Quality
Quality framework for the Indian B2B pharmaceutical trade
SPK Pharma India operates to pharmacopoeial standards, lot-matched documentation, and a documented quality management system. Every batch is verified, every shipment is documented, every buyer enquiry reaches a human within one business day.
Quality process
Supplier qualification
Partner manufacturing facilities qualified against WHO-GMP / Schedule T standards. Audit records, regulatory filings, and quality history maintained per supplier.
In-process control
Production runs in ISO-class cleanroom environments with controlled air handling. In-process QC checks at defined batch stages.
Batch release
Every batch tested for identity, purity, and contamination. Pharmacopoeial methods (USP / EP / BP / IH) applied per molecule. Third-party verification on representative samples.
Shipment
Lot-matched COA, MSDS, commercial invoice, packing list, and Certificate of Origin (Pharmexcil) accompany every shipment. Cold-chain handling with data loggers in transit.
Pharmacopoeial compliance
Quality testing follows the relevant pharmacopoeia for each product and destination market. The standard pharmacopoeias applied across the SPK Pharma India supply chain are:
- •USP (United States Pharmacopeia) — for products destined for the US market and as the default standard where the buyer specifies USP compliance.
- •EP (European Pharmacopoeia) — for products destined for EU member states.
- •BP (British Pharmacopoeia) — for products destined for the UK market.
- •IH (Indian Pharmacopoeia) — for products destined for India and as the default standard for APIs manufactured in India.
- •JP (Japanese Pharmacopoeia) — applied where the buyer specifies JP compliance for Japan-destined product.
Test methods, acceptance criteria, and reference standards are documented per product on the lot-matched COA. Where multiple pharmacopoeias are acceptable, the buyer's specified standard is followed and documented.
What is on the Certificate of Analysis
- •Identity confirmation — HPLC retention time, mass spec molecular ion match, IR / UV-Vis where applicable
- •Purity / assay — HPLC area percentage at the specified wavelength, or assay by titration per pharmacopoeial method
- •Endotoxin — LAL test result for parenteral-grade and peptide API lots
- •Microbial limits — TAMC / TYMC per pharmacopoeial method where applicable
- •Residual solvents — by GC per ICH Q3C guidelines where applicable
- •Appearance — visual description of the API, excipient, or finished dosage form
- •Storage and handling — recommended conditions per product specification
- •Batch identifiers — manufacturing lot, SPK SKU, manufacturing date, expiry / retest date, and the issuing laboratory reference
Request a sample COA or quality dossier
Sample COAs and quality dossiers are available on request for any product in the catalogue. Reach out to the trade desk with the product name and intended destination market.
Contact trade desk