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

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


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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


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INTRODUCTION


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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


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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


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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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GENERAL REQUIREMENTS


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Raw

mat

eria

ls

Personnel Procedure

Standar-

dization Equipm

ents

BuildingEnvironment

Packaging

materials

Factorscontributing toProduct Quality

FACTORS AFFECTING PRODUCT QUALITY


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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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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


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DETAIL DESCRIPTIONS


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1. Surfaces must not be: Reactive Additive Adsorptive

DESIGN & CONSTRUCTION (1)


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2. Easily & conveniently cleanable

Before cleaning

After cleaning



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3. Must not affect the product through leaking valves, inappropriate maintenance, etc.



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4. Must use explosion proof materials for the manufacture of flammable substances.



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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



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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



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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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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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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)


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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


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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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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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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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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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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


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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)


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Documents

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