1. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 1 Prepared by Surachai Piyayodilokchai Surachai Piyayodilokchai - Thailand Approved by ASEAN Cosmetic GMP Team Endorsed by ASEAN Cosmetic Committee ASEAN GMP TRAINING MODULE EQUIPMENT

2. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 2 1.Introduction  Objective  Scope 2.General requirements  Basic principles  Basic requirements 3.The detail descriptions  Design and construction  Pipes and pipelines  Safety devices  Location & Installation  Maintenance program  Equipment compliance records  Training program 4.References CONTENT OF PRESENTATION

3. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 3 INTRODUCTION

4. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 4 Each manufacturer should assure that production equipment and quality control measurement equipment, including mechanical, electronic, automated, chemical, or other equipment, are:  suitable for the intended use in the design, manufacture, and testing of components, in- process devices and finished devices;  capable of producing valid results;  operated by trained employees; and  properly calibrated versus a suitable standard. INTRODUCTION

5. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 5 To ensure the equipment and apparatus used for manufacturing process that must be made with stable and proper material, correct design, safe and easy to operate. OBJECTIVE

6. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 6 This module addresses the steps necessary to ensure that manufacturing equipment and laboratory apparatus continuously operates within the parameters necessary to produce a product that meets specifications. SCOPE

7. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 7 GENERAL REQUIREMENTS

8. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 8 Raw materials Personnel Procedure Standar- dization Equipments Building Environment Packaging materials Factors contributing to Product Quality FACTORS AFFECTING PRODUCT QUALITY

9. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 9 Equipment should be appropriate for its intended purpose and be appropriately designed, located, cleaned, maintained and correctly installed, to:  prevent contamination of subsequent batches of product using the same area or equipment.  prevent contamination of personnel or the environment;  prevent contamination of product by personnel or the equipment. BASIC PRINCIPLES

10. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 10  Each cosmetic manufacturer should develop, conduct, control, and monitor production processes to ensure that the end product conforms to its specifications.  All equipment used to manufacture a product shall be appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use.  The degree of maintenance on equipment and the frequency of calibration of measuring equipment will depend upon the type of equipment, frequency of use, and importance in the manufacturing process.  Where deviations from product specifications could occur as the result of malfunctioning of equipment(s), the manufacturer shall establish and maintain process control procedures. BASIC REQUIREMENTS

11. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 11 DETAIL DESCRIPTIONS

12. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 12 1.Surfaces must not be:  Reactive  Additive  Adsorptive DESIGN & CONSTRUCTION (1)

13. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 13 2.Easily & conveniently cleanable Before cleaning After cleaning DESIGN & CONSTRUCTION (2)

14. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 14 3. Must not affect the product through leaking valves, inappropriate maintenance, etc. DESIGN & CONSTRUCTION (3)

15. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 15 4.Must use explosion proof materials for the manufacture of flammable substances. DESIGN & CONSTRUCTION (4)

16. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 16 Fixed pipelines for the transfer of products and materials should :  be clearly labelled  indicate contents  show direction of flow PIPES & PIPELINES (1)

17. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 17 Water, steam, pressure and vacuum lines where applicable should be installed :  easily accessible  clearly identified  instrument monitoring control PIPES & PIPELINES (2)

18. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 18  The material quality and quantity that uses piping system should be monitored and checked periodically.  Pipelines for hazardous gas and liquid installation… should be clearly labeled and pipe connections should use the right materials PIPES & PIPELINES (3)

19. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 19 All safety and regulator devices should be checked and calibrated regularly Air pressure regulatorPressure gauge & release valve Control panel SAFETY DEVICES

20. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 20 LOCATION & INSTALLATION (1) 1.Avoid congestion. 2.Properly identified. 3.Easily accessible during all phases of operation.

21. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 21 Equipment layout and design must aim: to minimize risks of error to permit effective cleaning to permit effective maintenance And to avoid: cross-contamination dust and dirt build-up any adverse effect on the quality of products Equipment must be installed to: minimize risks of error minimize risks of contamination LOCATION & INSTALLATION (2)

22. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 22  The transfer system of liquid product may be through flexible hoses made of suitable material and compatible with the product used, cleaning &, disinfecting agents and steam.  It should be clearly identified. FLEXIBLE HOSES

23. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 23 Most of the pipelines should be used with Stainless Steel 316L as it is stable when in contact with the materials, during hot sanitation & disinfection. TYPE OF MATERIALS USED (1)

24. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 24 Plastic pipelines may be cheaper in cost than stainless steel but the disadvantage of it is being unstable with hot sanitation and surface may not be perfectly smooth which poses a risk for germ contamination. TYPE OF MATERIALS USED (2)

25. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 25 CLEANING EQUIPMENT (1) Clean In Place

26. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 26 Cleaning protocol for trace back record Cleaning status of the equipment should be indicated on the label CLEANING EQUIPMENT (2) Cleaning in Process

27. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 27 A manufacturer should establish schedules to maintain, clean, and adjust equipment used in the manufacture of cosmetic products, where failure to do so could have an adverse effect on the equipment's operation and hence the product. To maintain, clean, or adjust equipment, the manufacturer should:  have a written schedule;  where adjustment is necessary to maintain proper operation, have special instruction;  document the maintenance activities;  check periodically;  audit the activities and document the inspection. MAINTENANCE SCHEDULE

28. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 28  The intent of the GMP calibration requirements is to assure adequate and continuous performance of measurement equipment with respect to accuracy, precision, etc.  The equipment should be calibrated according to written procedures that include specific directions and limits for accuracy and precision. All results should be documented.  Proper and periodic calibration will assure that the selected equipment continues to have the desired accuracy CALIBRATION

29. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 29 Calibration date : ____ By : ______________ Due : ______________ Typical calibration decals have a write-on surface. A tough paper or cloth stock and a pressure sensitive adhesive are used for easy application and removal of decal. “Due” is the blank for date when recalibration is due CAL. ID. No. _______________ Calibration Identification Number or its equivalent is usually the minimum information that may be on the equipment. This information allows the manufacturer to read by finding the associated calibration record/card/file1 CALIBRATION VOID DO NOT USE Measuring equipment that is not calibrated or otherwise unsuitable for use should be placed in a quarantine area or labeled with a “calibration void” decal. NOT A CALIBRATION INSTRUMENT A decal to be applied to measurement or monitoring instrument not intended to use in determining conformance to product master record specifications with respect to testing, manufacturing, environmental control, etc. CALIBRATION VOID IF BROKEN A seal or protective cover for exposed, recessed calibration controls on instruments. The calibration control cannot be adjusted without breaking the seal or removing the instrument case. CALIBRATION LABELS

30. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 30  All Change Control cases for equipment could be classified in the following five groups: Equipment Modification Equipment Relocation Equipment Status Changes Equipment Malfunctioning Calibration Failures  Where intended changes are to be made, corrective actions must be defined before their implementation for the first 3 groups. The other two groups, which are unplanned cases, need to provide proper documentation.  If equipment has malfunctioned, and as a result of repair, some critical components were replaced or readjusted, it should be recalibrated immediately.  Justification, necessary actions, and approval for all changes should be documented on Corrective Action forms, which are designed as a part of the Change Control SOP. CHANGE CONTROL

31. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 31  The training program should be established to assure that the personnel involved in execution, operation, calibration and preventive maintenance will understand and follow up all written Standard Operating Procedures and Equipment Work Instruction.  Training must be provided upon approval of each SOP or WI for the personnel that will be execute this particular procedure. TRAINING PROGRAM

32. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 32  Text of equipment of ASEAN GMP  Sanitation of equipment Sanitation of equipment  Checklist for equipment audit Checklist for equipment audit  Guidance for qualification performance Guidance for qualification performance RELATED HYPERLINK DOCUMENTS

33. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 33 REFERENCES 1.ASEAN Guidelines for Cosmetic GMP (2003) 2.WHO EDM, Basic Principle of GMP: Equipment part 1 and 2 (2004) 3.Validationworld.com, Equipment Compliance Program Elements and Realization (2002). 4.Labcompliance.com, Equipment Validation & Qualification. 5.www.fda.gov., Equipment & Calibration 6.WHO, Good Manufacturing Requirements – Part 2: Validation (February 1997) 7.Barwa, N.S., GMP Equipment, Bandung, (October 2004)

34. Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005 34