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Characteristics of Batch process. How it is different from Continuous process with examples. Is Batch process more complex and if yes, why? Hierarchy of S88 model Why do we have to have S88 model What are the constituents of Recipe with examples? S95 Concept of Shared resources with examples What is Arbitration Complexity matrix for Batch process automation What is the lowest level element in the Batch model.give example? Seven layers of Control Activity model Control Activity model Vs. Batch model What is FDA, What is Validation, Why is Validation so important in Bio-Pharma? GAMP project life cycleV model Documentation requirements in FDA validated projects..Documentation terms like URS, FDS, Scope of Batch Control System Interlocks, Exception Handling, Analog Variables Monitoring and Control, Sequence, Operations, Recipes etc. What is interlock and what is permissive. Explain the difference with example. What is fail safe position concept in case of any device? Explain with example. What are the different regulatory controls Feedback, Feed Forward, Ratio, Cascade etc. and do they exist in batch control systems? What are the challenges for Regulatory control in Batch processes?

21. Describe key differences which distinguish a batch process from a continuous process. Explain various classifications for batch processes. 22. Develop complete Physical and Procedural control S88 model for following Paint process. Assign components of following process to S88 elements appropriately.

23. Describe in detail various levels of Control Activity Model. Provide appropriate examples for each level from typical Pharmaceutical Batch process.

24. Discuss FDA Validation in detail on following points: a. What is Validation? b. Why is it necessary for Pharmaceutical manufacturers? c. What is GAMP and what is GAMP-4 Project life cycle? d. What are the key documents suggested in GAMP-4 project life cycle? e. What is 21 CFR Part 11? 25. Describe various challenges faced for Regulatory control in Batch processes. Discuss these challenges specifically for following: a. Reset Windup b. Cascade Control c. Set-point ramping 26. Discuss Control Activity inter-relationship model and various functions of Batch Management. 27. Define Recipe. Describe various components of Recipe. Develop Control Recipe with all essential components for following sequence: a. Initialize b. Charge A c. When enough A has been charged, turn on the agitator, start charging B. Ratio B to A so that they complete charging at the same time. d. Charge preset amount of catalyst D. e. Raise temperature to 100 degC as rapidly as possible while minimizing overshoot. f. When reactor is at 100 degC, start E feed. Feed E at the maximum possible feed rate to minimize cycle time as long as pressure and temperature do not exceed their respective set points. Raise temperature to 200 degC based on % of total E fed. g. Sample to lab and start cooling to 100 degC. h. Hold for 30 minutes. i. When lab analysis is OK and temperature is 100 degC, pump to storage. 28. Discuss project life cycle for a typical FDA validated Batch project. Describe various documentation requirements during each stage of this life cycle.