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Before
inspection
Much of the work needed to ensure that the inspection ends
successfully should be completed long before the FDA Investigators arrive. All
companies should begin work immediately to ensure that they have accomplished all
the critical tasks:
1 Notify all staff
/employee & contractual if pre plan/routine inspection
Notify the Sponsor of the Inspection as soon as it is
scheduled
Notify all relevant site personnel of inspection responsibilities and schedule and ensure they are trained on interacting with FDA
2 Drafting an Action
Plan
Most regulatory and quality professionals would agree that a
best practice is to have a pre-defined inspection preparation action plan at
the ready, rather than assembling and executing one in an ad hoc manner under a
tight timeline in an environment suddenly fraught with the tension and anxiety
inevitably accompanying the announcement of an impending inspection.
3 Review/Develop a SOP for hosting the inspections
Review /develop procedure for hosting inspections and follow
your procedure from beginning to end.
The 'Hosting Inspections' SOP mustinclude:
- Clearly state whom to contact
first when the inspector shows up at the site. The facility's quality lead
and the site operations lead and their backups should first be notified.
- Describe a mechanism for alerting
the entire facility that an inspector is in the building
- Describe how to document FDA
requests for information
- Describe how to handle the
inspector's request for photographs or videos
- Describe the method to respond to
FDA request that is not in agreement with your quality procedures such as
entry to cleanroom during operations, hours of operations etc.
4 Develop an inspection readiness team
It is good to have a team
that consists of members from the quality organization and cross-functional
groups as part of the inspection readiness team. This team can help in
identifying and completing preparation activities and support the inspection
throughout.
Assign right person for specific task is play vital role in
inspection management. Various factor are consider for selection SME (subject
matter expert).
The first step is evaluating your SMEs to decide which ones
will fare best in an inspection and which others may present too much of a risk
to put in front of investigators.
Assign a primary and secondary Designated Individual (DI)
for each facility to serve as the liaison with the FDA Investigators once they
arrive.
Designated Individuals should coordinate vacation time (and
time off) to ensure that one DI will always be available in the event FDA
arrives.
5 Identify a Meeting
Space:
Identify a space within the facility to host the FDA
investigators when they arrive.
This might be a conference room or a vacant office with
sufficient desk space to review large amounts of records.
It is recommended that the FDA
representative workspace be away from heavy traffic areas. The audit support
room, also known as the war room should not be located close to the FDA
representative's meeting space. The war room sometimes becomes busy and
inadvertently loud.
The escort should have made arrangements for a comfortable
work area for the FDA inspector(s) for the duration of the inspection. The room must contain no confidential
records, including clinical or research related
The space selected, however, should be free of any records
(in binders, boxes or on computers) which FDA Investigators could access,
unsupervised, while they occupy the space.
a.
The room should have a phone, and allow convenient access to study
staff.
b.
The room should be located away from the clinical/research area to
avoid such activities from being conducted near the inspector.
c.
The room should NOT contain any other study or
medical records, other than the study records that the inspector has requested.
d.
The room should be able to be locked when the inspector leaves.
e.
The requested staff should be readily available to the inspector
at all times. (The inspector generally will not want the study staff
coordinating the investigation in the room while s/he works.)
“Trust but Verify “ Ronald Reagan
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| Data Integrity App |
Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.
- Basic Data Integrity Concepts
- ERES & Its Requirement
- CSV & Its best practices
- Mock Inspection and General Q&A
- Checklist for inspection
- Inspection Readiness
- Useful SOP’s
- Stay Regulatory Compliant.
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Try our "Data Integrity" app which helps you to better understand current regulatory agencies thinking on Data Integrity & CSV.
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