A User Requirement Specification (URS) is a formal document that outlines the needs of a user for a system, product, or service. In the pharmaceutical industry, a URS is a crucial document that ensures that equipment, processes, or systems meet regulatory standards and user needs.
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This URS defines the user needs for manufacturing, filling, and packing of sterile ophthalmic products (e.g., eye drops/suspensions/ointments) in compliance with current GMP and applicable pharmacopoeial requirements. The facility and systems shall be designed to prevent microbial, particulate, and cross-contamination, and to ensure consistent product quality, patient safety, and regulatory compliance.
The process shall include receipt and quarantine of raw materials, controlled dispensing, compounding with validated mixing and holding times, sterile filtration (where applicable), aseptic filling, stoppering/capping, visual inspection, labeling, and secondary packing. The design shall provide segregated personnel and material flows with defined cleanliness zoning. Aseptic operations shall be performed under Grade A/ISO 5 conditions with Grade B background for open product exposure, supported by controlled Grade C/D areas as required for preparation and ancillary activities. Environmental monitoring (viable/non-viable), differential pressure cascades, temperature, and humidity control shall be provided with alarm and data trending.
Critical utilities shall include Purified Water and/or Water for Injection (as required), clean steam (if used), compressed air/nitrogen with appropriate filtration, and validated Clean-in-Place/Sterilize-in-Place where applicable. Equipment (vessels, filters, filling line, autoclave/depyrogenation tunnel if applicable) shall be qualified (DQ/IQ/OQ/PQ) and suitable for sterile production.
The system shall support process validation, media fills, container closure integrity, cleaning validation, and sterility assurance. Data integrity, controlled documentation, batch traceability, and deviation/CAPA management shall be ensured. Safety requirements include operator protection, ergonomic layouts, and controlled waste disposal for sterile and chemical waste.