Audits

Question 1

Two of the systems that require us to perform audits are:

Answer 1

1. The Internal Audit System (Self‐Inspections)
2. The Supplier Management System

Question 2

The internal audit system and the Supplier Management System allow us to

Answer 2

evaluate our suppliers and their quality systems and to evaluate our own company’s compliance with its own quality system.

These two systems are the starting point for all our audit programmes and individual audits performed.

Question 3

The purpose of an audit is to:

Answer 3

• To confirm compliance with company PQS
  
  • To confirm compliance with regulatory standards
  • To protect the patient
  • To protect the business
  • To identify potential risks
  • To identify opportunities for improvement

Question 4

Internal and External audits can add real benefits to a company by:

Answer 4

• Quality improvements
  
  • Benefit to the patient
  • Financial savings
  • Reduction in risks
  • Better regulatory compliance

Question 5

The Internal Audit System (Self‐Inspection System)
One of the requirements for a Pharmaceutical Quality System mentioned in EudraLex Vol 4 Chapter 1 and in ICH Q 10 is the requirement to continuously improve:

Answer 5

• Products
  
  • Processes
  • The Quality System

Question 6

The Audit process

Answer 6

• Programme Preparation and Planning for an Audit
  
  • On Site Audit - opening meeting and introductions, inspection, close out meeting and summary of findings and next steps
  • Writing Report
  • Observations
  • Post Report Activities
  • Follow Up

Question 7

Audit answer

Answer 7

Audit schedule
Audit agenda
Opening presentation and introductions
Inspection:
* I would look at the PQS to make sure this is in control - Review of previous findings, PQR, deviations, supplier management, change management etc
* I would include a factory tour and walk the process starting from materials in - concentrating on the process stream my product will be following
* I would take a fishbone approach to get a good cross section of the facility:
○ Materials - receipt, sampling, segregation and release
○ Methods - validated methods, validated recipes
○ Man - recruitment, training
○ Machine - water systems, maintenance and inspection
○ Measurement - calibration, validation, QC analysts
○ Environment - contamination control, controlled entry, cleaning
Close out meeting
Issue report
Audit follow up and close out