Process Validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics
FDA Guideline on General Principles of Process Validation
To support Good Manufacturing Practices by always focusing on the guidelines, ensuring the ultimate goal - patient safety.
Bestech GMP Contracting effectively partners with its clients to provide comprehensive technical services to support the manufacture of their drugs and biological products. Whether its process development, a start-up plant, renovation/addition, training or quality system improvements, Bestech can meet your needs by acting as an extension of your staff.
Bestech understands manufacturing in the GMP environment. Our team is comprised of qualified professionals who have been integral team members of Pharmaceutical or Biotech companies and have experienced first-hand the regulatory challenges of the industry.
From the outset of each project, Bestechs goal is to eliminate non-value added activities by basing decisions on product and process risk. This approach enables clients to competitively provide products that are safe and effective to their patients while remaining in a state of good regulatory compliance.
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