Its time to unlearn and relearn to align ourselves with the emergence of modern technology.

1. Make your
Pharmaceutical Drug
Product Trustable
How much you know your drug is
safe, Discuss, argue & learn.
Enhance capacity of learning, de-
learning & relearning.
CQS Training Session on
GMP of the 21st
Century
OR Centre for Quality Sciences

2. 1/3
GMP of the 21st
Century
Develop Desire to Excel in Quality
Venue & Date: 04th
April 2021 at Hotel Marriott, Karachi
Eligibility: Professionals with sufficient background knowledge of Good
Manufacturing Practices (GMP)
Fee: Rs.12,000/= per participant via bank.
Obaid & Roohi Centre for Quality Sciences
Allied Bank, Allama Iqbal Road Branch (Code: 0663)
Account No. 0010030041080020
Write complete name on cheque, take care of spelling.
Key Question of the Day: Can all generics be considered equal, while manufactured by different
people having different level of knowledge, skill and experience?
Course Facilitators: Obaid Ali & Roohi B. Obaid and guest experts
Both are postgraduate of pharmaceutical sciences who received
extensive knowledge on pre-market submissions, compliance &
enforcement strategies, approaches, tools and standards, as well as post
marketing variations through advanced academic and professional
courses beside series of trainings of regulators from US-FDA, Health
Canada etc. They worked on different regulatory agency desks as
functional head including pre and post registration of drugs, compliance
and enforcement of manufacturing facility, governing policy, designing
initiatives, developing strategies and conducting trainings within the
country, regulatory agency and outside Pakistan.
Contacts: WhatsApp. 03215150062 or send email at cqsciences@gmail.com
Fellowship Available: For deserving professionals. Write detail message of interest and
justification of receiving fellowship. It will be kept confidential.
Background: It was a time long ago when extensive testing was relied upon, to guarantee
a quality drug and all the quality affairs revolved around classical tool
(Testing). Later on with the experience and expanding knowledge, it came
to bright that the manufacturing process have a greater impact on drug
quality, hence, in-process controls were introduced and they became the
part of the regulation. Further moving upward on the ladder of age, the

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limitations of sampling was realized in representing the whole batch.
Moreover, the limitations of testing surfaced and established that testing
of 20 units of a batch consisting of millions of units cannot assure the
quality of every unit of the batch. Resultantly, emphasis was extended,
reshaped and focused more on the product development, process
understanding and control strategy to achieve consistency within a batch,
time after time and batch after batch.
Independent and integrated regulatory reviews under Good Review
Practices (GRP) as well as regulatory inspections of manufacturing sites
under Good Manufacturing Practices (GMP) standards to determine the
strength of product and manufacturing capacity are indispensable. So,
without understanding the entire manufacturing process and mechanism to
keep controls efficient throughout the manufacturing, no one will be able
to say that drug is consistent in the entire batch in terms of purity, right
dose and right delivery of drug inside the body and is without unreasonable
contamination of germs, particles and traces of other drugs. Such oversight
also ensures elimination of any potential mix up with other drug, same
drug of different strength or with sorted (defective) drug during the each
and every step of the manufacturing and distribution process until it
reaches to the patient.
It is necessary to be abreast of the fundamental dimensions that
categorically spell time and again about limitations of compendia
procedures of testing. In most instances testing is done on a small sample
of a batch, so that most of the batch can be used for patients rather than
destroyed by testing. Therefore, it is important that drugs are manufactured
under conditions and practices required by the GMP regulations to assure
that quality is built into the design and manufacturing process at every
step. Facilities that are in good condition, equipment that is properly
maintained and calibrated, employees who are qualified and fully trained,
and processes that are reliable and reproducible, are a few examples of
how GMP requirements help to assure the safety and efficacy of drug
products. FDA clearly describes “the “C” in cGMP denotes “current”. It
requires companies to use technologies and systems that are up-to-date in
order to comply with the regulations. Systems and equipment that may

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have been "top-of-the-line" to prevent contamination, mix-ups, and errors
10 or 20 years ago may be less than adequate by today's standards”.
Complying with the cGMP principles assures the identity, strength,
quality, and purity of drug products by requiring that manufacturers of
medications effectively and tolerably control manufacturing operations.
This includes establishing strong quality management systems, obtaining
appropriate quality raw materials, establishing robust operating
procedures, detecting and investigating product quality deviations, and
maintaining reliable testing laboratories. GMP via integrated System of
Quality Management prevents errors that are difficult to catch through
testing of the finished products.
Advancement in technology, Continuous Manufacturing, Data Sciences,
Artificial Intelligence, concepts of Culture of Quality & Quality System
Maturity, etc. are reshaping GMP and prompting us to become aware of
the tremendous storm of evolution in this field and need of diving in
molecular pharmaceutics. So let’s align our professional development
with the fast emerging technological landscape of the world. To ensure
public safety and quality of drug, we have no way left other than to
enhance capacity of learning, de-learning and relearning that could make
our walk compatible with the modern science and get it trusted all around.
Methodology: Tutorial will be accompanied by interactive discussion to initiate thinking
process and keep aligned with the objectives of the subject. Real time
examples and case studies pertaining to the topic will be used to describe
the scenarios and regulatory expectations.
Learning & Assessment: Participants’ assessment will be done on real time basis and performance
dashboard will be restricted to concerned and kept confidential.
Group Size: It will be small to maintain direct supervision during the training and
exercises.
Please Remember: One bioequivalence study and process validation on 3 batches cannot give
guarantee for lifetime manufacturing of quality drugs.
For Questions: Please write at info@orcqs.com or cqsciences@gmail.com
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