Attachment 1

PT TRIYASA NAGAMAS FARMA Jakarta - Indonesia Date Issued :

VALIDATION REPORT
PROCESS VALIDATION FOR MANUFACTURING OF OBATINE TABLET USING TABLETTING MACHINE FETTE P 1000 Doc. No. / Rev. No. : VR7527415207 / 0 Page 1 of 4

VERIFICATION OF DOCUMENT USED

No. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. Master Production Document - Obatine Tablet Batch Processing Record - Obatine Tablet Product Specification - Obatine Compressed Tablet Standard Testing Procedure - Obatine Compressed Tablet Standard Operating Procedure - Procedure for Entering to The Non Hormone Tablet Production Area Standard Operating Procedure - Cleaning and Sanitazing of Non Hormone Tablet Production Area Standard Operating Procedure - Cleaning of Oscillating Granulator Yen Chen Type YC-SEP-OG-2A Standard Operating Procedure - Cleaning of Super Mixer Machine Yen Chen Type YC-SEP-SMG-250 Standard Operating Procedure - Cleaning of Oscillating Granulator Yen Chen Type YC-SEP-OG-2 Standard Operating Procedure - Cleaning of Fluid Bed Dryer Yen Chen Type YC- SEP-FBD-100 Cap.100 kg Standard Operating Procedure - Cleaning of Ultra Turrax Machine Type T80 KT Standard Operating Procedure - Cleaning of Bin for Non Hormone Product Standard Operating Procedure - Cleaning of Dried Mixing Machine II Standard Operating Procedure - Cleaning of Tabletting Machine Fette P 1000 Standard Operating Procedure - Cleaning of Stainless Steel Container Standard Operating Procedure - Cleaning of Plastic Drum / Box Document Doc. No. MF730739029 FR751719107 SP824723064 IK824723026 IK751610401 IK751618401 IK751618403 IK751618405 IK751618406 IK751618407 IK751618408 IK751618409 IK751618410 IK751618411 IK751618417 IK751618420 Rev. No. 2 0 1 1 6 7 4 2 4 2 4 8 5 5 6 6 Valid Date May 18th, 2012 July 02nd, 2012 May 24th, 2012 May 24th, 2012 January 03rd, 2012 January 03rd, 2012 January 03rd, 2012 January 03rd, 2012 January 03rd, 2012 January 03rd, 2012 January 03rd, 2012 January 03rd, 2012 January 03rd, 2012 January 03rd, 2012 July 06th, 2012 January 03rd, 2012 Checked By Date

No.

Document

Doc. No.

Rev. No.

Valid Date

Checked By Date

Attachment 1
PT TRIYASA NAGAMAS FARMA Jakarta - Indonesia Date Issued : 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32.

VALIDATION REPORT
PROCESS VALIDATION FOR MANUFACTURING OF OBATINE TABLET USING TABLETTING MACHINE FETTE P 1000 Doc. No. / Rev. No. : VR7527415207 / 0 IK751618423 IK751618425 IK751618002 IK751618007 IK751616402 IK751616404 IK751616405 IK751616406 IK751616407 IK751616408 IK751616413 IK751616416 IK751616419 IK751616004 IK751610006 IK751626003 2 0 5 2 4 3 4 3 6 5 5 5 0 5 6 0 January 03rd, 2012 June 10th, 2010 January 03rd, 2012 January 03rd, 2012 January 03rd, 2012 January 03rd, 2012 January 03rd, 2012 January 03rd, 2012 January 03rd, 2012 January 03rd, 2012 January 03rd, 2012 January 03rd, 2012 June 10th, 2010 January 03rd, 2012 August 10th, 2011 February 01st, 2012 Page 2 of 4

Standard Operating Procedure - Cleaning of Balance Mettler Toledo Type AB 104 Cap. 100 g Standard Operating Procedure - Cleaning of Stripping Machine Kung Long Type SP-260 Standard Operating Procedure - Cleaning of Balance Mettler Type KB 60 Multi Range + ID - 3 Weighing Terminal Cap. 60 kg Standard Operating Procedure - Cleaning and Sanitazing of Weighing Room Standard Operating Procedure - Operation of Oscillating Granulator Yen Chen Type YC-SEP-OG-2A Standard Operating Procedure - Operation of Super Mixer Granulator Yen Chen Type YC-SEP-SMG-250 Standard Operating Procedure - Operation of Oscillating Granulator Yen Chen Type YC-SEP-OG-2 Standard Operating Procedure - Operation of Fluid Bed Dryer Yen Chen Type YC- SEP-FBD-100 Cap.100 kg Standard Operating Procedure - Operation of Dried Mixing Machine II Standard Operating Procedure - Operation of Tabletting Machine Fette P 1000 Standard Operating Procedure - Operation of Thickness Tester Sigmat Mitutoyo Type IDC-1012B Standard Operating Procedure - Operation of Balance Mettler Type AB 104 Cap. 100 g Standard Operating Procedure - Operation of Stripping Machine Kung Long Type SP-260 Standard Operating Procedure - Operation of Balance Mettler Type KB 60 Multi Range + ID 3 Weighing Terminal Cap. 60 kg Standard Operating Procedure - Weighing of Non Hormone Raw Material Standard Operating Procedure - Operation of Balance Mettler BB 2,400 Cap. 2,400 g

No. 33. 34.

Document Standard Operating Procedure - Environmental Monitoring Procedure in The Manufacturing of Non Sterile Product Standard Operating Procedure - Operation of Hardness Schleuniger 6 D Version 4.51

Doc. No. IK824720016 IK760716001

Rev. No. 5 3

Valid Date June 30th, 2011 April 10th, 2010

Checked By Date

Attachment 1
PT TRIYASA NAGAMAS FARMA Jakarta - Indonesia Date Issued : 35. 36. 37. 38. 39. 40. 41. 42. 43. 44. 45. 46. 47. 48. 49. Standard Operating Procedure - Operation of Friability Tester SOTAX Type FT2 Standard Operating Procedure - Operation of Disintegration Tester SOTAX Type DT2 Standard Operating Procedure - Operation of Moisture Analyzer Sartorius Type MA150Q Standard Operating Procedure - Operation of Strip or Blister Leakage Tester Star Blast Type TNF03 Standard Operating Procedure - Operation of Abrasion and Friability Tester Model TA - 10 Standard Operating Procedure - Operation of Analytical Balance Mettler Model AT 201 Standard Operating Procedure - Operation of Disintegration Tester Hanson Model QC - 21 Standard Operating Procedure - Operation of Dissolution Tester Model SR6 Standard Operating Procedure - Operation of Moisture Analyzer Standard Operating Procedure - Operation of pH Meter Model 654 Metrohm Standard Operating Procedure - Operation of Brookfield Viscometer DV - II + Standard Operating Procedure - Operation of Microbiological Air Sampler MAS - 100 NT Standard Operating Procedure - Operation of High Pressure Liquid Chromatography - LC 2010CHT Standard Operating Procedure - Operation of Tablet Hardness Tester Model 8M Basic H Standard Operating Procedure - Operation of Particle Counter Met One Type 3413

VALIDATION REPORT
PROCESS VALIDATION FOR MANUFACTURING OF OBATINE TABLET USING TABLETTING MACHINE FETTE P 1000 Doc. No. / Rev. No. : VR7527415207 / 0 IK760716002 IK760716004 IK760716009 IK760716008 IK760726001 IK760726002 IK760726004 IK760726005 IK760726015 IK760726019 IK760726049 IK760726063 IK760726064 IK760726066 IK751616111 0 0 0 0 3 3 3 3 3 3 3 0 0 0 3 May 23rd, 2011 June 06th, 2011 April 05th, 2012 September 07th, 2011 September 01st, 2010 September 01st, 2010 September 01st, 2010 September 01st, 2010 September 01st, 2010 September 01st, 2010 September 03rd, 2010 July 29th, 2010 November 10th, 2010 February 17th, 2012 January 03rd, 2012 Page 3 of 4

No.

Document Validation Protocol - Assay Method Validation for Determining of Acetaminophen, Phenylpropanolamine HCl, Chlorpheniramine Maleate and Dextromethorphan HBr in Obatine Tablet Using HPLC Method Validation Report - Assay Method Validation for Determining of Acetaminophen, Phenylpropanolamine HCl, Chlorpheniramine Maleate and Dextromethorphan HBr in Obatine Tablet Using HPLC Method

Doc. No.

Rev. No.

Valid Date

Checked By Date

50.

VP7527414202

August 07th, 2012

51.

VR7527414202

September 17th, 2012

Attachment 1
PT TRIYASA NAGAMAS FARMA Jakarta - Indonesia Date Issued :

VALIDATION REPORT
PROCESS VALIDATION FOR MANUFACTURING OF OBATINE TABLET USING TABLETTING MACHINE FETTE P 1000 Doc. No. / Rev. No. : VR7527415207 / 0 Page 4 of 4

Prepared by : Validation Staff

Reviewed by : Validation Manager

Approved by : QAC Manager

Date :

Date :

Date :