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

QMS Setup

As an extension to Facility Design, PharmSol also guides its clients in setting up a robust Quality Management System (QMS). PharmSol has developed a unique solution, wherein nearly 75% of the work can be done offsite by PharmSol and only 25% 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 (up to 30%).

Due Diligence

We conduct a technical assessment of the facility from a GMP & GEP perspective and also review the facility from an investor’s perspective.

Conceptual Design Review

We conduct reviews of the Concept Engineering Design of any proposed new facility or existing facility to be refurbished. In addition, we review the key Concept Design deliverables which determine GMP Compliance of the facility throughout critical design and construction stages as well as upon completion of construction.

Facility Remediation

We carry out complete engineering design for remediation of an existing facility from GMP & GEP compliance perspective. The scope of such assignments usually bundles the following services:

• Facility Technical Assessment
• Facility Due Diligence

Qualifications & Validations

As part of its service offering, PharmSol also guides its clients in commissioning, qualification and validation support for new / remediated facilities. PharmSol has developed standard templates of Qualification Protocols which need only limited customization at site. PharmSol offers support in reviewing the Qualification Reports prepared by the client’s Qualification team, thus ensuring execution of seamless and foolproof Facility Qualification process.