Validation Services

Process Validation

Our speciality is Validation of manufacturing processes - Bulk and Finished Products of Solid Oral Dosage form and Liquids, Granulation, Tablet Compression and Coating, various Sterilization processes – Steam, Dry Heat, Ethylene Oxide, Gamma Radiation and Filter sterilization processes. We help our clients in establishing a better understanding of the manufacturing processes and identifying Critical Parameters for setting up of Process controls. Estimate process capabilities and establish Specifications, develop Control Charts for monitoring and Trending of all the processes.

Cleaning Validation

Develop Master Plans, Product Matrices, Residue Recovery and establishing Limits and Protocols for effective execution of Pharmaceutical and Bio-Pharmaceutical Cleaning Validation. Also help clients in developing effective Cleaning methods for product contact and non-product contact surfaces, manufacturing floors and Cleanroom environment. Help test efficacy of the cleaning and sanitization procedures.

Analytical Method Validation

Develop strategies for Validation of various Analytical Test Methods including and not limited to HPLC, GC and Spectrophotometric methods. Prepare validation protocols in compliance with ICH Q2B and help execute them. Prepare SOPs for Analytical Method Validation both for initial and revalidation. Audit existing test methods for adequacy of Validation compliance and help complete them.