Checklist for Pharma Inspection Part 03

Data Integrity App

Review the Notification Letter

With luck, the letter will spell out the type of inspection the Agency intends to conduct, including the records the inspector expects to review.

This may be a preapproval inspection (PAI), “statutory” inspection, a “for cause” inspection or a “follow-up” inspection.

In such cases, the inspection is largely confined to those areas identified in the letter; although, the inspector can, and sometimes does, ask about and review supporting documentation for other areas of relevance. 

For example, one notification letter, sent by the FDA, informed a recipient that the Agency intended to conduct an inspection related to a whistleblower complaint around data integrity associated with clinical trial production or finished product contamination.

In that case, the inspection led to a review of risk evaluations for pilot plant production and process parameters, the risk evaluation, qualification and oversight of the active pharmaceutical ingredient manufacturer and so on, not just pilot plant batch records, electronic record integrity and clinical trial production quality control data.

 

7 Review Previous Inspections

Assuming the firm has been inspected by the Agency before, previous establishment inspection reports (EIRs) and FDA Form 483 observations should be available for review.

Companies that have not yet been inspected by the Agency can turn to their critical suppliers such as a contract manufacturer (CMO) or contract research organization (CRO).

This is especially important if the company is receiving a preapproval inspection or if a “for cause” inspection cites clinical or manufacturing oversight concerns. The CMO or CRO may have been inspected by the Agency. If so, they will have EIRs and Form 483s that can be reviewed.

 

8 Review the QSIT Manual &FDA Guidance

The next step is to review the FDA’s Quality System Inspection Technique (QSIT) manual, guidance documents on the FDA website & Relevant Harmonization Guidance’s.

Originally written to help inspectors of medical device and diagnostic firms since the publication of FDA’s Pharmaceutical cGMPs for the 21st Century:

A Risk-Based Approach with its emphasis on a holistic compliance framework and quality system, the QSIT is well worth the time to review; it provides example questions to which the FDA inspector might seek answers.

For instance, in order to assess the role of senior management in promoting and overseeing FDA compliance at a firm, the inspector may make sure to obtain answers to questions such as:

·         Have measurable quality policy

·         Objectives been implemented? Are quality audits conducted?

·         Does the quality unit have appropriate responsibility, authority, and resources?

 

9 Identify Records FDA are likely to Audit

Good organization of documents is important to successful completion of inspections. Organize all Regulatory Files by general heading arranged in chronological order (or reverse chronological order).

A visual presentation of documents can instill confidence in the inspector that the cGMP documentation practices are implemented and followed.

Well-written summaries too go a long way in simplifying the inspection. Inspectors may prefer well-written summaries over bulky documents.

 

10 Complete PCQI Training: 

Ensure that the primary DI has received FDA’s Preventive Control Qualified Individual (PCQI) Training. Although the training is not required under FDA regulations to become a Qualified Individual, FDA Investigators will typically expect the training to be completed by at least one facility employee.

 

11 Ensure Ease of Records Access: 

Keep record handy & produce within specific time give confidence to auditors.

Ensure that the supporting records for each of the programs are organized and maintained in such a way that the Designated Individual can immediately retrieve the past three months of records for FDA review.

Although FDA requires the majority of these records to be maintained for at least two years, the FDA investigators will typically ask only to review records for the preceding three months.

“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.