QUALITY ASSURANCE
100% Quality Assurance
At Psymer Biotech Private Limited – Quality That Inspires Trust
At Psymer Biotech Private Limited, quality is not just a process—it is our promise, our responsibility, and the foundation of our commitment to improving renal health and overall patient well-being.
Every product we manufacture reflects our dedication to delivering pharmaceuticals that meet the highest standards of safety, efficacy, purity, and reliability. As a company innovating for renal health, we understand the critical importance of precision in every capsule, tablet, and formulation we produce.
Quality-by-Design (QbD) Approach
- Our formulations are developed using a QbD framework, ensuring quality is built into every step—from concept to final product. This guarantees stability, accuracy, and consistent therapeutic performance.
Comprehensive Raw Material Testing
- Every API and excipient undergoes thorough identity, purity, and safety testing before entering production. We source only validated and certified raw materials for maximum product reliability.
GMP-Compliant Manufacturing
- Our manufacturing is carried out in controlled environments that follow WHO-GMP standards. From cleanrooms to hygiene protocols, we ensure contamination-free and safe production conditions.
In-Process Quality Checks
- Throughout manufacturing, each batch is continuously monitored for weight, hardness, dissolution, and coating uniformity. These checks ensure each tablet and capsule meets precise specifications.
Advanced QC Laboratory
- Using technologies like HPLC, UV Spectrophotometry, and FTIR, our QC team performs detailed analysis on every batch. This guarantees purity, potency, and safety before products reach patients.
Stability Studies & Shelf-Life Assurance
- We conduct ICH-guided stability testing to ensure our formulations remain effective throughout their shelf life. This ensures long-term efficacy under various storage conditions.
Secure & Compliant Packaging
- Each product is packed using high-quality Alu-Alu or blister materials to maintain integrity. We verify labeling, sealing, and artwork accuracy to meet strict regulatory guidelines.
Strong Documentation & Traceability
- Our robust documentation system ensures complete traceability at every stage of production. We maintain BMRs, BPRs, SOPs, and quality logs to support audit-readiness and transparency.
