The presentation provided an overview of recent advances in the pharmaceutical industry. It discussed improvements in several areas including dosage forms, drug development, manufacturing, analytics, quality and GMP compliance, outsourcing, data integrity, and quality by design. Key developments included new biologic drugs, specialized dosage forms, continuous manufacturing processes, enhanced analytical instrumentation, a focus on data integrity and quality attributes from product design through manufacturing, and increased outsourcing of services. The presenter emphasized that quality by design has become a modern regulatory expectation to increase process understanding and decrease patient risk through systematic product and process development and continuous improvement.

1. A
presentation
on
Recent Advances in Pharmaceutical Industry
By:
Amitabh Tripathi
Asst. Professor
Dept. of Pharmaceutics
United Institute of Pharmacy

3. Brief Introduction
O As the technology advances itself, there is advancement in
each and every aspect of life.
O The pharmaceutical field which can also be considered as
the lifeline of human race or an ever advancing human shield
in the battle between Man and Microbes.
O Listing out a few areas of advancement would be injustice
with the rest. But nevertheless a few segments can be
discussed.

4. Areas of development
Dosage Forms
 Solid/Semi-solid forms
 Biologic drugs
 Parenterals
 Highly potent drugs
 Inhalation drugs
 Vaccines
 Speciality dosage drugs
 Generic drugs
Development
 Biologics API
 Chemicals API
 Drug delivery
 Excipients
 Formulation
 Process development
 Scale up
Contd….

5. Manufacturing
 Equipment
 Aseptic/Sterile
Processing
 Fill-finish
 Continuous processing
 Process control/PAT
 Packaging
 Supply Chain
 Technology transfer
Analytics
 Analytical instrumentation
 Method development
 Drug substance analysis
 Finished drug analysis
Contd…

6. Quality / GMPs
 Quality by design
 Q.A / Q.C
 Regulatory/GMP
Compliance
 Compendial compliance
 Regulatory authority actions
 U.S Regulatory watch
 E.U Regulatory watch
Outsourcing
 Analytical services
 Development services
 Clinical trial services
 Manufacturing services
 Packaging services
 Partnership in outsourcing
 Outsourcing resources
Contd…

7. ALCOA+ and Data Integrity
Data supporting the quality and safety of product must meet the
ALCOA+ elements in order to avoid regulatory citations for data
integrity issues

8. Attributable:
The data generated or collected must be traceable back to the
individual who generated the information.
Legible:
The data recorded must be readable and permanent.
Contemporaneous:
The results, measurements, etc. must be recorded at the time
the work is performed.
Original:
Original or source data are the record, report, notebook etc.
where the data point was initially recorded.
Accurate:
The data recorded must be complete, consistent, truthful, and
representative of facts.

9. Complete:
Information that is critical to recreating and understanding an
event. This would include any repeat or reanalysis performed
on a laboratory test sample.
Consistent:
The data are presented, recorded, dated, or time-stamped in
the expected and defined sequence.
Enduring:
The data or information must be maintained, intact, and
accessible throughout their defined retention period.
Available:
The data or information must be able to be accessed at any
time during the defined retention period.

10. Quality by Design (QbD)
Quality by Design is the modern approach to ensure quality of
Pharmaceuticals.
What is Quality by Design (QbD)
• A Quality System for managing a product’s lifecycle
• A regulatory expectation
• Intended to increase process and product understanding and
thereby decrease patient risk.
Principle QbD Concepts:
• Risk and knowledge based decisions
• Systematic approaches process development
• Continuous Improvement
• This leads to “capable” processes

11. QbD is “Woven” into Regulatory Guidance
Documents
Process Validation Guidance
• A “Risk-Based Approach”
• Process Development
• Experimental design (DoE)
• Control Strategy
• Process Qualification
• Equipment qualification
• Process performance
qualification (PPQ)
• Continued Process
Verification
Primarily ICH Q8 through Q11
• Q8- Pharmaceutical
Development
• Q9- Quality Risk Management
• Q10- Pharmaceutical Quality
System
• Q11- Development and Mfg. of
Drug Substances

13. Quality Design
 Product is designed to meet patient needs and performance
requirements.
 Process is designed to consistently meet product quality
attributes.
 Impact of starting raw materials and process parameters on
product quality is understood.
 Critical sources of process variability are identified and
controlled.
 The process is continually monitored and updated to allow for
consistent quality over time.

14. Benefits of QbD
 QbD is good Business
 Eliminate batch failures
 Minimize deviations and costly investigations
 Avoid regulatory compliance problems
 Organizational learning is an investment in the future
 QbD is good Science
 Better development decisions
 Empowerment of technical staff

15. Opportunities (by implementing QbD)
 Efficient, agile, flexible system
 Increase manufacturing efficiency, reduce costs and project
rejections and waste
 Build scientific knowledge base for all products
 Better interact with industry on science issues
 Ensure consistent information
 Incorporate risk management

16. STEPS INVOLVED IN QUALITY BY DESIGN
PRODUCTS
1. Development of new molecular entity
 Preclinical study
 Nonclinical study
 Clinical Study
 Scale up
 Submission for market Approval
2. Manufacturing
 Design Space
 Process Analytical Technology
 Real time Quality Control
3. Control Strategy
 Risk based decision
 Continuous Improvement
 Product performance

17. Thank You