/n COMPANY NAME BATCH MANUFACTURING RECORD Page: 1 of 8 Department: Production Title : Tongkat Ali Tablet Batch Record : BMR-001 Name Prepared by: Production Manager Approved by: QA Manager Signature Date Revision No. : 0 Effective Date : 1 January 201 1. Product Details Description Batch Quantity Packaging Storage Conditions Tongkat Ali 250mg Tablet Colour: Pale Shape: Round/ Biconvex Batch size: 53 kg Approx No. tablets: Bottle of 60's - Ambient conditions, store in tight container protected from light and moisture 2. Production Batch Record Issuance Issued By - Issuer has reviewed the Batch Record to ensure that the copy is a complete, accurate copy of the Master Batch Record. (Print) Issued By - Quality Assurance Signature Date Issued To - Production has reviewed the Batch Record to ensure that the copy is a complete and correct. Production is responsible for the Batch Record following issuance. (Print) Issued By – Quality Assurance Signature 3. Reference Documents SOP 002: Non conformances SOP 007: Line Clearance - SOP-010: Temperature and Humidity Monitoring SOP-012: Facility Cleaning Procedures SOP 015: Material Weighing and Dispensing - SOP-017: Batch Manufacturing Records - SOP 019: Tray Oven SOP-021: Grinding and Milling Machine SOP 022: Cadmill - SOP - 023: Cube Mixer Batch No: TT 1606001 Manufacturing Date: 10 July 2016 Expiry Date: 9 July 2017 Date COMPANY NAME BATCH MANUFACTURING RECORD Page: 2 of 8 Department: Production Title : Tongkat Ali Tablet Batch Record : BMR-001 Name Prepared by: Production Manager Approved by: QA Manager SOP 028: Ribbon Mixer SOP 032: B2 Strokes Tablet Press 4. Raw Materials Signature Date Revision No. : 0 Effective Date : 1 January 2016 Quantity Part Description Required Lot No. Qty Staged Number Exp/ Retest Performed By/Date Verified By / Date (kg) Eurycoma R-0122 25.00 Longifolia Lactose R-2323 19.34 Monohydrate Gelatin R-7896 4.80 Corn Starch R-5858 2.40 Methocel R-0326 1.00 Magnesium R-9696 0.46 Stearate BP/USP 5. Processing Equipments Equipment Description ID No. Previous Calibration Calibration Required Performed By / Date Verified By / Date Weighing Balance 150 kg WB-01 Tray Oven OT-01 Grinding and Milling GM-01 Machine Cube Mixer MX-03 Ribbon Mixer MX-02 Cadmill GM-02 B2 Strokes Tablet Press TP-01 Stainless Steel Container CS-03 Mechanical Sieve (Mesh No: 12) SM-01 6. Area Clearance Batch No: TT 1606001 Manufacturing Date : 10 July 2016 Expiry Date: 9 July 2017 COMPANY NAME BATCH MANUFACTURING RECORD Page: 3 of 8 Department: Production Title : Tongkat Ali Tablet Batch Record : BMR-001 Name Signature Date Prepared by: Production Manager Approved by: QA Manager Step 1. GMP Processing Area(s): Room: 2. Review the GMP Processing Area Logbook(s) and ensure that the Logbook(s) is (are) complete, and up-to-date. 3. Review all applicable GMP Processing Area Logbook(s) and verify that Cleaning has been performed according to Facility Cleaning Procedures (SOP-011) Date Cleaning Complete: 4. Review Section 4: Raw Materials, and ensure that it is complete, accurate, and that all necessary materials are present for the GMP operation. 5. Ensure that all GMP Materials are Released, Approved and have sufficient time to the Expiry Date. 6. Review Section 5: Processing Equipment, and ensure that it is complete, accurate, and that all necessary equipment is present, cleaned and calibrated, as appropriate. 7. Review the Logbook for each piece of Equipment, and ensure that the Logbooks are correctly filled out. Tray Oven (OT-01) Grinding and Milling Machine (GM-01): Cube Mixer (MX-03) Ribbon Mixer (MX-02) B2 Strokes Tablet Press (TP-01) 8. Verify that the Production Area does not contain any items from previous batches or cleaning activities and that no items unrelated to the current batch are present. 9. Area Clearance Complete. QA shall Complete the Area Clearance Sign (SOP-007, Attachment 1) and affix it to the GMP Processing Area entrance. Batch No: TT 1606001 Revision No. : 0 Effective Date : 1 January 2016 Performed By / Verified By / Date Date Manufacturing Date : 10 July 2016 Expiry Date: 9 July 2017 COMPANY NAME BATCH MANUFACTURING RECORD Page: 4 of 8 Department: Production Title : Tongkat Ali Tablet Batch Record : BMR-001 Name Signature Date Prepared by: Production Manager Approved by: 7. Production Procedure Processing Step QA Manager A. Dispensing & Raw Material Preparation Location: Dispensing Room 1 1. Ensure room Temperature is within 22-24°C and Humidity is less than 65% 2. Weigh the ALL Raw Materials (RM) as mentioned in Part 4 separately into a suitable container/ plastic bags in. Label each of the container/ bags with a) Name of RM b) Lot No. 3. Wash Eurycoma longifolia (Tongkat Ali) with RO water and dry in Tray Oven (ID: OT-01) at 60°C for 8 hours. Temperature: °C Time Start: Time Stop: 4. Crush/powder the dry Eurycoma longifolia (Tongkat Ali) into fine powder with Grinding and Milling Machine (ID: GM-01). B. Mixing Location: Mixing Room 2 5. Ensure room Temperature is within 22-24°C and Humidity is less than 65% Revision No. : 0 Effective Date : 1 January 2016 Performed By/Date Verified By / Date Temperature: Humidity: 6. Mix Eurycoma longifolia powder, Lactose and Corn Starch in Cube Mixer (ID: MX-03) for 5 mins. Time Start: Time Stop: 7. Transfer all the contents of Cube Mixer (ID: MX-03) into a suitable container/plastic bags. 8. Label the plastic bag with a) "Tongkat Ali A Blend" Batch No: TT 1606001 Manufacturing Date : 10 July 2016 Expiry Date: 9 July 2017 COMPANY NAME BATCH MANUFACTURING RECORD Page: 5 of 8 Department: Production Title : Tongkat Ali Tablet Batch Record : BMR-001 Name Prepared by: Production Manager Approved by: QA Manager Signature Date Revision No. : 0 b) Batch No. 9. "Transfer Tongkat Ali A Blend” into Ribbon Mixer (ID: MX-02). 10. Blend for 3 mins at speed no: 3. Speed No: Time Start: Time Stop: 11. Dissolve Gelatin with hot water in a Stainless Steel Container (ID: CS- 03). 12. Pour the "Dissolved Gelatin" into the powder, granulate for 5 mins at speed no: 3.. Speed No: Time Start: Time Stop: 13. Transfer all the contents of Ribbon Mixer (ID: MX-02) into Cadmill (ID: GM-02). Operate the machine according the SOP-022. 14. Dry the granules at 60°C for 6 hours in Tray Oven (ID: OT-01). Temperature: °C Time Start: Time Stop: 15. Sieve into fine powder with Mechanical Siever (Mesh No: 12) 16. Transfer the fine powder into Cube Mixer (ID: MX-03), add in Magnesium Stearate and mix for 10 minutes at speed no: 3. Speed No: Time Start: Time Stop: 17. Transfer the contents of the Cube Mixer into a suitable plastic bag. 18. Label the plastic bag a) "Blend for Tableting: Tongkat Ali❞ b) Batch No C. Tableting 19. Ensure room Temperature is within 22-24°C and Humidity is less than 65% Temperature: Batch No: TT 1606001 Humidity: Manufacturing Date : 10 July 2016 Expiry Date: 9 July 2017 Effective Date : 1 January 2016