A low quotation and a current GMP certificate do not tell you whether a manufacturer is authorised to make your exact medicine, control its process, or support the product after launch. Use the checklist below to verify licences, quality evidence, scale-up capability, packaging, supply terms and contractual responsibilities before you sign.
Key takeaways
- Ask for the exact site licence and endorsed product list.
- Audit batch records, deviations, CAPA and test results—not certificates alone.
- Compare pilot and market batches for reproducibility before approving production.
- Define testing, release, complaints and recall duties in the quality agreement.
Verify the Licence Covers Your Exact Product
A current manufacturing licence is not enough: match the licensed Delhi site, product permission, dosage form, strength and API verification to the medicine you intend to sell. Ask for a legible licence and its endorsed product list, not a corporate certificate or marketing presentation.
| Document | What to verify | What failure means |
|---|---|---|
| Manufacturing licence | Form 25 or Form 28, as applicable, naming the site, dosage form, strength and product category | The factory may not legally manufacture that medicine |
| Product permission | State licensing authority approval, or CDSCO permission where applicable; for a new drug, check the approval under the New Drugs and Clinical Trials Rules, 2019 | A quotation does not prove permission to make or sell the product |
| Outsourced manufacture | The applicable loan-licence structure, the licence holder’s name and the written manufacturing arrangement | Responsibility may sit with the wrong party |
For a loan-licence arrangement, identify who holds the licence, who releases each batch and whose name appears on the label. Confirm that the approved label contains the batch number, manufacturing and expiry dates, strength, storage conditions and manufacturing-licence details.
For a generic, request the regulatory evidence supporting therapeutic equivalence: comparative dissolution, a documented biowaiver justification or an in-vivo bioequivalence study, according to the product category. Manufacturing experience does not establish equivalence.
Finally, match the licence to the proposed formulation and container-closure system. Request product-specific stability data covering commercial batch scale and India’s hot, humid storage conditions; generic accelerated data cannot fill that gap. Check the actual site and licence against CDSCO and state drug-control recalls, restrictions and inspection findings, then request closure evidence for significant observations.
Audit the Quality System, Not Just the Certificate
A current Schedule M GMP certificate proves a legal baseline, not that the site can control your product. Audit whether the quality unit operates independently from production and has authority to reject a batch, stop a process and escalate a defect.
Ask to review these records from the actual manufacturing site:
- Approved master batch records, including specifications, processing limits and in-process checks
- Executed batch records showing entries, corrections, yield reconciliation and review signatures
- Deviation reports with root-cause analysis, corrective and preventive action, and effectiveness checks
- Change-control records showing impact assessments and post-implementation verification
- Internal-audit findings, management responses and closure evidence
- Documented batch-release decisions, including rejected or conditionally held batches
Check vendor qualification files and incoming-material testing records. They should show how suppliers are approved, how identity and quality are confirmed, and what happens when a material fails.
Review the laboratory’s method suitability or validation, reference-standard control, instrument qualification, chromatographic data review, system-suitability results and sample traceability. A scientifically documented OOS investigation must explain the failure; repeated testing until a passing result appears is a serious warning sign.
Ask for a written quality agreement before commercial work begins. It must assign responsibilities for testing, deviations, OOS investigations, change control, stability, complaints, recalls and records. Check CDSCO and state drug-control history, then request closure evidence for significant findings.
For sterile or ophthalmic products, also inspect media fills, environmental trends, sterilisation validation, water systems and container-closure integrity.
Test Reproducibility from Pilot Batch to Market Pack
A pilot batch proves the formula works once; it does not prove that commercial equipment, operators and production schedules will deliver the same result. Establish reproducibility through documented technology transfer, process validation and product-specific stability data.
1. Request the technology-transfer package. It should identify critical quality attributes, critical process parameters, in-process limits, hold times, sampling plans, equipment differences and process-performance qualification requirements.
2. Check that process validation covers commercial-scale batches, not only laboratory or pilot runs. Review executed batch records, yield trends, deviations and cleaning validation for shared equipment; uncontrolled residue or an untested hold time can affect assay, impurities and microbial quality.
3. Require a stability protocol for the exact formulation, batch scale and container-closure system. Review stability data from the proposed commercial pack under long-term and accelerated conditions, with a storage justification for India’s hot and humid climate rather than generic accelerated results alone.
4. Inspect packaging controls before approving the market pack. Confirm approved artwork and component versions, line clearance, printed-material reconciliation, coding and readability, plus the batch number, manufacturing and expiry dates, strength, storage conditions and manufacturing-licence details.
5. For sterile, ophthalmic or contamination-sensitive products, demand cleanroom monitoring trends, media-fill results, sterilisation validation, qualified water systems, container-closure integrity and microbial or particulate controls. Ordinary non-sterile GMP evidence is not enough.
Use Schedule M GMP compliance as a legal baseline, not as proof of scale-up capability. The manufacturer must show executed records and trend evidence that connect the pilot formula to a controlled, releasable market pack.
Put Responsibilities into a Detailed Quality Agreement
Before the first commercial batch, sign a quality agreement; a purchase order cannot replace it. Assign each task to a named party, define required records and timelines, and state who has final authority.
| Duty | Manufacturer | Brand owner |
|---|---|---|
| Specifications and suppliers | Draft and control specifications; qualify suppliers; sample and test incoming materials | Approve specifications, critical suppliers and testing strategy |
| Deviations and changes | Investigate deviations and OOS results; run CAPA; obtain approval through change control | Assess regulatory and product impact; approve changes before implementation |
| Batch release and stability | Execute the batch record, perform release testing, retain samples and stability data; independent quality unit makes batch release decision | Review the release package and approve market distribution |
| Complaints and pharmacovigilance | Log complaints, investigate manufacturing defects, preserve samples and provide records | Operate complaint intake, assess adverse events, manage pharmacovigilance reporting and meet escalation timelines |
| Recall and regulators | Support traceability, stock reconciliation, investigation and regulator inspections | Decide on recall, notify regulators, direct customer communication and verify returned-stock reconciliation |
Write inspection access, record-retention periods, distribution traceability, artwork changes and approval routes into the agreement. Specify who communicates with regulators and who supplies documents during an inspection. Without these terms, the brand owner can carry legal accountability while lacking batch, complaint or adverse-event records needed to act.
Compare Capacity and Quotations on Total Delivery Cost
A quotation is workable only when its batch size, minimum order quantity, lead time, packaging components and payment terms fit your launch plan—not merely when the unit price is low. Calculate total delivered cost for the medicine, printed materials, testing, freight, insurance, storage, rejected packs and working capital.
| Cost or capacity item | Evidence to request | Hidden constraint to test |
|---|---|---|
| Manufacturing capacity | Validated batch size, available production slots and process-performance qualification plan | A pilot batch does not prove commercial capacity |
| Supply timing | Typical and worst-case lead time, safety-stock policy and approved material sources | One API supplier can stop the schedule |
| Packaging | Approved component specifications, artwork versions, line-clearance and reconciliation records | Artwork changes or component shortages can delay release |
| Commercial terms | Minimum order quantity, payment terms, testing fees and freight responsibility | A low unit price can require excess inventory or early cash payment |
Before accepting the offer, ask for:
- A technology-transfer package defining critical quality attributes, critical process parameters, in-process limits, hold times, sampling plans, equipment differences and scale-up requirements.
- A capacity schedule covering your forecast, peak demand, alternate equipment or sites, and notice periods for material or process changes.
- Packaging controls confirming batch number, manufacturing and expiry dates, strength, storage conditions and licence details will be coded and readable.
- A product-specific stability plan for the proposed batch scale and container-closure system, including India’s hot and humid conditions.
For a Delhi supplier such as Monique Pharmaceuticals Pvt Ltd, compare the quoted delivery date with confirmed production slots, not a standard lead-time statement. A signed quotation should also state who pays for rework, rejected packaging and expedited freight.
Frequently asked questions
What should you verify on a pharmaceutical manufacturer’s licence?
Match the licensed Delhi site, product permission, dosage form, strength and API to your intended medicine. Request a legible licence copy and its endorsed product list.
How do you audit a pharma manufacturer’s quality system?
Review batch records, deviation reports, corrective and preventive actions, testing results, document controls and release procedures instead of relying only on a certificate.
Why test reproducibility between pilot and market batches?
Compare the pilot batch with the proposed market pack for identity, assay, dissolution, appearance and packaging performance before approving routine production.
What belongs in a pharmaceutical quality agreement?
Assign responsibilities for specifications, sampling, testing, batch release, change control, deviations, complaints, recalls, records and regulatory communication.
How should you compare pharmaceutical manufacturing quotations?
Calculate total delivery cost, including minimum order quantities, tooling, testing, packaging, freight, lead time, rejected batches and capacity commitments.
