Knowledge article
What to Include in a Pharmaceutical Equipment RFQ
A clear RFQ shortens model selection by defining the product, process, output, utilities, format, documentation, and site constraints.
Make the RFQ a decision document
Use the RFQ as a decision document rather than a request for a generic brochure. Give the project a revision number, owner, response deadline, destination, and clear machine boundary. Separate mandatory requirements, preferred features, and information requests. Ask suppliers to answer against the same numbered clauses and to identify deviations in one place. This structure exposes assumptions early and allows engineering, quality, operations, procurement, and finance to compare the same configured scope instead of five differently worded offers.
Describe the product and process
Describe what the equipment must process. Include dosage form or product type, formulation behaviour relevant to the machine, density or viscosity range, particle or component dimensions, temperature, moisture sensitivity, foaming, dust, potency or containment concerns, and product-contact restrictions. State the dose, fill, batch, or count range and its tolerance. If actual material cannot be shared initially, define a representative substitute and list which decisions must wait for production-intent samples. Avoid unsupported phrases such as 'standard powder' or 'normal bottle'.
Define operational capacity
Define capacity in operational terms. State batch size, batches per shift, target sustained units per minute or hour, shift length, planned changeovers, replenishment method, expected efficiency basis, and future range. Identify the minimum acceptable rate as well as the desired rate. For connected lines, provide the upstream and downstream operating windows and any buffer requirement. Ask the supplier to state the product, format, speed, and test conditions behind each capacity value so a nameplate maximum is not mistaken for guaranteed plant output.
Control every product and pack format
Attach controlled format information. Depending on the project, this may include capsule or tablet samples, container and closure drawings, tube dimensions, pouch or film structure, label roll and release-liner data, carton drawings, leaflet folds, print repeats, coding area, tolerances, and supplier specifications. Name every format expected at launch and distinguish future formats. Request a change-part list, format-range limits, changeover method, and sample quantity for trials. Photographs help orientation, but dimensioned drawings and physical samples control the machine design.
Record the site and utilities
Document the installation environment and utilities. Provide room dimensions, access route, floor loading, drainage, ceiling height, equipment layout, operator and maintenance clearance, temperature and humidity range, classification or hygiene requirement, and any hazardous-area constraint. State voltage, phase, frequency, earthing standard, compressed-air pressure and quality, vacuum, extraction, steam, cooling water, chilled water, process water, network, and exhaust availability. Ask for consumption at the quoted operating point, connection sizes, heat release, noise data, and responsibilities for interconnecting services.
Set hygiene and cleaning boundaries
Define hygiene, cleaning, and product-change expectations from the risk assessment. State contact-material and surface-finish requirements, permitted elastomers and lubricants, cleaning agents, dismantling limits, manual or automated cleaning, drainage, verification access, and cross-contact controls. If containment, sterile processing, LAF, RABS, isolator, CIP, or SIP is relevant, describe the required process boundary and validation responsibility instead of adding an acronym to the RFQ. Ask the supplier to mark exactly which quoted components meet each requirement.
Specify controls and data
Specify controls and data needs without assuming a standard PLC package covers them. List control language, recipe management, user roles, audit trail, alarm history, batch report, electronic records, printer, barcode or vision interfaces, remote support policy, network protocol, cybersecurity constraints, data backup, and time synchronization. Define handshakes with upstream and downstream machines, reject confirmation, line-stop logic, and emergency-stop zoning. Identify which software documents, source backups, licenses, and passwords must be delivered at handover.
List evidence, services, and delivery scope
List the evidence and services expected with the order. Examples include drawings, manuals, material certificates, component lists, electrical and pneumatic diagrams, software backup, calibration records, risk assessments, spare-parts lists, training, installation supervision, FAT, SAT, and qualification support. State language, file format, review cycles, approval gates, and delivery timing. Define warranty start, remote response, field-service assumptions, consumables, recommended spares, shipping terms, packing, lifting, storage, and the exact point where supplier responsibility ends.
Close with compliance and change control
Close the RFQ with a compliance matrix and change-control rule. Require price, lead time, and exclusions for the base scope and each option, then normalize taxes, freight, commissioning, change parts, trials, documentation, spares, and facility work before comparing totals. Record open questions with an owner and due date. Once selected, transfer the accepted clauses, clarifications, samples, drawings, and deviations into the technical agreement. If a requirement changes, update the revision and assess cost, schedule, validation, and interface impact before approval.
Turn the requirement into an equipment shortlist.
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