Change Request
The section that documents what you are proposing to change
What is Change Proposal?
The Genus position that reviews the MOC content after it has been launched by the NRP
What is Department Manager?
The section that records each departments review of the MOC to determine the influence it has on their department
What is the impact assessment summary?
This step has three (3) stages...initiation, competition, and acknowledgement
What is an action item?
The date that the MOC is being closed completely on
What is MOC Close Date?
Section that states what is being affected such as documents, systems, products, etc.
What is Scope of Impact?
The individual performing the MOC and is responsible for all data within the change control.
What is a Nominated Responsible Person?
This department records their impact by using a 0, 1, 2a, 2b, and 2c system.
What is Regulatory Affairs?
The person receiving an action item for updating a document, even though it is their MOC.
Who is the NRP?
Can be launched specifically by the NRP at the end of the change control process.
The section of the MOC where you can place additional supporting evidence for your change control that is supplemental to the process.
What are Attachment and Links
The position required in order to update any Packaging or Manufacturing documentation.
What is Operations SME?
This is launched in the event that an MOC is rejected to change the Scope, and needs to be reevaluated by the affected departments.
What is an Impact Assessment addendum?
This section should clearly state what occurred during the course of performing the MOC with details regarding dates of completion, references to associated MOC's or external documents.
What is Implementation Completion Summary?
Can choose to reject an MOC if during the assessment of the data any errors are found that require correcting.
What is an Approver?
The Dept. Manager of the proposed change who evaluates it and either approves/rejects it.
What is a Reviewer?
The other department who should also be on batch record changes other than QA, RA, and Operations if necessary.
Who is Product Development?
If a department documents there is an impact in their area, there will likely be an ______ ______ issued to them during Implementation and Verification?
Action item
As a general practice, if there are three (3) action items issued in Implementation, how many should there be in Verification?
Three (3) Verification Action Items
The details at the end of the MOC of what had occurred such as what was implemented, how it was verified to be correct, references to dates and documents.
What are MOC Closure Notes?
A document pertaining to a new GMP Asset is being brought into service for a commercial product. This will also require an update to a batch record. Which two (2) departments should be a Reviewer of the MOC?
What is Operations and Maintenance
These Approvers are needed for an MOC pertaining to the procurement and generation of a unique asset ID for an additional set of compression tooling.
Who is Operations, Maintenance, QA, and Regulatory?
Going forward, when an MOC is launched who is put on Impact Assessment?
What is every department at Genus?
The section used to confirm that what was deemed as a required action during Impact Assessment is confirmed to have been done and met all requirements.
What is Verification Summary?
Listing out the events of the Implementation and Verification without documenting the action items again
What are acceptable closure notes?