Dynamic Pharma Solutions

Quality Assurance, Validation, and Compliance consulting in the pharmaceutical industry We have varied expertise in all aspects of Quality, from writing SOPs, protocols and Master Plans for a new manufacturing facility and reviewing existing systems for compliance, effectiveness and efficiency. IQ, OQ and PQ Protocols : In order to be GMP compliant your processes, installations, machines, procedures and methods of analysis require and need to adhere to IQ, OQ and PQ protocols. These protocols help verify whether you live up to the specifications stipulated in the FDA, GMP and GLP guidelines. Installation Qualification (IQ): Our experts assess whether your equipment is installed properly. Points of attention include utility provisions, component specifications, construction materials, user manuals and safety measures. Operation Qualification (OQ): Our experts assess your operational efficiency. We assess whether your machines can perform within the set specifications and limits. OQ evaluation is based on calibration results, control functions and general operation results. Performance Qualification (PQ): In this initial validation we check all parameters, sensors and programs. Our consultants use the PQ to advise which parameters and programs need annual revalidation. • Review of manufacturing facilities and quality management systems • Review of your manufacturing processes • Audits of contractor facilities for supplier selection or GMP compliance • Work with in-house QA experts to improve presentation of facility and systems for Inspector Change Control • Assist clients with writing, approval and execution of change controls • Facilitate meeting by interfacing technical, quality, and manufacturing groups. • Drive change controls timely implementation and closure Our experts have over 25 years experience in the pharmaceutical arena. We'll help you set up the right quality systems covering the entire product lifecycle.