Who we are & What we do?

1. What, Why & How
OR Centre for Quality Sciences is
established with intent to extend
consulting and advisory services for
the pharmaceutical & biologic
industries on pharmaceutical
quality & regulatory affairs,
science, innovation and
technology. Real time experienced
subject matter experts will be
engaged to deliver sustainable
foundation support to Academia,
Industry and Government.
Contact Us
+92-21-372-91889
+92-321-515-0062
cqsciences@gmail.com
On the road to embrace Knowledge
& Moral Economy in the field of
Pharmaceutical Sciences
Keep every dose safe, effective and
of quality throughout the shelf life
Obaid & Roohi
Centre for Quality Sciences

2. Obaid & Roohi
Centre for Quality Sciences
A Bridge to Progress Safe and Go Far
The drive of OR Centre for Quality Sciences is to
shift towards quality culture from compliance
culture for the progress & sustainability
particularly in Pharmaceuticals, Biologics & Food
Industry. Post CoVid era will be the new world
and coming time will considerably revolve around
machine learning and artificial intelligence. Data
sensors will be performing an unprecedented role
in pharmaceutical care including manufacturing.
Technology is in mode of rapid changing and
novel innovations are being introduced. New tools
and novel approaches are creating a complex
environment of integration within regulatory arms
on the other side of the road. The only way to stay
competitive in a vibrant atmosphere is to embrace
with real time knowledge.
Professional development is critical not only for
quality of drugs but for current Good
Manufacturing Practices (cGMP) implementation
to ensure that the drug product is safe, effective
and of quality. Prevailing education, training and
experience unluckily not seem to be aligned with
exponentially increasing complexity in which
pharmaceuticals operate, such as complexity of
materials, their interactions, products, analytical
methods, etc. Manufacturing processes suitability
and its capability are always under microscope but
emphasis on the similar scale is required in the
thinking process. Transformation of professional
thinking is indispensable with the dawn of new
regulatory expectations. Continual development is
inevitable for systems to function effectively and
live on progressive mode.
From real world perspective, companies are judged
by their history of compliance and inherent
quality culture. A throw back at the past reveals
that only compliance to cGMP regulations does
not make zero the risk of regulatory actions
ranging from regulatory observations, or recalls or
warnings to closure of the manufacturing facility.
It also demands having a mature and sustainable
culture of quality that can establish cause and
effect relationship. It leads towards the degree of
consciousness where systems thinking begins and
dives deep for an insight while using reasons to
explore any atypical undescribed event.
The cGMP orbits around understanding the
process, controls on factors that may impact
product quality and its label claim. Learning to
define cGMP for own product and process is the
answer in the way of reducing uncertainty.
Applying similar tools to avoid contamination
between the same class of therapeutic products
and between antagonistic therapeutic products is
neither appropriate nor serves the rationale for
cGMP. Consumer centric approach asks for
differentiation and sound understanding of the
word “appropriateness” in the operations and
cleaning strategies. OR Centre for Quality
Sciences is following the thoughts of leaders on
the subject in its spirit and aligning its objectives
with post CoVid new world. Centre has
association with worthy professionals of rich
experience working all around the globe and
known to their expertise. The Centre is also
strengthening platform of subject matter experts
for enhancing activities to promote science by
sharing of knowledge.

3. Key Question
Can all generics be considered equal while manufactured by different people with different levels of
knowledge, skill, and experience?
It was a time long ago when extensive testing was
relied upon to guarantee a quality drug, and all the
quality affairs revolved around a classical tool
(Testing). Later on, with the experience and
expanding knowledge, it became evident that the
manufacturing process has a greater impact on
drug quality; hence, in-process controls were
introduced and became part of the regulations. In
moving upward on the ladder of knowledge,
sampling limitation, such as representing the
whole batch, is better appreciated.
Moreover, the limitations of “one size fit all”
testing in pre-specified 10- 20-30 unit samples
from a batch consisting of millions of units posed
a dilemma – can or when can these assure every
unit’s quality in a 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 lot after lot.
Independent and
integrated regulatory
reviews under Good
Review Practices (GRP)
and 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 whole batch in
terms of purity, right dose, and right delivery of
medication inside the body and is without
unreasonable contamination of germs, particles,
and traces of other drugs. Such oversight also
ensures eliminating any potential mix-up with
other drugs, the same drug of different strength,
or with sorted (defective) drugs during each step of
the manufacturing and distribution process until
it reaches the patient.
It is necessary to be abreast of the fundamental
dimensions that repeatedly remind us about
testing limitations via traditional compendial
procedures. In most instances, testing is done on a
small sample of a batch so that bulk of the batch
can be used for patients rather than destroyed by
testing. Therefore, we
expect drugs are
manufactured under
conditions and
practices required by
the GMP regulations
to assure that quality
is built by design and
manufacturing
process at every step.
Facilities in good
condition,
equipment that is
properly maintained
and calibrated,
employees who are
qualified and fully trained, and processes re
reliable and reproducible are a few examples of
how GMP requirements help 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 to comply with the regulations.

4. Systems and equipment that may have been “top-
of-the-line” to prevent contamination, mix-ups,
and errors 10 or 20 years ago maybe 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 expectation
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 by testing 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
the need for diving into 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 the
drug, we have no way left other than to enhance
the capacity of learning, de-learning, and
relearning that could make our walk compatible
with modern science and get it trusted all around.
Do Remember
One bioequivalence study and process qualification based on
three batches manufactured under ideal conditions open the
door to commerce, but it does not guarantee lifetime
manufacturing of quality drugs.

5. CQS Services
International Council for Harmonization – Common
Technical Document & Quality Guidance
Common Technical Document (CTD) is certainly the language of science in submission and review of drug
applications for enhancement of safety, efficacy and quality of drug products as well as reduction of
uncertainty. The expanding crisis of ability and passion for knowledge on one hand, whereas, relying on years
of experience instead of knowledge driven wisdom on the other hand in the society is a real challenge.
Development of all stakeholders is inevitable for fair progress of industry within and outside the country to
avoid any surprise uncertainty. The shrinking of space is rapidly proliferating in today’s dynamic world of
fastest communication and information. Although resistance to change is somewhere well justified, but at
the same time, preparedness to achieve the highest standards will not lose anything and will enrich with
support of modern science for sure.
Centre wishes to trigger a platform where knowledge can be cultivated. CTD and its expectations need to be
sincerely assessed and there is no reason to feel inability of compliance. We will be pleased to offer assistance
in the shape of training of individuals. The training will cover background knowledge that became the reason
of harmonized document and lessons learned by US-FDA regulators on CTD, when applied with question-
based review process of 21st
century. The real observations of greater impact recorded by FDA have always
been close to the circle of our interest. Those observations will be focused and counter argument with
scenarios will be framed. Some real time recent case studies of FDA covering complex products, complex
manufacturing process and difficult generics will be chosen to develop tutorials. These tutorials will be capable
to give an insight on expanding regulatory expectations.
Surveillance & Vigilance Support
Beside pharmacovigilance activities, continued monitoring of production and process provides better
understanding and real time knowledge. Centre will provide support in assistance of:
1. Market Complaints & Handling
2. Designing, development & implementation of Quality Surveillance Program
3. Development of Periodic Safety Update Reports & its Review before Submissions.

6. 4. Development & review of Quality Metrics & Quality Culture
5. Measuring the maturity of Quality Management System
6. Determination of strength and efficiency of ongoing programs
7. Submission of Adverse Drug Reactions (ADR) to concerned.
8. Assessment of therapeutic equivalency & generic performance
9. Responding to Unforeseen Incidence & Questions of Regulatory Agencies
10. Data learning to predict any potential shortage and crisis
Regulatory Submissions Support
Centre specialists have years of experience working with regulatory agency and global leading manufacturing
industries. Centre collaborates to analyze need and match the right experts for situations. It extends support
in pre-review of dossiers, developmental plans, critical writing, review of technical documents, generic drug
stability data, policies, SOPs, plans, validation protocols, validation reports, response to regulatory agencies
etc.
Quality System Support
Pharmaceutical quality ensures that every dose is safe, effective and free from contamination and defects time
after time, in every batch and in every season as per label promise. Its performance is consistent with label
claim. These labels are contract between company and consumer while the Government shares the
responsibility. Commitment to continual improvement leads to more robust manufacturing process, reduce
quality related problems, increase quality system efficiency, cost saving and regulatory flexibility. Centre’s
services will cover the following subjects, but not limited to:
1. Review & assistance of system to perform desired functions independently
2. Out Of Specification Investigation
3. Development of Master Validation Plan
4. Quality Risk assessment
5. Annual/ Periodic Reviews

7. 6. Change Management
7. Drug Recalls & Returns
8. Drug Stability Program
9. Calibration Program
10. Corrective & Preventive Action (CAPA)
11. Root Cause Analysis
Supplier Development Support
Suppliers are a critical element of GMP compliance. It is the responsibility of manufacturer to assure that
suppliers are compliant with standards and requirements applicable to their operations. Supplier
development starts with appropriate qualification, contract and quality agreements. Maintenance of trust
requires verification through continuing quality assurance practices including sampling, testing and audits.
Vigorous supplier qualification process and robust agreements are the key. Centre services include:
1. Reviews of documents
2. On-site inspections and follow up
3. Development of Quality Agreement
4. Maintenance of Trust etc.
GMP Training Exercises
Professional development is critical not only for quality of drugs but for current Good Manufacturing
Practices (cGMP) implementation to ensure that the drug product is safe, effective and of quality. Prevailing
education, training and experience unluckily not seem to be aligned with exponentially increasing complexity
in which pharmaceuticals operate, such as complexity of materials, their interactions, products, analytical
methods, etc. Manufacturing processes suitability and its capability are always under microscope but emphasis
on the similar scale is required in the thinking process. Transformation of professional thinking is
indispensable with the dawn of new regulatory expectations. Continual development is inevitable for systems
to function effectively and live on progressive mode. Subject matter experts will be invited to share knowledge

8. with participants. Fundamental, contemporary and customized trainings within company and within groups
on different essential, applied and emerging subjects will be organized such as:
1. GMP Elements & Intent
2. Validation Exercises
3. Documentation &Data Integrity
4. Operations & Control Strategies
5. Consistency & Contamination Affairs
6. Setting of specifications
7. Culture of Quality
8. ICH Q Guidance
9. GMP Attributes
10. Writing & Reviews etc. etc.
GMP Compliance Audits
It is assistance in assessment of compliance and strength of control strategy. Full plant Good Manufacturing
Practice (GMP/ current GMP) compliance audits, report and suggestion to improve facility consistent with
GMP standards. This service will help in designing and development of process control system. Strategic
compliance plan with desired manual and procedures will be extended and supported throughout the
execution. Following categories of audits are included in Centre’s services:
1. Assistance in Pre-approval Audits
2. Assistance in Compliance Audits
3. Assistance in Investigations
4. Assistance in for cause Audit
Facility Design Review
Efficient design with appropriate amount of flexibility is the gateway to enter in future with reasonable
certainty. Continuity is always hard to achieve if it has not been planned well. Flow of materials and flow of

9. personnel both in and out should be of prime importance. It should also be capable to support operational
effectiveness and uncertainty in compliance when planned for expansions. Determination of right sized
quality facility is the first step. The flexibility of decision corridor needs to find out where design, management
and operation considerations are balanced. Services include review and assessment of existing or planned
facilities, buildings, equipment and manufacturing process. Mapping of potential challenges in both scenarios
followed by advices will also be offered.
Clinical Trial Sites & Analytical Sites
Monitoring, Audit & Quality Assurance Support
Monitoring of clinical trials and studies for compliance of the International Council for Harmonization Good
Clinical Practices (GCP) and for Good Laboratory Practices (GLP). Support in the development of Quality
System, Trainings and Audits.
Independent Opinion & Legal Support Services
Profession of pharmaceutical sciences either from manufacturing, distributing or selling of drug product
touches the daily life and health of citizens directly that no other business does. Margin of omission, error,
negligence, and ignorance at both ends of law enforcement agencies and service providers sometimes come
into the wrangle that does not give benefit to the mission, but anxiety, panic and unwanted terrible
uncertainties. CQS feels its responsibility to provide paralegal and scientific support to deal with situations
and resolve matters, particularly for the salaried class individuals whose name is incorporated as accused just
because of their presence in the list of qualified persons and generally for all those entrepreneurs who are
innocent otherwise. Please feel free to contact us for scientific support, drafting a response or taking an as
first or second independent opinion on such regulatory affairs.

10. Independent Assessment & Review of your
Documentation Practices
Background: The integral essence and essential part of Quality System are recording data, extracting
information, creating knowledge and expanding wisdom to make decisions sensible. Documentation is an
obligatory requirement under every regulatory umbrella with discriminative expectations. It is the key to assess
the design of framework, its strength, its sustainability and predict unknowns.
Scope: The scope of independent services are:
• Batch histories
• Investigation reports
• Risk management
• Deviation management
• Change management
• Process Validation
• Validation plans
• Training plans
• Calibration plans
• Maintenance plans
• Aseptic Area Qualification
• Periodical quality reviews
• Site Master File
• Product Master File
• Audit/inspection reports
• Post marketing surveillance plan
• Stability studies
• Supplier qualification program
• Pharmacovigilance activities
Advantage: It will help management to have independent assessment, provide opportunity to understand the
reasons and navigate for efficient decisions in way to progress. Continual improvement is like breath that
guarantees life. Knowing unknowns and understanding with the help of verifiable evidences will remove fogs
to build sustainable protection based on science from potential uncertainty.
Assessment/Review Quality: Those who supervise the process have enough experience of the field.
Confidentiality: All reviews and assessment contracts will always be confidential and a well explained
agreement of confidentiality will be signed prior to commencement of any work.

11. Develop & Align System to Qualify the
Standards – US-FDA, ICH, PIC/S
Regulatory standards are getting harmonized rapidly in the new emerging post CoVid world. PIC/S is moving
towards manufacturing facilities inspection standards, whereas, ICH is focusing mainly on science of Product
Development and Quality Management throughout the lifecycle. The best existing real example is US-FDA
where questions and concerns are connected with the objectivity as well as corridor of risk calculation is wide
and open.
Misinformation and sometimes disinformation about PIC/S emerges that needs to be understood. Similarity
and differences in GMP standards among countries including WHO PQ program exist during the practices.
Clarity and understanding of the subject is the foundation block. CQS can help in achieving standards and
reshaping the existing system into the zone of expectations of science and compliance of country regulations
where someone intends to export.
Centre for Quality Sciences
Hands on Experience:
• GMP Inspections: Conducted inspections of hundreds of facilities covering various dosage forms.
• Complaint Handling: Investigation of complaints and working with other law enforcement agencies.
• Drug Testing: Supervision of chemical and microbiological testing and periodical reviews.
• Drug Master Files (DMFs): Engaged in synthesis route, impurities & genotoxic impurities, review of
supplier qualification.
• Biological Drugs: Supervision of pre & post reviews in CTD format, adverse events (AEFI)
• Policy & Pharmacy Services: Trainings of regulators, post marketing quality surveillance,
pharmacovigilance and clinical trials.
Key Deliverables:
• Facilitation in improvement of certainties and efficiencies of Pharmaceutical Submissions and Technical Operations
within the norm of modern science
• Facilitation in Strategic Mapping to ensure Quality Compliance in Submissions and to sustain QMS through
integration of Culture of Quality and Quality Metrics in challenging regulatory landscape of pharmaceuticals
• Consultation in identification, analysis and assessment of the fundamental, technical, scientific and compliance issues
through development of generic product to post-marketing aspects

12. • Conduct hands on training focusing Management of Change, Risk, Deviations, CAPA, Complaints, Outsource
activities. Conduct compliance assessment of manufacturing facilities and QMS
• Consultation on emerging subject of Quality Metrics, Data Sciences, Data Integrity, Human Factor Analysis,
Investigations and Study Designs to demonstrate the compliance with regulations
• Consultation in smart development of progressive policies/framework to walk with evolving field of Pharmaceutical
Quality
• Facilitation in triggering discussion among group driven by data and super science to manage prior qualified knowledge
in the development of roadmap for future
• Consultation in designing the strategy for impact analysis of master projects, its independent fragmentation and its
performance indicators parallel to managing the continuous knowledge of impact analysis
• Conduct supplier, materials and site qualifications for the suitability of desired performance, quality of product and
for integrity of claim.
Quality is more than just the State of Art Facility