Compliance


PharmSol carries out a complete chain of audits which assures product safety and quality to clients across the globe for Finished Products, APIs, Intermediates and Key Starting Materials (KSMs). The Auditors of Team PharmSol are accredited with various certifications including APIC/CEFIC and ISO.
EU GMP Certification

PharmSol provides end – to – end service for EUGMP Certification, which involves:

• Conducting GAP Analysis Audits
• Assistance in Facility Compliance based on the outcome of GAP Analysis Audit
• Assistance in application and triggering of EUGMP Inspection from the Competent Authority
• Conducting Preparatory / Mock Audit prior to Authority inspection
• Extension of Support by deputing PharmSol’s team at Site during authority inspection
• Support in Post-inspection CAPA Closure for submission to the authority

GMP Audits (QP Audits)

PharmSol conducts qualification of the manufacturing sites in accordance with ICH Q7, EudraLex Volume 4; Code of Federal Regulations 21 CFR Part 11; and PIC/s Guide to Good Manufacturing Practice for Medicinal Products, January 2013.

PharmSol is one of the first companies to have conducted third party GMP audits for its European clients in compliance with EC Directive 2004/27/EC. PharmSol has successfully conducted more than 500 GMP audits across the globe until the end of 2015.

GLP Audits

GLP Audits are essential to ascertain suitability & capability of contract development center (for APIs as well as FDFs) together with the Qualify Control Infrastructure, prior to initiation of a product development. With the enforcement of Data Integrity guidelines, this sector has assumed prominence and PharmSol has strong capabilities here.

GCP Audits

PharmSol through its network of associates offers this service exclusively under its banner. With the tough regulatory situation facing all CROs across the globe, it is crucial for all dossier developers to conduct an audit prior to initiation of a BE / Clinical Study.

Facility Feasibility Audits

A feasibility audit of a facility is conducted prior to scaling up or tech transfer of a new product to a CMO site. This is a very important aspect often overlooked, which can adversely impact project timelines, costs and resultant revenues.

GAP Analysis Audits

GAP Analysis Audits conducted by PharmSol, greatly support the clients of PharmSol in ensuring successful qualifications / regulatory inspections. Besides conducting thorough GAP Analysis Audits, Team PharmSol provides valuable assistance to all clients in bridging the gaps and accomplishing a sustainable level of GMP Compliance. The guidance provided by PharmSol also includes extensive training to the staff in maintaining Compliance and going through inspections.

Supply Security Audits (EHS)

Outsourcing and Contract Manufacturing are essential parts of pharmaceutical business and this necessitates reliance on third parties. Therefore, ensuring uninterrupted supplies from manufacturing sites not only depends on the GMP Compliance, but also on EHS Compliance. Supply Security Audits demand an integrated expertise of GMP, GEP and EHS and Team PharmSol has significant capabilities in this area.

Computer System Validations and CSV Audits

Use of Computer Systems in each area of Pharmaceutical business (inclusive of Manufacturing, Quality and Supply Chain) has become a necessity and the systems being deployed need to be validated in compliance with regulatory guidelines. 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 EUGMP and USFDA regulations.

GxP Compliance Training

PharmSol provides extensive trainings to all its clients in 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.


PharmSol carries out a complete chain of audits which assures product safety and quality to clients across the globe for Finished Products, APIs, Intermediates and Key Starting Materials (KSMs). The Auditors of Team PharmSol are accredited with various certifications including APIC/CEFIC and ISO.
EU GMP Certification

PharmSol provides end – to – end service for EUGMP Certification, which involves:

• Conducting GAP Analysis Audits
• Assistance in Facility Compliance based on the outcome of GAP Analysis Audit
• Assistance in application and triggering of EUGMP Inspection from the Competent Authority
• Conducting Preparatory / Mock Audit prior to Authority inspection
• Extension of Support by deputing PharmSol’s team at Site during authority inspection
• Support in Post-inspection CAPA Closure for submission to the authority

GMP Audits (QP Audits)

PharmSol conducts qualification of the manufacturing sites in accordance with ICH Q7, EudraLex Volume 4; Code of Federal Regulations 21 CFR Part 11; and PIC/s Guide to Good Manufacturing Practice for Medicinal Products, January 2013.

PharmSol is one of the first companies to have conducted third party GMP audits for its European clients in compliance with EC Directive 2004/27/EC. PharmSol has successfully conducted more than 500 GMP audits across the globe until the end of 2015.

GLP Audits

GLP Audits are essential to ascertain suitability & capability of contract development center (for APIs as well as FDFs) together with the Qualify Control Infrastructure, prior to initiation of a product development. With the enforcement of Data Integrity guidelines, this sector has assumed prominence and PharmSol has strong capabilities here.

GCP Audits

PharmSol through its network of associates offers this service exclusively under its banner. With the tough regulatory situation facing all CROs across the globe, it is crucial for all dossier developers to conduct an audit prior to initiation of a BE / Clinical Study.

Facility Feasibility Audits

A feasibility audit of a facility is conducted prior to scaling up or tech transfer of a new product to a CMO site. This is a very important aspect often overlooked, which can adversely impact project timelines, costs and resultant revenues.

GAP Analysis Audits

GAP Analysis Audits conducted by PharmSol, greatly support the clients of PharmSol in ensuring successful qualifications / regulatory inspections. Besides conducting thorough GAP Analysis Audits, Team PharmSol provides valuable assistance to all clients in bridging the gaps and accomplishing a sustainable level of GMP Compliance. The guidance provided by PharmSol also includes extensive training to the staff in maintaining Compliance and going through inspections.

Supply Security Audits (EHS)

Outsourcing and Contract Manufacturing are essential parts of pharmaceutical business and this necessitates reliance on third parties. Therefore, ensuring uninterrupted supplies from manufacturing sites not only depends on the GMP Compliance, but also on EHS Compliance. Supply Security Audits demand an integrated expertise of GMP, GEP and EHS and Team PharmSol has significant capabilities in this area.

Computer System Validations and CSV Audits

Use of Computer Systems in each area of Pharmaceutical business (inclusive of Manufacturing, Quality and Supply Chain) has become a necessity and the systems being deployed need to be validated in compliance with regulatory guidelines. 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 EUGMP and USFDA regulations.

GxP Compliance Training

PharmSol provides extensive trainings to all its clients in 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.

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