Understand the potential of error, be vigilant and have a vision to react before it happens

1. Where Attention & Judgment Saves from Catastrophe
Mix up Potential; A Dead End in Multiple Drug Manufacturing Facility
Roohi B. Obaid, R. Ph., M. Phil.
Alumni CDER-USFDA & HPFB-Health Canada
(Karachi the 04th
Mar, 2018)
“Leadership is essential to maintain a
companywide commitment to quality and for the
performance of Pharmaceutical Quality System”
[ICH - Q10]
he first ever intent of developing standards was nothing but to avoid mix up of different ingredients or
process materials in manufacturing operations. No matter how experienced you are, how sincere you
are, how intelligent you are, you may come across with the smallest error of mix up that may sometimes
end up with horrible consequences. The reason of Punjab Institute of Cardiology (Lahore, Pakistan) tragedy in
year 2011 was nothing but a small innocent mix up that cost lives of hundreds of people. Good Manufacturing
Practices elements, its system to integrate operations and smart indicators to catch strength and sustainability of
Quality Management are not a choice, but an indispensible obligation. It is not incorrect that nothing can be down
to zero or below zero but moving from doable to desirable is the sign of life and proof of commitment with
quality. Quality Risk Management, Dashboard of Quality Metrics and culture of Data Integrity drive on the path
where information is transformed into knowledge and thus makes strategy of control stronger.
Wrongly identifying one material as “X” instead of “Y” in pharmaceutical manufacturing industry can never be
believed as a plan but may happen mainly due to bad judgment or lack of attention or poor communication among
personnel. Other possible reasons may be as under:
 Poor control on location of different materials that look similar
 Poor control during dispensing and re-packaging
 Simultaneous handling of multiple materials
 Poor control on un-used labels
 Offsite documentation
 Poor control on rejections stay, storage and destruction
 One printer for multiple computers working simultaneously
 One person performing two different jobs simultaneously
 Materials packaging having same color or combination of colors or dress
 One facility for multiple products with poor physical controls and clearance oversight
 Placement of different in-process materials in one room e.g. sterile and non-sterile
Thank you of reading, your comments and critics will be acknowledged and appreciated. Please write
at rooahama@gmail.com.
T