Module 10

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ASEAN GMP TRAINING MODULESTORAGE
Prepared by Harris Lukmanto Indonesia Wan
Othman Wan Ismail Malaysia Approved by ASEAN
GMP Team Endorsed by ASEAN Cosmetic Committee

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CONTENT OF PRESENTATION

• Introduction
• Objective
• Scope
• Good Storage Practices
• General requirements
• Premises / warehouse
• Storage facilities
• Personnel
• Stock management and control
• Documentation
• Supporting explanations
• Relevant hyperlink documents
• References

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INTRODUCTION
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INTRODUCTION

• This module tackles briefly the role of warehouse
  or storage within the manufacturing and
  distributor operations.
• The current code of practice is being introduced
  to maintain high quality during storage and
  distribution of products.

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OBJECTIVES

• To gain basic understanding of the Good Storage
  Practice (GSP) applicable to the warehouse
• To list the key GSP requirements for storage of
  the materials or cosmetic products.

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SCOPE

• The module will cover the storage and
  distribution of all the materials or cosmetic
  products

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GOOD STORAGE PRACTICES
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DEFINITION OF GSP

• The special measures that need to be considered
  in the storage and distribution of cosmetic
  product, such that the products will be of the
  nature and quality intended when it reaches the
  consumer
• Specific procedures for
• ? receiving
• ? storage
• ? distribution
• of materials/cosmetic products

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REQUIREMENT OF GSP

• To ensure that when the end product reaches the
  consumer, it is of good quality and safe to use.

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GSP COMPONENTS

• Premises/warehouse
• Storage Facilities
• Personnel
• Stock management and control
• Documentation

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PREMISES

• General requirement
• Size storage requirements
• Temperature and humidity control (where required)
• Pest control

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GENERAL REQUIREMENTS

• Built for its intended purpose
• Suitable and approved location
• Suitable building materials
• Provide protection
• Provide security from unauthorized persons
• Properly maintained

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SIZE REQUIREMENT

• Adequate space provided for all storage
  activities to prevent mixed up and damage of the
  materials and products

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STORAGE REQUIREMENT

• Segregated areas required (category)
• Dedicated areas required (condition)
• Sampling area
• Wherever possible sampling area for starting
  materials should be provided to prevent
  contamination.

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STORAGE ENVIRONMENT

• Temperature humidity control (where required)
• Continuous monitoring of humidity and
  temperature
• Numbers locations of monitoring points
  (temperature mapping)
• Calibrated monitoring equipments
• Time frequency of monitoring

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STORAGE ENVIRONMENT

• Storage temperature requirement should comply
  with the labeling requirements.
• Storage condition must not compromise the safety
  and quality of the product

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PEST CONTROL

• Written pest control program
• Outsourcing is recommended
• Use of safe pest control agents
• No risk of contamination to the materials and
  products
• Proper records

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STORAGE FACILITIES

• General facilities
• ? sufficient lighting
• ? air-conditioning (where required)
• Safety facilities
• ? personal protective equipments
• ? safety signs
• ? alert/alarm system
• ? fire extinguishers, etc
• Forklifts / trolley
• Computers
• Generators, etc

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PERSONNEL

• Qualified personnel with
• ? experience
• ? good health status
• Sufficient number of personnel
• Appropriate continuous training programme
• Store organization
• department heads
• supporting staffs
• ? clerk/store keeper
• ? store attendant
• ? driver/ security guard

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TRAINING

• Basic training
• e.g. store / warehouse management, inventory ,
  safety, hygiene, good housekeeping (5 S)
• Specific training
• e.g. computerized stock management
• Documented procedure
• Control System

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STOCK MANAGEMENT CONTROL

• receiving identity inspection
• storage stock control
• product release, repackaging transportation
• product disposal

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RECEIVING INSPECTION (1)

• All deliveries should be checked
• containers are not damaged
• quantity of deliveries
• labels
• suppliers name address

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RECEIVING INSPECTION (2)

• product information
• product name, batch no
• manufacturing/expiry date,
• storage requirements
• Stack on pallets
• Use standard pallets
• wooden pallets should be free from pest
• Stacking height maximum 1.5 m
• Interlocking pattern of the box for stability

1.5 m
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STORAGE STOCK CONTROL

• systematic storage system
• ? sufficient passage way for easy movement
• ? inspection / checking
• ? apply stock card
• proper labeling
• scheduled stock check
  or count

Identification labels
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PRODUCT RELEASE

• To follow FIFO / FEFO system
• Recheck before delivery
• Monitor goods condition during transport and at
  delivery

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RETURNED GOODS

• Available written procedure
• segregation of returned goods
• labeling of returned goods
• investigations evaluations on
• quality and safety

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REJECTED/DAMAGED GOODS

• Apply written procedure
• segregation of returned goods
• labeling of returned goods
• investigations evaluations on
• quality, and
• safety
• disposal of goods

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PRODUCT DISPOSAL

• Written procedure should be established
• handling of products before disposal
• ? segregation
• ? labeling
• disposal method should be according to the
  company and country regulations
• regulatory requirements should be always observed

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DOCUMENTATION

• General requirements
• Types of documents
• Control of documents
• Record keeping

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DOCUMENTATION OBJECTIVES

• Provide clear explanation / instructions
• Avoids errors and confusions
• As a guideline
• Traceability
• Regulatory requirements

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TYPES OF DOCUMENT (1)

• Procedures proper
  instruction/explanation of
• handling an operation/activity that consist of
• explanations
• flowchart
• charts/photos

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TYPES OF DOCUMENT (2)

• Record
• written records of the operations or activities
• type of record
• hard copy stock cards, logbooks
• soft copy

Finished Product
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CONTROL OF DOCUMENT

• Master copy
• Distribution control
• Uncontrolled copies
• Retrieval process
• Obsolete copies

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RECORD KEEPING

• Kept in safe place
• Reviewed/updated from time to time
• Can be accessed and referred easily
• Kept within appropriate time
• Destroy/ dispose according to documented procedure

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Thank You
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SUPPORTING EXPLANATION
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GLP INTERNATIONAL STANDARD

• Guidelines
• WHO Annex 9 Guide to Good Storage
  Practices for pharmaceuticals, 2003
• UK/EU EC Directive (92/25/EEC) on wholesale
  distribution UK Guidelines on Good Distribution
  Practice
• Australia Code of Good Wholesaling Practices
  1991

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PREMISES
BUILT FOR ITS INTENDED PURPOSE

• Whenever possible, follow a warehouse layout /
  construction
• Lay out (drawing) refer to premises module
• Ceiling, not compulsory
• Adequate ventilation windows to allow air
  circulation
• Protected against flood

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FACTORY LAY OUT
STORAGE AREA
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WAREHOUSE AN EXAMPLE
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LOCATION LAYOUT
SUITABLE AND APPROVED LOCATION

• Location refer to premises
• Separated from production / other areas
• Should allow a smooth flow, one direction of
  incoming materials and outgoing finished goods
• The storage area should be suitable for
  receiving, loading, unloading, storing of
  materials, finished goods according to Good
  Storage Practice.

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BUILDING MATERIALS

• Suitable building materials
• Refer to premises
• Storage area/ warehouse is part of the premises
  of the factory building
• Whenever possible, apply appropriate building
  foundation, concrete floor, brick/solid walls,
  pile/steel construction, roof-tile or corrugated
  zinc/aluminum roof.
• Provide protection from
• excessive heat temperature
• ? sunlight, rain/floods
• ? dusts other contaminants
• ? security from unauthorized persons
• ? properly maintained, e.g. cleanliness,
  physical

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PROVIDE PROTECTION

• Provide protection from
• excessive heat temperature
• ? sunlight, rain/floods
• ? dusts other contaminants
• ? security from unauthorized persons
• ? properly maintained, e.g. cleanliness,
  physical

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ADEQUATE SPACE

• Storage should provide adequate space for
  activities includes the following
• product receiving inspection
• product storage
• product repacking
• product distribution
• ? product disposal

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SEGREGATED AREA

• Segregated area required for
• Different categories of products, e.g.
• ? starting materials,
• ? hazardous raw materials
• ? finished goods
• Products with different status, e.g.
• ? quarantine,
• ? rejected

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DEDICATED AREA

• Dedicated areas required for
• Rejected/damaged stock
• Returned goods from customers
• Recalled goods
• Not for Sale products

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MONITORING POINTS

• Numbers and locations of monitoring points
  (temperature mapping)
• to ensure a uniform temperature and humidity, at
  several location in the room a control
  thermometer and humidity meter is placed and
  monitor
• to ensure a uniform temperature and humidity at
  each location, the room could be provided by
  roofs ventilation fans to achieve air
  circulation.

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CALIBRATED MONITOR

• To ensure a correct and consistent monitoring the
  thermometer and humidity meter should be
  calibrated regularly

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MONITORING PERIOD

• Time and frequency of monitoring
• This should be determined, usually an hourly
  period of measurement is appropriate
• Suggest day and night measurement because of
  difference in temperature during that period
• The measurement at each monitoring point should
  be recorded

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STORAGE LIGHTINGS

• Guidelines or standard of lightings intensity
  should be applied according to the activity,
  i.e.
• Storage 50 100 Lux
• Laboratory 300 Lux
• Processing and filling/packing 500 Lux
• Visual examination 1000 Lux

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PERSONAL PROTECTIVE EQUIPMENT

• The use of PPE (Personal Protective Equipment)
  should be considered when handling of raw
  materials
• Usually each raw material is labeled with a
  safety sign and recommendation which PPE to be
  used

Bio-hazard cabinet, to handle toxic, irritating
substances.
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DIFFERENT KIND OF PPE
Hand gloves and respiratory mask
Safety shower eye spray
Eye goggles
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PPE SIGNS
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SAFETY SIMBOLS
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ALERT / ALARM SYSTEM
The alarm system should comply with your local
national regulation
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FIRE EXTINGUISHERS

• A suitable fire extinguisher should be provided
  at working areas. There are several extinguisher
  types
• Powder (electricity)
• Foam (paper, solid substances)
• CO2 (all type of fire accident)
• Avoid all CFC extinguishers (ozone depletory)

Water mist
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CARRIAGE TOOLS

• Depending on the size and activities of the
  factory movement of the goods could be done using
  forklift, trolley or hand pallet
• Usually battery operated forklift of reach trucks
  are used for indoors operation.
• Less expensive carriage are trolleys or hand
  pallet as those are manually operated

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ADMINISTRATION SYSTEM

• For monitoring and administrative purpose, a
  personnel computer (PC) is convenient to operate
• A stand alone PC or a LAN system may be used
  depending on the requirements. A larger company
  may be convenient to use a LAN system
• A back up system should be provided to prevent
  data loss, incase there is a failure in
  electricity as well as trouble of the computer
  system

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GENERATORS

• Is an alternative electricity source, next to the
  municipal electricity source, if the latter is
  not reliable
• Could be used as a back up of electricity failure
• There are several types depending on the power
• It is noisy and should be located at a remote
  area, however there are now silent types

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5 S WORKPLACE ORGANIZATION
SEIRI (CLEARING UP) Remove what is not needed
and keep what is needed SEITON (ORGANIZING)
Place things in a such way that they can be
easily reached whenever they are
needed SEISO (CLEANING) Keep things clean and
polished no trash an dirt in workplace SEKETSU
(STANDARDIZING) Maintain cleanliness after
cleaning-perpetual cleaning SHITSUKE (SELF
DICIPLINE) Commitment, a typical teaching and
attitude towards any undertaking to inspire pride
and adherence to standards established for the
four components
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5 S WORKPLACE ORGANIZATION

• Benefit of 5S implementation
• reduce inventory,
• efficient on workplace usage,
• reducing time for searching material and finished
  goods,
• keep workplace clean and tidy,
• improve working condition,
• reduce work accident,
• increase discipline,
• follow procedure etc.

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RECEIVING INSPECTION

• Receiving identity inspection
• Monitor stocks of received materials to be done
  every time, and
• the identity of goods to be checked to prevent
  wrong interpretation

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STOCK CONTROL

• Storage stock control
• The stock of all storage material and finished
  product should be periodically monitored,
• A periodic stock count should be done so that a
  proper reconciliation could be performed

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PRODUCT HANDLING

• Product release, repackaging transportation
• It is important to periodically monitor stock of
  all the materials, including
• release finished goods to,
• repackaging of miss-production, and
• the number of transported materials to the
  customers

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PRODUCT DISPOSAL
Any material / product disposed should be
recorded and stock monitored especially for
reconciliation of losses.
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GOODS IDENTITY

• Material and finished product identification
• Ensure, delivery / production date, batch number
  of each material / finished product are legible,
  recorded and monitored when used for production.
  This is important for traceability purpose
• During stock take this should be verified and
  rechecked whether it is still not expired

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TRACEABILITY

• Tracking / trace-ability purpose
• A proper labeling / identification, systematic
  storage and stock card system will facilitate
  traceability and retrieval of suspected stocks.
• The stocks should be properly recorded,
  documented and retain.
• A PC will help to organize documents and support
  tracking system

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FINISHED GOODS MONITORING

• It is important to monitor the condition of
  finished goods at delivery
• During the transport, the finished goods may
  experience rough handling, a fluctuation of
  temperature, exposed to direct sunlight as well
  as rain and may affect its stability.
• It is always useful to have a reliable transport
  agent and explain when sensitive products should
  not de placed at the top of the box fan. Open
  trucks should be provided with tarpaulin cover.
• Suggest to make a contract with the transport
  agent, when finished product is received in
  defect condition because of mishandling during
  transport, that the transported should bear the
  responsibility.

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RELATED HYPERLINK DOCUMENTS

• Training manual for trainer
• Pest control program

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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)