A manufacturer’s catalogue and sales presentation do not prove that its facility can legally make, test, release and consistently supply your product. By checking licences, GMP evidence, technical capability, quality records and regulatory responsibilities in the right order, you can reject unsuitable factories before signing or printing packaging.
Key takeaways
- Ask for a Form 20B licence copy showing the correct factory address.
- Confirm permissions cover your dosage form, formula and intended product.
- Compare batch records, test reports and samples for consistent quality.
- Approve specifications, packaging artwork and responsibilities in the manufacturing agreement.
Verify the licence, premises and product permissions
A valid pharmaceuticals manufacturer licence must match your product, dosage form and factory address. For a Delhi site, ask for the drug manufacturing licence India requires, issued by the competent state licensing authority—not a GST registration, FSSAI licence or company incorporation certificate.
Check the licence itself, not a certificate image or sales claim. Confirm these details:
- Licence number, issuing authority and validity dates
- Exact factory address, including the premises named on the licence
- Approved dosage forms, such as tablets, capsules, oral liquids, creams or sterile injections
- Covered product categories and any restrictions
- The proposed product’s formulation, strength and pack configuration
A GMP certificate answers a different question: whether the site’s manufacturing system meets the stated standard. It does not authorise a particular formulation, strength, indication, label or promotional claim.
Ask for the product permission India requires for your product and compare it with the proposed composition and label. A manufacturer authorised to make tablets is not automatically authorised to make your modified-release capsule or sterile injection. The permission must also identify the manufacturing premises.
If production uses a loan-licence arrangement, identify the licence holder, manufacturer of record, batch releaser and regulatory contact. Reject any proposal where the licence names another factory, expired premises approval or excludes your dosage form. Keep copies of the licence, GMP certificate and product permission in your supplier file.
Test the quality system behind the certificate
A GMP certificate is a snapshot, not proof that a site controls every batch. Request GMP verification from the issuing authority, confirm its scope, validity and matching factory address, then examine the systems that turn requirements into investigations, records and release decisions.
Before approval, request evidence for:
- The site master file, recent inspection or audit findings, Schedule M GMP gap assessment and remediation records. Look for named owners, completion dates and effectiveness checks.
- Deviation, out-of-specification and CAPA files with personal or commercial details redacted. Each investigation should identify root cause, impact assessment, corrective action and quality assurance approval.
- Quality control laboratory records showing validated or verified methods, approved specifications, reference-standard traceability, raw-data review and an approved batch-release process. A certificate of analysis alone proves little.
- Computerised records with unique user access, audit trails, controlled changes, backup and restoration testing, and protection against deletion or retrospective alteration. A printout does not establish ALCOA-consistent data integrity.
- Complaint and recall simulations, including batch traceability and retrieval of manufacturing, testing and distribution records within the required retention period.
Put responsibilities into the technical agreement. It must state who handles sampling, testing, deviations, change control, batch disposition, complaints, recalls, inspections and record access. Outsourcing production does not transfer the marketing authorisation holder’s responsibility for product quality and ongoing safety oversight.
A manufacturer that cannot produce complete records quickly cannot demonstrate control, regardless of its certificate.
Match factory capability to your formula and specification
A site is suitable only if it can reproduce your exact dosage form, strength, pack, release profile and batch size—not merely make a similar product. A facility that produces immediate-release tablets may lack the equipment, coating controls or validated process for a film-coated modified-release tablet.
Confirm the approved manufacturing licence and the site address before accepting its capability claim.
Request written evidence for each specification:
- Dosage form capability, including the equipment and line used for your tablet, capsule, oral liquid, topical preparation or sterile product.
- Strength capability, including the smallest and largest practical API loading and the formulation’s API and excipient controls.
- Pack capability, including the exact blister, bottle, sachet or vial format, fill count, closure and labelling line.
- Batch-size capability, including a validated commercial scale rather than an unproven pilot quantity.
For modified-release manufacturing, ask for the release mechanism, coating or matrix process, in-process controls and comparative dissolution data. “Assay and dissolution” results from one trial batch do not prove repeatable performance; review specifications, method validation, reference-standard traceability and results across development or validation batches.
A release profile that shifts between batches can alter exposure even when the assay passes.
Check that the manufacturer can produce your required quantity without excessive scale-up risk. If your order is below its validated range, segregation, mixing and fill-weight variation can undermine uniformity. If it is above that range, the process may need a documented validation exercise before commercial release.
Use samples and data to judge consistency
A single passing sample proves only that one batch met its tests. Ask for results from at least three consecutive commercial-scale batches made to the same formula, process, batch size and specification; compare numerical results, not just “pass” entries.
Request these records for each batch:
- Certificate of analysis showing assay, impurities, microbial limits, physical tests and release date
- Approved specifications, test methods, raw-data review and batch-release approval
- Batch manufacturing and packing records, including yields, deviations and reprocessing
- Stability data from the proposed pack, storage condition and testing intervals
Use independent laboratory testing on retained samples from more than one batch. Include identity, assay, impurities and dissolution testing for solid oral medicines. A result is useful only when the receiving laboratory has validated or appropriately verified the method and can trace measurements to identified reference standards.
Compare its results with the manufacturer’s original data; unexplained gaps or unusually perfect figures require investigation.
Check whether dissolution profiles remain comparable across batches, since matching assay alone will not prove the same release behaviour. Review stability data through the proposed shelf life, not just an initial time point. Look for trends in assay, degradation products, dissolution, moisture and appearance.
Ask how failed results, atypical trends and out-of-specification results were investigated. A manufacturer that supplies samples but cannot produce complete, traceable records has not demonstrated repeatable commercial quality.
Define the legal arrangement and approve the pack before production
Before production, put in writing who legally manufactures each batch, who releases it, and who answers regulators. A contract manufacturing or third-party manufacturing deal may use the factory’s manufacturing licence; a loan licence uses separate application and licence forms and depends on an already licensed manufacturing premises.
The contract must name the licence holder, manufacturer of record, batch releaser and regulatory contact.
1. Identify the arrangement as contract manufacturing, third-party manufacturing, loan licence or private labelling. Check that the named licence covers the product, strength, dosage form and factory address; GMP certification alone does not authorise a formulation, indication or claim.
2. Assign responsibility for specifications, sampling, testing, deviations, out-of-specification investigations, change control, batch disposition, complaints, recalls, inspections and record access. Require validated or verified analytical methods, reference-standard traceability, raw-data review and an approved batch-release process—not only a certificate of analysis.
3. Send the artwork, composition and promotional copy through regulatory review before printing. Confirm the approved strength, pack size, storage conditions, manufacturer details and expiry format, plus the prescription and warning statements required for Schedule H, H1 or X medicines.
4. Approve one controlled master artwork and master manufacturing record. Block production after any unapproved change, including an altered excipient, indication, dosage claim, pack count or label statement.
When assessing Monique Pharmaceuticals Pvt Ltd, request the proposed licence or loan-licence documents and compare their product scope with the exact pack you intend to market, rather than relying on a catalogue or certificate image.
Frequently asked questions
Which licence should you verify before choosing a pharmaceuticals manufacturer?
Ask for the drug manufacturing licence issued by the competent state licensing authority. Check that it names the correct factory address and covers your product and dosage form; GST, FSSAI and incorporation certificates do not replace it.
How do you assess a pharmaceutical manufacturer's quality system?
Review the quality manual, standard operating procedures, batch manufacturing records, deviation and complaint logs, change-control process, and certificates of analysis. Confirm that records are complete, signed, dated and traceable to the batch.
What factory capabilities must match your medicine specification?
Match the site’s equipment, clean areas, utilities, storage conditions and testing facilities to your formula and dosage form. Check requirements such as temperature control, humidity limits, microbial testing and specialised processing.
What should a pharmaceutical manufacturing agreement define?
Define product specifications, testing, batch release, documentation, deviations, recalls, confidentiality, intellectual property, approved suppliers, change control and responsibility for packaging artwork. Approve the final pack design before production begins.
