head Vial Sealing Machine
- URS for Automatic High Speed Rotary Vial Washing Machine
- URS for Automatic Visual Vial Inspection Machine
- URS for Fix Conveyor 2000 MM Length
- URS for injectable Powder Filling & Rubber Stoppering Machine
- URS for Swing Conveyor 850 mm Length
- URS for Swing Conveyor 1000 mm Length
- URS for Tunnel
- URS for Vertical Vial Labelling Machine
- URS for Aseptic Liquid and Powder Filling Line
1. Purpose
Define the user requirements specification for injectable (parenteral) manufacturing facility/equipment to ensure compliant, safe, and efficient production of sterile injectable products in accordance with applicable GMP and regulatory guidelines.
2. Scope
- Covers: e.g. SVP/LVP vials, ampoules, PFS, ophthalmic/injectable solutions, suspensions, lyophilized products.
- Includes (as applicable):
- Solution preparation area
- Filtration & sterilization system
- Aseptic filling line
- Lyophilizer & loading system
- Terminal sterilizer (autoclave)
- Visual inspection & leak testing
- Primary & secondary packing
- Associated utilities (HVAC, WFI, clean steam, compressed air, nitrogen)
3. Regulatory & GMP Requirements
The system/facility shall:
- Comply with current GMP requirements (e.g. WHO, EU-GMP, USFDA, local regulations).
- Support classification of areas: Grade A/B/C/D or equivalent.
- Enable compliance with:
- Data integrity principles (ALCOA+)
- 21 CFR Part 11 / Annex 11 where computerized systems are used
- Cleanroom standards for particulate and microbiological control
- Facilitate qualification & validation (DQ, IQ, OQ, PQ; process validation; media fills).
4. Product & Process Requirements
- Product Types
- Aqueous / non-aqueous solutions
- Suspensions / emulsions
- Lyophilized powders (if applicable)
- Vial/ampoule sizes, LVP volumes, etc.
- Batch Size & Throughput
- Minimum and maximum batch volume (e.g. 50 L – 500 L)
- Target line speed (e.g. X vials/hour, Y ampoules/hour)
- Process Steps to be Supported
- Solution preparation & pH/osmolarity adjustment
- Sterile filtration (0.22 µm)
- Aseptic filling & stoppering/sealing
- Terminal sterilization and/or lyophilization
- Visual inspection (manual/automatic)
- Labeling and packing
5. Critical Quality Attribute (CQA)–Related Requirements
The design shall support achieving & controlling CQAs, including:
- Sterility
- Bacterial endotoxin level
- Particulate matter (visible & sub-visible)
- Assay and content uniformity
- Degradation products / impurities
- pH and osmolality (where applicable)
- Container closure integrity (CCI)
- Clarity/appearance and absence of defects
- Fill volume accuracy
6. Critical Control Point (CCP) / Critical Process Requirements
The system shall provide appropriate controls and monitoring at, at minimum, the following CCPs:
- WFI generation & distribution – temperature, conductivity, TOC, microbiological control
- Solution preparation – mixing, temperature, pH, time, order of addition
- Sterile filtration – validated 0.22 µm filters, integrity testing (pre & post)
- Aseptic filling – Grade A at point of fill, laminar flow, environmental monitoring
- Stoppering/sealing & capping – preventing loss of sterility, ensuring CCI
- Terminal sterilization cycle – F₀, temperature, time, pressure (if used)
- Lyophilization cycle – shelf temperature, chamber pressure, product temperature (if applicable)
- Visual inspection – 100% inspection capability for particulates and container defects
7. Facility & Layout Requirements
- Zoning & Flows
- Clearly defined cleanroom grades with proper pressure cascades
- Unidirectional flows for personnel, material, waste
- Segregation of sterile and non-sterile operations
- Airlocks for personnel & material.
- HVAC
- Classified areas with defined ACH, temperature, RH
- HEPA filtration with required air velocities and patterns
- Pressure differentials between rooms as per design (e.g. ≥ 10–15 Pa).
- Surfaces & Finishes
- Smooth, cleanable, non-shedding, resistant to disinfectants
- Cove junctions, minimum ledges, flush fittings.
8. Equipment Requirements (High Level)
- Solution Preparation Vessels
- GMP design, sanitary fittings, CIP/SIP capability
- Agitation, jacketed heating/cooling if required.
- Filtration System
- Sterile-grade filters, integrity test devices
- Suitable for SIP or pre-sterilized assemblies.
- Filling Line
- Suitable for vials/ampoules/pre-filled syringes as required
- Laminar airflow (LAF/RABS/Isolator) over critical zone
- Accurate dosing with in-process weight/volume checks
- Automatic rejection for under/overfill and visible defects.
- Lyophilizer (if applicable)
- CIP/SIP, cleanable chamber, automated loading/unloading (if required)
- Control of shelf temperature and chamber pressure with data recording.
- Terminal Sterilizer
- Autoclave with validated cycling, load mapping, data logging.
- Inspection & Packing
- Manual or automatic visual inspection units
- Labelers, cartoners, and serialization (if required).
9. Automation, Control & Data Management
- Automation Level
- PLC/SCADA or DCS with HMI
- Recipe management for batches and cleaning cycles.
- Data Integrity
- Audit trails, user access control, electronic signatures (if applicable)
- Secure data storage and backup.
- Alarms & Interlocks
- Critical alarms for deviations in process parameters (temperature, pressure, speed, etc.)
- Interlocks to prevent operation in unsafe or non-compliant conditions.
10. Utilities & Services
- Clean utilities: WFI, clean steam, compressed air (oil-free, dry, filtered), nitrogen
- Black utilities: chilled water, cooling water, electricity, drainage
- Requirements for quality, pressure, flow, redundancy clearly specified.
11. Safety, Ergonomics & Environmental Requirements
- Compliance with occupational health & safety regulations.
- Adequate access for operation, cleaning, and maintenance.
- Appropriate containment or PPE if handling potent / toxic materials.
- Safe handling and disposal of waste, effluents, and used filters/consumables.
12. Qualification, Validation & Documentation
The supplier/system shall provide:
- Design & engineering documents (P&IDs, GA drawings, layouts).
- Material & weld certificates where applicable.
- IQ/OQ protocols & reports, FAT/SAT documents.
- Guidance/assistance for PQ & process validation, sterilization validation, and media fill strategy (if part of scope).
- User manuals, maintenance manuals, and spare parts list.
13. Training & Support
- Training for operators, maintenance, QA/QC personnel.
- Support for troubleshooting, upgrades, and change control documentation.