Pharmaco Consulting International Ltd

SERVICES

• Quality system design and implementation to meet GXP or ISO.

• Perrsonnel Trained in GAMP5 regulations.

• Generation of Change Controls, URS, FAT review, SAT review, IQ, OQ, PQ protocols, ERES, Data Flow Maps, Requirement Traceability Matrix, Validation Reports.

• Computer System Validation of Automation Systems, Including Emerson Dell VRTX, Delta V HFAT, CMSAT, Simatic S7, Unicorn, Parker Bulk Fill, WinCC.

• SFAT reviews for Zenith Technologies including VF DF, UFDF, VI.

•C&Q for various Direct and Indirect Utilities and Process Systems.

• System Boundary Implementation.

• Computer System Validation of Laboratory Systems Water HPLC, Polarimeters, UV-Vis Spectrometers, GC, pH meters, Fridge/Freezers, Mastersizer

• Data Integrity Audits and remediation.

• Lead auditor pre-inspection and 483 remediation.

• Mock audits in preparation for FDA or EU inspections.

ASTM E2500 verification approach.

• Contracted staff to cover 3 - 24 month periods.

• Customised training courses.

• Design of compliant Food, Feed or Medicinal facilities and associated manufacturing systems.

• Advice on the relevant laboratory testing to comply with relevant legislation.

• Assisting with Regulatory Documentation for Medicine submission.

• Assisting and advising on the validation of methods and systems for Medicines.

• Technology and method transfers.

• Project Management and Scheduling.