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.
We conduct a technical assessment of the facility from a GMP & GEP perspective, identify & report the gaps with due reference to the relevant clause of concerned international regulatory guidelines & provide conceptual remedial measures to mitigate the same, to the extent practically feasible.
We carry out complete engineering design of a new facility. This comprises of the following:
• Concept Engineering Design
• Detailed Engineering Design
• Procurement Support (Major Capital Items only)
• Project Team Structure Building
• Construction Management Support
• Construction Quality Supervision
As an extension to the Facility Design, PharmSol also guides its Clients in setting up a robust Quality Management System. PharmSol has developed a unique solution, wherein nearly 75% of the work can be done offsite by Team PharmSol and only 25% work needs to be done at site. PharmSol has developed standard templates of QMS documentation (both in English & Chinese language), which need only limited customization at site. PharmSol also offers training to the Client’s team, on specific SOPs mutually agreed between them. This approach results in significant savings in start-up time (possibly up to 30%).
We conduct a technical assessment of the facility from a GMP & GEP perspective & in addition also review the facility from an Investors perspective.
We conduct the review of the Concept Engineering Design of any proposed new facility OR existing refurbished facility, which must have been carried out either in-house by the Client OR by an Engineering Consultant. We review the key Concept Design deliverables which determine the GMP compliance adherence of the facility upon construction completion, as well as certain critical design basis, based on which the commercial viability, operational ease & maintainability of the proposed facility will depend.
We carry out complete engineering design of remediation of an existing facility from as GMP & GEP compliance perspective. Such project assignments comprise of bundling of the following service scoping:
• Facility Technical Assessment
• Facility Due Diligence
As part of its service offering PharmSol also guides its Clients in commissioning, qualification & validation support of new / remediated existing facilities. PharmSol has developed standard templates of Qualification Protocols, which need only limited customization at site. PharmSol offers support in reviewing the Qualification Reports filled in by Client Qualification team, thus ensuring execution of seamless & foolproof Facility Qualification process.
Bad Oldesloe, Germany
Jebel Ali, Dubai, United Arab Emirates
Jumeirah Lakes Towers, Dubai, United Arab Emirates
Heliopolis, Cairo, Egypt
Nanjing City, Jiangsu Province, PR China
Hong Kong, China
Makati City, Philippines
Ho Chi Minh City, Vietnam