Uncompromising Quality Assurance
Every Swashree product passes rigorous multi-stage quality testing before reaching a healthcare professional or patient.
Our Philosophy
Quality is built in, not inspected in
At Swashree Pharmaceuticals, quality assurance is not a final checkpoint — it is woven into every stage of the product lifecycle, from supplier qualification to shelf-ready packaging.
We work exclusively with manufacturing partners who meet WHO-GMP standards and subject all incoming materials, in-process intermediates, and finished products to documented analytical testing before any batch is released.
Supplier qualification and approved vendor list management
Written Standard Operating Procedures (SOPs) for all critical processes
Batch-level documentation and full traceability
Deviation and CAPA (Corrective & Preventive Action) management
Periodic self-inspections and third-party audits
End-to-End Testing
Four-Stage Quality Process
Every batch progresses through four defined quality gates before product release.
Raw Material Testing
Every incoming raw material and excipient is sampled and tested before it enters the production area.
- Identity confirmation (IR / HPLC)
- Purity and assay testing
- Microbial limit tests
- Heavy metal screening
- Approved vendor verification
In-Process Checks
Continuous monitoring of critical quality attributes during every stage of manufacturing.
- Weight variation checks
- Hardness and friability
- Disintegration time
- Blend uniformity
- Fill volume for liquids
Finished Product Analysis
Comprehensive testing on finished, packaged product before batch release authorisation.
- Assay and content uniformity
- Dissolution / release profile
- Appearance and packaging integrity
- Microbiological analysis
- Related substances / impurities
Stability Studies
Long-term and accelerated stability testing per ICH guidelines to confirm shelf life and storage conditions.
- ICH Zone IVb conditions (40°C/75% RH)
- Accelerated 6-month studies
- Long-term real-time studies
- Photostability testing
- Label claim verification
International Standards
WHO-GMP Commitment
All Swashree manufacturing partners operate under WHO Good Manufacturing Practice (GMP) guidelines — the internationally recognised benchmark for pharmaceutical quality management.
WHO-GMP compliance ensures consistent processes, documented batch records, validated equipment, trained personnel, and a structured approach to deviations and corrective actions.
View Our CertificationsSOP-Driven Processes
All manufacturing and quality activities are governed by approved, version-controlled Standard Operating Procedures.
Clean Room Standards
Injectable and sterile product manufacturing in classified clean rooms with environmental monitoring.
Batch Documentation
Complete batch manufacturing and packaging records maintained for every product lot produced.
Equipment Qualification
All critical manufacturing equipment is IQ/OQ/PQ qualified and subject to scheduled calibration and maintenance.
Common questions
Frequently Asked Questions
Questions about our quality standards?
Our quality team is happy to provide detailed documentation, certificates of analysis, and batch testing reports upon request.