Personal point of view based on current judgment, knowledge and real time experience of sitting on the other side of table

1. Inspection: A Challenge or Opportunity (Writing Series - 01)
Opening Presentation: Let’s start to demonstrate the Quality System efficiently
Obaid Ali, R. Ph., M. Phil. Ph. D.
Deputy Director/ Civil Service Officer
(Karachi the 30th
Sept, 2017)
The word audit is originated from an old Greek word used to verify the accounts maintained in the register.
Journey from verification to assessment followed by investigation have a long history to emphasize inspection
process as one of the fundamental and inevitable tool where question of human protection arises.
Good Manufacturing Practices (Pre-approval, post-approval, regular compliance and for cause) inspection of your
drug manufacturing facility is a real time expanding challenge in this emerging world because different inspectors
of different countries and sometimes of the same country came in with different approaches. The one most
common practice that certainly derived from their principle / policy / procedure is to hear from your own opening
presentation. Let me advice you, it is a very important and crucial time that may navigate inspector(s) to drive in.
Be prepared and do work hard to make this presentation responsive, impressive and based on facts. Do not waste
time in discussing things that may not attract the inspector’s interest and attention. Please understand why the
inspector is at your facility and what he or she needs to know. Your first presentation may germinate the seed of
thinking to travel and grow across the boundary that you may influence in designing. It is advised to please make
a framework that encourage thinking process across the all operations to participate in designing and developing
the opening presentation. Enough pre discussion on the presentation and practice should be conducted both to
have a critical review and making it worthy enough. In this way you will be able to deliver the messages in
simple, clear and pictorial language more efficiently. Logical elucidations of subject certainly strengthen the
confidence and create space in the long lasting memories and minds of inspector(s). It is suggested not going
beyond 20 minutes leaving another time span of 10 minutes for question answers related to the presentation. Be
prepared for presenting systematic details, if asked by the inspector. It means first 30 minutes are yours and
further extension may not be requested by you. The same time, you should be ready to explore further on a single
click upon inspector interest or concern or question. I will suggest hyperlinks of every potential area of questions.
These hyperlink presentations must also be concise on one slide (however, detail explanation in simple preferably
pictorial case study or scenario is encouraged to describe in minimum follow up slides). Please do not take much
time in responding question or explaining scenario. The presenter must be knowledgeable, confident and best in
communication skills, no matter he or she is from any department. The underline regulator expectations is to hear
about your organogram, outline of manufacturing facility, control strategy, progressive mode, performance
indicators, resistance to aging of your systems and strength of your overall quality management. Do not make

2. more than 10 slides and do not stay more than 3 minutes on any slide. Avoid writing sentences or reducing font
size and loosing or diverting the subject. Safety is above all economics, never give words or focus the subject to
attract inspector(s) sympathy against any social or regulatory burden you experience in maintaining quality
standards.
Do a lot of homework for opening presentation and be prepared to take part in discussion within the norms of
good and super science. Participate generously in inspection process to achieve the outcome of inspection that is
confidence and trust of inspectors. Respond the inspector confidently in a nice way but do not make the discussion
complex, don’t worry, language of science cannot be mutated or thrown away by anyone. It is my personal advice
for international inspections where structured policies and procedures prevail to govern the inspection process.
Note: This is not written for DRAP authorized current inspection scenarios under practice unfortunately, as it is likely designed against the
regulatory science to deceive public and enjoy the misuse of powers for exploitation. Teachers of Pharmacy Schools & Hospital
Pharmacists (who do not have relevant GMP experience) and more interestingly fresh graduates without suitable knowledge and experience
conduct regulatory inspections of complex pharmaceutical engineering, manufacturing processes, and its facilities within few hours or less
than a day. No one relies on inspection process of DRAP, hundreds of inspections have no value in the world as knowledge and integrity is
indiscriminatingly respected.
Disclaimer: Not the obligation of organization or association from where I belong, It is personal point of view based on decades experience
as regulator and student of regulatory sciences
Feedback: It is current thinking and shared just to trigger and sensitize the importance of opening presentation during inspection process.
All critics, comments and questions will be welcome on obaidali1971@gmail.com