SB PHARMA Validation Master Plan Proposal New Pharmaceutical Production Unit INTRODUCTION SB Pharma is developing a facility for the

manufacture and packaging of a range of pharmaceutical products, primarily based on their existing portfolio of products . The GMP Group Ltd (GMPG) has prepared this proposal at the request of Dr. S Raza. All facilities are to be designed, specified, equipped, built and operated in fu ll compliance with European & US standards of Good Manufacturing Practice (cGMP). This proposal is presented in three parts Validation Master Plan (VMP) Audit of Detailed Design & Construction GMP & Validation Training Project Team SCOPE OF WORK The services to be provided by GMPG during the design and construction of the ne w production facilities will be undertaken in the following stages: Prepare the Validation Master Plan Audit of Detailed Design and tender for construction Audit of the Construction at all stages The services to be provided by the (GMPG) for the training of staff will be unde rtaken in the following stages; Prepare the training modules Deliver the training modules to the relevant SB pharma personnel VALIDATION MASTER PLAN The VMP will detail the approach to be used for validation together with the sco pe of work and will cover specifically the following areas Details of what is to be validated Approach to how this will be validated The time required for carrying out the validation. The number of people required in the validation team Prerequisites prior to the validation

Writing of Standard Operating Procedures Writing of Planned Maintenance Procedures and Work Sheets Training in all procedures. (SB Pharma will undertake all training involved in t he confidential technology processes) The VMP will detail all the documentation required to be produced at each stage of the validation process. The main activities within each of these stages will be identified and the sequence of operation will be determined. The time taken to carry out all tasks will be eval uated and incorporated into the overall schedule. Proposal E1097rev01 1 of 3 03/11/2010

SB PHARMA Validation Master Plan Proposal New Pharmaceutical Production Unit The VMP will determine the detailed strategy for the validation of the facility, the qualification of equipment and the systems to be validated this includes, equipment, facilities, utilities, analytical instruments, analytical methods, processes, and computerised systems. This part of the scope will take 6 weeks to complete and will be written at our UK office. We will deliver the VMP in person. PROJECT AUDITING & COMPLIANCE The GMP Group will attend the project to assist SB Pharma to ensure that the res pective consultants, contractors and specialist suppliers, deliver the cGMP requirements for qualification and validation. The personnel attending the project meetings will depend upon wh ich stage the project has reached, and the skills, which SB Pharma & The GMP Group agree, are required. The GMP Group will ensure that the required personnel with the necessary skills are available for the project when needed: We would recommend that the visits to SB Pharma by our team will be throughout t he project at intervals of 6/8 weeks. This means that we will make perhaps 8 over a project li fe of 12 months visits at 5 days per visit (including travel). The number of visits will be depe ndent on SB Pharma progress in completing the project. GMP & VALIDATION TRAINING Development & Delivery of Training Packages We will prepare the draft-training module and we will agree the full content of the training module in a meeting with SB Pharma QA Group prior to the final version. They will be ba sed on our Audit Report but will cover at least: GMP and the Law Environmental Standards Documentation Change Control Engineering and Maintenance Programmes Deviation Management Validation The delivery of this part of the scope will be agreed during our visit to presen

t the VMP. The training module will be written in our UK office prior to approval by SB Pharma QA team. PROGRAMME The GMP Group will carry out the following operations, The Validation Master Plan to be delivered 8 weeks from date of order. Write Training Module for Engineers associated with the Project. Visit to SB Pharma to present VMP Visit to SB Pharma to present Training Modules Visit to SB Pharma as required to Audit Facilities and Documentation. Proposal E1097rev01 2 of 3 03/11/2010

SB PHARMA Validation Master Plan Proposal New Pharmaceutical Production Unit FEE PROPOSAL Our fee for the scope of works detailed above will be as follows Section Total Cost Prepare the Validation Master Plan 14250.00 Audit of Detailed Design and tender for construction 7250.00 (per visit, allow 8 visits for 1 year) GMP & Validation Training Project Team 21374.00 We will have a presence on site for approximately 5 days in 1 visit We trust this meets with your approval, should you wish to discuss this further please contact me at the office. Audits will be to an agreed programme with visits by the relevant staff and will be charged at the fee per day as detailed below. The proposal is based on payment in pounds sterli ng () and excludes VAT. Airfares, car hire and hotel accommodation expenses are not included in our cost s. This offer is based on work being completed in accordance with an agreed program me. 30% of the fee is to be paid in advance with the remainder paid against monthly invoices paid 14 days from invoice date. Method of payment shall be direct to our bank; details will be forwarded upon ag reement to proceed. The daily rate for all works outside of the above scope will be 650 per day (Six Hundred & Fifty Pounds) The prices quoted are valid for 3 months from date of tender Pakistan taxes and bank charges are to be paid by the client. Trusting this meets with your approval Yours sincerely Frank Donegan Managing Director The GMP Group Proposal E1097rev01

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