Academic Year : 2024-2025

Programme : B. Pharmacy Year & Semester: IV/I

Course Code & Title : Industrial Pharmacy-II Subj. code: BP702T
Syllabus Covered : 2.5 Units Date: 26-11-2024 FN
Max. Marks: 30M Max. Time: 1:30 hr
II - Internal Examination Question Paper
Answer any one of the following questions (1x10=10M)
S.No. Blooms level/ Questions Marks
Course code with
Course Outcome
Explain in detail about New Drug Application (NDA)
1. L2/ BP702T –CO4 process as a complete flow chart 10M

Discuss the significance of Quality by Design (QbD) in

2. L2/ BP702T –CO5 Pharmaceutical Product Development 10M

Section-B
Answer any two of the following questions (2x5=10M)
S. No. Blooms level/ Questions Marks
Course code with
Course Outcome
3. L2/ BP702T –CO5 Describe sigma six concept with its application in 5M
pharmaceutical industry
4. L2/ BP702T –CO5 Explain in detail about total quality management 5M

5. L2/ BP702T –CO6 Discuss about certificate of Pharmaceutical Product 5M

Section-C
Compulsory question 5 x 2 = 10 Marks
S.No. Blooms level/ Questions Marks
Course code with
Course Outcome
List out applications of biostatistics in Pharmaceutical
6. L1/ BP702T –CO4 2M
Product Development
L1/ BP702T –CO4 What are the Bioequivalence protocols
7. 2M
L1/ BP702T –CO5 What are the responsibilities of CDSCO
8. 2M
L1/ BP702T –CO6 What is the concept of change control, certificate of
9. 2M
Pharmaceutical Product
10. L1/ BP702T –CO4 Define investigational Brochure 2M
 Answer any one of the following questions (1x10=10M)
S.No. Blooms level/ Questions Marks
Course code with
Course Outcome
Explain in detail about New Drug Application (NDA)
1. L2/ BP702T –CO4 process as a complete flow chart 10M
S.No. Blooms level/ Questions Marks
Course code with
Course Outcome
Discuss the significance of Quality by Design (QbD) in
2. L2/ BP702T –CO5 Pharmaceutical Product Development 10M

Quality by Design (QbD) is a critical approach in pharmaceutical product

development, signifying a systematic and science-based method to ensure consistent high quality
in drug products by deeply understanding the manufacturing process and identifying key factors
that influence product quality, ultimately minimizing variability and optimizing product efficacy
while proactively managing potential risks throughout the development lifecycle.
Key aspects of QbD in pharmaceutical development:
Target Product Profile (TTP):
Defining the desired quality attributes of the final drug product, including efficacy, safety, and
performance characteristics, which serves as a guiding principle throughout development.
Critical Quality Attributes (CQAs):
Identifying the specific product quality characteristics that significantly impact the therapeutic
efficacy and safety of the drug.
Critical Material Attributes (CMAs):
Recognizing the critical properties of raw materials that influence the CQAs.
Critical Process Parameters (CPPs):
Identifying the key process variables that have a significant impact on the CQAs.
Design Space:
Establishing a defined operational range within which process variables can be manipulated
while still ensuring consistent product quality.
Benefits of QbD:
Enhanced Quality and Consistency:
By proactively understanding the impact of process variables on product quality, QbD helps to
minimize batch-to-batch variability, leading to more consistent and reliable drug products.
Reduced Development Time:
Identifying critical factors early in development allows for focused optimization, potentially
reducing development time and costs.
Improved Regulatory Compliance:
A robust QbD approach provides a strong scientific rationale for regulatory submissions,
demonstrating a thorough understanding of the product and process, leading to smoother
regulatory approvals.
Enhanced Process Control:
By monitoring CPPs within the design space, manufacturers can actively identify and address
potential quality issues before they become significant problems.
Flexibility in Manufacturing:
The design space allows for controlled changes to the manufacturing process without
compromising product quality, facilitating process improvements and adaptation to market
demands.
Implementation of QbD:
Risk Assessment:
Conducting thorough risk assessments to identify potential quality risks throughout the
development process.
Design of Experiments (DoE):
 Employing statistical methods to systematically study the relationship between process
parameters and product quality attributes.
Section-B
Answer any two of the following questions (2x5=10M)
S. No. Blooms level/ Questions Marks
Course code with
Course Outcome
3. L2/ BP702T –CO5 Describe sigma six concept with its application in 5M
pharmaceutical industry
Sigma six concept with its application in pharmaceutical industry
Six Sigma is a data-driven methodology focused on minimizing process variation and
defects, aiming to achieve near-perfect quality by utilizing statistical tools and a structured
approach, making it highly valuable in the pharmaceutical industry due to the stringent quality
standards required for patient safety, where even minor defects can have serious consequences; it
helps identify and eliminate issues within manufacturing processes, leading to improved product
quality, increased efficiency, and compliance with regulations.
Key aspects of Six Sigma in the pharmaceutical industry:
DMAIC Cycle:
The core framework of Six Sigma involves the "Define, Measure, Analyze, Improve, and
Control" (DMAIC) cycle, which provides a structured approach to identify problems, collect
data, analyze root causes, implement improvements, and monitor results to maintain quality
consistently.
Process Improvement:
Six Sigma helps pharmaceutical companies identify and eliminate variations in crucial
production processes like drug formulation, packaging, and quality control, leading to consistent
product quality and reduced waste.
Compliance with Regulations:
The pharmaceutical industry is heavily regulated, and Six Sigma assists in ensuring compliance
with strict quality standards by providing a systematic approach to identify and address potential
risks.
Applications of Six Sigma in Pharmaceuticals:
Reducing Manufacturing Defects:
By analyzing data, Six Sigma can pinpoint areas where defects occur in the manufacturing
process, allowing for targeted improvements to minimize product recalls and ensure patient
safety.
Optimizing Production Processes:
Identifying bottlenecks and inefficiencies in production lines through Six Sigma can lead to
streamlined operations, faster production cycles, and cost reduction.
Improving Quality Control:
Through statistical analysis, Six Sigma enables robust quality control procedures, identifying
potential issues before they impact finished products.
Data-Driven Decision Making:
By relying on data analysis, Six Sigma provides valuable insights to inform critical decisions
regarding process improvements, product development, and resource allocation.
Employee Engagement:
Implementing Six Sigma encourages employee involvement in identifying and resolving quality
issues, fostering a culture of continuous improvement within the organization.
Examples of Six Sigma projects in pharmaceutical industry:
 Reducing contamination levels in sterile production areas, minimizing variation in tablet weight
during manufacturing, improving accuracy of drug labelling, and streamlining the drug approval
process.

Section-B
Answer any two of the following questions (2x5=10M)
S. No. Blooms level/ Questions Marks
Course code with
Course Outcome
4. L2/ BP702T –CO5 Explain in detail about total quality management 5M

Total Quality Management

TQM leads to continuous development in quality of the products by the involvement of the
employees and management. Total Quality Management is a managerial approach used by
pharmaceutical manufacturers in ensuring pharmaceutical products meets the required quality
with regard to their uses.
Quality Assurance (QA) Programs:
Establishing protocols for medication preparation, storage, and dispensing, including regular
quality checks and documentation to ensure adherence to standards.
Error Prevention Strategies:
Implementing measures like double-checking prescriptions, utilizing automated systems for
medication dispensing, and utilizing barcoding technology to minimize medication errors.
Training and Education:
Providing ongoing training for all staff on proper medication handling, quality standards, and
customer service best practices.
Performance Monitoring:
Regularly evaluating key performance indicators (KPIs) like error rates, patient satisfaction, and
medication turnaround times to identify areas for improvement.
 Compliance with Regulations:
Adhering to all applicable local and national pharmacy regulations, including Good Pharmacy
Practice (GPP) guidelines, to ensure patient safety.

Section-B
Answer any two of the following questions (2x5=10M)
S. No. Blooms level/ Questions Marks
Course code with
Course Outcome
5. L2/ BP702T –CO6 Describe about Out of specification 5M
Out of specification (OOS)
OOS can be defined as those results of any procedures which may fall out of specified limits,
which are represented in the official monograph or compendia. The arising of OOSin any
procedure indicates that procedure are not in control which result in rejection of final products
which could be an ultimate loss for any pharmaceutical industries. So that it is an important
criterion to address the OOS results.
 Section-C
Compulsory question 5 x 2 = 10 Marks
S.No. Blooms level/ Questions Marks
Course code with
Course Outcome
List out applications of biostatistics in Pharmaceutical
6. L1/ BP702T –CO4 2M
Product Development

Applications of Biostatistics in Pharmaceutical Product Development (PPD):

1. Clinical Trial Design and Analysis: Ensures proper study design, sample size
determination, and evaluation of safety and efficacy data.
2. Pharmacokinetics and Pharmacodynamics (PK/PD): Models drug behavior in the
body and dose-response relationships.
3. Bioequivalence Studies: Compares generic drugs with innovator products.
4. Quality Control: Monitors manufacturing consistency and analyzes stability data.

S.No. Blooms level/ Questions Marks

Course code with
Course Outcome
L1/ BP702T –CO4 What are the Bioequivalence protocols
7. 2M
Bioequivalence Protocols
1. Study Design:
 Typically a randomized, crossover design.
 Includes sufficient washout periods to avoid carryover effects.
2. Subject Selection:
 Healthy volunteers, usually 18–55 years old, balanced by gender.
 Screening for medical and drug-use history.
3. Dosing and Sampling:
 Administration of test and reference products under similar conditions.
 Collection of blood/plasma samples at specific time intervals.
4. Parameters Assessed:
 Pharmacokinetic (PK) parameters: Cmax (peak concentration), AUC (area
under the curve).
 Acceptance criteria: 90% confidence intervals for Cmax and AUC within 80–
125%.
5. Statistical Analysis:
 Use of ANOVA to compare formulations.
 Log-transformation of PK parameters for evaluation.

S.No. Blooms level/ Questions Marks

Course code with
Course Outcome
L1/ BP702T –CO5 What are the responsibilities of CDSCO
8. 2M

Responsibilities of CDSCO (Central Drugs Standard Control Organization)

1. Drug Approval and Regulation:
  Approves new drugs, clinical trials, and fixed-dose combinations in India.
2. Quality Control:
 Ensures the safety, efficacy, and quality of drugs, cosmetics, and medical devices.
3. Licensing and Inspections:
 Oversees import/export licenses for pharmaceuticals and conducts GMP
inspections.
4. Pharmacovigilance:
 Monitors adverse drug reactions (ADRs) and ensures drug safety.

S.No. Blooms level/ Questions Marks

Course code with
Course Outcome
L1/ BP702T –CO6 What is the concept of change control, certificate of
9. 2M
Pharmaceutical Product
Concept of Change Control

 Definition: A systematic process to evaluate and manage changes in pharmaceutical

processes, equipment, or documents to ensure product quality and regulatory compliance.

 Purpose: Minimizes risks to product safety, efficacy, and quality by thoroughly assessing
the impact of changes before implementation.

Certificate of Pharmaceutical Product (CPP)

 Definition: A document issued by the regulatory authority (e.g., CDSCO) certifying that
a pharmaceutical product is approved for sale in the issuing country.

 Purpose: Facilitates drug registration and export by confirming compliance with Good
Manufacturing Practices (GMP) and regulatory standards.

S.No. Blooms level/ Questions Marks

Course code with
Course Outcome
10. L1/ BP702T –CO4 Define investigational Brochure 2M
Definition of Investigational Brochure (IB):

The Investigational Brochure (IB) is a comprehensive document provided to clinical trial

investigators containing all relevant information about an investigational product. This includes
its preclinical and clinical data, pharmacology, toxicity, pharmacokinetics, dosing
guidelines, and potential side effects.

 To ensure investigators are well-informed about the investigational product.

 To provide guidance for safe and ethical clinical trial conduct.