Course Outcome

On successful completion of the course, the students will be able to

Sem I

MQA101T – Modern Pharmaceutical Analytical Techniques   

  1. The analysis of various drugs in single and combination dosage forms
  2. Theoretical and practical skills of the instruments
  3. Skills in selecting the suitable techniques for analysis of drugs and pharmaceuticals
  4. To apply the knowledge learnt in developing new procedures of their own design
  5. Comparing various methods of analysis and their outcomes

MQA102T – Quality Management System

  1. The student will understand the quality parameters and quality attribute in Pharmaceutical industry sectors
  2. Tools for quality improvement
  3. Importance of the quality of medicines in the public.
  4. The subject will afford methodology in the regulatory body requirements for the import and export pharmaceutical products
  5. Stability testing of drug and drug substances

MQA103T – Quality Control and Quality Assurance          

  1. Understand the cGMP aspects in a pharmaceutical industry
  2. Understand GLP and regulatory Affairs
  3. Appreciate the importance of documentation
  4. Understand the responsibilities of QA & QC departments
  5. Appreciate the importance of documentation

MQA104T – Product Development and Technology Transfer      

  1. Understand the new product development process
  2. Explain information to transfer technology from R&D to actual manufacturing
  3. Elucidate necessary information to transfer technology of existing products between various manufacturing places
  4. Understand the practices of packaging technology
  5. Understand the Regulatory requirements in drug development stages

MQA105P – Pharmaceutical Quality Assurance Practical – I      

  1. Estimation of process capability
  2. In process and finished product quality control tests for tablets, capsules, parenteral and semisolid dosage forms
  3. Estimation of drug in pharmaceutical by using modern analytical techniques
  4. Development of Stability study protocol for pharmaceuticals
  5. To carry out pre formulation study for successful formulation of pharmaceuticals

Sem II

MQA201T – Hazards and Safety Management

  1. It creates the passage to understand, Determine and to take control measures to eliminate or minimize the level of the risks
  2. It support the student to recognize the control measures to eliminate or minimize the level of the risks
  3. Ensure safety standards in pharmaceutical industry
  4. Provide comprehensive knowledge on the safety management
  5. Teach the method of Hazard assessment, procedure, methodology for provide safe industrial atmosphere

MQA202T – Pharmaceutical Validation

  1. Importance of patent and intellectual property rights
  2. The students are trained on the qualification aspects of instruments
  3. Cleaning validation of equipments employed in the manufacture of pharmaceuticals
  4. Validation of analytical method for estimation of drugs
  5. The qualification of various equipments and instruments

MQA203T – Audits   and   Regulatory Compliance

  1. To understand the importance of auditing in pharmaceuticals
  2. To understand the methodology of auditing for pharmaceutical industry
  3. To prepare the check list for auditing
  4. To carry out the audit process

MQA204T – Pharmaceutical Manufacturing Technology

  1. The common practice in the pharmaceutical industry developments, plant layout and production planning
  2. Will be familiar with the principles and practices of aseptic process technology, non-sterile manufacturing technology and packaging technology
  3. Explain principles and implementation of Quality by design (QbD) and process analytical technology (PAT) in pharmaceutical manufacturing
  4. Understand the practices of packaging technology
  5. Understand the practices of aseptic process technology

MQA205P – Pharmaceutical   Quality Assurance Practical II

  1. Validation of an analytical method for pharmaceuticals
  2. Qualification of Pharmaceutical Testing Equipment
  3. Design of plant layout: Sterile and non-sterile
  4. Case study on application of QbD
  5. Identification & estimation of drug in pharmaceuticals & assess the impurities

Sem – III

MRM 301T – Research Methodology and Biostatistics

  1. Identify the overall process of designing a research study from its inception to its report.
  2. Familiar with ethical issues in educational research, including those issues that arise in using quantitative and qualitative research
  3. Identify a research problem stated in a study.
  4. Why educational research is undertaken and the audiences that profit from research studies.