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For pharmaceutical companies · Supplier onboarding

Before signing a pharma manufacturing agreement, make these responsibilities explicit.

Use this business checklist to prepare a focused discussion with a prospective contract manufacturer. It helps your commercial, quality, regulatory and legal teams find gaps before the first order.

Walter’s manufacturing network

Six manufacturing units across three states.

When reviewing a manufacturing agreement, identify the specific Walter unit covered by the proposed project. Walter’s published network includes six manufacturing units across Punjab, Himachal Pradesh and Uttarakhand.

Unit I

Chanalon, Kurali, Punjab

Plot No. B-29, Focal Point, Industrial Area, Chanalon, Kurali, Punjab 140103

Unit II

Phase 7, Mohali, Punjab

Plot No. D-97, Industrial Area, Phase 7, Mohali, Punjab 160062

Unit III

Kala Amb, Himachal Pradesh

Mouza Ogli, Suketi Road, Kala Amb, Himachal Pradesh 173030

Unit IV

Roorkee, Uttarakhand

Village Narsan Khurd, Khasra No. 215, NH-334, Roorkee, Uttarakhand 247670

Unit V

Chanalon, Kurali, Punjab

B-29, First Floor, Focal Point, Industrial Area, Chanalon, Kurali, Punjab 140103

Unit VI

Phase IX, Mohali, Punjab

Plot No. 01/111, Phase IX, Industrial Area, Mohali, Punjab 160062

Unit-level equipment, dosage forms, permissions and availability vary. Walter’s team confirms the proposed unit and current product-specific scope for each project.

See Walter’s published facility details ↗

Pharma contract manufacturing agreement checklist

Ten work areas to put on the review agenda.

These are questions to resolve with the manufacturer and your advisers. The table is a discussion aid, not a model contract or an exhaustive list of legal requirements.

Work areaQuestion to resolveUseful project record
Product and site scopeWhich exact products, strengths, forms, markets and manufacturing units are covered? What happens if the site or product changes?Product specification, current site/product-scope documents and the approved market list.
Technical transfer and developmentWho supplies the formula, process information and methods? What review or approval is needed before a commercial batch?Agreed technical package, specification versions, responsibilities and open development items.
Quality responsibilitiesWho handles deviations, investigations, complaints, changes, audits, recalls and batch disposition? Where are the operating details recorded?A quality agreement or clear quality responsibilities, with contacts and escalation steps.
Materials and suppliersWho buys, tests, approves, stores and reconciles active ingredients, excipients and printed components?Approved material/specification list, ownership and handling responsibilities.
Packaging and artworkWho prepares and approves artwork, pack specifications, proofs, change requests and market-specific text?Approved artwork versions, packaging specification and named approval owners.
Orders and commercial assumptionsHow are purchase orders accepted? Which quantity basis, prices, taxes, one-time costs, exclusions and payment milestones apply?A written quotation and purchase-order terms that match the agreed product and pack.
Planning and deliveryWhat prerequisites start the planning timeline? How are delays, changes to the requested quantity and dispatch coordination handled?A project plan with dependencies; requested dates kept separate from confirmed commitments.
Records and product documentsWhich records, test results, certificates or release documents are included, and how are corrections and retention handled?A product-specific document list agreed by the commercial, quality and regulatory teams.
Confidential information and intellectual propertyWho owns customer materials, formulas, specifications, artwork, results and any new work? How may each party use or disclose them?Explicitly reviewed confidentiality, ownership, permitted use and return or destruction terms.
Changes, complaints and ending the arrangementHow are changes approved? What happens to open orders, materials, records and customer property if the arrangement ends?A reviewed change process, issue contacts and agreed close-out responsibilities.

The final documents depend on the product, site, market and commercial arrangement. This checklist is general business information, not legal advice or a substitute for an agreement prepared or reviewed by qualified counsel.

Prepare before negotiations

Bring one controlled version of the product brief.

Commercial terms are hard to compare if the underlying product, market and pack keep changing between quotations.

Technical identity

Freeze the draft specification

List ingredients, strength, dosage form, release characteristics, target market and the specification revision being quoted.

Manufacturing location

Name the proposed site

Ask which unit is proposed and request current evidence for its scope. Company-wide certificates do not answer every product/site question.

Commercial basis

State quantities and packs

Distinguish dosage units from finished packs. Make forecasts, requested dates and open assumptions visible in writing.

Internal review

Assign decision owners

Identify who can approve technical, quality, regulatory, legal, artwork and commercial decisions on your side.

For a qualified manufacturing discussion

Start with the product and the responsibilities to resolve.

A manufacturing enquiry can run alongside your agreement review. Ask the team to identify the proposed unit, product scope, available documents and commercial assumptions before legal sign-off.

  • Company and buyer role
  • Product, specification and market
  • Manufacturing scope and proposed site
  • Quality, packaging and document questions
  • Target timing and open commercial terms
Review Walter’s RFQ checklist ↗

Prepare a company enquiry

Fill in what you know. You can edit the message in WhatsApp before sending it.

Open my WhatsApp message

Preparing this brief does not send an enquiry. WhatsApp opens so you can review and choose whether to send the message.

Common questions

Agreement review basics.

Is this a contract template?

No. It is a checklist of discussion topics. It does not create legal terms or replace a contract drafted or reviewed for your situation.

Should the quality responsibilities be written down?

Ask your quality and legal advisers how the responsibilities should be recorded for the specific product, site and markets. Teams often need a clear document or annex for operating responsibilities.

Does a quotation become part of the agreement automatically?

Do not assume. Have your advisers check how the proposal, purchase orders, accepted changes and the final contract relate to one another.

Next step

Make the manufacturing brief comparable before signing.

Share the product, intended market and the open questions.

Start a manufacturing enquiry ↗
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