The URS belongs to the buyer. A supplier can clarify feasibility and propose a design, but should not define the user’s product-quality, operating, data or site requirements on the user’s behalf. Issue the controlled URS with the request for quotation so competing proposals answer the same requirement set.
Write each requirement so it can be tested
A useful requirement identifies the system, required outcome, condition, limit or range and verification method.
URS-[section]-[number]: The system shall [measurable outcome] when [defined condition]. Verification: [document review / inspection / test / demonstration].
Requirement record template
| ID | Requirement | Priority | Rationale / risk | Verification | Supplier response |
|---|---|---|---|---|---|
| URS-___ | The system shall __________________ under __________________. | Mandatory / Optional / Information | Product quality, patient, data, safety or business need | Review / Inspect / Test / Demonstrate | Comply / Partial / Deviation, with evidence reference |
1. Scope and system boundary
- Name the blister machine, feeders, inspection, coding, reject handling, conveyors, cartoner and external systems included in scope.
- Identify buyer-supplied and supplier-supplied equipment, tooling, materials, utilities, samples and services.
- Define the accepted output point: good blister card, accepted carton or another final unit.
- List installation site, room constraints, access route, working height and maintenance-clearance requirements.
- State target markets and applicable internal standards for buyer confirmation.
2. Product, blister and material matrix
| Input | What to provide | Why the supplier needs it |
|---|---|---|
| Product | Type, dimensions, tolerances, orientation, fragility, dust, static, surface and representative samples | Feeder, cavity, handling and inspection design |
| Blister drawing | Card size, cavity layout, pitch, draw depth, corner radii and product count | Forming, indexing, sealing and cutting format |
| Forming material | Structure, width, thickness range and approved supplier information | Heating, forming, cooling and web transport |
| Lidding material | Structure, width, coating or seal requirements and print registration | Sealing, tension, coding and registration |
| Carton interface | Blisters per carton, leaflet, carton dimensions, coding and inspection | Line balance and transfer design |
3. Capacity and operating pattern
Do not request only a peak catalog speed. Define the required accepted output, format, material, product, inspection scope, downstream boundary, test duration and loss convention. State the shift pattern, planned changeovers, replenishment method and expected product mix.
| URS field | Buyer input |
|---|---|
| Required accepted output | ________ good blister cards/minute or accepted cartons/minute |
| Reference format | Product ________; drawing ________; forming ________; lidding ________ |
| Test boundary | Duration ________; planned stops ________; included modules ________ |
| Changeover target | From format ________ to ________; start and finish definitions ________ |
| Operating pattern | Shifts/day ________; hours/shift ________; days/week ________ |
Use the real output and OEE calculation guide to normalize supplier capacity claims.
4. Functional requirements by station
| Station | Requirement topics |
|---|---|
| Web handling | Roll diameter, splice detection if required, tension, alignment, end-of-roll response and material identification |
| Forming | Thermoforming or cold forming, heating zones, forming method, cooling, cavity acceptance and tooling identification |
| Feeding | Product range, orientation, damage limits, empty-cavity detection, change parts, access and cleaning |
| Inspection | Attributes inspected, challenge method, fail-safe behavior, reject confirmation, data and access |
| Sealing | Method, temperature, pressure or force, dwell or speed, parameter control and seal-quality verification interface |
| Coding and registration | Code content, print system, registration, verification and reject response |
| Cutting and discharge | Cut profile, perforation, burr criteria, discharge orientation, transfer and accumulation |
5. Inspection and reject strategy
- List every defect or attribute the system is expected to detect.
- Define the reject unit, physical reject method and reject confirmation.
- Specify response to full reject bin, missing confirmation, sensor fault and communication loss.
- Define challenge pieces, challenge frequency and who approves acceptance criteria.
- State reconciliation, access and record needs without assuming functions not required by intended use.
6. Controls, recipes and data
Describe intended use before naming a compliance feature. A PLC or HMI alone does not establish 21 CFR Part 11 applicability. Identify which electronic records, signatures, recipes, audit trails, reports, backups, interfaces and retention needs are in scope, then have the quality and IT functions confirm applicable requirements.
- User roles, permissions and authentication expectations.
- Recipe creation, approval, version identification and restore behavior.
- Alarm history, event history and production-report content.
- Time synchronization, data interface, backup, restore and disaster-recovery responsibilities.
- Software and configuration documentation required for change control.
7. Utilities, environment and installation
| URS item | Define at the machine boundary |
|---|---|
| Electrical | Voltage, frequency, phases, permitted variation and connection responsibility |
| Compressed air | Pressure, quality, consumption basis and connection |
| Cooling and extraction | Temperature, flow, pressure, heat load, exhaust and responsibility |
| Room | Temperature, humidity, classification if applicable, floor loading, height and available footprint |
| Interfaces | Upstream, downstream, data, safety and utility isolation points |
8. Cleaning, changeover and maintenance
- Define product-contact and non-product-contact boundaries.
- State permitted cleaning agents, methods and access constraints confirmed by the buyer.
- Identify removable parts, tools, storage, status identification and reassembly checks.
- Define changeover start and finish events and the reference formats.
- Request lubrication information, preventive-maintenance tasks, parts list and safe access.
Cross-reference the blister machine maintenance checklist when defining service access and documentation.
9. Safety and ergonomics
The buyer should state site safety standards, risk-assessment expectations, guarding, emergency stops, interlocks, hot surfaces, sharp tooling, lifting, noise, operator access and energy-isolation requirements. The supplier should document the proposed response and unresolved residual risks for review.
10. Documentation, FAT, SAT and qualification support
| Deliverable group | Specify required content, format and approval point |
|---|---|
| Engineering | General arrangement, utilities, drawings, component lists, materials and configuration |
| Operation and maintenance | Manuals, cleaning, maintenance, calibration inputs, troubleshooting and spare parts |
| Software | Version, functional description, access, recipe, backup and interface documents where applicable |
| Testing | FAT and SAT protocols, prerequisites, samples, raw data, deviations, reports and acceptance authority |
| Qualification support | Supplier templates, execution support and evidence boundary for DQ, IQ and OQ |
| Training | Audience, topics, language, location, duration, records and competence responsibility |
Use the FAT checklist and DQ/IQ/OQ/PQ guide to map requirements to later evidence.
Bad versus testable wording
| Avoid | Use a testable requirement |
|---|---|
| Machine shall be high speed. | The system shall produce at least ______ accepted units/minute under the defined reference format and FAT boundary. |
| Machine shall be GMP compliant. | List the specific design, documentation, cleaning, data and qualification requirements to be reviewed and tested. |
| Changeover shall be fast. | Changeover from format A to B shall meet ______ minutes, measured from ______ to ______ using the approved procedure. |
| Vision shall detect defects. | List each attribute, challenge method, acceptance criterion, reject response and failure behavior. |
| Supplier shall provide validation. | List each required document, template, test, raw record, execution role and approval responsibility. |
URS release checklist
- Every requirement has a unique ID, owner, priority and verification method.
- Product, material and format matrices are attached and version controlled.
- Capacity uses accepted output under a defined condition.
- Buyer and supplier scope, interfaces and exclusions are explicit.
- Data and regulatory statements are based on intended use and confirmed by responsible functions.
- FAT, documentation, training, spare parts and qualification support are commercial deliverables.
- Open questions are recorded; they are not hidden as supplier assumptions.
Review suitable blister packing machine configurations only after the approved requirements and product-format matrix are ready.
Frequently asked questions
Who should write the blister packing machine URS?
The buyer should own and approve it through a cross-functional team that may include production, engineering, quality, validation, safety, maintenance, IT and procurement. The supplier can clarify feasibility and respond to requirements.
Should the URS specify a particular component brand?
Only when a justified site standard, lifecycle need or interface requires it. Otherwise state the required performance, documentation, serviceability and verification outcome.
What is the difference between a URS and a supplier quotation?
The URS defines the user’s approved needs. The quotation describes the supplier’s proposed scope, design, price, exclusions and response. Every deviation should remain visible for technical and commercial review.
How does a URS support DQ and FAT?
Unique requirement IDs allow each need to be linked to design evidence and an agreed verification stage. The resulting traceability matrix shows open requirements, deviations and completed evidence.
Should 21 CFR Part 11 be written into every blister machine URS?
No. First determine whether regulated electronic records or electronic signatures are in scope. Then define the applicable functions and controls with quality and IT review.
This template is a procurement starting point. Adapt it to the installed system, products, target markets, site standards and approved pharmaceutical quality system. It is not legal or regulatory advice.
Request a requirement-gap review
Send your product-format matrix, material structures, target accepted output, inspection scope, utilities, site constraints and required documents. HIJ will identify technical assumptions and supplier-response items for review.
Request URS Gap Review
