Business Biotics Group has developed a streamlined and standardised procedure for equipment selection, procurement and validation. The process is based on the industry standard Validation “V” model. The major steps of the Validation “V” model are shown in the following Table.
|
Process Stage |
Description |
1 |
User Requirement
Specifications (URS) |
Documentation of the client’s URS. This document will contain regulatory, functional, operational, validation, after-sales-service, operating and maintenance manuals and installation specifications. The URS is authorised by the client. |
2 |
Request for Quotation/Tender |
Business Biotics Group project manages and co-ordinates the issuing of the URS for quotation or tender. This includes the co-ordination of all supplier communication on behalf of the client. The process ensures that a comprehensive price spectrum is covered. |
3 |
Quotation/Tender Technical
Analysis |
Business Biotics Group has developed an extremely efficient procedure for the arduous task of analysing volumes of technical data presented in the quotations. The analysis is presented in a concise and intuitive format that will enable the client to cross reference all equipment options. |
4 |
Equipment Selection Report |
Business Biotics Group prepares an Equipment Selection Report based on the information presented in the Technical Analysis. The selection criteria are based on the needs of the client. |
5 |
Client’s Superintendent |
Business Biotics Group can further maintain the client’s productivity by acting as the client’s superintendent during the equipment manufacturing phase. Business Biotics Group manages and co-ordinate all of the technical liaisons with the supplier of the equipment with minimum interruption for the client |
6 |
Design Qualification (DQ) |
Business Biotics Group will complete a DQ to ensure that the client’s investment is protected by cross checking the supplier’s Functional Specification with the URS. Critical changes are managed and documented in accordance with Business Biotics Group Change Control Management System. |
7 |
Factory Acceptance Testing
(FAT) |
Business Biotics Group offers the advantage of the FAT management. FAT procedures are reviewed and upgraded to meet the client’s requirements. We will generate a FAT Deviation Report and manage the implementation of changes. |
8 |
Site Acceptance Testing (SAT) |
Business Biotics Group will supervise the SAT. SAT procedures are reviewed and upgraded in accordance with the client’s requirements. We will generate a SAT Deviation Report and manage the implementation of changes |
9 |
Installation Qualification (IQ) |
Business Biotics Group will draft specific IQ test protocols or review and update proprietary IQ protocols. Our integrated Project Management System will ensure there is continuity of technical information from the URS to the IQ Test Protocols |
10 |
Operational Qualification (OQ) |
Business Biotics Group will draft specific OQ test protocols or review and update proprietary OQ protocols. Business Biotics Group approach offers the advantage of drafting critical production documentation at the OQ stage of the Project. This includes drafting of Standard Operating Procedures, Training Protocols, Batch Process Documentation and OQ Test Procedures. |
11 |
Performance Qualification (PQ) |
A significant advantage of Business Biotics Group is our ability to actively assist the client at the final stage of validation. Our clients can rely on our manufacturing experience to supervise these critical trials in a methodical and efficient manner to ensure that the equipment is fully validated prior to handover to manufacturing. |
Business Biotics Group offers corporate financial planning expertise specifically aimed at assisting the executive management of the company during the initial planning stage of a project. We will develop a number of models indicating typical expenditure levels for the type of equipment being investigated. These models are based on our knowledge of world wide pharmaceutical manufacturing centres. We will research pricing from the traditional and well established European manufacturers through to the middle priced emerging manufacturers and the lower cost Asian manufacturers. We will then prepare “Net Present Value” (NPV) analysis for each option that will clearly delineate the most appropriate Return on Investment (RoI) scenario for the client. Both the NPV and RoI scenarios are substantiated with Risk Analysis Investigation reports.
Business Biotics Group is cognisant of the far-reaching and long term financial, technical and regulatory issues and responsibilities confronting a company when purchasing plant and equipment. Business Biotics Group is well positioned to assist clients navigate potential pitfalls and help them to maximise the value of the purchase for the company.
