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Warehouse and Distribution - Coggle Diagram
Warehouse and Distribution
What is inside a pharma warehouse
Hazardous Chemicals
Rejects
Quarantined materials
Retention samples
Intermediates
Products
Raw materials
Components
Main Concerns
Products spoilage
Product mix-ups
Contaminations
Presence of pests
Measures to tackle concerns
Control & monitor temperature, humidity, lighting
increased humidity results in
mold, corrosion, rust
Lead to contamination & suitable conditions for pest
condensation on walls, ceiling & floor
adequate lighting
for workers comfort oi
ability to perform effectively & efficiently
Proper segregation of materials
require suitable capacity
ensure orderly storage
prevent contamination or mix-up of the various categories
example
product & materials
Starting & packaging material
intermediate & finished product
in quarantine, rejected or recalled
Maintain facility at required level of cleaniless
Effective pest control systems
Warehouse environment
Purpose
Receive, hold and distribute materials
Take appropriate actions to receive raw materials from suppliers
After checking, take appropriate actions to hold them in the warehouse and eventually distribute them for use in production
Receive finished products and hold them for sale
Requirements
Maintain in a state of good repair
Provide protection
Free from pests
Written program for pest control
Pest control agents should be safe and pose no risk of contamination
For cGMP compliant companies:
Basic environmental control of temperature, humidity and lighting
Cannot affect material quality
Comfortable for personnel
All environmental conditions should be
validated
and all instruments
calibrated
Temperature sensors should be located in areas more likely to show fluctuations
Calibration should be done at defined intervals
Quarantine areas to hold goods awaiting release
Proper material movements system. (First-in-first-out, First-expire-first-out)
Must be able to protect products in the following way:
Protect from damage during storage + transport
Prevent degradation if materials is exposed to adverse temp conditions
Prevent mix-up/contamination by other materials
Prevent loss by maintaining product identity and traceability
Prevent expired product/material from being used
Level of cleanliness
Level 1: Normal cleaning and maintenance
Usually in processing area as materials are in containers or original packaging so well-protected from the environment
Level 2: Environment control depends on product storage requirements
Special areas for storage
Toxic/flammable materials
Separate storage room
Special exhaust and drainage systems
Fire safety facilities
For highly active, radioactive, narcotics, hazardous and sensitive products
Should be stored in dedicated areas with appropriate and additional safety + security measures
Storage Method
Key Objective of warehouse operation
minimize deterioration of materials since most material have limited shelf life
follow "older approved materials to be distributed first"
First-in-First-out (FIFO)
First-expire-first-out (FEFO)
Resealed partly used containers
Materials from opened containers
Storage location
goal
to facilitate easy retrieval of stored materials
to achieve, warehouse should have
Proper layout
Location codes assigned to all locations
stored materials to be assigned location codes
segregated to prevent mix up
similar materials stored together
sufficient capacity to have orderly storage
prevent mix up
Inventory control system
Issue of matching actual inventory level in stock with those on records
Inventory control system serves to minimise discrepencies
Common reasons for discrepencies:
Stock loss due to damage
Stock in incorrect location
Human error in accounting for stock
Theft
Labelled with incorrect identification
Mistaken for similar
Investigation must be done to investigate the cause followed by update of inventory
Done at defined intervals
Adjust existing inventory records, detect unusual/unacceptable discrepancies and improve inventory management
Fixed annual inventory
Counting performed once at the close of the financial year
Need to shut down warehouse
Need special team to count
Too expensive to shut down the whole warehouse
Cycle count/Continuous inventory
Items divided into 52 groups
Each group is counted during 1 week of the year
Less interruption to warehouse operation
Less mistakes when counting small groups
Low point inventory
Counting is done when stock reaches its lowest point
Minimum interruption to normal warehouse operation
Identify low point and order when stock reaches low point
Pharmaceutical products have limited shelf-life and need to have an effective system to track them
Monitor expiry date of items through inventory records or labels
Less than 75% expiry date needs to be reported
Expired items should be timely removed and disposed
Warehouse Design
requirement
loading & unloading bays should be protect materials and products from the weather
Receiving area should be separated from the rest of warehouse
Pharmaceutical products should be stored off the floor and suitably spaced to permit cleaning, retrieval and inspection
Prevent unauthorized entry
installing alarm system and card access control system
Handling of Stocks
Receiving, storing and issuing are important control activities
prevent issues from arising during production
Key functions of receiving and storage operation
organise materials from production or suppliers into storage area
Safe keep and protect stored materials
issue materials to designed parties and keep records of distribution
Point of receipt
Steps:
1) Receipt of items
2) Checking of items
3) Labelling of items
4)Assignment of storage locations
5) Updating of inventory records
Assignment depends on size, weight nature of items, shelf life, turnaround time
heavy items at midway, lighter on top of shelving units
Fast paced groups at the front , slow at the back
Heat and light sensitive stored in cold storage
Check for visual defects on contianers
Check items against delivery order
Issuing of items
Steps:
1) Generating pick list
2) Picking the item
3) Generating delivery document (Delivery Order, D.O)
Includes: items, qty issued, receiving party, date of issued, carrier particulars, etc)
A copy filed in store
Items are gathered and placed in a designated area
Physical condition checked
Update inventory records
document for the items to be taken for production
cGMP require all issue of product/ RM must be accompanied with document
Handling of Damaged Goods
reasons for damage
shelf life expiry
poor inventory mangement
Mishandling
improper storage of heat sensitive product
Accidental damge
damaged due to forklift
Returned by customer
placed in quarantine area while waiting for QC test results
After test results, 2 actions depending on results
Recover/ recycle/ salvaging
results must show conformity to specifications
drug must meet all requirement in lab test of
strength
identity
purity
quality
and evidence from inspection of premises to prove that the drug is not subjected to improper storage due to disaster or accident
can be returned back to storage or to appropriate stage of production for rework
Destroyed
if they cannot be reworked
Hazardous materials destructed by incineration
Small scale, non-hazardous materials could be treated as domestic waste
Must be supervised and recorded in the controlled drug register
Measures against insects and foreign particles
Warehouse
Closed docking
similar to airplane boarding
eliminates pest entry into warehouse controlled environment
use of insecticides
Install electronic fly killers in whole warehouse area
-Glue trap
Ensure windows are closed
incoming materials in pallets are double shrinked
use plastic pallets or impregnated wooden pallets
De-dusting mats in front of airlocks and elevators
Automated storage and retrieval system (ASRS)
Saves space
Reduces labour cost
Reduces damage
Increases accuracy in retrieval and inventory management
Wireless Warehouse
Replaces pen and paper with barcodes
scan item
location & information will be transmitted to the inventory system via radio frequency
Benefits
faster than manual counting
Eliminates error from manual data entry
Cold Chain Management
needs to be evaluated and controlled
usage of refrigerated warehouse, trucks, vans, ships, containers
use of temperature data loggers to help monitor the temperature history of the warehouse, trucks, vans, ships, containers and temperature history of the product
use of insulated shipping boxes during transportation
Is a system of storing and transporting temperature-sensitive products at recommended temperature
from point of manufacture to the point of use
biopharmaceuticals/Biologics have a fragile nature
Insulated shipping boxes
Consists of
Consists of:
Vacuum flask
Fabricated thermal blankers/liners
Moulded expanded polystyrene foam (Can be polyurethane, polyethylene)
Vacuum insulated panels (VIPs)
Reflective materials
Bubble wrap or other gas filled panels
may be used with a refrigerant or coolant
like
block/ cube ice, slurry ice
dry ice
Gel or ice packs
A digital temperature data logger or a time temperature indicator often enclosed together
monitor the temperature inside the box for its entire shipment