1. A
presentation
on
Recent Advances in Pharmaceutical Industry
By:
Amitabh Tripathi
Asst. Professor
Dept. of Pharmaceutics
United Institute of Pharmacy
2.
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…
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
12.
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