Cleaning Validation in Pharmaceutical Industry
Cleaning Validation - A Practical and Compliance Approach
Ratings 3.91 / 5.00
What You Will Learn!
- Upcon completion of the course,participants will learn and equipped to Undertand the importance of CV in line with regulatory guidelines
- Identify worst case product and limit, how to solve the practical problems during execution of cleaning validation,
- Preparation of protocol and report in easy and pragmatic way in line with regulatory guidelines
- How to justify the cleaning validation with regulators
Description
Welcome to the online learning platform. This session is for learning the Cleaning validation with a special focus on practical implementation and compliance approach.
This session comprises of total 6 different video lectures.
1. The first lecture - Is an introduction to cleaning validation.
2. The Second and Third lectures - Are detailed sessions. These sessions will help to understand what is cleaning validation, and why it is important. Examples of FDA citations, regulatory agency's requirements, the role of quality risk management, finding worst case limit, LOD, LOQ, and recovery study concepts, calculation of the acceptance limit, sampling methodologies, SMART objectives, and different methodologies of finding the microbiological limits. Surviving audits with the aspect of cleaning validation, Handling of new product introduction in the manufacturing plant, and inspection readiness.
3. The remaining three lectures - Include key questions and answers related to cleaning validation.
The questions are below;
1. Is it required to evaluate the variability in residue levels during cleaning validation?
2. During cleaning validation, Do we have to wait for swab and rinse samples to be approved before using the equipment for production?
3. During MACO (Maximum Allowable Carry Over) calculation, Do we have to use a safety factor depending on the nature of the formulation?
4. Is Dedicated equipment required for manufacturing potent compounds (e.g., compounds that are cytotoxic, mutagenic, or have high pharmacologic activity)?
5. Is testing rinse solution enough to support residue determinations for cleaning validation?
6. Is it necessary for companies to validate a maximum time allowed for a piece of equipment to be dirty before cleaning?
7. Do we need to perform validation of the cleaning process for product non-contact surfaces?
8. As we know that, process validation is done in three stages – Process design, process qualification, and continued process verification. Whether the cleaning validation also to be done in three stages?
9. Only QA is responsible for approval of the cleaning validation report.
Who Should Attend!
- Professionals of pharmaceutical industry, Quality Assurance, Quality control (Analytical laboratory), production, engineering, R&D, development, investigation team, compliance team etc.