Facility Design & Project Management

PharmSol provides end-to-end solutions right from facility conceptual engineering design to successful commissioning of facility with requisite international regulatory approvals like EUGMP, TGA, PIC/s, etc. Solutions provided are based on the principles of GEP & GMP. The rich experience of Team PharmSol inherently ensures Economics of Design (CAPEX & OPEX), Efficient & Lean Process Operations, Ease of Maintainability, Flexible Plant Operation Philosophy (multi-product manufacturing) & Sustainable Compliance with Optimal Investments.

Facility Technical Assessment

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.

Due Diligence

We conduct a technical assessment of the facility from a GMP & GEP perspective & in addition also review the facility from an Investors perspective.

Conceptual Design Review

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.

Facility Design

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

Facility Remediation

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

QMS Setup

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%).

Qualifications & Validations

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.

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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