Factory Manager

Production Yield: Loss on components and raw materials per batch must not exceed the 5% of the total batch output.

Output: The average output per packaging line must equal or exceed from 3000 – 6000 units per single shift.

Non-conformance: The purpose is to ensure that no unnecessary changes must be made and that all changes are documented on the batch manufacturing or packaging documents. Only the Factory Manager can decide and approved any corrective action.

New product development: The responsibility of the Factory Manager is to assess any new formulations brought by the Chief Executive Officer and decide if a trial batch will be initiated before creating a batch manufacturing and packaging documents.

Planned preventative maintenance: The Factory Managers duty and responsibility to ensure that the maintenance contractor adheres to the preventative maintenance schedule on a monthly basis. In the instance of a breakdown the Factory Manager responsibility is to called out the maintenance contractor to assess the damage and repair.

Stock control: The Factory Manager must ensure that stock count of raw materials and components is performed every quarter by the stores personnel and if any shortfalls must be reported to the Chief Executive officer.

Turn-around Time: Procurement must ensure that all materials and components must be received on a timeous basis as to prevent holding back the production schedule.

On-Time Delivery: Each material and component must be tracked according to purchase order number and supplier and the estimated time of delivery stated by the supplier upon order placement (receiving must not exceed 15 days).

Price Qualification: New quotations must be compared to historical costs as per Pastel Accounting to ensure that the new price falls within 5% of the average historical coat. Should this new price exceed the 5% increase in cost then the procurement personnel must request authorization for the purchase from the Factory Manager or Chief Executive officer.

Chief Executive Officer

Sales: Sales to new and existing customers are facilitated by the CEO.

New business development: The CEO implements all tasks and processes to develop and implement growth opportunities within the company.

New product development: All new product development is steered by the CEO from packaging selection, label artwork, carton artwork, package insert artwork, branding and marketing content. The CEO must sign off on all artwork before manufacturing and packaging commence.

Product Costing: The CEO gathers all material and component quotations via procurement to put together the product costs for potential new or current businesses. These approved finished good costs are given to the administration department to be forwarded to the customer in the form of a sales order.

Quality Manager

Receiving: All raw materials and components received must be allocated to a quarantine area whereby they must undergo sampling by the sampling personnel.

Sampling: The sampling personnel must follow the recommended sampling method as specified on the sampling SOP for raw materials and components by visually compairing the sample taken with the retention sample. If raw material or components rejected transfer them into the rejected area and stick a rejected label and notify the Quality Manager and Factory Manager. If accepted stick a release label over the quarantine one and transfer into the specified stores.

Dispatching: The Quality Manager must conduct a physical inspection of the completed manufacturing and packaging documents and check the IPC checks are compliant with the documents specifications before the product can be released for dispatching to the customer.

Internal process checks: The Quality Manager must ensure that the IPC inspector is performing the in-process checks as specified on the manufacturing and packaging documents.

Supplier audits: Each supplier must be audited annually by the Quality Manager.

Complaints:  The Quality Manager responsibility is to manage all product complaints, by retrieving the problematic stock, and investigating the root of the problem and then initiate a non-conformance report and a corrective action change control.

Maintenance

Planned preventative maintenance: All equipment in manufacturing and packaging areas must be checked and evaluated by maintenance personnel a list of preventative maintenance for each machine must be given to the Factory Manager to create a monthly schedule to ensure the preventative maintenance is performed accordingly.

Breakdown maintenance: The Factory Manager must notify the maintenance personnel of a break breakdown immediately and log an appointment to repair the equipment.

Assistant Production Manager

Production yield: Assistant Production Manager must monitor each production department to ensure that the line does not exceed 5% loss during all manufacturing and packaging processes. Therefore, batch yield must not be under 95% on the final reconciliation.

Output: Output through one shift on a single packaging line must be not less than 3500 units per day.

Non-conformance: Ensure no unnecessary changes occur during manufacturing or packaging processes without the approval of the Factory manager and ensure the approved changes are recorded on the relevant document.

Change Controls: If a manufacturing or packaging documents are requiring to have change during the production process the Assistant Factory Manager must fill a change control form with the required change to be matt and request approval from the Factory Manager before continuing with the change. If the requested change is successful the Factory Manager must update the specific production documents with the change.

Stock Control: The Assistant Production Manager must ensure on a quotably bass a stock count is performed in the R/Materials and components stores and the accuracy must be within 98%of Pastel accounting system.

Tableting Department

Yields: The tablet operator must achieve a batch yield of 98% from the theoretical batch document (Effective not more than 2% loss). Therefore, batch yield must not be under 95% on the final reconciliation.

Outputs: A single compression machine shift out per date must fall within 70,000 – 100,000 tablets.

Non-conformance: if during a compression process the tableting operator identifies that the product is not conforms to the product specifications it must not continue with the process and reported it to Assistant Production Manager until further instructions is given.

No reject batches: No rejected batches due to hardness, thickness, disintegration, friability or mass uniformity during the compression process.

Time keeping and breaks: compression operators must be present at the working place at all times during working hours (working hours are 8am to 4.3pm Monday to Thursday Friday 8am to 3pm tea time Monday to Thursday 10am to 10,15am Friday no tea).

Dress Code: The compression operators must have dressed in the appropriate clean room uniform and change the working shoes before entering the working place is strictly forbidden to wear the factory clothing or shoes outside the working place.

Accurate stock count: The compression operator is responsible for accuracy of table counting between theoretical and actual quantity specified on the document (the variance must note exceeded 2%)

Any other reasonable task: the compression operator may be requested by the Assistant Production Manager or Factory Manager to perform any responsible tasks required at Sparta Pharma.

Capsule Department

Yields: The encapsulating operator must achieve a batch yield of 98% from the theoretical batch document (Effective not more than 2% loss). Therefore, batch yield must not be under 95% on the final reconciliation.

Outputs: A single encapsulation shift out per date must fall within 60000 – 100000 capsules.

Non-conformance: if during an encapsulation process the encapsulating operator identifies that the product is not conforms to the product specifications it must not continue with the process and reported it to Assistant Production Manager until further instructions is given.

No reject batches: No rejected batches due to disintegration, or mass uniformity during the encapsulated process.

Time keeping and breaks: Encapsulation operators must be present at the working place at all times during working hours (working hours are 8am to 4.3pm Monday to Thursday Friday 8am to 3pm tea time Monday to Thursday 10am to 10,15am Friday no tea).

Dress Code: The encapsulating operators must have dressed in the appropriate clean room uniform and change the working shoes before entering the working place is strictly forbidden to wear the factory clothing or shoes outside the working place.

Accurate stock count: The encapsulating operator is responsible for accuracy of capsule counting between theoretical and actual quantity specified on the document (the variance must note exceeded 2%)

Any other reasonable task: the encapsulating operator may be requested by the Assistant Production Manager or Factory Manager to perform any responsible tasks required at Sparta Pharma.

Coating Department

Yields: The coating operator must achieve a batch yield of 99% from the theoretical batch document (Effective not more than 1% loss). Therefore, batch yield must not be under 95% on the final reconciliation.

Outputs: 1-2batches output on a single shift per day.

Non-conformance: if during a coating process the coating operator identifies that the product is not conforms to the product specifications it must not continue with the process and reported it to Assistant Production Manager until further instructions is given.

No reject batches: No rejected batches due to over spray the tablets or allow the tablets to run dry on the coating pan during the coating process.

Time keeping and breaks: Coating operators must be present at the working place at all times during working hours (working hours are 8am to 4.3pm Monday to Thursday Friday 8am to 3pm tea time Monday to Thursday 10am to 10,15am Friday no tea).

Dress Code: The coating operators must have dressed in the appropriate clean room uniform and change the working shoes before entering the working place is strictly forbidden to wear the factory clothing or shoes outside the working place.

Accurate stock count: The coating operator is responsible for accuracy of coated tables counting between theoretical and actual quantity specified on the document (the variance must note exceeded 1%)

Any other reasonable task: the coating operator may be requested by the Assistant Production Manager or Factory Manager to perform any responsible tasks required at Sparta Pharma.

Packaging Department

Yields: The packaging department operator must achieve a batch yield of 98% from the theoretical batch document (Effective not more than 2% loss). Therefore, batch yield must not be under 95% on the final reconciliation.

Outputs: Output 3,000-6,000 units on a single shift per day on a single line.

Non-conformance: if during a packaging operation the packaging operator identifies that the product or packaging components is not conforms to the product specifications it must not continue with the process and reported it to Assistant Production Manager until further instructions is given.

No reject batches: No rejected batches due to incurred count in the container, Incorrect cap used, incorrect label used, incorrect bottle used or incorrect tablet packed during the packaging operation.

Time keeping and breaks: Packaging operators must be present at the working place at all times during working hours (working hours are 8am to 4.3pm Monday to Thursday Friday 8am to 3pm tea time Monday to Thursday 10am to 10,15am Friday no tea).

Dress Code: The packaging operators that working in the primary they must dressed in the appropriate clean room uniform and change the working shoes before entering the working place is strictly forbidden to wear the factory clothing or shoes outside the working place. The packaging operators that working in the secondary areathey must dressed in the appropriate clean room uniform before entering the working place is strictly forbidden to wear the factory clothing outside the working place.

Accurate stock count: The packaging operator is responsible for accuracy of tables counting between theoretical and actual quantity specified on the document (the variance must note exceeded 1%)

Any other reasonable task: the packaging operators may be requested by the Assistant Production Manager or Factory Manager to perform any responsible tasks required at Sparta Pharma.

Accountin

Gross margin: As a % of selling price – The average Gross profit margin per product must not be less than 20%

Debtor’s management: Debtor’s age analysis must be sent to the CEO before the 3^rd day of each month for review. Statements must be forwarded to customers no later than the 1st day of each month.

Creditor’s Management: Creditor’s age analysis must be sent to the CEO before the 7^th day of each month for review. Statements must be received from suppliers no later than 5^th day of each month.

Debtors Management: Once the debtor’s statements are sent out, the Financial Manager will send put a first request for payment to replenish cash flow. If an account is not settled in a timely manner, the manager will then make a second request for payment telephonically until payment is received. The company has a Nil provision doubtful debt as it the opinion of the finance department, that all debts are fully recoverable.

Creditors management: Any unreconciled items are reconciled between the company’s bookkeeper and the supplier’s accounting department.

Administration

Sales quotations: Once the product coasting has been received from the Chief Executive Officer, a sales quotation should be sent to the customer within 48 hours.

Cycle time of purchase order: The time taken for the Procurement personal to send a requisition for a Purchase order to the Administration department and then receiving it back to forward onto the supplier must not exceed 48 hours.

Data capturing: Capturing of all components batch manufacturing documentation into Pastel must be completed within 48 hours. This will prevent Pastel from booking stock which doesn’t exist and appropriating it to further batches.

Stock Control on pastel: The administration department must ensure that the Pastel system is accurate within 99% on each raw material and component when compared to actual physical stock count received from the Factory Manager. Non-conformances must be reported to the Factory Manager.

On-time invoicing: The administrator department must ensure that a copy of the invoice and delivery note must be sent to the customer within 48 hours of the batch completion. More specifically the invoice must be received prior to the consignment arriving with the customer.

Artwork and Design Manager

Packaging artwork: The artwork and design manager must receive a Label spec document from the Chief Executive Officer prior t commencement of label design

Artwork lead time: A theoretical lead time must be communicated to the Chief Executive Officer and monthly updates must follow as to the progress and estimated time completion.

Print: Print ready artwork must be kept on file and sent to the Factory Manager to include in the product must file.