PBE Expert Inc, we Process, Build, Engineer
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C&Q – Validation & Maintenance
- Pharmaceuticals
- Cannabis
- Biotechnology
- Fine Chemicals & API
- Healthcare & Hospitals
- Traceability matrix and URS and validation cross references.
- Validation Master Plan, (VMP).
- Plan of predictive maintenance, systemic, and preventive.
- Metrology, calibration program, calibration of the instruments, and traceability.
- Mapping (temperature, humidity) cold room, warehouse, freezer, incubator, depyrogenation, autoclave, freeze dryer.
- Commissioning (DQ, FAT, SAT).
- Qualification DQ, IQ, OQ: equipment & classified cleanrooms, quality control Labs equipment, freezer & cold rooms, autoclave, freeze-dryer, isolator, oven, stability room, CIP, SIP, HVAC, PW, EPPI, pure steam, compressed air, N2.
- Sampling Plan, and MACO.
- Process Validation, of cleaning and sterilization (FDA 2011, EMA 2015).
- Sterilization cycles development, Media-Fill tests.
- Computer validation, CSV: BMS, PLC, qualification of ERP software, SAP (GAMP, CFR21-11), data integrity.
- Traceability matrix and URS and validation cross references.
- Validation Master Plan, (VMP).
- Predictive, systemic, and preventive maintenance plan.
- Metrology, calibration program, calibration of the instruments, and traceability.
- Mapping (temperature, humidity) cold room, warehouse, freezer, incubator, autoclave, freeze dryer.
- Commissioning (DQ, FAT, SAT).
- Qualification DQ, IQ, OQ: equipment & classified cleanrooms, quality control Labs equipment, freezer & cold rooms, autoclave, freeze-dryer, oven, stability room, CIP, SIP, HVAC, PW, EPPI, compressed air, N2.
- Sampling Plan, and MACO.
- Process Validation, of cleaning and sterilization (FDA 2011, EMA 2015).
- Sterilization cycles development, Media-Fill tests.
- Computer validation, CSV: BMS, PLC, qualification of ERP software, SAP (GAMP, CFR21-11), data integrity.
- Traceability matrix and URS and validationcross references.
- Validation Master Plan, (VMP).
- Plan of predictive maintenance, systemic, and preventive.
- Metrology, calibration program, calibration of the instruments, and traceability.
- Mapping (temperature, humidity) cold room, warehouse, freezer, incubator, depyrogenation, autoclave, freeze dryer.
- Commissioning (DQ, FAT, SAT).
- Qualification DQ, IQ, OQ: equipment & classified cleanrooms, quality control Labs equipment, freezer & cold rooms, autoclave, freeze-dryer, isolator, oven, stability room, CIP, SIP, HVAC, PW, EPPI, pure steam, compressed air, N2.
- Sampling Plan, and MACO.
- Process Validation, of cleaning and sterilization (FDA 2011, EMA 2015).
- Sterilization cycles development, Media-Fill tests.
- Computer validation, CSV: BMS, PLC, qualification of ERP software, SAP (GAMP, CFR21-11), data integrity.
- Traceability matrix and URS and validationcross references.
- Validation Master Plan, (VMP).
- Plan of predictive maintenance, systemic, and preventive.
- Metrology, calibration program, calibration of the instruments, and traceability.
- Mapping (temperature, humidity) cold room, warehouse, freezer, incubator, depyrogenation, autoclave, freeze dryer.
- Commissioning (DQ, FAT, SAT).
- Qualification DQ, IQ, OQ: equipment & classified cleanrooms, quality control Labs equipment, freezer & cold rooms, autoclave, freeze-dryer, isolator, oven, stability room, CIP, SIP, HVAC, PW, EPPI, pure steam, compressed air, N2.
- Sampling Plan, and MACO.
- Process Validation, of cleaning and sterilization (FDA 2011, EMA 2015).
- Sterilization cycles development, Media-Fill tests.
- Computer validation, CSV: BMS, PLC, qualification of ERP software, SAP (GAMP, CFR21-11), data integrity.
- Traceability matrix and URS and validation cross references.
- Validation Master Plan, (VMP).
- Plan of predictive maintenance, systemic, and preventive.
- Metrology, calibration program, calibration of the instruments, and traceability.
- Mapping (temperature, humidity) cold room, warehouse, freezer, incubator, depyrogenation, autoclave, freeze dryer.
- Commissioning (DQ, FAT, SAT).
- Qualification DQ, IQ, OQ: equipment & classified cleanrooms, quality control Labs equipment, freezer & cold rooms, autoclave, freeze-dryer, isolator, oven, stability room, CIP, SIP, HVAC, PW, EPPI, pure steam, compressed air, N2.
- Sampling Plan, and MACO.
- Process Validation, of cleaning and sterilization (FDA 2011, EMA 2015).
- Sterilization cycles development, Media-Fill tests.
- Computer validation, CSV: BMS, PLC, qualification of ERP software, SAP (GAMP, CFR21-11), data integrity.
Are you looking for a Partner in Process Engineering, Clean Utilities, Project Management, CIP, Layout, Compliance, Validation, QA, Audit, PAI, Calibration or Energy Efficiency?
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