Quiz 6
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...
quiz 6 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 phas
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
Info from slide
Minor change
● Minimal impact/risk to product QuIPS
● Require a summary of the change in their annual report to the FDA
● Documentation required to support this change would include technical study
reports and possible re-validation
● Includes tightening of acceptance criteria, alternative analytical SOPs
What is the first step in a document change control process?
Originator drafts the proposed change. 1
The revised document is distributed to users. 5
QA assigns an effective date. 4
A document number is assigned by the QA. 2
Users are trained on the execution of the revised SOP 6
The proposed changes are circulated for review. 3
Info from slides
The change control process starts with an author, i.e., the person making the change
If it’s a new document, this person writes it up
For changes or obsoletions, the author makes the appropriate changes with a red pen
directly on to the document
There is an intermediate approval by key people that will be affected by the document,
then it formally enters the QA Document System
QA assigns a document number, if it’s new, the document is circulated for review
The document is evaluated and approved
The effective date is assigned
QA then distributes the document to authorized personnel who are then trained. Master
, copy is retained
Document now effective
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
A company's change control board is made mainly of members of the quality assurance
and quality control groups
TRUE
FALSE
Info from slide
Include QA, QC, Regulatory, Production, Product/Process Development, Research
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
Modern
Small changes to a process can over time can add up and lead to a product that is no
longer what was promised in the New Drug Application. The result is what is referred to
as product ______________.
Creep
Recall
Validation
Failure
Specification
Malfunction
Info from slide
Creep- changes to documentation, big and small, over time can add up and
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