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Cleaning Validation in Pharmaceutical Industry
Rating: 3.9 out of 5(20 ratings)
128 students

Cleaning Validation in Pharmaceutical Industry

Cleaning Validation - A Practical and Compliance Approach
Created byHitendrakumar Shah
Last updated 12/2023
English
English [Auto],

What you'll 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

Course content

1 section • 6 lectures • 5h 38m total length

  • Introduction11:04

    This training video will insight into Cleaning Validation - Inspection observations, Visual cleaning criteria, and solving practical problems during cleaning validation.

  • Cleaning Validation Part - 12:29:55

    This training session will help to understand what is cleaning validation, and why cleaning validation is important. This session will take you through some examples of FDA citations, regulatory agency's requirements, the role of quality risk management in cleaning validation, finding worst case limit, LOD, LOQ, and recovery study concepts, Surviving audits with the aspect of cleaning validation, Handling of new product introduction in the manufacturing plant and inspection readiness.

  • Cleaning Validation Part - II2:12:35

    This training session will take you through a quick recap of Part I of the same training topic. This part-II will put a major focus on the practical implementation approach. This includes the calculation of the acceptance limit, sampling methodologies, SMART objectives of cleaning validation, and different methodologies of finding the microbiological limits. This whole training with one case example to learn and calculate the acceptance limit.

  • Cleaning Validation - Key Questions 115:35

    This video is prepared to make all of you understand key expectations from different guidelines. For that purpose, 3 questions are identified and answered in line with current guidelines. In this video, the questions answered are;

    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?

  • Cleaning Validation - Key Questions 211:37

    This video is prepared to make all of you understand key expectations from different guidelines. For that purpose, 3 questions are identified and answered in line with current guidelines. In this video, the questions answered are;

    1. Dedicated equipment required for manufacturing of potent compounds (e.g., compounds that are cytotoxic, mutagenic, or have high pharmacologic activity)?

    2. Is testing rinse solution enough to support residue determinations for cleaning validation?

    3, Is it necessary for companies to validate a maximum time allowed for a piece of equipment to be dirty before cleaning?

  • Cleaning Validation - Key Questions 317:31

    This video is prepared to make all of you understand key expectations from different guidelines. For that purpose, 3 questions are identified and answered in line with current guidelines. In this video, the questions answered are;

    1. Do we need to perform validation of the cleaning process for product non-contact surfaces?

    2. 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?

    3. Only QA is responsible for approval of the cleaning validation report.

Requirements

  • The person should be full focussed during the session.

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 this course is for:

  • Professionals of pharmaceutical industry, Quality Assurance, Quality control (Analytical laboratory), production, engineering, R&D, development, investigation team, compliance team etc.

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