What this policy covers
This page sets out how Monark Criticare manufactures and releases the injectables it sells. It applies to everything we supply, whether it carries our own label, a distributor's label under a franchise arrangement, or a customer's brand under a third party manufacturing agreement. The commercial terms differ between those three. The manufacturing standard does not.
We manufacture, we do not trade
Formulation, filling, inspection and quality control happen on our own site at Plot No. 201, Ground Floor, HSIIDC Phase 1, Industrial Area, Alipur, Barwala, Panchkula, Haryana 134118. That is a deliberate position rather than a detail of logistics. When a customer asks why a particular batch behaved the way it did, we can answer from our own records instead of forwarding the question to a third party and waiting.
It also fixes what we will and will not take on. We fill injectables only: dry powder, liquid injectable, lyophilised and IV infusion. We do not make tablets, capsules, syrups or ointments, and we do not broker them for anyone else. A supplier who quotes for everything is buying most of it somewhere you cannot see.
Materials and vendors
Nothing enters production on a supplier's word alone. Active ingredients and excipients are bought against a written specification, sampled on arrival and tested before release to production. Each lot is quarantined until it passes.
- Every incoming lot is identified, sampled and tested against its specification before it can be issued to a batch.
- Materials are approved by vendor and by lot, not by vendor alone, so a qualified supplier still cannot push through an out-of-specification consignment.
- Primary packaging that touches the product, including vials, stoppers and seals, is qualified the same way as the ingredients.
- Rejected material is physically segregated and recorded, not returned to the general store.
In-process control
Checks run during the batch, not only at the end of it. Weighing is verified, filling volumes are sampled across the run rather than at the start, sealing integrity is checked, and every filled unit passes visual inspection for particulate matter and container defects. A parameter that drifts outside its limit stops the batch and is investigated before it moves.
Line clearance between batches is documented. Equipment and rooms are cleaned to a written procedure and signed off before the next product is set up, which is what keeps one product out of the next.
Release against specification
A batch is released by quality control, not by production and not by the sales desk. It is tested against the specification for that product and it ships only if it passes. If it does not pass it is not reworked into a pass; it is rejected and recorded.
A certificate of analysis travels with the consignment. It carries the batch number, the date of manufacture and the date of expiry, and the results the batch was released on, so the receiving party has the evidence in hand rather than having to write and ask for it.
Batch records and traceability
Every batch has a manufacturing record that follows it from the raw material lots issued to the quantity dispatched and to whom. Records are retained so that any vial in the market can be traced back to its batch, and from that batch to the materials, the line and the people who ran it. That is what makes a recall or a market complaint answerable in hours instead of weeks.
- Batch numbers are unique and never reused.
- Manufacturing and packing records are retained for the statutory period after expiry.
- Control samples are retained for each batch.
- Complaints are logged, investigated against the batch record and answered in writing.
Labelling, artwork and third party manufacturing
Where we manufacture under a customer's brand, the customer owns the brand and we own the batch. Artwork is approved in writing before printing and is checked against the approved proof at packing, because a correct product in a wrong carton is a recall.
The customer is responsible for holding the licences and registrations its own market requires, and for the claims its artwork makes. We are responsible for the product in the vial matching the specification the label declares. Neither of us can discharge the other's half.
Storage and dispatch
Finished goods are stored to their label conditions and dispatched with the batch and expiry legible on the outer. Where a molecule requires a cold chain we say so on the order rather than at delivery, and we ship it packed for the transit time the destination actually takes.
We dispatch to licensed parties only. A distributor, stockist, hospital or institution has to be able to hold what it is buying, and we ask for the documentation that shows it before the first consignment moves.
What we will not do
- We do not supply prescription injectables to anyone not licensed to hold them.
- We do not release a batch that has failed its specification, in any quantity, at any price.
- We do not backdate, reissue or amend a certificate of analysis after release.
- We do not put a claim on a label that the batch record does not support.
Questions about a batch
If you are holding a consignment and something about it does not look right, contact us with the batch number before you distribute it further. Write to monarkcriticare@gmail.com or call +91 90567 60548. We would far rather answer a question about a batch than a complaint about one.