cleaning validation in pharmaceutical industry.pptx

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1. Mahatma Gandhi Vidyamandir’s Pharmacy College, Panchavati , Nashik - 422003 A seminar on Cleaning validation Presented by- Ms. Diksha Kailas Sonawane F. Y. M. Pharmacy (Semester II) Roll no- 43 Under The Guidance Of – Prof. Harshada Patil Department of Phamaceutical Quality Assurance Sub : Pharmaceutical Validation

2. Vision: “To be a centre of professional excellance by contributing honestly to the pharmacist moulding process.” Mission : Impart high quality education to graduates. Contribute to all spheres of professional activities. Up hold human values and ethics. Nurture them into globally competent professionals.

3. Content Cleaning Method development Validation of analytical method used in cleaning Cleaning of Equipment Cleaning of Facilities Cleaning in place (CIP) Validation of facilities in sterile and non-sterile plant 1

4. Cleaning Validation The process of providing documented evident which provides a high degree of assurance that specific process method, will consistently produce a result with pre – determine specificaition and acceptance criteria Types of validation Analytical method validation Process validation Software validation Cleaning validation 2 MGV’s Pharmacy College, Panchavati , Nashik

5. Types of validation Analytical validation Process validation 3

6. Software validation Cleaning validation 4

7. WHAT IS CLEANING? Cleaning is the process of removing unwanted substances such as dirt, infectious agents and other impurities from an object or environment. Cleaning occurs in many contexts and uses in many different methods . WHAT IS A CLEANING VALIDATION? As applied to a cleaning process, validation means evaluating a cleaning SOP on specified equipment after the manufacture of certain drug products (or APIs).

It involves setting acceptance criteria (visually clean and specific analytical limits based on possible contamination of subsequently manufactured products).

Cleaning validation is applicable to processes that are done repeatedly. This includes a consistent cleaning SOP and a consistent soil/drug on the equipment surfaces to be cleaned.

8. Level of Cleaning

9. Cleaning Method Development Cleaning methods are usually differential based on the extent of disassembly required for the cleaned equipment and on the method of contacting the chemical cleaning agent with the surface to be cleaned. Cleaning application are as follows : CIP (class-in-place) Agitated immersion Static immersion (soaking) Automated parts washing Ultrasonic cleaning High pressure spraying Manual cleaning 5 MGV’s Pharmacy College, Panchavati , Nashik

10. Validation of analytical method used in cleaning Validation of analytical procedure is the process by which it is establish by laboratory studies, that the performance characteristics of the procedure meet the requirements for its intended use. All analytical methods that are intended to be used for analyzing any cleaning samples will need to be validated. Validation of analytical method is essential but time consuming activity for most analytical development laboratories. It is therefore important to understand the requirements of method validation in more detail and the options that are available to allow for optimal utilization of analytical resources in a development laboratory. The analytical methods should be validated before the cleaning validation is performed and the methods chosen should detect residuals or contaminants specific for the substance being assayed at an appropriate level of cleanliness (sensitivity). The detection limit the established acceptable level of the residue or contaminants. 6 MGV’s Pharmacy College, Panchavati , Nashik

11. Validation of analytical method should include

1. precision

2. linearity

3. accuracy

4. limit of detection

5. limit of quantitation

6. ruggedness

7. robustness

12. Cleaning of Equipment Cleaning of equipment in cleaning validation is a critical aspect of ensuring that pharmaceutical manufacturing equipment is adequately cleaned between batches to prevent cross-contamination and ensure product quality and safety. Here’s an overview of the process: Cleaning Procedure Development: Develop a detailed cleaning procedure that outlines the steps, cleaning agents, equipment, and acceptance criteria for cleaning the equipment. Selection of Cleaning Agents: Select cleaning agents that are appropriate for the equipment and the residues to be removed. Consider the solubility of the residues and the compatibility of the cleaning agents with the equipment. Cleaning Validation Study Design: Design a cleaning validation study to demonstrate that the cleaning procedure effectively removes residues to an acceptable level. Consider factors such as worst-case scenarios, sampling locations, and analytical methods. 7 MGV’s Pharmacy College, Panchavati , Nashik

13. Pre-cleaning Inspection: Inspect the equipment before cleaning to ensure that it is visually clean and free from any visible residues. Cleaning Process: Follow the cleaning procedure, including disassembly of equipment, application of cleaning agents, rinsing, and drying. Sampling: After cleaning, take samples form critical locations on the equipment to test for the presence of residual contaminants. Analysis: Analyze the samples using validated analytical method to determine the level of residual contaminants. 8 MGV’s Pharmacy College, Panchavati , Nashik

14. Sampling Methods : The sampling procedure refers to the selection of which surfaces are targeted for collecting residues for measurement and to the method of collecting the residues from the surface so that they can be measured . The sampling methods are Swab sampling Rinse sampling

15. Cleaning of Facilities Cleaning of facilities in cleaning validation involves ensuring that the manufacturing environment, including surfaces, equipment, and utilities is cleaned to a predefined standard to prevent contamination of pharmaceutical products. Cleaning Procedure Development: Develop a detailed cleaning procedure that specifies the cleaning agents, methods, equipment, and acceptance criteria for cleaning the facility. Selection of Cleaning Agents: Select cleaning agents that are appropriate for the surfaces and contaminants to be removed, considering factors such as compatibility factors such compatibility factors such as compatibility and effectiveness. Cleaning Validation study Design: Design a cleaning validation study to demonstrate that the cleaning procedure effectively removes contaminants from the facility surfaces Revalidation: Periodically revalidate the cleaning procedure for the facility to ensure its continued effectiveness. 9 MGV’s Pharmacy College, Panchavati , Nashik

16. CLEAN IN PLACE Cleaning applications can be classified into two groups based on the extent of disassembly CIP(clean-in-place) COP (clean-out-of-place) CIP applies to all situations in which disassembly is not performed and can apply to situations in which process equipment is merely flooded with cleaning solution. CIP is usually used as an automated cleaning system involving spray devices to distribute the cleaning solution to all process vessel surfaces. CIP involves no disassembly of the equipment prior to initiation of the cleaning cycle. The equipment which is designed with CIP in mind-it is " prepiped " to handle the introduction of chemical cleaning solutions into the equipment, the flow of that cleaning solution through the equipment to contact and clean all surfaces, the discharge of the spent cleaning solution to drain, the rinsing of all cleaned surfaces, and, optionally, the drying of the cleaned surfaces. CIP systems are usually designed for cleaning with aqueous cleaning solutions. 10 MGV’s Pharmacy College, Panchavati , Nashik

17. Validation of facilities in sterile and non-sterile plant The validation of facilities in both sterile and non-sterile plants is crucial to ensuring the quality and safety of pharmaceutical products. Here's an overview of the validation process for both types of facilities: 11 MGV’s Pharmacy College, Panchavati , Nashik

18. Sterile Plant Validation: Design Qualification (DQ): Ensure that the facility design meets the intended use, including considerations for sterility, cleanability, and compliance with regulatory requirements. Installation Qualification (IQ): Verify that the facility and its components are installed correctly and according to the manufacturer's specifications. Operational Qualification (OQ): Ensure that the facility operates as intended under normal operating conditions, including testing of equipment and systems. Performance Qualification (PQ): Validate that the facility consistently produces sterile products of the required quality, including environmental monitoring, personnel monitoring, and process simulation studies. 12 MGV’s Pharmacy College, Panchavati , Nashik

19. Non-Sterile Plant Validation: Design Qualification (DQ): Ensure that the facility design meets the intended use, including considerations for cleanliness, segregation of operations, and compliance with regulatory requirements. Installation Qualification (IQ): Verify that the facility and its components are installed correctly and according to the manufacturer's specifications. Operational Qualification (OQ): Ensure that the facility operates as intended under normal operating conditions, including testing of equipment and systems. Performance Qualification (PQ): Validate that the facility consistently produces products of the required quality, including testing of product characteristics, equipment performance, and process parameters 13 MGV’s Pharmacy College, Panchavati , Nashik

20. References 14 MGV’s Pharmacy College, Panchavati , Nashik Manohar A. Potdar : pharmaceutical quality assurance: cleaning validation: page no: 8.22-8.28 08) https://www.slideshare.net/slideshow/cleaning-validation-250532151/250532151 Clean-in-place (CIP) in Pharmaceutical Manufacturing – Grantek https ://grantek.com > clean-in-place- cip -in-pharmaceutical manufacturing

21. Thank You !!! 15 MGV’s Pharmacy College, Panchavati , Nashik