BIOMEDINTERNATIONALRequest a sampleBiomed’s quality system follows each batch from raw-material receipt to dispatch. It is backed by a drug manufacturing licence, cGMP compliance and certifications recognised by pharmaceutical, nutraceutical and food customers.
Licences & certifications
Recognised standards
Each entry states what it is and who issued it.
Regulatory licence
Drug Licence
Licence to manufacture Chondroitin Sulphate Sodium as a drug. Biomed is India’s only drug-licensed manufacturer of it.
- Issued by
- Drugs Control Administration, Andhra Pradesh
Manufacturing standard
cGMP
Current Good Manufacturing Practice, followed across production and quality control.
Certification
ISO 9001:2015
Certified quality management system.
- Issued by
- QRO (Quality Research Organization)
Regulatory licence
FSSAI
Food safety licence for food-grade products.
- Issued by
- Food Safety and Standards Authority of India
Certification
Halal
Halal certification for applicable products.
- Issued by
- Halal India
How each batch is controlled
Checked at every stage
Biomed’s QC and microbiology laboratories are equipped for HPLC, GC, UV-visible spectrophotometry and polarimetry.
Incoming materials
Every raw-material lot is sampled, tested and recorded against its supplier and date of receipt before release to production.
In-process control
Critical parameters are checked at each stage, so problems are caught before a batch moves on.
Finished-product testing
Each batch is tested against USP or BP monographs where applicable, or against the agreed customer specification.
QA release
Quality Assurance reviews the batch record and test results, then releases the batch with its Certificate of Analysis.
What each product is tested to
| Product | Made from | Standard |
|---|---|---|
| Chondroitin Sulphate Sodium | Bovine cartilage | USP · BP |
| Collagen Peptides | Bovine hide · Fish skin | Food grade |
| Glucosamine HydrochlorideGlucosamine Sulphate 2KClGlucosamine Sulphate 2NaCl | Chitin | USP |
| Cholic Acid | Bovine bile | In-house / customer specification |
Every product can also be made to a customer specification. Typical specifications are on the Products page.
Quality system
Behind every batch
These controls run all the time, for every product, alongside the checks on each batch.
Full traceability
Any finished batch can be traced back to the raw-material lots, suppliers and receipt dates behind it.
Retained samples
A sample from each batch is kept after dispatch, so a later query can be checked against it.
Stability studies
Products are kept on stability studies at several storage conditions, which supports their shelf life and storage instructions.
Approved suppliers
Raw materials are bought only from suppliers approved by Quality Assurance.
Written procedures and batch records
Each stage follows a written procedure, and each batch has its own manufacturing record.
Deviations and changes
Deviations, complaints and process changes are recorded, investigated and closed with corrective action.
Documentation
Paperwork for faster supplier approval
Biomed provides the documents a buyer’s quality team needs to approve a new supplier.
- Certificate of Analysis with every batch
- Drug Master File (DMF) for Chondroitin Sulphate Sodium
- Product specification
- Safety Data Sheet
- Method of analysis
- Stability data
- TSE/BSE statement
- Allergen statement
- Supplier questionnaire
- Other declarations