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Prepared by Surachai Piyayodilokchai - Thailand Approved by ASEAN Cosmetic GMP Team Endorsed by ASEAN Cosmetic Commi

ASEAN GMP TRAINING MODULE EQUIPMENT. Prepared by Surachai Piyayodilokchai - Thailand Approved by ASEAN Cosmetic GMP Team Endorsed by ASEAN Cosmetic Committee . CONTENT OF PRESENTATION. Introduction Objective Scope General requirements Basic principles Basic requirements

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Prepared by Surachai Piyayodilokchai - Thailand Approved by ASEAN Cosmetic GMP Team Endorsed by ASEAN Cosmetic Commi

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  1. ASEAN GMP TRAINING MODULEEQUIPMENT • Prepared by • Surachai Piyayodilokchai - Thailand • Approved by • ASEAN Cosmetic GMP Team • Endorsed by • ASEAN Cosmetic Committee Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  2. CONTENT OF PRESENTATION • Introduction • Objective • Scope • General requirements • Basic principles • Basic requirements • The detail descriptions • Design and construction • Pipes and pipelines • Safety devices • Location & Installation • Maintenance program • Equipment compliance records • Training program • References Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  3. INTRODUCTION Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  4. INTRODUCTION 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. Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  5. OBJECTIVE 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. Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  6. SCOPE 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. Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  7. GENERAL REQUIREMENTS Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  8. Personnel Standar- dization Procedure Factors contributing to Product Quality Raw materials Equipments Packaging materials Building Environment FACTORS AFFECTING PRODUCT QUALITY Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  9. BASIC PRINCIPLES 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. Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  10. BASIC REQUIREMENTS • 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. Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  11. DETAIL DESCRIPTIONS Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  12. DESIGN & CONSTRUCTION (1) • Surfaces must not be: • Reactive • Additive • Adsorptive Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  13. DESIGN & CONSTRUCTION (2) • Easily & conveniently cleanable Before cleaning After cleaning Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  14. DESIGN & CONSTRUCTION (3) 3. Must not affect the product through leaking valves, inappropriate maintenance, etc. Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  15. DESIGN & CONSTRUCTION (4) • Must use explosion proof materials for the manufacture of flammable substances. Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  16. PIPES & PIPELINES (1) Fixed pipelines for the transfer of products and materials should : • be clearly labelled • indicate contents • show direction of flow Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  17. PIPES & PIPELINES (2) Water, steam, pressure and vacuum lines where applicable should be installed : • easily accessible • clearly identified • instrument monitoring control Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  18. PIPES & PIPELINES (3) • 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 Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  19. SAFETY DEVICES All safety and regulator devices should be checked and calibrated regularly Air pressure regulator Pressure gauge & release valve Control panel Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  20. LOCATION & INSTALLATION (1) • Avoid congestion. • Properly identified. • Easily accessible during all phases of operation. Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  21. LOCATION & INSTALLATION (2) • 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 Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  22. FLEXIBLE HOSES • 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. Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  23. TYPE OF MATERIALS USED (1) 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. Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  24. TYPE OF MATERIALS USED (2) 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. Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  25. CLEANING EQUIPMENT (1) Clean In Place Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  26. CLEANING EQUIPMENT (2) Cleaning in Process Cleaning protocol for trace back record Cleaning status of the equipment should be indicated on the label Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  27. MAINTENANCE SCHEDULE 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. Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  28. CALIBRATION • 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 Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  29. 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 Calibration date : ____ By : ______________ Due : ______________ 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 CAL. ID. No. _______________ 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. 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. CALIBRATION VOID DO NOT USE 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. NOT A CALIBRATION INSTRUMENT CALIBRATION LABELS Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  30. CHANGE CONTROL • 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. Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  31. TRAINING PROGRAM • 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. Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  32. RELATED HYPERLINK DOCUMENTS • Text of equipment of ASEAN GMP • Sanitation of equipment • Checklist for equipment audit • Guidance for qualification performance Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  33. REFERENCES • ASEAN Guidelines for Cosmetic GMP (2003) • WHO EDM, Basic Principle of GMP: Equipment part 1 and 2 (2004) • Validationworld.com, Equipment Compliance Program Elements and Realization (2002). • Labcompliance.com, Equipment Validation & Qualification. • www.fda.gov., Equipment & Calibration • WHO, Good Manufacturing Requirements – Part 2: Validation (February 1997) • Barwa, N.S., GMP Equipment, Bandung, (October 2004) Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  34. Thank You Module 4 GMP Workshop Kuala Lumpur 14-16 Nov 2005

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