PROPOSAL TO

SHANGHAI GREENWICH PHARMACEUTICAL COMPANY LIMITED

MEDICATED LOZENGE DEVELOPMENT AND MANUFACTURE

Presented to:
Allan Hong
Managing Director
Shanghai Greenwich Pharmaceutical Co. Ltd
999 Zhong Shan Nan Er Road, Suite 14-3B
Shanghai 200030
China

Prepared by:
Philip A. Hall
Technical Director
QA Pharmaceutical Services
58 Galston Road,
Hornsby, NSW, 2077
Australia

E-mail: pahall@qaps.com.au


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TECHNICAL RATIONALE

There are 8 aspects for this project:

1 Product
1.1 Formulation - identify and develop the most suitable medicated lozenge formulation to suit marketing, manufacturing and regulatory requirements. 100 hours (assume 20 hours per 4 brands with 20 hours to cover flavour variants)
1.2 Validation - demonstrate and document that the manufactured product meets marketing and regulatory requirements. Ensure all raw materials used in the manufacturing process function correctly with the equipment. 50 hours (assume validation is required for one variant within each brand)
1.3 Stability verification - determine optimum storage conditions of raw materials and finished product to achieve proven life expectancy. 10 hours
1.4 Registration - provide the necessary information about the product, manufacturing process, and testing procedures for regulatory submission for product registration with local and international authorities. 5 hours per product

2 Equipment
2.1 Selection - identify suitable suppliers of lozenge manufacturing and packaging machines and recommend, with reasons, required equipment within budgetary constraints. 30 hours
2.2 Layout - determine appropriate positioning of plant equipment for optimum work flow and safety. 50 hours
2.3 Factory - design environmental requirements into the manufacturing facility to meet local EPA standards, and identify all the utility services for each piece of equipment. 20 hours
2.4 Installation - supervise the installation of the equipment to ensure the facility is functioning in a timely fashion. 100*2 (may require a second resource to assist in this exercise)
2.5 Validation - demonstrate and document that the equipment functions to requirements. 50*2 (may require a second resource to assist in this exercise)
2.6 Optimisation - ensure plant equipment is working to specification. 10*2 (may require a second resource to assist in this exercise)

3 Procedures
3.1 Batch Manufacturing and Packaging procedures - prepare suitable manufacturing and packaging documents to ensure the product is manufactured and packaged to achieve quality, consistency and cost standards, including occupational health and safety considerations. 10 hours per documentation.
3.2 Raw material test procedures - prepare laboratory test procedures for each raw material to ensure specifications are achieved. 10 hours per procedure.
3.3 Finished goods test procedures - prepare laboratory test procedures for the testing of the manufactured product to ensure quality standards are achieved. 50 hours per procedure.
3.4 Standard Operating Procedures - prepare procedures to describe the correct set-up and operation of each machine and key processes used in the manufacture and packaging of the product. 10 hours per procedure.
3.5 Standard Cleaning Procedures - prepare procedures to describe the correct cleaning of each machines used in the manufacture and packaging of the product to meet pharmaceutical standards. 5 hours per procedure.

4 Quality Assurance
4.1 Standards - select the most appropriate standard criteria from the most stringent pharmacopoeia to ensure compliance to the available markets. 2 hours per standard.
4.2 Component suppliers - specify compliance certification for raw material and packaging components, negotiate supply agreements to meet cGMP requirements. 5 hours per component.
4.3 Documentation - design to include appropriate audit trails for each phase of the manufacturing and packaging process. 20 hours
4.4 Approvals - set out the approval process and sign off procedure. 10 hours
4.5 Record keeping - control and storage of documentation to meet regulatory requirements. 10 hours
4.6 Audit - set up audit procedures for suppliers and in house documentation compliance. 20 hours
4.7 Rejects - analyse the reasons for rejects to minimise future repeated problems. 20 hours

5 Quality Control
5.1 Raw material - identification and purity testing. 20 hours
5.2 In-process manufacturing checks - quality checks to ensure product is manufactured within product limits. 10 hours
5.3 In-process packaging checks - quality checks to ensure product is packaged within product limits. 10 hours
5.4 Finished goods checks - determine quality standards and testing for compliance to regulatory standards. 20 hours
5.5 Reprocessing - determine suitable methods to reuse materials previously rejected. 50 hours

6 Personnel
6.1 Recruitment - provide advice on selecting suitable candidates to operate equipment. 2 hours
6.2 Training - conduct operator training on medicated lozenge manufacturing techniques and in-process testing requirements. 50 hours

7 Supply Chain
7.1 Raw Materials - determine suitable suppliers, negotiate minimum order quantities and procurement lead times, to minimise costs, and to ensure consistent supply. 20 hours
7.2 Production - determine timely manufacturing quantities based on sales and marketing forecasts. 30 hours
7.3 Inventory - determine suitable inventory levels and buffer stock to ensure maximum availability with minimum inventory investment. 30 hours

8 Administration
8.1 Contract - determine scope of the project, agree on remuneration and prepare Contract Agreement. 30 hours
8.2 Internet - setup “Yahoo” e-mail account to provide a means for cost effective telecommunication.
8.3 Resource - if required, identify appropriately skilled expertise to get involved to achieve project goals. 5 hours
8.4 Correspondence and Reports. 50 hours

TOTAL: 1,780 hours (178 days or about 36 weeks)



THE BENEFITS TO SHANGHAI GREENWICH PHARMACEUTICAL COMPANY LIMITED IN CONTRACTING PHILIP HALL.

1 Philip Hall has extensive experience in medicated lozenge manufacturing and a proven record in achieving the high quality standards of the pharmaceutical industry.

2 Philip Hall has practical experience in quality assurance, quality control, quality auditing, manufacturing, international procurement, optimised production planning, logistics, demand management, sales and operations planning, six sigma techniques, and international business.

3 As a history, Philip Hall was transferred from testing raw materials in Quality Assurance to Lozenge Production at a time when the Lozenge production was poor and erratic.

4 Philip Hall identified the need and instigated the re-positioning of the plant equipment to optimise the work flow.

5 Philip Hall wrote the specification, was involved in the selection, design, installation and implementation of the electronic and computer monitoring systems that improved quality, output and reduced waste.

6 As supervisor, Philip Hall selected and trained the Lozenge plant operators in the use of the plant, the monitoring system and conformance to regulatory standards, and was able to build an “esprit de corps” amongst the manufacturing team.

7 Having come from a raw material testing background, and having been trained in the discipline of applied science, he is in a unique position to assess the available raw materials and to adjust the plant equipment to any required differences.

8 In addition to the above, Philip Hall has contacts throughout the Lozenge manufacturing industry if additional advice or assistance is required.

9 Philip Hall has also been trained at Boots Contract Manufacturers in Nottingham, UK the largest producer of medicated lozenges in Europe.

10 As a result of the above, Philip Hall is ideally suited to assist Shanghai Greenwich Pharmaceutical Co Ltd to undertake the selection of the manufacturing and packaging equipment, correct placement of plant equipment, study of available raw materials, adjustment of the equipment to suit, testing of equipment, training of the supervisors and operators in the effective use of the plant equipment and the commitment to achieve the results expected is the benefit that Shanghai Greenwich Pharmaceutical Co Ltd would enjoy by contracting Philip Halls’ services.