Good Warehousing
Practice
1. Premises
2. Security
3. Temperature and humidity control
4. Equipment
5. Personnel
6. Sanitation
7. Receipt of incoming goods
8.
Warehousing of FG (Finished Goods) and Dispatch of FG
9. Packing for transportation
10. Transport
PREMISES:
·
Premises
should be of suitable size and construction to facilitate cleaning, maintenance
and orderly, segregated storage.
·
Storage
areas must be designed to provide adequate Ventilation, Temperature,
Sanitation, Humidity, Space, Equipment, security conditions.
·
Each
material should be stored separate from other materials to avoid the risk of
cross contamination.
·
Incoming
materials should be Quarantine until approved by the responsible person.
·
A
segregated area must be provided for returned, recalled and rejected goods
prior to a decision on further action.
·
A secure,
segregated area must be provided for the storage of controlled drugs
SECURITY:
·
Storage
areas should be provided with security to prevent theft or unauthorised entry.
·
Maintain a
control of who may enter the facilities.
·
Establish
system for controlling access to the facility (including all entrances and
exits)
TEMPERATURE AND HUMIDITY CONTROL:
·
All
materials must be stored at appropriate conditions as stated on the label of
the material.
·
The
temperature of all storage areas should be regularly monitored.
·
Controlled
temperature storage areas should be equipped with recorders and devices which
indicate when the specific temperature range has not been maintained.
·
A written
procedure must specify the action to be taken when this occurs.
·
Control
should be adequate to ensure that all parts of the storage area are kept within
the specified temperature range
·
Should
always have a backup system in case main system fails
·
The
humidity of all storage areas should be regularly monitored and recorded.
·
If the
product specification require a specific humidity, a written procedure must
specify the action to be taken when the specified humidity range has not been
maintained
·
Establish a
normal operating baseline of humidity if no specific value is required
·
Records of
temperature and humidity in all storage areas should be reviewed and retained
by a designated responsible person
EQUIPMENT:
·
There
should be a planned preventative maintenance programme in place (i.e. RLAF, AHU
etc.)
·
Recording
and control equipment should be verified & calibrated in intervals by
appropriate methods (i.e. Electronic Balances, Thermo hygrometer, RLAF, AHU, Dynamic
pass box)
Reverse Laminar Air Flow
Bench
Dynamic Passbox
Palate
·
Alarm
set-points should be checked on periodic intervals
·
A
computerised system (SAP) used for stock control/distribution should be
validated.
PERSONNEL:
·
The
organisation chart should be in place.
·
There
should be a sufficient number of staff.
·
There
should be clearly defined job description.
·
Personnel
should be trained in relation to good storage and distribution practice and to
the duties assigned to them.
·
The current
records of training should be in place.
·
The
trainers should have established and approved qualification.
·
ORGANIZATION
CHART (STORES)
¾
Head Stores
¾
Deputy
Manager Stores
¾
Sr.
Executive Stores
¾
Executive
Stores Assistant
¾
Stores
Manager Stores
SANITATION:
·
A written
sanitation program should be in place indicating the frequency and method of
cleaning the facility (i.e. Area cleaning SOP)
·
A pest
control program should be in place .
·
Smoking,
eating and drinking should be permitted only in segregated areas, and not in
those areas used for the storage and handling of final drug products
·
Material
spill must be promptly cleaned-up in accordance with the relevant health and
safety requirements for materials.
·
Adequate
toilet and changing facilities should be provided, and they should be
segregated from the main storage and order assembly areas.
RECEIPT OF INCOMING GOODS:
·
It should
be carried out according to approved adequate SOP.
·
Visually
examine delivery documents of the consignment (i.e. delivery challan, LR Copy,
excise invoice,COA etc.)
·
The
documents should be essentially consist of following information (Name of
material, Name of manufacturer, batch no, manufacturing date, expiry date, qty.
etc.) ü
·
Visually
examine physical condition & verification of consignment for damage.
·
Cross
verify container labels with documents, Batchwise segregation reject product if
damage or otherwise unfit for use
·
If any
discrepancies is observed in documents, material packing, vehicle condition, then
warehouse officer should bring notice this to head warehouse.
WAREHOUSING & DISPATCH OF FG:
·
It should
be carried out according to approved adequate SOP:
·
Storage
area should be maintained or designed to ensure good storage practice
·
Finished
product shippers should be kept on pallets batchwise in defined high stacking
to avoid fails down
·
Stores area
should be suitably secured and of sufficient capacity to allow for the safe
storage & handling.
·
Storage
area should be clean & dry and maintained within acceptable temperature
limit
·
Record
should be maintained of storage conditioned, Records of temperature monitoring
data should be available for review
·
Prepare
adequate shipping package to protect any damage of goods, seal pack and provide
relevant identification.
PACKING FOR TRANSPORTATION
·
Products
should be packed in such a way that the identification of the product is not
lost, the product does not contaminate and is not contaminated by other
products or materials
·
Adequate
precautions are taken against breakage.
·
Products
requiring controlled temperature storage should be provided with insulated
packs.
·
There
should be in place documented evidence that the insulated packs ensured
adequate transport conditions with regards to: product quantity, ambient
temperature, maximum delivery time.
TRANSPORT:
·
Products
should be transported in such a way that the safety, identity, strength,
quality of the product is not lost
·
The product
is not contaminated by other products or materials.
·
Adequate
precautions are taken against breakage.
·
The product
and its package are not subjected to unacceptable degrees of heat, cold, light,
moisture or other adverse influences nor to attack by micro-organisms or pests ü
·
Drug
products requiring controlled temperature storage by appropriate specialised
means or should be packed with adequate insulation 16 STAC Academy
·
TRANSPORT
Documents should be provided to cover all shipments. These document should
include as minimum: name of the product, quantity of the product, special
storage and handling instructions.
RECORDS:
Following records should be in place:
¾
Receiving
material (delivery challan, invoice, check list)
¾
Issuing
material (BMR/BPR issuance copy)
¾
FG
(receiving packing list, outgoing invoice, delivery challan, ARE1 copy with
authorised signature)
¾
Training
¾
Monitoring
temperature and humidity
¾
Cleaning
operation
¾
Pest
control
¾
Calibration
¾
Preventative
maintenance
¾
Recall
¾
Complaints
¾
Inventory
(Inward, stock registers)
¾
Log of
signature (formats)
REFERENCES: Good manufacturing practices for pharmaceutical products. In: Quality
assurance of pharmaceuticals. A compendium of guidelines and related materials.