Self Inspection

For my part, whatever anguish of spirit it may cost, I am willing to know the whole truth; to know the worst and to provide for it

Patrick Henry

Primary Guidance

This article primarily relates to legislation and approaches that are EU centric.  However there are a range of GMP standards (EU, FDA, ICH etc) and each of them, requires the documentation of any deviation.

The primary EU Guidance on the principle of self-inspection is outlined in Part 1, Chapter 9 (Self Inspection) of EudraLex Volume 4 (Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use).

There is a link to the full text of this Chapter here. (EudraLex 4 – Chapter 9)

There is also reference to self-inspection in Chapter 5 (Production) here.

What is self-inspection?

All production systems are invariably human in nature and hence fallible.  Self inspection is one of the mechanisms that can be used to monitor the effectiveness of a company’s own compliance with it’s marketing authorisation(s), GMP and pharmaceutical quality standards in general

It is a means of checking your own work, that can be performed with more frequency and resources (over a sustained period) than could be feasibility done by national regulators.  It is also a way for a company to be frank with itself and address any areas of improvement.

Minimum requirements

Self-inspections should be conducted in an independent manner – this can be achieved by using personnel dedicated for the task or alternatively using contractors or even personnel from different parts of the company to perform the inspection itself.

As with all PQS relevant activities and detailed way by designated competent person(s) from the company. Training and competency should be recorded. 

The self-inspection rota/plan should cover the following areas as a minimum.

• Personnel matters (training etc)
• Premises
• Equipment
• Documentation
• Production
• Quality control
• Distribution of the medicinal products
• Arrangements for dealing with complaints and recalls
• The self inspection system / process itself

A short description of the self-inspection system with focus on criteria used for selection of the areas to be covered during planned inspections, practical arrangements and follow-up activities should also be included within the site master file.

Self Inspection Process

In general

1. Planning of the self inspection, in keeping with the master plan / rota
2. The Inspection itself
3. Recording and analysis of any observations and findings
4. Communication of the observations and findings
5. Proposed corrective and preventative actions if appropriate

What is the  Role of a QP in self inspection?

As self inspection is a critical tool for the monitoring the effectiveness of the pharmaceutical quality system and the general state of compliance to GMP and the principles of Quality assurance within a business the QP should understand the process and be aware of its findings and be ready to propose CAPA actions based on the findings as necessary. The QP may also take part in or direct part of the self-inspection process.

Disclaimer

This document is not a legal document not should it be interpreted in any fashion as a guide.  This is a set of notes compiled as part of a personal training program.  

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

Revision History

Version	Reason for revision / Changes made	Date
01	First Draft	15/04/2020