BTEC 3320 Exam 2 Questions And Answers 2022/2023

Which of these changes to protein purification using an AKTA would most likely be classified as minor change? The flow rate was increased 25% higher. The buffer that is used in the mobile phase was replaced with a different weak acid The set number of times the column can be washed and reused is changed from 20 to 25 reuses. The tempeature setting for the column was decrease 25% from the earlier settings. The detector was replaced with a newer model that is more sensitive in detecting lower amounts of impurities - Answer - The detector was replaced with a newer model that is more sensitive in detecting lower amounts of impurities What is the first step in a document change control process? Originator drafts the proposed change. The revised document is distributed to users. QA assigns an effective date. A document number is assigned by the QA. Users are trained on the execution of the revised SOP The proposed changes are circulated for review. - Answer - Originator drafts the proposed change. What is not part of the change control process? Older SOPs are rendered obsolete The draft of the revised document is circulated for review Users are trained prior to the document becoming effective A master copy of the approved document is retained within the QA document system Older SOPs are retained by users - Answer - Older SOPs are retained by users A company's change control board is made mainly of members of the quality assurance and quality control groups TRUE FALSE - Answer - FALSE The intent of change control system is to determine the need for actions that would ensure that the system is maintained in a ________________ state. Innovative Balanced Validated Advance