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GMP Training Module

Storage in Warehouse
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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
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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 good
products.
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SCOPE

The module will cover the storage and

distribution of all the materials or good
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 good product, such that
the products will be of the nature and
quality intended when it reaches the
customer

• Specific procedures for :

 receiving
 storage
 distribution
of materials/good products
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REQUIREMENT OF GSP

To ensure that when the end product

reaches the customer, it is of good
quality and safe to use.
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GSP COMPONENTS

1. Premises/warehouse
2. Storage Facilities
3. Personnel
4. Stock management and control
5. 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 and/or regulatory
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 – material handlers
 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 - Macola

 Documented procedure – SOP; Work Instructions

 Control System – First in-First Out ( FIFO )

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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 – 7 point inspection
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 1.5 m
 Stacking height maximum 1.5 m
 Interlocking pattern of the box for stability
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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)

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)

2. Record
 written records of the operations or
activities
 type of record;
 hard copy; stock cards, logbooks
 soft copy
h ed Pro d u ct
Finis
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CONTROL OF DOCUMENT

 Master copy Mas te r Cop

y

 Distribution control Distribu

tion
Control

 Uncontrolled copies Obsolete 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 – shelf life
 Destroy/ dispose according to
documented procedure
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SUPPORTING EXPLANATION
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GLP INTERNATIONAL STANDARD

Guidelines :
1. WHO : Annex 9 – Guide to Good Storage
Practices for pharmaceuticals, 2003
2. UK/EU: EC Directive (92/25/EEC) on wholesale
distribution UK Guidelines on Good Distribution
Practice
3. 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 - EXAMPLE

STORAGE AREA

LABELING/
AREA
REJECT
PACKAGING

CARTONS/BOTTLES

PACKAGING
MATERIALS
AREA
TINE
QUARAN-

LABELING/ LABELING/ LABELING/

COMPOUNDING/
PACKAGING PACKAGING PACKAGING
FILLING
RECEIVING

STORAGE WASHING
AREA

FILLING FILLING MICRO

APPROVED

FILLING
RM

G
IN

QUALITY CONTROL
PL

AREA
M
SA

COMPOUNDING LOCKERS
COMPOUNDING
FEMALE
CODING AREA
STORAGE /

DISPENSING
LABEL

BATCHING
MALE
LOCKERS
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WAREHOUSE : AN EXAMPLE
SCREEN
LAMP, PROTECTED WITH SCREEN

SCREEN
VENTILATION
CANOPY

WEIGHING AREA
DOOR
PLASTIC CURTAIN Pedestrian mark

EXTINGUISHER

QUARANTINE
REJECTED
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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 and/or 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 - QUARANTINE

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 roof’s 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
RECOMMENDATION TO USE PROTECTIVE EQUIPMENTS

Use Mask Use Hand Gloves Use respirator Use helmet

Use ear protector Use

Use eye goggles Use welding cover
face cover
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SAFETY SYMBOLS

SAFETY WARNING SIGNS

TOXIC
OXIDIZING EXPLOSIVE
CORROSIVE

Toxic Oxidizing Corrosive

Explosives
substance substance substance

FLAMMABLE IRRITANT

Flammable
Flammable Irritant substance Environment toxic
substance
substance substance
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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 or 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 be 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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Thank you.