MANAGING THE RISK OF CROSS CONTAMINATION

MANAGING THE RISK OF CROSS CONTAMINATION

Risk Assessment
  1. Is your manufacturing and/or packaging facility and equipment multi-product? (this includes handing commercial products with IMPs.)
  2. If so, have you completed a documented risk assessment of the need for dedication of your facility and/or equipment?
  3. Does this risk assessment support your cleaning acceptance criteria using the health based exposure limits as per current EMA guidance?
  4. Have you a QRM process in place to ensure control of cross-contamination and to support your continued multi-product use of your facility and equipment ? Can you demonstrate appropriate risk controls, appropriate risk review processes, & appropriate risk communication processes between internal and external stakeholders?
  • Updates to Chapters 3 & 5 of the EU GMP Guide (March 2015) require a structured QRM approach to evaluate the need to dedicate premised and equipment for manufacturing and/or packaging operations to control cross-contamination risks presented by some medicinal products.
  • A QRM process should be used to assess, control, review & communicate the cross-contamination risks presented by products manufactured.
  • Factors including; Facility/ equipment design and use, personnel and material flow, microbiological controls, physico-chemical characteristics of the active substance, process characteristics, cleaning processes and analytical capabilities relative to the relevant limits established from the evaluation of the products should be taken into account.
  • The QRM process needs to include a potency and toxicological evaluation in accordance with current EMA guidance.
  • Setting health based exposure limits need to be done in accordance with the current EMA guideline.
  • Setting cleaning acceptance criteria needs to take account of these new approaches.
If you would like to speak to one of our team about working with you to risk assess your operations for cross contamination email us, info@miaspharma.com or call us today on 01 846 3605/ 4.