GMP regulations mandate a risk-based quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. Key GMP processes include including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Failure of firms to comply with GMP regulations can result in very serious consequences including product recall, plant closure, penalties, fines and severe legal proceedings.

As most GMP requirements are very general and open-ended, manufacturers find it difficult to interpret critical requirements and implement necessary quality and risk controls that assure proper design, monitoring, and control of manufacturing processes and facilities. The Regulatory team at Techsol specializes in providing very focussed cGMP regulatory services that meets the quality criteria mandated by agencies.