Good dispensing practices in

a pharmaceutical industry
DR. BUYINZA NICHOLAS MPS
Bpharm, Mpharm
• Production department gives bill of materials or requisition sheet as
per batch manufacturing record to the stores manager of the
pharmaceutical industry.
• Stores manager on receiving the bill of materials first checks for the
availability of the materials as per the FEFO (First Expire First Out)
system
• If one of the required materials is still under test and not yet
approved by QC then the stores manager shall inform QC immediately
about the need of the item in the production unit.
• Stores person shall then transfer all the materials on the requisition
sheet as per the FEFO system to the dispensing area.
• Before entering the dispensing area all the personnel in this area have
to follow the secondary gowning procedure and this aims at ensuring
that no contamination of the raw materials to be dispensed occurs
from the personnel to carry out the dispensing exercise.
• Stores manager then has to check all the raw material detail including
the name, approval date, the nature the manufacturer, the
manufacturing date, expiry date, retest date and many more before
dispensing
• The stores manager shall now put on the RLAF (Reverse Lamina Air
Flow) system 15 minutes before start of the dispensing procedure.
this system ensures that there is a unidirectional airflow in the
dispensing area to avoid any contamination of the materials to be
dispensed following contaminants from the stores personnel.
• One product is dispensed at a time to control cross contamination of
the products.
• Stores manager has to check for the general cleanliness of the
dispensing area before start of dispensing as per SOP of clean
dispensing area
• Stores manager must check the pressure difference in the dispensing
area before start of dispensing as it needs a positive air pressure in
the dispensing room with respect to the surrounding environment to
control entry of air contaminants into the room.
• Stores manager must check the temperature and relative humidity in
the dispensing room before start of the dispensing process
• Stores manager must ensure that all equipment to be used in the
dispensing processes are extremely clean and dry and free from any
contaminants.
• Ensure that the weighing balances to be used in the process are fully
calibrated to avoid any errors in dispensing.
• Ensure you get line clearance from the quality assurance officer
attached to dispensing before you start the dispensing.
• Following line clearance from a quality assurance personnel ensure
you only start dispensing in presence of a stores manager and a
production manager and also fill the dispensing log book
• Production manager must check also the temperature and relative
humidity and also check all the raw material detail including the
name, approval date, the nature the manufacturer, the
manufacturing date, expiry date, retest date and many more before
dispensing
• If there is any discrepancy found then notification should be given to
the head of department quality control and quality assurance and
necessary steps taken as per guidance
• Stores person must use separate scoops while dispensing to avoid
cross contamination
• While dispensing, if any spillage or breakage or leakage of the
material is found, immediately inform the superiors that is head of
department quality control and quality assurance and necessary steps
taken as per guidance.
• Stores person should only dispense under RLAF and should only open
the material container for dispensing in a safe working zone free from
any contamination.
• Sequence of measurement should be excipients, colors and flavor,
actives next
• After weighing, the stores manager must mention the gross weight,
tare weight and gross weight of what is measured and a weighing slip
is printed and signed and production must verify the weights against
the slip when the dispensed material reaches the production unit.
• Put UNDER LOOSSE (Loose quantity) label on the last container that a
material was measured from and return it to the appropriate storage
area.
• All approved material is transferred to the dispensed material store
• From the dispensed material store materials are moved through a
pass box to the production unit
• After completion of dispensing the stores manager has to put off the
RLAF system.
• Document all that was on the bill of materials
• Clean up the whole dispensing area.