Overview of Pharma Inspection from Ground Level

Data Integrity App

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.

 

Data Integrity App

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

 

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.

 

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.


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