Change control in pharmaceutical industry l Interview preparation
Change control in pharmaceutical industry l Interview preparation
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Questions covered:
Q.1 : What is change control ?
Q.2: What are the types of change control?
Q.3: When we should classify change control as minor change control?
Q.4 : When we should classify change control as major change control ?
Q.5: Which Guidelines are referred for change control handling in pharmaceutical industry ?
Q.6: Can we raise temporary change controls instead of planned deviation ?
Q.7: What are the categories for change control or where changes are required ?
Q.8 Where documented change controls shall be kept ?
Q.9: Can we stamp change control document as ‘Confidential’ before handing over it to auditor?
Q.10: Who shall initiate change control and who shall review change control?
Q.11: What is responsibility of change control co-ordinator?
Q.12: What is responsibility of Head QA in change control ?
Q.13: Whether all change controls needs to be forwarded to RA for assessment ?
Q.14 Which type of change controls shall be forwarded to customer or qualified person for comments or approval or notification?
Q.15 What should be the timeline for change control closing?
Q.16 What are the major steps for change control procedure ?
Q.17 How the change control form shall be closed?
Q.18 Explain about change control timeline extension procedure?
Q.19 What is CBE 30 filing for change controls?
Q.20 Which software's are commonly used for change control management in pharmaceutical industry?
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