B.Pharm 7th Semester Industrial Pharmacy 2 Important Question Answer
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| Industrial Pharmacy 2 Important Question Answer |
Industrial Pharmacy 2 Very Short Question Answer {2- Marks}
1. Mention two major applications of platform technology.
Rapid development of vaccines (e.g., mRNA-based COVID-19 vaccines).
Flexible manufacturing of multiple biologics using the same delivery system or vector.
2. Mention the basic role of SUPAC guidelines.
SUPAC (Scale-Up and Post-Approval Changes) guidelines ensure consistent product quality during changes in manufacturing scale, site, or equipment by specifying documentation and testing requirements.
3. Name at least 4 agencies responsible for successful technology transfer in India.
DSIR (Department of Scientific and Industrial Research)
NRDC (National Research Development Corporation)
TIFAC (Technology Information Forecasting and Assessment Council)
BCIL (Biotech Consortium India Limited)
4. State the role of one major TT agency of India.
NRDC promotes technology transfer by licensing innovations from public R&D institutions to industries, thus supporting commercialization and entrepreneurship.
5. State two important functions of the Regulatory Affairs Department.
Ensuring compliance with national and international drug regulations.
Preparing and submitting dossiers for product approval and registration.
6. What do you mean by ‘Non-Clinical Drug Development’?
It refers to laboratory and animal studies conducted before human trials to assess safety, pharmacokinetics, and toxicology of new drugs.
7. What do you mean by ‘Six Sigma concept’?
Six Sigma is a quality management methodology aimed at reducing defects and variability in processes, enhancing productivity and customer satisfaction.
8. Mention the specifications of ISO 14000 series of quality systems standards.
ISO 14000 series defines standards for Environmental Management Systems (EMS), covering waste management, pollution control, and legal compliance.
9. State the responsibilities of CDSCO.
CDSCO regulates drug approval, clinical trials, import/export, and ensures drug safety, efficacy, and quality in India under the Drugs and Cosmetics Act.
10. Define Pilot Plant.
A pilot plant is a small-scale facility where manufacturing processes are tested and optimized before full-scale commercial production.
11. Describe Platform Technology.
Platform technology is a core system used to develop multiple products efficiently, such as using viral vectors or mRNA for different vaccines or therapies.
12. Define Confidentiality Agreement.
A Confidentiality Agreement is a legal contract ensuring that proprietary or sensitive information shared between parties remains undisclosed to outsiders.
13. Discuss the practical aspects of Commercialization.
It includes technology validation, market analysis, securing funding, regulatory approval, production scale-up, and launching the product in the market.
14. Explain Drug metabolism and Toxicology.
Drug metabolism refers to the body's enzymatic breakdown of drugs, while toxicology studies the harmful effects of substances on biological systems.
15. Quote the responsibilities of Regulatory Affairs professionals.
They handle drug submissions, ensure regulatory compliance, update documentation, liaise with authorities, and manage product lifecycle approvals.
16. Define ISO 14000.
ISO 14000 is a family of international standards that specify requirements for effective environmental management systems in organizations.
17. Write a short note on GLP.
Good Laboratory Practice (GLP) ensures the quality, integrity, and reliability of non-clinical safety studies, especially in drug development and research labs.
18. Define CDSCO.
Central Drugs Standard Control Organization is India's national regulatory body responsible for drug approval, clinical trials, and enforcing drug standards.
19. Define Certificate of Pharmaceutical Product (COPP). Mention the significance of COPP.
COPP is an official document issued by the national regulatory authority that certifies a pharmaceutical product is authorized for sale in the country. It is essential for drug export.
Industrial Pharmacy 2 Short Question Answer {5- Marks}
1. Describe the pilot plant scale-up considerations for solid dosage forms.
Pilot plant scale-up involves replicating lab-scale formulations at a production scale while ensuring product quality, safety, and efficacy. For solid dosage forms, key considerations include:
Equipment Selection: Scaled-down versions of commercial equipment are used to simulate manufacturing. Equipment design, speed, and mixing time are adjusted accordingly.
Blending and Granulation: Uniform mixing and controlled granulation (wet/dry) must be achieved. Variability in particle size and flow properties are assessed.
Drying Parameters: Moisture content is closely monitored. Drying techniques like fluid bed drying are optimized.
Compression: Tablet press settings (force, speed, dwell time) are fine-tuned to maintain uniformity, weight variation, and hardness.
Coating: Equipment must ensure uniform application of coating material. Spray rate, atomization pressure, and drying temperature are monitored.
In-process Testing: Parameters like flow properties, tablet weight, friability, disintegration, and dissolution are evaluated.
Scale-up also involves validation of cleaning procedures, documentation of batch records, and analysis of deviations. It serves as a bridge between R&D and commercial production, minimizing risks during full-scale manufacturing.
2. Discuss the significance of space requirements and raw materials in pilot plant setup.
Space Requirements:
Adequate space ensures smooth workflow, reduces cross-contamination risk, and complies with cGMP standards.
Designated areas are required for dispensing, granulation, compression, coating, packaging, and storage.
Utility areas for HVAC, water systems, and waste disposal must be planned.
Raw Materials:
Quality of raw materials directly affects product consistency and efficacy.
Sourcing from approved vendors, proper storage (temperature/humidity control), and documentation are essential.
Material handling equipment like bins, scoops, and hoppers must be validated to avoid contamination.
Both space and raw materials are foundational elements ensuring efficient operations, safety, and regulatory compliance in pilot plant manufacturing.
3. Explain various Technology Transfer agencies in India.
Several Indian agencies facilitate effective technology transfer (TT) from research institutions to industry:
NRDC (National Research Development Corporation): Helps commercialize R&D findings from public research institutions.
TIFAC (Technology Information Forecasting and Assessment Council): Promotes technology innovation and patenting.
BCIL (Biotech Consortium India Limited): Facilitates TT in biotech and life sciences sectors.
DSIR (Department of Scientific and Industrial Research): Supports innovation through its autonomous bodies.
SIDBI Innovation & Incubation Centre: Aids start-ups with funding and TT support.
These agencies provide legal, technical, and financial support to ensure successful commercialization of pharmaceutical and scientific innovations.
4. Outline Validation and Qualification. Write a short note on Analytical Method Transfer.
Validation is the documented act of proving that any procedure, process, equipment, or system leads to expected results.
Qualification is part of validation focused on ensuring that equipment/facilities are installed and operate as intended. It includes:
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Analytical Method Transfer involves transferring validated analytical methods from one laboratory (sending unit) to another (receiving unit). It ensures consistency in testing, accuracy, and reproducibility. It includes comparative testing, documentation, and analyst training.
5. Summarize Investigation Reports and CAPA.
Investigation Reports are detailed documents prepared when a deviation or failure occurs. These include:
Description of the event
Root cause analysis
Impact assessment
Preventive measures
CAPA (Corrective and Preventive Action) is a quality tool used to rectify and prevent recurrence of such issues:
Corrective Action: Taken to eliminate the root cause of a detected problem.
Preventive Action: Taken to eliminate potential causes before problems arise.
CAPA ensures continuous quality improvement, regulatory compliance, and risk mitigation in pharmaceutical manufacturing.
6. Explain the significance of personnel requirements in pilot plant scale-up.
Personnel are critical in ensuring successful pilot plant operations and scale-up. Skilled, trained, and experienced staff are essential to execute processes accurately and comply with regulatory requirements.
Key Significance:
Technical Expertise: Staff must understand equipment operations, formulation techniques, and troubleshooting during scale-up.
GMP Compliance: Personnel should be trained in current Good Manufacturing Practices (cGMP) to ensure product quality and regulatory compliance.
Cross-functional Collaboration: Scientists, engineers, quality assurance, and production teams must work together to address scale-up challenges.
Documentation and SOPs: Staff must maintain accurate batch records, follow Standard Operating Procedures (SOPs), and report deviations or changes.
Safety: Trained personnel follow proper safety protocols, minimizing risks associated with handling equipment and hazardous materials.
In summary, well-trained personnel are a pillar of success in the pilot plant, ensuring efficient, safe, and regulatory-compliant scale-up of formulations.
7. Describe the significance of master formula record in scale-up.
The Master Formula Record (MFR) is a detailed document that specifies the materials, quantities, processing steps, equipment, and in-process checks required to manufacture a product batch.
Significance:
Standardization: Ensures consistent product quality across different batches.
Reference for Scale-Up: Provides a base for pilot and production scale manufacturing.
Regulatory Compliance: Required by regulatory authorities (e.g., FDA, CDSCO) as part of documentation.
Error Minimization: Reduces chances of deviation or mix-ups during manufacturing.
Audit and Review: Used in inspections to verify GMP adherence.
MFR is essential for ensuring repeatability, traceability, and quality in manufacturing, especially when scaling up from lab to production.
8. Discuss the regulatory requirements for NDA submission in the USA.
A New Drug Application (NDA) must be submitted to the US FDA to seek approval for marketing a new drug. The NDA includes:
Preclinical Data: Animal testing data showing safety.
Clinical Data: Results from Phase I, II, and III human trials demonstrating efficacy and safety.
Chemistry, Manufacturing, and Controls (CMC): Detailed manufacturing process, specifications, and quality control measures.
Labeling Information: Proposed drug label, dosage, indications, and warnings.
Patent Certification: Information about drug patents or exclusivity.
Risk Management Plans: REMS (Risk Evaluation and Mitigation Strategies), if applicable.
The FDA reviews the NDA for at least 6–10 months, after which approval may be granted if all criteria are met.
9. Describe process validation and its types.
Process Validation is documented evidence that a process operates within predefined limits and consistently produces a product meeting specifications.
Types of Process Validation:
Prospective Validation: Conducted before commercial production begins.
Concurrent Validation: Carried out during actual production.
Retrospective Validation: Based on past production data of marketed products.
Revalidation: Done after significant changes in process, equipment, or facility.
Process validation ensures consistency, compliance with cGMP, and robust manufacturing, thereby enhancing product quality and patient safety.
10. Explain the role of documentation in technology transfer.
Documentation is essential in technology transfer (TT) as it provides a structured and traceable record of the transfer process.
Roles:
Knowledge Transfer: Technical know-how from the sender (R&D) to the receiver (production site) is documented clearly.
Process Understanding: Batch manufacturing records, SOPs, analytical methods, and validation reports guide the receiver.
Compliance and Traceability: Ensures regulatory compliance and serves as evidence in audits.
Training Aid: Used to train personnel on new processes.
Risk Management: Identifies critical parameters and control points during transfer.
Accurate documentation ensures the success, reproducibility, and regulatory acceptance of technology transfer.
11. Discuss the process of scale-up of solid oral dosage forms.
The scale-up process of solid oral dosage forms (like tablets and capsules) involves transferring a formulation developed at the laboratory level to a pilot plant and then to full-scale commercial production.
Key Steps:
Pre-formulation Studies: Evaluate physicochemical properties of the drug—solubility, particle size, stability.
Selection of Equipment: Use geometrically similar but scalable equipment for mixing, granulation, drying, compression, and coating.
Process Parameter Optimization: Adjust critical parameters like mixing time, drying temperature, compression force, and coating conditions.
In-process Controls: Monitor blend uniformity, moisture content, hardness, friability, and disintegration.
Batch Size Increase: Gradually increase batch size through trial batches to assess process consistency.
Validation: Conduct process validation (3 consecutive successful batches) to ensure repeatability.
Scale-up ensures quality and efficiency in commercial production, minimizing the risk of batch failure or regulatory rejection.
12. Explain different types of audit and their role in QA.
Audits are systematic evaluations of processes and systems to ensure compliance with regulatory standards and internal SOPs.
Types of Audits:
Internal Audit: Conducted by in-house QA team to ensure compliance with SOPs and GMP.
External Audit: Done by external bodies (e.g., FDA, WHO) to assess regulatory compliance.
Supplier Audit: Evaluates raw material vendors or contract manufacturers for quality assurance.
Regulatory Audit: Conducted by regulatory authorities during product registration or licensing.
For-cause Audit: Initiated in response to product complaints or quality issues.
Role in QA:
Identifies gaps in processes.
Enhances GMP compliance.
Prepares for regulatory inspections.
Improves overall product quality and safety.
Audits are vital tools in maintaining and improving the pharmaceutical quality system.
13. Explain the role of documentation in regulatory submissions.
Documentation is a backbone of regulatory submissions and is critical for ensuring transparency, traceability, and compliance.
Key Roles:
Data Compilation: Includes clinical trial data, manufacturing process, stability data, validation, and quality control information.
Regulatory Dossiers: Documents like CTD (Common Technical Document) are prepared for submission to authorities like US FDA, EMA, CDSCO.
Legal Compliance: Ensures that all products meet national and international legal and technical standards.
Review and Approval: Well-prepared documentation speeds up regulatory review and approval process.
Audit Trail: Provides evidence during inspections and supports product lifecycle management.
Complete, accurate, and well-organized documentation is essential to gain and maintain marketing approval for pharmaceutical products.
14. Describe the process of regulatory approval for new drug development in India.
The new drug approval process in India is governed by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act.
Steps:
Preclinical Studies: Conducted on animals to assess toxicity and pharmacology.
IND Application: An Investigational New Drug application is submitted to CDSCO for clinical trial permission.
Clinical Trials (Phase I–III):
Phase I: Safety in healthy volunteers.
Phase II: Efficacy and side effects in patients.
Phase III: Large-scale efficacy and monitoring.
New Drug Application (NDA): Submitted with data from all phases, including CMC and safety data.
Review and Approval: CDSCO reviews and, if found satisfactory, grants marketing authorization.
The entire process ensures that only safe and effective drugs reach the Indian market.
Industrial Pharmacy 2 Long Question Answer {10- Marks}
1. State and explain the Technology Transfer Protocol following WHO guidelines.
Technology Transfer (TT) as per WHO guidelines refers to the systematic procedure for transferring information and processes from development to manufacturing or between manufacturing sites. The goal is to maintain product quality, efficacy, and safety across locations.
Key Elements of TT Protocol (WHO Guidelines):
Organization of TT:
Identification of sending unit (SU) and receiving unit (RU).
Assignment of responsibilities and communication plans.
Technology Transfer Plan:
Define scope, objectives, and deliverables.
List equipment, documentation, and training needed.
Documentation Transfer:
Includes master formula records, process descriptions, equipment SOPs, validation protocols, and analytical methods.
Transfer of batch manufacturing records (BMRs), cleaning procedures, and stability data.
Product/Process Evaluation:
Evaluation of critical process parameters (CPP) and critical quality attributes (CQA).
Perform gap analysis between SU and RU.
Analytical Method Transfer:
Verification or validation of analytical methods at the RU.
Comparative testing with results from the SU.
Trial Batches and Process Validation:
Pilot-scale or exhibit batches are produced and assessed.
Full validation of three consecutive commercial-size batches.
Training of RU Staff:
Hands-on training on processes, equipment, and documentation.
Quality assurance team oversight.
Evaluation and Reporting:
Transfer report includes data analysis, deviations, CAPA, and final approval.
Regulatory submission if required.
The WHO protocol ensures consistency, product integrity, and regulatory compliance across different manufacturing sites or partners.
2. Describe the steps of data presentation for FDA submissions.
FDA submissions require structured and standardized documentation, primarily through the Common Technical Document (CTD) format. For electronic submission, the eCTD format is preferred.
Steps of Data Presentation:
Compile CTD Modules:
Module 1: Regional administrative information (cover letter, forms, labeling).
Module 2: Summaries of quality, nonclinical, and clinical data.
Module 3: Quality (CMC – Chemistry, Manufacturing, and Controls).
Module 4: Nonclinical study reports (pharmacology, toxicology).
Module 5: Clinical study reports.
Follow eCTD Format:
Structure files in XML and PDF format.
Ensure correct naming conventions and granularity.
Technical Requirements:
Digital signatures, bookmarks, hyperlinks, and metadata must be properly used.
Validate using FDA’s eCTD validation tool.
Use of FDA Gateway:
Submit using Electronic Submissions Gateway (ESG).
Maintain version control and submission history.
Data Integrity:
Ensure data is accurate, traceable, and compliant with 21 CFR Part 11.
This approach enables efficient regulatory review and faster approval timelines.
3. Give a brief idea on regulatory requirements and approval procedures for new drugs.
In India, the approval of new drugs is regulated by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act, 1940 and Rules, 1945. The regulatory approval process ensures that the drug is safe, effective, and of high quality before being marketed.
Regulatory Requirements:
Application Submission:
The applicant must submit Form 44 with necessary fees.
Includes Investigator’s Brochure, Chemistry Manufacturing and Control (CMC) data, and proposed protocol for clinical trials.
Pre-Clinical Studies:
Conducted on animals to evaluate pharmacological and toxicological profile.
Includes acute, sub-chronic, chronic toxicity, genotoxicity, and reproductive toxicity.
IND Submission:
Investigational New Drug (IND) application is filed to begin clinical trials.
Clinical Trials:
Phase I: Assess safety and tolerability in healthy volunteers.
Phase II: Evaluate efficacy and side effects in patients.
Phase III: Confirm effectiveness in larger patient groups.
Phase IV: Post-marketing surveillance.
NDA (New Drug Application):
Submitted after successful clinical trials.
Includes all trial data, manufacturing details, stability, and labeling.
Ethics and DCGI Approval:
Ethics Committee and Drug Controller General of India (DCGI) must approve the trial protocols.
Grant of Permission:
If all documents and data are satisfactory, the drug is approved and marketing authorization is granted.
This process ensures new drugs meet the safety, efficacy, and quality standards required for public use.
4. What are SUPAC Guidelines? Explain the SUPAC guidelines for immediate release dosage forms.
SUPAC (Scale-Up and Post-Approval Changes) guidelines are issued by the US FDA to manage changes in the manufacturing of approved drug products. These guidelines help manufacturers implement changes without needing to repeat clinical studies, as long as the product quality is maintained.
Categories of Changes:
Level 1 – Minor Changes
Level 2 – Moderate Changes
Level 3 – Major Changes
SUPAC for Immediate Release (IR) Dosage Forms:
Components and Composition:
Level 1: Minor excipient changes; requires annual report.
Level 2: Moderate changes (5–10%); requires prior approval.
Level 3: Major changes (>10%); full documentation and bioequivalence studies needed.
Site of Manufacture:
If the site is under same cGMP controls, a prior approval supplement may not be required.
Scale of Manufacture:
Scale-up within 10x the original size can be managed with minimal data if process parameters remain unchanged.
Manufacturing Process:
Equipment changes or process changes (e.g., wet to dry granulation) may require validation, stability, and bioequivalence studies.
Analytical Testing:
Includes dissolution, assay, content uniformity, and stability testing based on the level of change.
SUPAC guidelines ensure flexibility in post-approval changes while maintaining product integrity.
5. Outline Quality Risk Management. Discuss the various risk management tools and methodologies.
Quality Risk Management (QRM) is a systematic process for the assessment, control, communication, and review of risks to product quality. It is essential for decision-making in pharmaceutical development and manufacturing.
Steps in QRM:
Risk Assessment: Identify hazards, analyze and evaluate risks.
Risk Control: Determine measures to reduce or eliminate risks.
Risk Communication: Share risk information with stakeholders.
Risk Review: Regular review and monitoring of risk control measures.
Risk Management Tools:
FMEA (Failure Mode and Effects Analysis):
Identifies potential failures and their impact.
Assigns Risk Priority Numbers (RPN).
Fishbone Diagram (Ishikawa):
Helps in root cause analysis by mapping causes under categories like man, machine, method, etc.
Fault Tree Analysis (FTA):
Uses logic diagrams to determine causes of system failures.
HACCP (Hazard Analysis and Critical Control Points):
Systematic preventive approach used in food and pharma industries.
Risk Ranking and Filtering:
Prioritizes risks based on severity and probability.
QRM promotes proactive decision-making, regulatory compliance, and continuous improvement in quality assurance.
6. Explain:
i. Total Quality Management (TQM)
TQM is a holistic approach focused on continuous improvement in all aspects of an organization with full involvement of all employees to achieve customer satisfaction.
Principles:
Customer-focused
Employee involvement
Process approach
Continuous improvement
ii. Out of Specification (OOS)
OOS results are test results falling outside pre-established acceptance criteria. These results must be investigated to identify root cause and implement CAPA before batch release.
iii. Change Control
A formal system to evaluate, document, and approve any planned changes in manufacturing, equipment, or process to ensure product quality is not impacted.
iv. ISO 9000 Series
ISO 9000 is a family of quality management standards developed by ISO. It includes ISO 9001 (quality management systems) and ensures consistent product quality, documentation, and customer satisfaction.
B.Pharmacy 7th Semester Industrial Pharmacy 2 Important Question Answer
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