- Get link
- X
- Other Apps
 |
| Data Integrity App |
During Inspection
1 Arrival
of Inspector
Ensure that ALL members of the research team know that the
FDA is in the facility. Inform other staff when you will be giving the inspector
a tour of the facility.
The escort will walk the inspector to an appropriate meeting
room. The inspector will present his/ her credentials to verify that they are
in order; do not expect the investigator to permit a copy to be made of his/her
badge/credentials.
The designated escort should stay
with the inspector at all times
The inspector will then present a Notice of Inspection (482)
to the Principal Investigator, this notice authorizes the inspection and its
presentation officially begins the inspection.
The inspector will explain the intended purpose and scope of
the inspection, then ask the PI to summarize the study.
2 Opening Meeting
The inspector should present his/her credentials to the PI to verify
that they are in order
Ask the inspector to see his/her credentials if he/she does not present
them
Document all information from the inspector’s identification as no
copies of the identification
badges can be made.
The inspector will present a Notice of Inspection (Form FDA 482) to the
PI authorizing the
inspection.
This presentation officially begins the inspection.
The inspector will explain the intended purpose and scope of the
inspection.
If the team does not ask for the inspector’s credentials and/or the
Form 482, the inspector
may note this as a deficiency in his/her report.
The inspector will ask the PI to summarize and discuss the study
identified for inspection and
his/her responsibilities with respect to the
study.
The inspector may ask the PI for the list of his/her studies.
3 Attempt to Negotiate the Areas Being Sampled:
During the entrance meeting, the FDA Investigators will
typically disclose the types of ingredients, products and/or environmental
areas they intend to sample. Attempt to negotiate with the agency to limit the
amounts, types or overall focus of the sampling in such a way that, if any
results are positive, you can limit to the greatest extent possible the scope
of any recall.
4 Escort’s Role& Responsibility
The escort’s role is to coordinate all FDA requests and see
that the inspector’s questions are answered honestly and completely. Listen to
the question; answer the question that was asked. Defer to others if you don't
know; when possible use documents already provided for support of answers. Stop
when the question is fully answered. There is nothing wrong with silence: when
you have answered, wait for the next questions.
How to answer FDA Questions:
Be concise; answer only the question that is asked.
Always be clear with the answers to questions.
Be positive and confident.
Take corrective actions if possible, commit only to what you can deliver.
DO NOT volunteer information. DO NOT guess or speculate
DO NOT lie. DO NOT argue.
DO NOT panic.
DO NOT sign affidavits.
Always be clear with the answers to questions.
Be positive and confident.
Take corrective actions if possible, commit only to what you can deliver.
DO NOT volunteer information. DO NOT guess or speculate
DO NOT lie. DO NOT argue.
DO NOT panic.
DO NOT sign affidavits.
5 Carefully Document
the Areas Being Sampled by FDA:
While the FDA Investigators are conducting their sampling, be sure to carefully document the exact areas from which the FDA Investigators are collecting their samples.
In addition, be sure to appropriately
characterize the areas being sampled by the agency as Zone 1, Zone 2, Zone 3,
or Zone 4. This information will be critical in the event that any samples are
positive to determine the most appropriate response.
“Trust but Verify “ Ronald Reagan
Across the internet, there are millions of resources are available which provide information about Everything.
If you found all content under one roof then it will save your time, effort & you will more concentrated on your important activity.
 |
| 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.
Comments
Post a Comment