Compliance

PharmSol does not limit itself only to offering Audits, but we expand our solution offerings to ensure complete Compliance at the client’s site. Towards obtaining GMP Certification from Europe, United States or WHO, PharmSol has a very effective, systematic and rational approach in providing solutions efficiently. PharmSol operates on a turnkey basis and gets involved completely, ensuring success to its clients, which is the overall objective.

EU/ AU/ WHO/ PIC/s GMP Certification

GDP

Serialization

CAPA Support

Computer System Validations and CSV Audits

GxP Compliance Training

EU/ AU/ WHO/ PIC/s GMP Certification

With ever-increasing outsourcing of Finished Products, APIs, KSMs from Asia, there is a sudden surge in demand for compliance. PharmSol, with its team of CEFIC/APIC/ASQ CQA/IRCA Certified auditors can provide end-to-end service and facilitate in getting the client’s facility approved by competent EU / AU / WHO / PIC/s Authorities and realize their objective of establishing their presence in international markets.

GDP

PharmSol carries out GDP Audits of various cargo operators including warehouses, logistic companies, airports, airlines etc. In 2017, 10 of PharmSol auditors were qualified as CEIV Pharma Independent Validators. (CEIV, Centre for Excellence of Independent Validators is a proprietary program of IATA under which air cargo handling companies are certified with the principle of compliance with pharma GDP guidelines).

Serialization

With Serialization guidelines in place, PharmSol offers customized solutions for Compliance around serialization.

CAPA Support

More than non-compliances per se, the pattern of the non-compliances reveals the holistic CAPA to be established. PharmSol, with its ample experience of Remediation and handling of Authority Inspections across the world, firmly believes in the flawless execution of CAPA followed by its closure.

Computer System Validations and CSV Audits

PharmSol provides comprehensive support and guidance to its clients in performing validations of the computer systems. In cases where systems are already validated, PharmSol conducts CSV Audits in accordance with 21 CFR part 11 compliance and ALCOA, CFR 210, CFR 211, ICH Q7 &, GAMP 5. A Risk Based Approach to Compliant GxP Computerized System, ALOCOA+, EUGMP Annex 11, WHO Guideline on Validation – Appendix 5.

GxP Compliance Training

PharmSol organizes extensive training sessions for all its clients covering all areas of Compliance. While trainings are conducted, wherever needed after the audits, PharmSol also arranges training sessions for QA and Manufacturing personnel of clients, keeping them abreast with latest regulatory requirements and market challenges.