Audits & Risk Assessments

What are Laboratory Quality Audits and Risk Assessments?

Honeyman Laboratories can aid in the preparation of regulatory audits by running mock audits and reporting deficiencies where highlighted. Additionally, Corrective and Preventative Actions can be established for all deficiencies. These can form part of your internal site self-inspection audit plan.

A critical element of Pharmaceutical manufacture is assessment of the risks that could impact product quality. Honeyman Laboratories are experienced in performing risk assessments related to:

• Manufacturing Environment
• Manufacturing Process
• Aseptic Filling Processes
• Sterilisation of Products
• Product and People Flow Plans
• Raw material, API and FP testing requirements
• Validation of processes and methods
• Environmental monitoring programme design and risk assessment
• Disinfectant and cleaning validation support and advice
• Trending and interpreting facility Data.
• Risk Management of Contamination (RMC)
• Risk Management Systems for Cleanroom Operations