Valeshvar

Quality Management

Quality Management Systems

Quality is one of our core values, and as such, we invest a significant amount of attention and resources into ensuring that we support our continuous improvement process and culture in this area.

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To provide high quality products and professional services to the global pharmaceutical industry

To surpass regulatory requirements and the expectations of our customers

Quality Assurance System
Unwavering Commitment to Excellence

At Valeshvar, we prioritize the highest quality standards throughout our entire manufacturing process. Our robust Quality Assurance System is fully compliant with the rigorous requirements of Good Manufacturing Practices for Active Pharmaceutical Ingredients (ICH Q7). Furthermore, our facilities are fully auditable, ensuring transparency and adherence to regulatory guidelines.

A Proven Track Record of Excellence

For over five years, we have maintained a successful inspection track record, reflecting our unwavering commitment to quality. This achievement demonstrates our ability to consistently meet the stringent standards set forth by regulatory agencies.

Customer Focus and Continuous Improvement

Leading pharmaceutical companies regularly visit our facilities to verify our GMP compliance. We view these customer audits as valuable opportunities to showcase our commitment to quality. Additionally, these visits provide us with valuable insights into the latest industry trends, which we actively leverage to drive continuous improvement within our Quality Assurance System.

Partnering with Valeshvar means
Getting the highest quality products & consistently exceeding regulatory expectations
Quality Assurance
An experienced and qualified quality unit team is present at our sites to maintain local compliance with cGMP and regulations led by the site quality assurance. Furthermore, this quality assurance team ensures consistency, sharing of best practices and continuous quality system improvement at all of our sites.
Measurement of performance
In order to support our constant improvement process, our quality performance is internally monitored with a set of broadly based measures. These measures are collected and reviewed by the quality teams at each site and monitored by Quality management to identify and understand any trends, potential issues and, most importantly, to ensure that any necessary preventive actions are taken to guarantee the quality, continuous improvement and success of our business.
Quality Control

Well-equipped, state-of-the-art laboratories perform complete tests according to the Pharmacopoeia (e.g. EP, USP, JP), in-house developed analytical methods and customer requirements.

Our staff of chemists have extensive knowledge and expertise in validating analytical methods for raw materials, intermediates, API’s and cleaning procedures in compliance with the current ICH and FDA guidelines.

ICH stability studies, stress tests and forced degradation studies are also performed to guarantee the long-term quality of our products. Furthermore, the Corporate Quality Control team ensures DL response in terms of development and validation of the analytical method and on-site support for all QC activities.

Equipments
  • HPLC unit with UV detector
  • HPLC unit with RI detector
  • GC unit with direct injection
  • GC unit with headspace unit for residual solvents
  • Polarimeter
  • Melting Point Apparatus
  • Karl-Fischer (volumetric and coulometric) titrator
  • Stability Test Chambers
  • Digital Mirco Moisture Balance
  • Lab equipment (pH-meter, conductometer, heating plates, …)
  • COD Analyze