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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 - PowerPoint PPT Presentation
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Project co-financed by European Union Project co- financed
by Asean
European Committee for StandardizationImplementing Agency
Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 20051
Prepared by Surachai PiyayodilokchaiSurachai Piyayodilokchai - Thailand
Approved by ASEAN Cosmetic GMP Team
Endorsed byASEAN Cosmetic Committee
ASEAN GMP TRAINING MODULE
EQUIPMENT
Project co-financed by European Union Project co- financed
by Asean
European Committee for StandardizationImplementing Agency
Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 20052
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
Project co-financed by European Union Project co- financed
by Asean
European Committee for StandardizationImplementing Agency
Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 20053
INTRODUCTION
Project co-financed by European Union Project co- financed
by Asean
European Committee for StandardizationImplementing Agency
Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 20054
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
Project co-financed by European Union Project co- financed
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European Committee for StandardizationImplementing Agency
Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 20055
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
Project co-financed by European Union Project co- financed
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European Committee for StandardizationImplementing Agency
Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 20056
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
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Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 20057
GENERAL REQUIREMENTS
Project co-financed by European Union Project co- financed
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European Committee for StandardizationImplementing Agency
Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 20058
Raw
mat
eria
ls
Personnel Procedure
Standar-
dization Equipm
ents
BuildingEnvironment
Packaging
materials
Factorscontributing toProduct Quality
FACTORS AFFECTING PRODUCT QUALITY
Project co-financed by European Union Project co- financed
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European Committee for StandardizationImplementing Agency
Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 20059
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
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Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 200510
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
Project co-financed by European Union Project co- financed
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Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 200511
DETAIL DESCRIPTIONS
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Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 200512
1. Surfaces must not be: Reactive Additive Adsorptive
DESIGN & CONSTRUCTION (1)
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Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 200513
2. Easily & conveniently cleanable
Before cleaning
After cleaning
DESIGN & CONSTRUCTION (2)
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Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
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3. Must not affect the product through leaking valves, inappropriate maintenance, etc.
DESIGN & CONSTRUCTION (3)
Project co-financed by European Union Project co- financed
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Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 200515
4. Must use explosion proof materials for the manufacture of flammable substances.
DESIGN & CONSTRUCTION (4)
Project co-financed by European Union Project co- financed
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European Committee for StandardizationImplementing Agency
Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 200516
Fixed pipelines for the transfer of products and materials should : be clearly labelled indicate contents show direction of flow
PIPES & PIPELINES (1)
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Water, steam, pressure and vacuum lines where applicable should be installed : easily accessible clearly identified instrument
monitoring control
PIPES & PIPELINES (2)
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European Committee for StandardizationImplementing Agency
Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 200518
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 labeledand pipe connections should use the right materials
PIPES & PIPELINES (3)
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Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
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All safety and regulator devices should be checked and calibrated regularly
Air pressure regulator Pressure gauge & release valve
Control panel
SAFETY DEVICES
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LOCATION & INSTALLATION (1)
1. Avoid congestion.2. Properly identified.3. Easily accessible during
all phases of operation.
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Equipment layout and design must aim:to minimize risks of errorto permit effective cleaningto permit effective maintenance
And to avoid:cross-contaminationdust and dirt build-upany adverse effect on the quality of products
Equipment must be installed to:minimize risks of errorminimize risks of contamination
LOCATION & INSTALLATION (2)
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Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 200522
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
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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)
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Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
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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)
Project co-financed by European Union Project co- financed
by Asean
European Committee for StandardizationImplementing Agency
Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 200525
CLEANING EQUIPMENT (1)Clean In Place
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Cleaning protocol for trace back recordCleaning status of the equipment should be indicated on the label
CLEANING EQUIPMENT (2)Cleaning in Process
Project co-financed by European Union Project co- financed
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Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
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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
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Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 200528
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
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Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
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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 VOIDDO 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 CALIBRATIONINSTRUMENT
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.
CALIBRATIONVOID
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
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Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 200530
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
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Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
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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
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Text of equipment of ASEAN GMP Sanitation of equipment Checklist for equipment audit Guidance for qualification
performance
RELATED HYPERLINK DOCUMENTS
Project co-financed by European Union Project co- financed
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European Committee for StandardizationImplementing Agency
Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
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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)
Project co-financed by European Union Project co- financed
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Module 4Module 4 GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 200534
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