It is an original piece of writing. Represented thoughts are outcome of reading materials and experience as a regulator and shared to promote culture of reading, writing and managing the knowledge. All critics and comments are welcome.
Chemometrics Pharmacometrics Econometrics of QbD Swiss Pharma-6 2012Ajaz Hussain
The notion ‘by design’, in the phrase ‘Quality by
Design’, conveys an intention to deliver a product
or service with a pre-defined ‘quality’ so as to satisfy
intended customers. When the quality of a medicinal
product is considered, customer satisfaction
is often not easily measured. Therefore, regulatory
approval is important, and, it may be viewed as a
surrogate for confidence and satisfaction patients
and their physicians perceive.
This SWISS PHARMA presentation by
the author on 25 May 2012, in Basel, explored the
potential role of mathematical modeling tools, categorized
as Chemometrics, Pharmacometrics and
Econometrics, in improving regulatory communications
on ‘quality by design’. This article provides a
summary of arguments outlined during this presentation.
Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...Ajaz Hussain
An updated version of the article published in the Financial Express, Express Pharma on 16 May 2016. The picture below is based on a LinkedIn blog by the author entitled
“Pharmaceutical quality: Elephant in the Dark or Six Blind Men?” (September 8, 2015).
2016. Dosage Form Optimization: Technology to Advance the Patient-Centric Dru...Valentyn Mohylyuk
A supplement to American Pharmaceutical Review
September / October 2016
Dosage Form Optimization: Technology to Advance the Patient-Centric Drug-Development Process
Catalent Development
Quality metrics approach is indeed building up the foundation of culture of quality in pharmaceutical manufacturing operations. This is a practical navigation appearing on global radar and will rule all around in the same manner on the principle of similarity in human physiology irrespective of geographical locations. Strengthening the quality system will strengthen the culture of quality both in business of pharmaceutical manufacturing and regulations.
Chemometrics Pharmacometrics Econometrics of QbD Swiss Pharma-6 2012Ajaz Hussain
The notion ‘by design’, in the phrase ‘Quality by
Design’, conveys an intention to deliver a product
or service with a pre-defined ‘quality’ so as to satisfy
intended customers. When the quality of a medicinal
product is considered, customer satisfaction
is often not easily measured. Therefore, regulatory
approval is important, and, it may be viewed as a
surrogate for confidence and satisfaction patients
and their physicians perceive.
This SWISS PHARMA presentation by
the author on 25 May 2012, in Basel, explored the
potential role of mathematical modeling tools, categorized
as Chemometrics, Pharmacometrics and
Econometrics, in improving regulatory communications
on ‘quality by design’. This article provides a
summary of arguments outlined during this presentation.
Pharmaceutical Quality Assurance in the 21st Century, Sharper Focus Needed on...Ajaz Hussain
An updated version of the article published in the Financial Express, Express Pharma on 16 May 2016. The picture below is based on a LinkedIn blog by the author entitled
“Pharmaceutical quality: Elephant in the Dark or Six Blind Men?” (September 8, 2015).
2016. Dosage Form Optimization: Technology to Advance the Patient-Centric Dru...Valentyn Mohylyuk
A supplement to American Pharmaceutical Review
September / October 2016
Dosage Form Optimization: Technology to Advance the Patient-Centric Drug-Development Process
Catalent Development
Quality metrics approach is indeed building up the foundation of culture of quality in pharmaceutical manufacturing operations. This is a practical navigation appearing on global radar and will rule all around in the same manner on the principle of similarity in human physiology irrespective of geographical locations. Strengthening the quality system will strengthen the culture of quality both in business of pharmaceutical manufacturing and regulations.
Current issues and challenges in demonstrating QbD Korea 1 December 2014Ajaz Hussain
2014 Ministry of Food and Drug Safety (MFDS) International Workshop: Quality by Design (QbD) Implementation and Regulatory Challenges in theNew Pharmaceutical Quality ParadigmDecember 1 -2, 2014, Grand Hilton Hotel, Seoul, Korea.
Legitimate pharmaceutical community has practiced QbD for decades; however in ways that vary undesirably.
Demonstration of QbD is multifaceted.
There are serious consequences …in ways that can vary undesirably…
The consequence of “Cheating by Design” are almost always catastrophic.
Perhaps we need to view QbD applications/submissions as an additional layer of protection; to gauge the Culture of Quality.
Legitimate efficiency – is a key business driver, good for the patients, and the society overall.
Proposed ICH Q12: Regulatory Dossier - “regulatory commitments”.
Pharmaceutical Quality System aspects (ICH Q10) – risk and knowledge management system.
Post-Approval Change Management Plans and Protocols.
A reminder of the approach utilized for FDA’s PAT Guidance, Comparability Protocol and Team Approach.
Must focus on integrated implementation.
Team-building and training for Review, Compliance & Inspection functions.
Recognize that QbD Applications/submissions serve as an additional layer of protection; to gauge the Culture of Quality.
Pharmaceutical quality decisions are made by multidisciplinary teams (a range of maturity), at different times and in various organizations; understanding of the QbD paradigm and methodology is derived experientially -One Quality Voice is hard to achieve!
Legacy challenges, various ontological assumptions, and weak epistemology curtails knowledge sharing, delays consensus and keeps us trapped in a reactive mode (3rd Order)
The risk of irrational decision making needs to be accounted. ”Cut-paste” or “check-the-box” practices are reminders that we are not achieving an optimal integration or practicing systems thinking.
A reactive approach (3rd Order) to filling the noted gaps poses risk of continued erosion in the confidence the public should have in our assurance of pharmaceutical quality
We need a thoughtful, planned approach to filling these gaps –NIPTE should take on this challenge! Will it?
The Integrated Early Drug Development Platform White PaperCovance
Is it possible to deal with the explosion of complexity in the early clinical development space? Is the traditional clinical pharmacology unit obsolete? The answers are yes and no, respectively. The optimal engine for early clinical development in the modern era is an integrated early drug development platform.
“Pharmaceutical Quality Matrices in determining overall state of Quality and ...Marcep Inc.
Introduction to Quality Matrices
•What is Quality metrics
Background&Glossary
•Modernization of Regulatory Oversight of Drug Quality and Promotion of Post-Approval Improvements
•Use of Quality Metrics by FDA for Risk-Based Inspection Scheduling and Prediction of Drug Shortages
Legal authority
•Records Associated with the Process Validation Lifecycle and PQS Assessment
•Authority to Inspect Records and Request in Advance of or In Lieu of an Inspection
The Use of Quality Metrics and Effect of Non-Reporting
•How FDA Intends to Use Quality Metrics
•Effect of Non-Reporting
Group Discussion:
Implementing Trending of Quality Indices in Your Organization
The importance of the right culture and people
• Role of leadership in trending of Quality Indices
• Developing anonline data base for Quality Indices
•Analysis, interpretation and reporting of Quality Indices
The Process Flow
• Establishing the ground rules, procedures, forms and mechanismfor data collection for Quality indices
• Determining responsibilities and roles for the implementation of trending of Quality Indices
Starting the Quality Indices Management Process
•Review of Quality Indices and Gap evaluation
•Preparation of Data bases for Data acquisition
•Collection data for completeness and Accuracy
•Processing and Reporting of Quality Metrics
Day Two
Reporting of Quality data and Calculation of Quality Metrics
• Who Reports and Who May Contribute to the Report
• Quality Metrics that FDA Intends to Calculate
• What Quality Data Would Be Reported
• How to Report Quality Data to FDA
Instructions for Quality Metric Data Submission
•Worksheet for Data Tables
•Product Specific Information
•Mandatory Data •ICH Q9
•Optional Metrics
Recognizing and Understanding the Trending of Quality Indices
Working Session, I:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis on a given data. Each group will present theresults of its analysis
Working Session II:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis and propose a Quality metric by using Risk Based approach for the specific set of data. The results of the analyses willbe shared in the class.
Complexities of Implementation Quality Metrics
•Overcoming the pitfalls
•Benefits and Risks
General Discussion and Questions
Following our past four highly successful events, this event focuses on “A Critical Guide for Successfully Conducting “6th Annual Clinical Trials Summit 2015” It gives me great pleasure in welcoming all of you to The Virtue Insight’s “6th Annual Clinical Trials Summit 2015”.
Current issues and challenges in demonstrating QbD Korea 1 December 2014Ajaz Hussain
2014 Ministry of Food and Drug Safety (MFDS) International Workshop: Quality by Design (QbD) Implementation and Regulatory Challenges in theNew Pharmaceutical Quality ParadigmDecember 1 -2, 2014, Grand Hilton Hotel, Seoul, Korea.
Legitimate pharmaceutical community has practiced QbD for decades; however in ways that vary undesirably.
Demonstration of QbD is multifaceted.
There are serious consequences …in ways that can vary undesirably…
The consequence of “Cheating by Design” are almost always catastrophic.
Perhaps we need to view QbD applications/submissions as an additional layer of protection; to gauge the Culture of Quality.
Legitimate efficiency – is a key business driver, good for the patients, and the society overall.
Proposed ICH Q12: Regulatory Dossier - “regulatory commitments”.
Pharmaceutical Quality System aspects (ICH Q10) – risk and knowledge management system.
Post-Approval Change Management Plans and Protocols.
A reminder of the approach utilized for FDA’s PAT Guidance, Comparability Protocol and Team Approach.
Must focus on integrated implementation.
Team-building and training for Review, Compliance & Inspection functions.
Recognize that QbD Applications/submissions serve as an additional layer of protection; to gauge the Culture of Quality.
Pharmaceutical quality decisions are made by multidisciplinary teams (a range of maturity), at different times and in various organizations; understanding of the QbD paradigm and methodology is derived experientially -One Quality Voice is hard to achieve!
Legacy challenges, various ontological assumptions, and weak epistemology curtails knowledge sharing, delays consensus and keeps us trapped in a reactive mode (3rd Order)
The risk of irrational decision making needs to be accounted. ”Cut-paste” or “check-the-box” practices are reminders that we are not achieving an optimal integration or practicing systems thinking.
A reactive approach (3rd Order) to filling the noted gaps poses risk of continued erosion in the confidence the public should have in our assurance of pharmaceutical quality
We need a thoughtful, planned approach to filling these gaps –NIPTE should take on this challenge! Will it?
The Integrated Early Drug Development Platform White PaperCovance
Is it possible to deal with the explosion of complexity in the early clinical development space? Is the traditional clinical pharmacology unit obsolete? The answers are yes and no, respectively. The optimal engine for early clinical development in the modern era is an integrated early drug development platform.
“Pharmaceutical Quality Matrices in determining overall state of Quality and ...Marcep Inc.
Introduction to Quality Matrices
•What is Quality metrics
Background&Glossary
•Modernization of Regulatory Oversight of Drug Quality and Promotion of Post-Approval Improvements
•Use of Quality Metrics by FDA for Risk-Based Inspection Scheduling and Prediction of Drug Shortages
Legal authority
•Records Associated with the Process Validation Lifecycle and PQS Assessment
•Authority to Inspect Records and Request in Advance of or In Lieu of an Inspection
The Use of Quality Metrics and Effect of Non-Reporting
•How FDA Intends to Use Quality Metrics
•Effect of Non-Reporting
Group Discussion:
Implementing Trending of Quality Indices in Your Organization
The importance of the right culture and people
• Role of leadership in trending of Quality Indices
• Developing anonline data base for Quality Indices
•Analysis, interpretation and reporting of Quality Indices
The Process Flow
• Establishing the ground rules, procedures, forms and mechanismfor data collection for Quality indices
• Determining responsibilities and roles for the implementation of trending of Quality Indices
Starting the Quality Indices Management Process
•Review of Quality Indices and Gap evaluation
•Preparation of Data bases for Data acquisition
•Collection data for completeness and Accuracy
•Processing and Reporting of Quality Metrics
Day Two
Reporting of Quality data and Calculation of Quality Metrics
• Who Reports and Who May Contribute to the Report
• Quality Metrics that FDA Intends to Calculate
• What Quality Data Would Be Reported
• How to Report Quality Data to FDA
Instructions for Quality Metric Data Submission
•Worksheet for Data Tables
•Product Specific Information
•Mandatory Data •ICH Q9
•Optional Metrics
Recognizing and Understanding the Trending of Quality Indices
Working Session, I:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis on a given data. Each group will present theresults of its analysis
Working Session II:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis and propose a Quality metric by using Risk Based approach for the specific set of data. The results of the analyses willbe shared in the class.
Complexities of Implementation Quality Metrics
•Overcoming the pitfalls
•Benefits and Risks
General Discussion and Questions
Following our past four highly successful events, this event focuses on “A Critical Guide for Successfully Conducting “6th Annual Clinical Trials Summit 2015” It gives me great pleasure in welcoming all of you to The Virtue Insight’s “6th Annual Clinical Trials Summit 2015”.
Pakistan's Regulatory Approach: Can Quality of Drug be assured through Testin...Obaid Ali / Roohi B. Obaid
Disclaimer: It is purely personal point of view written in the best of professional knowledge and experience of dealing with affairs of regulatory sciences as Federal Regulator. In any way, it is not an obligation to agree by the organization or association to which we belong. The intent of writing is to sensitize culture of reading, learning, arguing and writing. Feedback: All critics, comments and questions will be welcome
Pharmaceutical Quality - The Office ofAjaz Hussain
The keynote address at the Fall meeting of the CPPR Industrial Advisory Board and the Site Directors held yesterday (27 October 2014) at Purdue University. The talk provides a perspective on the recent organizational changes announced by FDA CDER - the Office of Pharmaceutical Quality.
Most Visionary People Transforming Pharma and Life Sciences (2).pdfCIO Look Magazine
Meet Dr. Reem Yasin, the Head of Quality Assurance and Pharmacovigilance at Hawkary Pharmaceuticals Co., one of Iraq’s premier pharmaceutical companies. With a background in pharmacy, Dr. Reem graduated from the University of Jordan and later lectured at the College of Pharmacy there.
Greetings from Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “5th Pharmacovigilance Congregation 2013” The conference will be held on 20th November 2013, Kohinoor Continental Hotel, Mumbai, India.
Following our past four highly successful events, this event focuses on “A Critical Guide for Successfully Conducting “6th Annual Clinical Trials Summit 2015” It gives me great pleasure in welcoming all of you to The Virtue Insight’s “6th Annual Clinical Trials Summit 2015”.
Quality Perspective of ‘Good Distribution Practices’ in Indian Pharmaceutical...iosrjce
The operation of Supply Chain of Management (SCM) is predominantly perceived from commercial facet of a
business. Pharmaceutical products affect the health of the user hence it is obligatory to produce and deliver the
products of predetermined quality standards. This can only be achieved by designing quality centric procedures
and pursue them at each stage during distribution process. Quality is considered as the most sensitive aspect of
pharmaceutical business during manufacturing as well as distribution. Quality of medicinal products is
concurrent to its objective of curing the patients. Many drug regulatory agencies have issued guidance ‘Good
distribution practices (GDP)’for pharmaceutical manufactures. The Good Distribution Practices (GDP) is
considered an essential basis of pharmaceutical SCM to ensure systematic distribution of medicinal products.
Due to lack of proper understanding and commitment, product quality issues are noticed by manufacturer’s
quality assurance department. Since most of the quality aspects of pharmaceutical products are not known to
the common patients, the survey to characterise them with help of quality professionals has been found useful.
This research study finds that there is an enhanced need of control over the supply chain management
operations to align its procedure and practices with quality objectives of pharmaceutical ‘Good Manufacturing
Practices (GMP)’
Guidelines on Virtuous Pharmacovigilance Practices | Pepgra HealthcarePEPGRA Healthcare
Pepgra explains the general guidelines of pharmacovigilance for all clinical research organization. Medical-related problems for the Clinical trial monitoring services have a considerable impact on the pharmacovigilance process as it detects monitors and analyze the medical activities. Some general guidelines to promote the regulations in health care sectors are given below:
• Planning of quality
• Adherence to quality
• Quality assurance and control
• Improvements in quality
• Documenting the legal requirements
• Protecting humans from the adverse effects
• Building safe and practical applications
Continue Reading: http://bit.ly/2WosJSS
Contact Us:
Website: https://bit.ly/33Fwsye
Email us: sales.cro@pepgra.com
Whatsapp: +91 9884350006
Greetings from Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “9th Pharmacovigilance 2015” The conference will Be held on 2nd September 2015, Kohinoor Continental Hotel, Mumbai, India. Please find the detailed agenda for the same with this email.
FMD:- + 91 9171350244 or deepak@virtueinsight.co.in, deepakrajvirtueinsight@gmail.com
An article on contamination of Diethylene Glycol in Pharmaceuticals. Thanks to Dr. Ajaz S. Hussain for all teaching, sharing knowledge and supporting in professional development.
Artificial intelligence (AI) offers new opportunities to radically reinvent the way we do business. This study explores how CEOs and top decision makers around the world are responding to the transformative potential of AI.
The Team Member and Guest Experience - Lead and Take Care of your restaurant team. They are the people closest to and delivering Hospitality to your paying Guests!
Make the call, and we can assist you.
408-784-7371
Foodservice Consulting + Design
The case study discusses the potential of drone delivery and the challenges that need to be addressed before it becomes widespread.
Key takeaways:
Drone delivery is in its early stages: Amazon's trial in the UK demonstrates the potential for faster deliveries, but it's still limited by regulations and technology.
Regulations are a major hurdle: Safety concerns around drone collisions with airplanes and people have led to restrictions on flight height and location.
Other challenges exist: Who will use drone delivery the most? Is it cost-effective compared to traditional delivery trucks?
Discussion questions:
Managerial challenges: Integrating drones requires planning for new infrastructure, training staff, and navigating regulations. There are also marketing and recruitment considerations specific to this technology.
External forces vary by country: Regulations, consumer acceptance, and infrastructure all differ between countries.
Demographics matter: Younger generations might be more receptive to drone delivery, while older populations might have concerns.
Stakeholders for Amazon: Customers, regulators, aviation authorities, and competitors are all stakeholders. Regulators likely hold the greatest influence as they determine the feasibility of drone delivery.
Specific ServPoints should be tailored for restaurants in all food service segments. Your ServPoints should be the centerpiece of brand delivery training (guest service) and align with your brand position and marketing initiatives, especially in high-labor-cost conditions.
408-784-7371
Foodservice Consulting + Design
Senior Project and Engineering Leader Jim Smith.pdfJim Smith
I am a Project and Engineering Leader with extensive experience as a Business Operations Leader, Technical Project Manager, Engineering Manager and Operations Experience for Domestic and International companies such as Electrolux, Carrier, and Deutz. I have developed new products using Stage Gate development/MS Project/JIRA, for the pro-duction of Medical Equipment, Large Commercial Refrigeration Systems, Appliances, HVAC, and Diesel engines.
My experience includes:
Managed customized engineered refrigeration system projects with high voltage power panels from quote to ship, coordinating actions between electrical engineering, mechanical design and application engineering, purchasing, production, test, quality assurance and field installation. Managed projects $25k to $1M per project; 4-8 per month. (Hussmann refrigeration)
Successfully developed the $15-20M yearly corporate capital strategy for manufacturing, with the Executive Team and key stakeholders. Created project scope and specifications, business case, ROI, managed project plans with key personnel for nine consumer product manufacturing and distribution sites; to support the company’s strategic sales plan.
Over 15 years of experience managing and developing cost improvement projects with key Stakeholders, site Manufacturing Engineers, Mechanical Engineers, Maintenance, and facility support personnel to optimize pro-duction operations, safety, EHS, and new product development. (BioLab, Deutz, Caire)
Experience working as a Technical Manager developing new products with chemical engineers and packaging engineers to enhance and reduce the cost of retail products. I have led the activities of multiple engineering groups with diverse backgrounds.
Great experience managing the product development of products which utilize complex electrical controls, high voltage power panels, product testing, and commissioning.
Created project scope, business case, ROI for multiple capital projects to support electrotechnical assembly and CPG goods. Identified project cost, risk, success criteria, and performed equipment qualifications. (Carrier, Electrolux, Biolab, Price, Hussmann)
Created detailed projects plans using MS Project, Gant charts in excel, and updated new product development in Jira for stakeholders and project team members including critical path.
Great knowledge of ISO9001, NFPA, OSHA regulations.
User level knowledge of MRP/SAP, MS Project, Powerpoint, Visio, Mastercontrol, JIRA, Power BI and Tableau.
I appreciate your consideration, and look forward to discussing this role with you, and how I can lead your company’s growth and profitability. I can be contacted via LinkedIn via phone or E Mail.
Jim Smith
678-993-7195
jimsmith30024@gmail.com
CV Ensio Suopanki1.pdf ENGLISH Russian Finnish German
Emergence of Enhanced Quality Expectations in Pharmaceuticals
1. Emergence of Enhanced Quality Expectations in Pharmaceuticals
Roohi Bano Obaid, R. Ph., M. Phil
Civil Services Officer/ Deputy Director
Drugs Regulatory Authority of Pakistan
Government of Pakistan
Member, ISPE & Member PDA
Disclaimer:
It is personal point of view written in best of
professional knowledge and experience of
regulatory sciences. It is not an obligation to
agree by the organization or association to
which I belong. The intent of writing is to
sensitize culture of reading and learning.
(Oct 29th
2017)
Commercial viability of any drug product may often bring pain for patients who otherwise wait for their
drug to improve their quality of life and breath. Dryness of drug products like thyroxin, warfarin,
phenobarbitone, salbutamol inhalers, morphine etc. from the market leave patient on the mercy of nature.
The heart wrenching healthcare professional burst out when lifesaving drugs are not available due to any
reason. Voice of civil society rises in community where care of others is felt as a moral responsibility
beside capitalism and/or socialism. It is also observed and quite possible that quality defects may create
similar situations of drug shortage. Manufacturing facility or its control may go out unwittingly due to
knowledge limitation. A quality defect that impacts delivery and performance of drug and/or carries
harmful potential has always been a matter of top priority. In both cases, ability to detect, report and
assess defines presence and thickness of protection wall for the public. Power to predict uncertainty and
taking measures well in time is a challenge for industry and regulators to maintain uninterrupted supply of
quality drugs. Journey of quality testing from representative samples to understanding the product and
process ending up with the best efficient controls has undoubtedly reduced the grey corridor of failures.
At the same time a lot of opportunity for industry and regulators is available to enhance the quality
profile. With the innovation and expansion of knowledge, the shape of both pharmaceutical quality and
regulatory sciences is being designed in a way that has a great impact on product quality and
strengthening the certainty throughout the lifecycle operations. Drive and direction of regulatory and
modern sciences, such as science of quality risk management, quality by design, continuous
manufacturing, quality metrics and creating a culture of quality are itself forecasting the roadmap of
future. De-learning and re-learning are inevitable to live in the harmonized global village of
pharmaceutical landscape. Absence of international professional knowledge based associations here in
Pakistan like International Society of Pharmaceutical Engineering (ISPE), Parenteral Drug Association
(PDA), Drug Information Association (DIA) etc. and reducing global initiatives within corporate
organization are leaving a deep mark on the face of pharmaceutical business. Current absence of the Drug
Regulatory Authority of Pakistan (DRAP) in the international arena through membership, Memorandum
of Understanding (MOUs), Mutual Recognition Agreement (MRAs), Mutual Reliance Initiatives (MRIs),
2. Emergence of Enhanced Quality Expectations in Pharmaceuticals 2 | 5 Pages
Roohi Bano Obaid Karachi the Oct 29th 2017
collaborative and joint working with other counterparts is increasing the burden of resistance in progress
to make pharmaceutical business credible and reliable on the scale of modern science. Proportionality
placement of DRAP and industry requires quality education, current knowledge and enthusiasm to
guarantee the prosperity.
Nobody wants to see complain for their drug products early in the morning and do its best to maintain
quality as its inherent attribute. As a matter of fact, a lot of drug product recalls identify the weaknesses,
residual negligence and space to improve. In a number of cases, failure to deliver the performance and
fulfill therapeutic promises is visible and increases to the trouble of patients, sometimes with irreversible
consequences. Every incident carries a series of actions that contributes in understanding the reasons and
implanting the measures for better protection from its recurrence. Reactive approach to an incident is
becoming obsolete and is being replaced speedily with proactive approaches. Power to predict the
happenings is derived by integrating the data (often unorganized, inaccessible and inconsequential) and
scientific theories. Knowledge about failures or acceptance rates, changes in deviation trends, shift in
complaint natures, change in output pattern etc. can be synchronized to make power of certainty visible.
This ability can give an insight on the aging process and health status of manufacturing facilities to move
forward.
It was a time when representative samples of products were screened through destructive chemical,
microbiological and pharmacological testing for their registration and release of other units (e.g. tablet or
syrup bottle) manufactured with taken samples as a part of batch. These testing include assay, weight,
color, smell etc. With the passage of time, tests related to purity of product and dosage form performance
were incorporated in the row. Likewise, control on impurities and degradation within drug product is
defined in the same specifications spelling product quality attributes. In spite of testing, it is quite obvious
that no one can guarantee quality of every unit (e.g. each tablet of batch) of the product upon testing
unless capacity/strength of manufacturing process to absorb unavoidable shocks of variation is well
understood, efficiently designed & controlled. Knowledge pursuance from how to what and what to how
provided enough command to shrink uncertainty of failures within batch and batch after batch. This
traditional knowledge is being evolved in the shape of enhanced approach that speaks about established
conditions and control strategies in manufacturing, holding, storing and distributing pharmaceutical
products. Cost, objectivity and drug shortage threat is used to determine rationality and significance of
both traditional and enhanced approaches. Its co-existence at the same time and age is well protected
within science of risk.
The last two decades have seen tremendous advancement in the innovation of tools and introduction of
approaches to achieve better insight into product and process understanding and to design quality in the
3. Emergence of Enhanced Quality Expectations in Pharmaceuticals 3 | 5 Pages
Roohi Bano Obaid Karachi the Oct 29th 2017
product instead of relying on end product testing. This involves Quality by Design (QbD) and application
of Process Analytical Technology (PAT) tools. QbD approach is indeed a process of designing quality
into a product that promotes innovation and encourages continuous quality improvement. It gives a lot of
flexibility in post approval variations and thus reduce regulatory load and fortifies certainty index. PAT is
a tool to assess the process quality in real time and so helps in proactive working of any unwanted shifting
of any specification from desired space. Smart tools and innovative ideas that can reduce regulatory
burden and improve efficiency attracts regulatory and quality sciences attention. Limitation of batch size
is certainly to control uniform character (consistency) within a batch / batch after batch and to avoid
potential of shifting towards inconsistency as well as unreasonable contamination possibility from the
manufacturing environment and process. Demonstration of trusted and efficient control to resist the
influence of factors impacting character of uniformity does not leave space to respect regulatory words
over super science. Leading regulatory authorities have yet approved continuous process from
manufacturing of Drug substance to finished drug product delivery in one case while accepted conversion
of traditional manufacturing process to continuous manufacturing process in other case. However, a lot of
considerations are still under discussion to manage the knowledge for reaching on some workable
approach throughout the pharmaceutical operations and in defining the batch.
The intent of modern tools is to identify and assess potential risk for quality failures before they happen
for efficient scrutiny and inspections within limited resources. Data integrity and signals generation
through trends and patterns integration is arising to reshape the regulatory oversight methodology more
successfully and proficiently. Creation of culture to resist behavior that believes on non-recording, non-
reporting deviations and mistakes is inevitable. Quality improvement initiatives and clear demonstration
by the top management about their own personal commitment to creating culture of quality is the
indispensible foundation block. Clarity in delivering the messages, friendly quality competitions and
freedom of expressing point of view are essentially required to bring everyone on stage where he or she
can talk fearlessly.
Information is shared in discussion to generate knowledge that gives a strong value upon synchronizing
with real time experience. Associations of subject matter professionals from different industries and their
diversified experience comes up with worthy knowledge. Regular debate, discussions and conferences
provide opportunity to exchange views, scientific judgments and real time bumpers in progress. The
credibility and indigenous contribution both from regulatory and industry has not yet crossed the residual
level of global radar.
Harmonizing and globalizing efforts for quality of drugs demand reshaping of the regulatory authority
from policeman approach to a knowledge based scientific organization that believes on continuous
4. Emergence of Enhanced Quality Expectations in Pharmaceuticals 4 | 5 Pages
Roohi Bano Obaid Karachi the Oct 29th 2017
change, continuous learning, de-learning and re-learning, honesty, transparency, joint working, sharing of
information, over and above respecting value of patient. It is unfortunate that DRAP or any segment of
DRAP could not achieve or end up with any MOU, MRA, MRI or any membership in global initiatives
like International Council for Harmonization (ICH) or Pharmaceutical Inspection Cooperation Scheme
(PIC/S) so far. It is time to think that 100’s of meetings are sponsored by international agencies where
DRAP leadership or nominees participated in recent years but why they lost the marathon where dozens
of small countries from Eastern
Europe, Russian, Eastern
Mediterranean, South Asian,
South American or North African
region etc. got success.
Identification of reason of failure
is very important to know otherwise
chances of repetition
cannot be excluded. It is
time to design millennium
goals/project and strategy to
protect project continuity.
Strength of idea, rightness and
robustness of the concept,
complete strong plan with
appropriate design and its religious implementation need to be tabled for worthy discussions. Openness,
transparency, merit, credibility and knowledge based working requires core attention. To walk with the
modern pharmaceutical world in a trustable and respectable manner one have to define the available
knowledge capital, exclude what one should not do and include what can be done to start appearing on the
global arena.
5. Emergence of Enhanced Quality Expectations in Pharmaceuticals 5 | 5 Pages
Roohi Bano Obaid Karachi the Oct 29th 2017
US-FDA Progress as a Case study
21st Century broke the static approach and FDA came up with new measurable guiding
principles through real time quality monitoring approach, quality risk, quality management,
quality by design approach, data integrity and quality metrics etc. etc. in its first 15 years.
They emphasized on performance based regulatory approaches to concentrate on desired
measurable outcomes instead of processes and procedures. It should navigate to improve
quantitative quality performance of individuals and organizational behavior, such as
through quality metrics and by building a quality culture. Unlikely, relying on testing the
batches, building quality in the product to achieve clinical performance through
specification acceptance criteria is the fundamental area of interest. Migration from
traditional approach to enhanced approach for putting more energy in controlling the
variability of input materials and keeping the process parameters flexible is being
encouraged from countervailing forces. Real time monitoring through PAT assuring quality
on line and diminish the requirement of end product testing. Variable process and variable
input guarantee a more uniform output if pre-studied and controlled well.
The advancements in technology are making its way to continuous manufacturing (CM)
from typical manufacturing of a batch. Enhanced process capacity and reduced product
variability with an efficient manufacturing process to achieve meaningful product
specifications based on clinical performance will be more secure in CM. A strong
leadership to take lead in quality improvement and to make substantial investment towards
quality is the prerequisite and grows upon substantial rewards on quality efforts. The
stringent regulatory authorities are encouraging CM as well as putting a number of
questions as they have limited experience at present. There are many challenges in evolving
CM such as defining a batch, material traceability, segregation of non-confirming material,
applying qualified tools for risk communication and knowledge management, performance
indicators of control strategy, establishing flawless relations of control points to finished
product critical quality attributes and the process parameters objectivity, as well as efficient
cleaning approaches for rapid switch over from one product to another avoiding cross-
contamination etc. Side by side, the opportunities in CM are small facility area required for
operation and maintenance, being highly flexible due to movable parts for a wide range of
products and supervision through an integrated process control system.
Collaboration and effective communication with other regulatory counterparts and the
pharmaceutical industries has been initiated in the recent past to extract benefits of
opportunities in CM as well as to cope up with the challenges. Transparency, Openness and
willingness to learn about the potential of new technologies are vibrant within the agency.
The academia is being involved by them to keep organizing continuous discussions among
professionals and formal forums to exchange scientific point of views are underway on CM
and associate concerns.