Quality & Regulatory
At Vilayat, we regard quality as a shared responsibility and a core value of our organization. Our unwavering commitment to quality has enabled us to earn customer trust and establish a strong reputation within the industry. We focus on robust systems, efficient processes, advanced technology, and skilled people to foster a culture of quality.
Vilayat Pharma is dedicated to delivering comprehensive services—from laboratory development to commercial-scale production—offering competitively priced, high-quality products and thorough documentation support in alignment with Good Manufacturing Practices (GMP).
To uphold this commitment, our organization focuses on:
- Continual assessment and enhancement of our Quality Management System, personnel, and processes
- Ongoing training of staff in current GMP standards by both internal and external industry experts
- Integration of SAP ERP System to embed quality into every aspect of business operations
- Adoption of environmentally friendly processes and technologies
Key Highlights of Our QC Department
- Adherence to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
- Well-equipped laboratory facilities, including both Wet Lab and Instrument Lab
- Regular calibration of testing instruments
- Conducting hold time studies for intermediates and advanced intermediates
- Sampling and testing of raw materials, solvents, and in-process materials
- Sampling and testing of finished products
- Comprehensive procedures for data and record keeping
Key Highlights of Our QA Department
- Quality Management System compliance as per ICH Q7 guidelines
- All changes managed through a structured change control procedure
- Rigorous document control measures
- Established deviation management procedures
- Annual product quality reviews
- Defined batch release procedures
- Vendor qualification protocols
- Market complaint management procedures
- Corrective and preventive action (CAPA) procedures
- Provision of CMC documents for advanced intermediates to support regulatory filings
- GMP-compliant training for all personnel
Regulatory Support
Our documentation practices adhere to ICH guidelines, enabling our customers to file DMFs with the FDA in the required ICH format and access all necessary CMC documents.
We provide comprehensive support for client filings and documentation to facilitate DMF submissions in various regions according to client needs.
Our expert Regulatory Affairs team promptly addresses customer complaints and regulatory queries, positioning us as a preferred CMO/CDMO service provider for our clients.
