Cleaning Validation Training

This course is designed for QA managers, validation engineers, production supervisors, and regulatory affairs professionals responsible for cleaning validation programmes in pharmaceutical manufacturing - including both solid oral and sterile product environments.

Yes - PHARPRO delivers this training both online (live instructor-led sessions) and on-site at your facility anywhere in the MENA region and beyond. On-site sessions can incorporate your equipment list and actual product matrix for tailored worked examples.

The training covers EU GMP Annex 15 (cleaning validation requirements), EU GMP Annex 1 (2022, sterile manufacturing cleaning), FDA cleaning validation guidance (1993 and updated expectations), ICH Q7 (API cleaning requirements), and WHO Technical Report Series guidance on cleaning validation.

MACO (Maximum Allowable Carryover) is the maximum amount of a previous product's residue permitted to carry over into the next batch without adversely affecting patient safety or product quality. It is calculated using either the safety-based (TTC/PDE) or the dose-based (10 ppm or 0.1% of therapeutic dose) approach - whichever is more stringent. The PHARPRO Cleaning Validation training covers MACO calculation from first principles with worked examples for both solid oral and sterile product scenarios.

Swab sampling involves physically wiping a defined surface area with a pre-moistened swab and analysing the swab for residue. It is the preferred method for direct surface sampling and is required for hard-to-clean areas. Rinse sampling involves collecting a known volume of the final rinse solvent and analysing it for residue - suitable for large or inaccessible surfaces but subject to dilution effects. The PHARPRO training explains when to use each method, swab recovery studies, and how to set acceptance criteria for both.

All participants receive a PHARPRO Certificate of Attendance documenting the course title, content summary, delivery date, and instructor credentials - suitable for annual training files and regulatory inspection review by FDA, EU GMP, WHO, or JFDA authorities.

Yes. The training addresses the EU GMP and FDA expectations for dedicated equipment - including when product or process characteristics require dedicated rather than shared equipment, and how to document and justify the decision in a cleaning validation strategy. Topics include highly potent compounds, allergenic substances, and sterile product scenarios.

Yes - PHARPRO delivers this training in English and Arabic. Arabic-medium sessions are available for private and on-site engagements, serving pharmaceutical teams across Jordan, Saudi Arabia, UAE, Egypt, and the wider MENA region.