Checklist for Pharma Inspection Part 08

 

Data Integrity App

6 Hold any Product from any Lines that FDA Samples:

 In the event FDA collects any Zone 1 samples from any processing lines, be sure to hold the products that were produced during the periods that FDA was sampling until the FDA results come back.

Here too, if any results are positive, and the product has been held, a recall will not be necessary.

To provide additional protection, the company may also consider holding any product processed on equipment where Zone 2 samples were collected as well.

 

7 Aggressively Clean and Sanitize all Areas Sampled by FDA: 

As soon as possible after FDA has completed its sampling, be sure to aggressively clean and sanitize each of the areas that the agency sampled. This is because, in the event any sample is positive, you will be able to argue that whatever contamination existed at the time of sampling was eliminated and thus could not have affected any additional production.

 

8 Correct all FDA Observations Immediately: 

During the course of the inspection, the FDA Investigators will likely share their findings and observations with the DI.

Wherever possible, make sure to immediately correct to the satisfaction of the FDA Investigators any observations that are critical of the company. Doing so will demonstrate that the company is committed to quickly resolving any concerns, and the FDA Investigators may choose not to record those observations in the final FDA Form 483.

  

9 Know What Records FDA is permitted to Review:

 FDA has very broad powers to access records. Generally speaking, FDA will be able to review a company’s written food safety programs and related records. The agency is not entitled, 

however, to review or copy any recipes, financial data, pricing data, personal data (other than to ensure that the company’s employees have received training appropriate to their position and responsibilities), research data, and sales data (other than shipment information).

 

 10 Protect the Confidentiality of any Records FDA Copies:  

If FDA requests copies of any records the company deems confidential, be sure to mark those records with the following statement: 

“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.

 

Data Integrity App Include 

- 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” 

Data Integrity App Link:

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.