Cleanroom Auditing

Cleanroom Auditing

At SSE we provide a Cleanroom Auditing Service performed by our qualified Auditors and experienced Biologists.

This service ensures a high standard of GMP is adhered to on an on-going basis and prepares our clients for Regulatory Body Audits such as FDA, HPRA and ISO.

We have completed hundreds of external Audits throughout the industry over the past number of years. The outputs of these Audits include observations on processes, behaviors, Cleanroom environments and the facility.

Based on our recommendations, our clients have significantly reduced contamination within their Cleanrooms, and improved processes by implementing some very simple but effective changes. 

  • Reduced Contamination by over 60%
  • Reduced CAPA’s significantly
  • Reduced rework of product
  • Phenomenal cost savings. 

Why Cleanroom Auditing?

Regular Cleanroom Auditing is vital to the ongoing development and high standards guarantee of any Cleanroom.

Cleanroom Audit

Here are just some reasons why Cleanroom Auditing is a necessity:

  • Issues that may arise within the Cleanroom.
  • Experienced External Advice.
  • Ensures a high standard of GMP is adhered to.
  • Improving the standards of the Cleanroom and personnel awareness.
  • Support corrective / preventive action process.
  • Provide objective evidence through a written and photographic report.
  • Preparation for Regulatory Body Audits such as FDA, HPRA, ISO to ensure clients are Audit ready at all times. 
  • Advise on changes in policies and procedures where necessary.

What is Audited?

  • Relevant Procedures.
  • Level of GMP within the Cleanroom & Supporting Areas.
  • Cleanliness & Housekeeping.
  • Personnel Behaviour.
  • Material Transfer Practices.
  • Overall effective Contamination Control Practices & Methods used.

Audit Reporting & Training

A follow up Audit is performed after the Training has been complete in order to review improvements in Contamination Control Practices and to offer further guidance and support where required.Very often a Cleanroom Audit is performed inorder to examine specific problems or issues within the Cleanroom Environment, for example,  current Cleanroom Processes or Methods, Personable Behaviours and Environmental Monitoring Trends.  All Training Programmes are delivered specific to the client’s requirements based on the results of the Cleanroom Audit.A detailed written and photographic Report outlining observations, suggestions and recommendations as to how the standard of GMP and policies and procedures can be improved will be submitted to the client. Any suggestions or changes taken on board by the client can then be rolled out as part of a specific Training Programme delivered by SSE.