Assignment on Pharmaceutical Management Submitted by:

Sajan Maharjan
M. Pharm (1
st
Year)
Kathmandu University
Q. Suppose you are first line manager of operation department of a reputed Pharmaceutical
company. There have been problem of customers complaints on hardness of tablet. The
company may incur losses. How do you protect the company from heavy loss?
Plan for addressing the problem.
Decision making (goal)
Planning: strategic and operational plan
Use appropriate tools
Answer:
Goal- Prevention and monitoring of hardness of tablet so as to prevent heavy loss.

Planning- Should be formal; goal should be written and shared within the department
Plan 1: Strategic Planning:

a. PEST analysis:
Hiring qualified and competent pharmacists.
Assessing the quality of raw materials and excipients that might create problem in hardness of
tablet.
Proper validation and monitoring of drying machines as hardness is directly related to moisture
content.
Find the alternatives to control the temperature and humidity of production area (granulation,
quarantine and compression room)
Check for the production rooms Heating, Ventilation and Air Conditioning (HVAC) system.
Proper monitoring in packaging of tablets and packaging conditions.
b. Michael Porters 5 forces (external analysis):
Assess the threats of substitute of raw materials, excipients by a supplier; and if found, warn
the supplier or change the supplier.
c. Organizational Analysis:
Within the production department, an operator might be indulged in destroying image of our
company.
The pharmacists, operators or workers entrusted the task of drying the granules, compression of
tablet and packaging of tablets may not be competent or may not be much attentive at his/her
work.
d. SWOT Analysis:
It can be carried out to find the overall strength of our organization (internal+ external).
It helps in assessing the financial constraints, employee constraints, quality raw material and
high tech drying, compression and strip/blister packaging machines.

Plan2: Operational Planning:

We can make Load Chart for each operator and pharmacist to delegate work in the
granulation, tablet compression and packaging section.
For example, we can make a schedule to each personnel working out there so that they will
fill themselves responsible at their work.
If possible, we can go for Management By Objective (MBO) so that each production
pharmacist/operator deployed in granulation, compression and packaging will bring out their
proposal for masking the problem of tablet hardness so that newer alternatives can be
devised.

Other strategies at the operational level may be:

Proper handling and storage of moisture sensitive raw materials and all other excipients.
Use of drying machine, tablet compression machine and strip/blister packaging machine
properly
Checking for the moisture content of granules during drying within certain intervals
Checking hardness and friability of the compressed tablets frequently during compression.
Checking proper conditions of packaging room (temperature, humidity) and packaging
materials used.
In case of problem from market, in order to assure the complaints, appropriate control samples
of all the bathes must be stored in appropriate conditions.
Use Strip packing for moisture sensitive tablets as moisture may affect in hardness of tablet.
Continual monitoring of HVAC, temperature, humidity requirements of the granulation,
compression and packaging room.
Regular Calibration of drying and compression machines
Regular training to the operators/pharmacists at the granulation, compression and primary
packaging section
Check for container-closure system functionality (example by performing leak test) after
packaging to assure no affect in hardness due to error in packaging.
Hardness problem can develop through rough handling during transportation. So, proper
arrangements must be made in the vehicle for safe transportation.
Moisture-sensitive tablets such as effervescent tablets, should be stored in tightly closed
containers or moisture-proof packs, and may require the use of separate packages containing
water-adsorbent agents, such as silica gel.