Quality & compliance
The controls behind every consignment
Certifications matter, but what determines whether your shipment clears customs and passes your own QA is the discipline behind them. Here is what we run.
Certifications
Approvals we hold
Documentary evidence for any of the below is available on request as part of a supplier qualification pack.
WHO-GMP
Facilities operate to WHO Good Manufacturing Practice standards, with dedicated beta-lactam and non-beta-lactam blocks.
ISO 9001:2015
Certified quality management system covering manufacturing, quality control and dispatch.
Revised Schedule M
Compliant with the revised Schedule M of the Drugs and Cosmetics Rules, India's upgraded GMP standard.
DCGI
Registered with the Drugs Controller General of India.
FDA Approved
Food and Drug Administration approved. Certification documents are supplied on request as part of a supplier qualification pack.
Manufacturing licences
- Manufacturing Licence
- 711B(H)
- Manufacturing Licence
- 1054-OSP(H)
Process controls
What we actually do on the floor
Segregated beta-lactam manufacturing
Cephalosporins and penicillins are produced in a dedicated block with independent air handling, physically separated from non-beta-lactam capsule and liquid oral production. This is the single most scrutinised control in any pharmaceutical audit.
Raw material qualification
Incoming actives and excipients are tested and released against specification before they enter production. Vendor qualification records are maintained for each material.
In-process controls
Checks at each critical stage (weight, fill volume, sealing integrity and appearance), with deviations recorded and investigated before a batch proceeds.
Finished goods testing
Every batch is tested for assay, sterility where applicable, and physical parameters before release, with a Certificate of Analysis issued against the batch number.
Retained samples & traceability
Control samples are retained for every batch, and batch manufacturing records allow a shipment to be traced back to its raw material lots.
Export packing integrity
Leak-resistant primary packing and cartons qualified for long-haul sea and air freight, protecting product through humidity and temperature variation in transit.
Certificates
Our certificates, on record
Scans of the certificates issued to Yashwin Healthcare. Select any card to view it full size.