Supplier qualification

How to evaluate a pharmaceutical contract manufacturer

Compare pharmaceutical manufacturers using product and site fit, quality evidence, packaging readiness and quotation scope. Prepare a focused Walter supplier review.

Compare the proposed product and site together

Start with a defined product brief, not a company-wide certificate or a unit price alone. Give each prospective supplier the same composition, strength, dosage form, release type, market, quantity and packaging requirements. Ask which site and manufacturing stream would handle that exact project.

Use a comparison sheet that makes gaps visible

DecisionEvidence to requestQuestion to resolve
Product and site fitProposed facility, current licence and applicable product scopeDoes the evidence cover this composition, form and market?
Quality readinessDocument list, current specifications, methods and relevant validation informationWhat exists, what can be reviewed, and what work remains?
Pack readinessPrimary pack specification, printed components and stability requirementsWhich pack is included in the quote and what changes need assessment?
Commercial scopeBatch and pack quantities, one-time costs, exclusions and payment milestonesAre quotes based on the same units and responsibilities?
Delivery readinessMaterial, artwork, production, testing and release dependenciesWhat starts the lead-time clock and who controls each dependency?
Lifecycle supportAgreed change, complaint, recall and reorder responsibilitiesHow will issues and changes be communicated after dispatch?

Use Walter's published evidence to plan the review

Explore the facility pages, certification library and plant walkthrough to prepare specific questions. Photos identify their location or representative status; equipment and dosage-form scope vary between sites. Ask for the document scope and current validity relevant to your proposed engagement before making a supplier decision.

Reference: Facilities and site information · Certification library · Plant and laboratory walkthrough

Separate an open question from a confirmed commitment

Record each item as confirmed with evidence, awaiting clarification, or not applicable. Include the document revision and the person responsible for the next answer in your own review record. A proposed MOQ, dispatch date or shelf life should remain a proposal until the relevant technical and commercial work supports it.

Prepare a focused plant visit

  • Name the dosage form, proposed product and supplier-review objectives.
  • Agree the relevant site, participants and areas available for the visit.
  • List the documents and processes you want to discuss in advance.
  • Agree confidentiality and permitted access before sharing controlled information.
  • Record follow-up questions, owners and the evidence needed to close each item.

Useful next steps

Start the conversation

Discuss your product-specific requirements.

Walter confirms product, facility, documentation and commercial scope after reviewing your brief.

Request a quote