Webinar Details:

Cleaning validation is a key part of pharmaceutical, biopharmaceutical, and medical device manufacturing. One of the critical steps in performing a successful cleaning validation is establishing the limits of residue that can remain on the surface being cleaned.

Is your cleaning validation program in compliance with establishing limits for cleaning validation?

In 2020, the World Health Organization (WHO) issued a draft document on points to consider in establishing cleaning limits using Health Based Exposure Limits (HBELs); the Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-Operation Scheme (PIC/S) released an aide-memoire titled inspection of HBEL assessments and use in quality risk assessment; and the Brazilian National Health Surveillance Agency (ANVISA) published a technical note on HBEL limits. These recent guidance documents support the PIC/S GMP for Medicinal Products, Annex 15, Qualification and Validation Section 10, regulation approved in 2015 to include setting HBELs for use in risk identification in the manufacture of different medicinal products in shared equipment and revised in 2022.

During the webinar, the speaker will explore approaches to establishing limits for cleaning validation, specifically looking at the following areas and recent regulatory guidance documents:

• Sampling methods – The two most often used sampling methods, swab sampling and rinse sampling, will be compared and the speakers will elaborate on the appropriate use of each sampling method.
• Detection methods – Available detection methods will be examined, and insight offered on each methods’ respective advantages and disadvantages versus one another.
• Calculating limits- By detailing the factors used in the limit calculation, the presenters offer the attendees a robust approach to calculating residue limits for a variety of dosage forms and products.

The instructor will also shed light on the current WHO, PIC/S, and ANVISA documents as well as provide a chronological review of related documents and best practice references. Following the review, the instructor will share the impact on the cleaning validation program, discussing process capability and level of risk. Additionally, the instructor will explore approaches to establishing limits for cleaning validation using permitted daily exposure (PDE), acceptable daily exposure (ADE), and the traditional approach. Lastly, an example using HBELs to calculate the maximum allowable carry-over (MACO) as well as the acceptable limit per surface area and rinse volume will be provided.

What the attendee will learn:

• How to determine limits by going over real examples
• Selecting worse-case residue limits
• Incorporation of health-based limits into an existing Cleaning Validation program
• How to deal with limits lower than assay detection
• Answers to common questions and issues
• Things to avoid when setting limits

Fee:
$385 for one person
$700 2-5 people
$999 6-10 people

Register for ECC-630