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Mock Inspection:
Mock FDA inspection is an essential tool in
identifying issues that could affect the quality of manufactured
pharmaceuticals or medical devices, and become compliance issues with FDA.
Mock inspections help to determine audit
readiness by testing knowledge of procedures and by creating a process that
simulates the pressure of an actual inspection.
One of
the most effective methods to prepare SMEs is to conduct mock inspections.
What is Mock Inspection?
Mock audits are simulations of actual FDA
audits conducted to assess Good Clinical Practice, Good Laboratory Practices,
and Good Manufacturing Practices.
MHRA has said, “QA should
also review a sample of relevant audit trails, raw data and metadata as part of
self- inspection to ensure ongoing compliance with the data governance
policy/procedures.”
According to PIC/S, “The effectiveness of data integrity
control measures should be assessed periodically as part of self-inspection
(internal audit) or other periodic review processes. This should ensure that
controls over the data life cycle are operating as intended.”
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| Data Integrity App |
Mock
inspection can be performed by:
• Internal team using FDA procedures
• External team of ex-FDA employees
An internal team consists of qualified
professionals with experience in regulatory compliance.
If an external team is used, it generally
consists of members of an outside consulting firm with FDA work experience.
Purpose of Mock Inspection:
1.
Determination of what inspectors
are looking for during an actual inspection.
2.
Preparation for an actual FDA
inspection.
3.
Identification of common issues
of compliance & learn how to rectify them
Prepare
for inspections, it is useful to have an external organization perform a mock
inspection.
A mock
inspection simulates an actual inspection and the inspection report is
structured in the same way as an inspection report from a regulatory agency.
Outcomes
of Mock Inspection:
• Obtain evidence that management is
overseeing operations effectively
• Review the compliance of
contract service providers
• Verify that quality
assurance and regulatory affairs departments are operating appropriately
• Evaluate process controls,
records, and document controls; and
• Determine whether the
mechanisms are compliant
Day wise Mock Inspection:
A mock
audit is usually conducted over four to five days and utilizes FDA inspection
procedures. At the end of each day, the auditor provides a recap of findings at
a closing meeting and identifies personnel to interview.
·
Day One: Mock
inspector’s meets with people from the company, tours facilities & reviews internal
quality files.
· Day Two: Mock
inspector’s reviews the policy for retaining records & product controls at facilities.
· Day Three: Mock
inspector’s reviews procedures for corrective action plans, handling of
complaints & oversight of suppliers.
· Day Four: Mock
inspector’s reviews any remaining compliance programs & interviews any
personnel that he or she still needs to interview.
· Day
Five (if needed): additional areas of the quality systems not previously covered
will be reviewed.
End of the fourth or fifth day, mock inspector conducts an exit meeting with company.
During this meeting mock inspector provides a review of major
& minor findings & suggests actions to improve the issues they found.
Mock
inspection move around:
Mock
inspection moves around three factors People, Preparation & Process.
- People-
Put right people in right roles.
- Preparation
Appropriately
prepare team & documentation.
- Process Follow industry standard inspection process.
Mock FDA audits are important for the
identification of gaps in the quality systems related to pharmaceutical or
medical device manufacturing.
“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.
“Stay One Step Ahead in Pharma IT Compliance”
https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity
Try our "Data Integrity" app which helps you to better understand current regulatory agencies thinking on Data Integrity & CSV.
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