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What is Inspection?
All
Records required under CGMP are subject to FDA inspection. This applies to
records generated & maintained on computerized systems, including
electronic communications that support CGMP activities.
For
example, an email to authorize batch release is a CGMP record that FDA may
review.
You must allow authorized inspection, review, and copying of records, which includes copying of electronic data.
Purpose
of Inspection:
The
purpose of the inspections on manufacturers is to assess their compliance to
the GxP.
Inspection
Duration;
Depending
on the complexity of the company’s operations & purpose of inspection, an
inspection generally takes two to five days.
FDA
investigator arrives at the site?
•
To see the Top Management
•
Present credentials (identification as an authorized FDA investigator)
•
Issue FDA-482 “Notice of Inspection” (explains FDA’s legal authority
to inspect)
•
FDA calls domestic manufacturers up to 5 calendar days before the
inspection,
•
FDA contacts foreign manufacturers 2–3 months in advance to schedule
inspection
•
Manufacturer may be requested to send Quality System Manual or
equivalent for pre-inspection review.
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Inspection
Team:
An
inspection team generally consists of one lead inspector and assisting
inspector(s). Where appropriate, one or more technical specialists may be
included.
The lead inspector is responsible for leading the inspection and compiling the inspection report.
The
inspection team may also include inspector trainees or observers. All
inspection team members are bounded by obligations of confidentiality.
All records required under CGMP are subject to FDA inspection.
This applies to records generated & maintained on computerized
systems, including electronic communications that support CGMP activities.
For example, an email to authorize batch release is a CGMP record that
FDA may review.
You must allow authorized inspection, review, and copying of records,
which includes copying of electronic data.
FDA Forms
When the FDA begins an inspection,
a Form 482 (notice
of inspection) will be presented, along with contact information. The 482
explains the agency’s inspectional authority and provides expectations for the
inspector and the firm. The 482 is issued to the organization’s top management
official or the most responsible person at the site at the time of the
inspection.
The Form 483 (inspectional
observations) lists observations made by the FDA representative(s) during the
inspection.
These observations do not represent
a final agency determination regarding compliance.
The 483 formally notifies the
organization’s top management of objectionable conditions or practices relating
to violations of the Federal Food, Drug, and Cosmetic (FD&C) Act that were
observed during the inspection.
The Form
484 (receipt for samples) is issued at the end of an
inspection describing any samples obtained during the inspection. The 484 is
given to the same individual who received the FDA 482.
Inspection Steps:
The
major stages of inspection processes are
•
Opening meeting
• Site
inspection
•
Closing meeting
Opening
meeting
In the
opening meeting, inspectors shall meet the management and key personnel from
the manufacturer to discuss the arrangements for inspection.
The
lead inspector will typically explain the purpose and scope of inspection, the
inspection plan and schedule.
Representative
of the manufacturer is required to brief the inspection team on any significant
changes since the last inspection.
Site
inspection
The
scope of inspection includes inspecting the manufacturing, quality control and
storage facilities, interview with personnel and a review of system,
documentation and procedures of the manufacturer.
Inspectors
may take samples during inspection for analysis by the Government Laboratory
when necessary.
Closing
meeting
The
inspection team will provide a verbal summary of inspection findings and allow
the manufacturer to clarify any deficiencies.
The
priorities and timelines for corrective and preventive actions may be
discussed.
The
manufacturer’s representatives attending the closing meeting normally include
the key personnel and the senior management
Inspection Report
The
lead inspector shall prepare an inspection report describing findings,
observations and deficiencies.
The
report will be reviewed by a senior pharmacist before sending to the
manufacturer.
The
manufacturer shall normally rectify the deficiencies within the timeframe
specified in the covering letter to the report.
Follow-up
inspection may be conducted to verify the effectiveness of the manufacturer’s
rectification measures.
New Inspection Approach
Focus -Potential for fraudulent activity within your quality
systems.
“Guilty until proven innocent” approach to auditing!
“Data
to good to be true!”.
Assumptions: Will assume fraudulent activity is taking place if
they identify weaknesses in your quality systems.
Meta Data is data about data.
Electronic Data (Meta data) is -preferred choice for regulatory
authorities as this is the original (“official”) data.
Meta data is dynamic and can be queried / searched / trended.
There is a much higher probability of identifying fraudulent
activity within an organization if Meta data is reviewed.
Hard copy (Flat data –printed, pdf, photocopy) is no longer
considered to be acceptable by regulatory authorities as this data is not
complete and not original.
If
you state that paper is your original raw data in your internal procedures this
will alert an auditor that you are probably not managing and reviewing
electronic (meta) data.
Key Inspectors questions Data
Integrity.
•Is electronic data available?
•Is electronic data reviewed?
•Is meta data (audit trails) reviewed regularly?
•Are there clear segregation of duties?
•Has the system been validated for its intended use?
The answers to the above questions will determine whether
companies are in compliance with 21 CFR part 11 (Electronic records and
signatures).
Leave
the Original Meta data in the CD’s & review / approval electronically to
avoid increased Data Integrity risk (the paperless lab).
Inspection Strategy:
•Starts with a specific result or record
•Re-create the sequence of events that occurred at time the
result was generated using the electronic meta data.
•The auditor will want to know:
•WHO performed the analysis?
•WHAT equipment was used
to perform the analysis?
•WHEN the analysis was performed?
•WHY the analysis was performed?
•WHERE the electronic (meta) data is stored?
•Answers
to the above may lead to more detailed questioning / inspection.
Facilities that fall under
FDA’s eye include:
- Drug
manufacturers
- Device
manufacturers
- Facilities
that conduct studies in people
- Laboratories that
conduct studies in animals
- Food
processing facilities
- Compounding
pharmacies relevant to your FDA inspects
- Dairy farms
- Animal feed
processors
“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”
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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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