A brochure, product catalogue or scanned GMP certificate cannot establish whether a pharmaceutical company is authorised to make, release and support the products you plan to sell. Use a document-first sequence, verify the evidence with the issuing authority, inspect operational controls and compare the full commercial risk before signing a supply, PCD, loan-licence or third-party manufacturing agreement.
Key takeaways
- Request the manufacturing licence, drug-control permissions and GST registration before price talks.
- Confirm the site can manufacture, test and release your specific dosage forms.
- Review certificates of analysis, stability data, labels and batch-release records.
- Put quality duties, costs, timelines and rejection rights into the agreement.
Verify the Company, Licence and Product Permissions Before Discussing Price
Before discussing price, complete pharmaceutical company due diligence with documents, not brochure claims. Request the legal entity’s incorporation details, company PAN, GST registration, manufacturing licence, drug-control licence, WHO-GMP or GMP certificate, complete product list, recent batch-release records, certificates of analysis and stability data.
- Match the licence holder’s legal name and approved premises address across every document.
- Ask for the applicable licence forms, such as Form 25 for non-biological drugs, Form 28 for specified categories, or Forms 25F and 28B where applicable.
- Request the product permission, approved composition, strength, dosage form and indication for every proposed SKU.
- If production uses a loan licence, request that licence, the licensed site details and a written allocation of batch release, complaints and recalls.
| Product type | Evidence to match | Do not assume |
|---|---|---|
| Tablets or capsules | Licence covering oral solid dosage forms; product permission for the exact composition and strength | A catalogue entry proves approval |
| Sterile injections | Licence covering sterile manufacture, such as Form 28; permission for the named injection | Tablet authorisation covers injections |
| Supplements or nutraceuticals | FSSAI licence, permitted ingredients, category, limits, label and claims | A drug licence covers FSSAI compliance |
Verify licence numbers, validity dates, legal names, premises and dosage forms through the issuing authority or its online register. Treat ISO 9001 as supplementary; it does not replace Schedule M GMP evidence or a drug-manufacturing inspection.
Review promotional claims and distributor incentives separately against the Uniform Code for Pharmaceutical Marketing Practices before approving artwork or commercial terms. A missing product permission or mismatched site is a stop signal.
Test Whether the Site Can Actually Make and Release Your Products
A catalogue proves intent, not pharmaceutical manufacturing capacity. Ask for the manufacturing licence and confirm the site address, legal entity, validity date and dosage forms against the proposed products. Forms 25 and 28, or the applicable licence category, must cover the actual formulation; tablet authorisation does not cover sterile injections or ophthalmics.
Request a site audit or live video walkthrough, then compare the stated capacity with records from recent commercial batches. Ask for:
- Installed and available capacity, batch size, minimum order quantity, lead time and changeover time
- In-house or subcontracted production, including the subcontractor’s site and licence
- Equipment lists, packaging-line capacity and records showing preventive maintenance and cleaning
- Batch manufacturing records, certificate of analysis, deviation reports and release approval
A functioning quality control system leaves an evidence trail. Check whether analysts use approved methods, whether out-of-specification results are investigated, and whether quality staff—not sales personnel—release each batch. Confirm traceability from incoming API and excipients through manufacture, testing, release and dispatched customer lots.
Do not treat ISO 9001 as proof of drug GMP. Indian Schedule M assessment covers sanitation, premises, production controls, validation, documentation, quality control and records specific to medicines; an ISO certificate is supplementary. Require written approval for changes to API or excipient source, site, process, test method, specifications, packaging, batch size or shelf life.
A supplier that cannot show controlled change management is not ready for your order.
Inspect Product Evidence, Packaging and Stability Before Approval
A sample order should prove more than appearance: match the received product against its approved specification, certificate of analysis and label. Check the batch number, manufacturing and expiry dates, dosage strength, storage statement, seal, container, closure, print quality and transport condition.
Compare the certificate of analysis with raw test results or batch-release records, not just a supplier-created summary.
1. Request the approved specification, analytical method, certificate of analysis, batch-release records and stability data for the exact batch and packaging configuration. Confirm identity, assay, impurities and dosage-form-specific tests through risk-based independent testing; for sterile products, include endotoxin, particulate matter and container-closure integrity.
2. For injectables, demand injectable quality control evidence covering environmental-monitoring trends, media-fill results, sterilisation or aseptic-process validation, bioburden controls and investigations into contamination or sterility failures. A passing sterility test alone cannot prove that the aseptic process remained controlled.
3. For temperature-sensitive or short-shelf-life products, obtain the approved storage range, transport qualification, stability-indicating methods and ongoing-stability commitment. A long expiry printed on a batch certificate does not establish real-time stability in your packaging, climate and distribution route.
4. For supplements, verify ingredient identity, assay, microbial limits, heavy metals, allergens and contaminant controls, then check that claims and nutrition information match the tested formula.
5. For a new formulation, require development, compatibility, process-validation and accelerated and real-time stability evidence before approval. Ask how changes to excipients, packaging, test methods or batch size will be notified and approved; a nominally unchanged formula can lose comparability after an undocumented substitution.
Compare the Full Cost and Put Responsibilities Into the Agreement
A low ex-factory price can become the expensive option after freight, GST, testing, artwork, credit terms, breakage, expiry replacement and minimum-order commitments. Compare every supplier using one delivered unit, the same pack size, shelf life, order quantity and destination, then calculate total landed cost before choosing a PCD pharma franchise partner.
| Term | Supplier A | Supplier B | Record before approval |
|---|---|---|---|
| Ex-factory price | Per pack and batch size | ||
| Freight, insurance and GST | Included, excluded or separately invoiced | ||
| Testing, artwork and tooling | One-time or recurring charge | ||
| Credit, MOQ and lead time | Days, units and dispatch date | ||
| Expiry, damage and returns | Replacement rule and cost | ||
| Price ceiling | DPCO schedule status and applicable ceiling price |
Use the agreement to assign one named owner for each event. A loan licence agreement must identify the licensed manufacturer, label manufacturer, batch-release authority, approved premises and testing party; the arrangement does not transfer your verification duties.
Specify written approval before any change to API or excipient source, site, process, test method, specification, packaging, batch size or shelf life.
State who receives complaints, acknowledges them within a fixed time, investigates, accesses batch and distribution records, and decides corrective action or recall. Allocate recall costs, stock reconciliation, customer notices and mock-recall testing. For pharmacovigilance, name the recipient of adverse-event reports, medical assessor, signal-review owner and regulator-submission party, with exchange deadlines.
The contract should also grant access to the dossier, methods, stability data, artwork, regulatory correspondence, retained samples and manufacturing records after termination. kelps healthcare should be held to the same written allocation when you compare its supply or franchise proposal.
Run a Final Audit and Set a Clear Go-or-No-Go Decision
Repeated unexplained OOS results, retrospective data entry, missing raw chromatograms, or CAPA limited to staff retraining are go-no-go findings. Do not place an order until the supplier proves the underlying failure is corrected and the evidence is independently reviewed.
A supplier audit must examine unresolved deviations, OOS/OOT investigations, CAPA effectiveness, data-integrity controls, rejected-batch trends, recalls, regulatory observations and employee qualification records. A clean production-floor tour proves little if batch records cannot be traced from incoming material through release and every dispatched customer lot.
| Finding | Decision | Required evidence |
|---|---|---|
| Unresolved data-integrity breach or falsified record | Stop | Investigation, impact assessment and verified corrective action |
| Repeated unexplained OOS/OOT results | Stop | Root-cause analysis, batch impact review and effective CAPA |
| Uncontrolled product recall or missing traceability | Stop | Reconciled distribution records and a successful mock recall |
| Unassigned safety or release responsibility | Stop | Signed contract naming the batch-release owner, complaint investigator and pharmacovigilance contact |
Before the first commercial order, confirm all of these in writing:
- The approved specification matches the COA, method and dosage form; arrange risk-based independent testing of identity, assay, impurities and critical attributes such as endotoxin, particles and container closure.
- The agreement sets complaint acknowledgement and investigation deadlines, recall authority, stock reconciliation, communication templates and cost allocation.
- Pharmacovigilance procedures name the adverse-event recipient, medical assessor, signal-review owner and reporting timelines.
- The label manufacturer, licensed premises, batch-release party and product recall decision-maker are identified, with current records available.
Frequently asked questions
Which documents should you request before discussing price?
Request the legal entity’s incorporation details, PAN, GST registration, manufacturing licence, drug-control licence, GMP certificate and product permissions.
How can you check whether a pharmaceutical site can make your products?
Inspect the approved dosage forms, production areas, equipment, testing laboratory, batch records and release process for the products you need.
What product evidence should you review before approval?
Review certificates of analysis, recent batch-release records, packaging artwork, label details, stability data and storage requirements.
What costs and responsibilities belong in the pharmaceutical supply agreement?
Define product price, testing, packaging, transport, storage, regulatory duties, release decisions, complaint handling, rejected batches and replacement costs.
When should you reject a pharmaceutical company?
Choose no-go when licences do not cover the product, records cannot be verified, the site lacks suitable capacity or the contract leaves quality responsibilities unclear.
