Start preparing for your next audit with a 100 point Cleaning Validation Audit Readiness Checklist
FDA audits in 2022 have surfaced significant problems when it comes to Cleaning Validation. In order to prepare for your next audit, you want to check all the boxes.
Use the new 100-point audit-readiness checklist designed by CLEEN experts based on first-hand experience of several FDA audits in 2022.
This checklist will guide you through 5 core aspects of your company's cleaning quality procedures and systems, including:
Use the new 100-point audit-readiness checklist designed by CLEEN experts based on first-hand experience of several FDA audits in 2022.
This checklist will guide you through 5 core aspects of your company's cleaning quality procedures and systems, including:
Risk Assessment: Risk Assessment is not only a regulatory requirement but also a foundation of a good cleaning validation program. You will be asked about your QRM related to HBEL, Equipment & Sampling, Residue Characterization, and more.
Validation SOP & Execution: Once you have a robust risk assessment in place, the identified risks and the associated mitigation procedures need to be documented and the teams need to be trained on executing the written procedures. This section of the evaluation will focus on identifying any deficiencies you may have in these areas.
Equipment Cleaning: Your cleaning procedures, either manual or automated, need to have detailed work instructions, the process parameters need to be logged in a compliant manner, and any exceptions need to be managed via a QMS. This section of the evaluation will focus on educating about various gaps that may be identified.
Routine Monitoring: In this section, you will be asked about the procedures related to monitoring & maintaining the validated state of your cleaning procedures.
Data Integrity: A robust data integrity program is at the heart of any compliant pharma manufacturing facility. In this section, you will learn about any steps that you may need to take in order to fortify the data integrity aspects of cleaning validation.
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