Compliance

PharmSol does not limit itself only to offering Audits, we expand our solution offerings to ensure complete Compliance at Client’s site. Towards obtaining GMP Certification from Europe or United States or WHO, PharmSol has a very effective, systematic and rationale approach in providing solution 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

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

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 on Remediation and experience on handling a number of Authority Inspections across the world firmly believes in the flawless execution of the 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.

GDP

PharmSol carries our 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).

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.

Serialization

With Serialization guideline in place, PharmSol Group offers towards customizing solutions for Compliance around Serialization.

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Our Establishments

PharmSol GmbH

Bad Oldesloe, Germany

PharmSol Europe Limited

Balzan, Malta

Pharmaceutical Solutions FZCO

Jebel Ali, Dubai, United Arab Emirates

Pharmaceutical Solutions DMCC

Jumeirah Lakes Towers, Dubai, United Arab Emirates

PharmSol India Pvt. Ltd.

Hyderabad, India

PharmSol (Nanjing) Pharmaceutical Technology Co.Ltd

Nanjing City, Jiangsu Province, PR China

PharmSol APAC Limited

Hong Kong, China