PEEQ CONSULTING

We can support your business in : Cleanroom qualification and monitoring - Disinfectant selection and qualification (strategy, protocol and report) - Cleaning room validation (risk assessment, protocol and report) - Establishment of environmental monitoring program - EM oversight and EM trends (trends analysis of EM data) Clean utilities qualification and monitoring - Purified water, water for injection, pure steam and compressed air - Qualification strategy's definition and execution (risk assessment, protocol and report) - Monitoring program's implementation, oversight and trends Management of quality system - Management of deviations, CAPA, change control, OOS. - Writing of quality documents (SOP, rationales, quality and technical agreements and memos) - QC matter specialist for project and during audit/inspections - Management of Audits / Inspections (Inspection readinness, coordination and response process) - Management of regulatory compliance of QC analytical methods Lab set-up and management - Laboratory implementation and budgeting, planning and follow-up of the lab activities - Equipment’s selection, purchase and qualification (URS, qualification and SOP writing) - Microbial methods development and validation comply with USP/EP/ISO (Bioburden, Endotoxin test, BI’s, growth promotion test, mycoplasma test), - Follow-up of release testing and lab activities, analytical data review. - Lab technician's recruitment, training and coaching