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11 Prioritize Areas
of Scrutiny
With the list of potential questions and possible
documentation to provide, it is time to prioritize likely inspection points.
Identify between 5-10 likely areas that will be reviewed.
For instance, if the review indicates the agency is concerned about management
involvement and support for the company’s quality system, then what is it about
management involvement and support that is likely to draw inspector scrutiny?
For a more virtual pharmaceutical firm, one specific area
might be the effectiveness of supplier oversight in the context of management
involvement.
12 Upgrade Sanitation Flashlights:
This may seem obvious, but many facilities are still using
flashlights that are severely underpowered or outdated.
Be sure to equip your sanitation employees with the same
high-power flashlights that the FDA Investigators will use so that your
employees will be able to see (and then clean) what the FDA would observe with
its own flashlights when it arrives.
13 Review Allergen Controls:
FDA is requiring companies to recall vast amounts of
products if the FDA Investigators find, during their visual inspection, that
the companies’ allergen controls are not adequate. Make sure that your
ingredient labels are accurate, and that opportunities for cross-contact are
being guarded against and avoided.
14 Conduct
Environmental Monitoring:
If your company processes ready-to-eat food products that
are exposed to the environment prior to packaging,
FDA will require you to have an environmental monitoring
program. Ensure that an appropriate program is developed and implemented before
FDA arrives.
15 Conduct More Environmental Sampling:
Because FDA will collect between 100 and 200 microbiological
samples from your facility, it is critical to know exactly what FDA will find
before it arrives.
Thus, you should “Play FDA for a Day,” and conduct your own
FDA-style facility swabbing, to identify and immediately correct any hidden
problems.
If done correctly, and if your swabbing and testing plan is
developed with the assistance of legal counsel, the final testing results can
be kept confidential.
16 Develop a Microbiological Sample Retain Policy:
If, after reporting your testing results, your lab retains
your isolates or testing materials indefinitely, create a policy requiring the
lab to discard all testing material within 24 hours after testing. This is
appropriate as long as the records of the final results are maintained.
17 Develop a Companion Sample Policy:
When FDA collects food product or environmental samples,
some companies elect to collect companion samples at the same time. Although we
typically counsel against this practice, if you choose to collect companion
samples, make sure to have a policy in place governing exactly how those
samples will be handled, tested and/or discarded following collection.
18 Develop a “Photographs”
Policy:
In many cases, FDA Investigators will insist on taking photographs
while inspecting the processing environment.
If you have a corporate policy which helps visitors from
taking photographs, you may be able to use the policy to FDA from taking
pictures.
If the FDA
inspector insists on taking photographs or other video or audio recordings,
take and retain duplicates at the same time.
19 Develop a “Do Not
Sign” Policy:
At the conclusion of the inspection, the FDA investigators
may ask you or your employees to author or sign a statement or affidavit
describing the inspection, the observations and/ or the conclusions.
Sometimes, during an FDA inspection, the FDA Investigators
will insist that a company representative sign a statement or affidavit.
You have no legal obligation to do so. Develop a policy that
states you will neither sign nor acknowledge any written statements presented
by FDA Investigators.
Do not sign,
correct or acknowledge any documents, as you have no legal obligation to do so.
If the
inspector presents an affidavit for signature, politely decline to sign and
tell the inspector that you must first consult with the FDA lawyer/ consultant
“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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