CLEANING VALIDATION PROTOCOL
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Product :
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Protocol No. :
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Revision No. :
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Page No….of …..
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1. Introduction
One equipment used at one stage, manufacturing of different products is very common in pharmaceuticals manufacturing. After use, the equipment is cleaned to prevent cross-contamination of drug products.The efficacy of cleaning procedure should be such that it effectively removes traces of the previous product and detergent used.
2. Purpose
To validate the cleaning procedure for equipment used for manufacturing is effective to remove the ingredients of previous product and detergent used to reduce the microbial contaminants.3. Objective
• To establish a documented evidence of the cleaning effectiveness of the cleaning procedure to a predetermined residue level.• To verify that the cleaning procedure is able to clean the defined equipment consistently and reliably.
4. Responsibilities
I. Production Supervisor• To ensure that the various pieces of equipment are cleaned according to the relevant SOP. (SOP no :…….)
• To train and monitor the operator for collecting sample by final rinse/swab of the various parts of the equipment.
II. Head of Q.C Department
• Responsible for validating analytical method used to analyze traces of active ingredients of the previous product and traces of detergent used.
• To test sample according to validated analytical method
III. Head of Microbiology Department
• Responsible for validating analytical used to analyze and count the microbial contamination
IV. Head of Q.A Department
• Responsible for writing of the protocol and final report
• To supervise the operation to ensure everything is done according to the protocol
V. Production Manager
• Responsible for checking of the protocol and final report
VI. Engineering Foreman
• Responsible for supporting production personnel during cleaning validation.
5. Procedure
A. After completion of manufacturing of drug product, cleaning will be carried out by production personnel according to the relevant SOP. (SOP No.: …..)B. The production supervisor inspects the equipment visually to assure that it is clean, and fill the inspection form.
C. For determining the active residue, the sample are taken according to the following steps:
• Wipe off the cleaned equipment with swab test kit saturated with purified water or methanol (according to the solubility of the API of the previous product) on the critical areas.
• Put the cotton swab into the vial and close the vial with plastic pilfer proof cap. Collected swabs should not be hold more than 24 hours under refrigeration.
• Then send the collected sample to the Q.C department for analysis (method of analysis should be validated).
D. For determining detergent residue, the sample are taken according to the following procedure:
• Rinse the clean equipment with purified water
• Collect approx. 500 ml from the final rinse into a clean amber glass bottle and close the bottle with the lid.
• Then send the collected sample to the Q.C department for analysis (method of analysis should be validated).
E. For determining microbial contaminants, the sample is taken according to the following procedure:
• Open the lid of the RODAC plate.
• Put the nutrient agar surface on the cleaned equipment at the critical area.
• Close the RODAC plate with the lid immediately.
• Then send the RODAC plate to the Microbiological Lab for incubation.
Related: SOP for Environmental Monitoring of Parenteral Processing Area by RODAC Plate and Swab
6. Acceptance criteria
The following criteria are established:
• Visual examination should not reveal any evidence of contamination. The equipment will be checked for this and will be recorded.
• Active ingredient of the previous product: Not more than 10 ppm.
• Samples from final rinse have purified water.
• Conductivity of the samples: Not more than 1.3µS.
• Microbial contaminants of the sample: Not more than 25 CFU/25 cm2
7. Corrective action (If required)
• If the cleaning validation results show that the equipments are below the acceptance limits or not more than the maximum detectable limit, the cleaning SOP is adequately validated.
• A failure to meet this equipment would necessitate a review of the cleaning procedure of the residual limits. Modification in the procedure to make it more effective, or a change to more realistic limits would again necessitate three successful cleaning of the equipment before the procedure can be considered acceptable.
8. Attachments
• Visual inspection form
• Surface sampling form
• Final rinse sampling form
• Monitoring form
9. Protocol Prepared By:
S. No
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Name
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Department
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Signature
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Date
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1.
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Quality Assurance
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10. Protocol Reviewed By:
S. No
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Name
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Department
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Signature
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Date
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1.
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Quality Control
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2.
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Microbiology
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3.
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Production
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4.
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Engineering
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11. Protocol Approved By:
SI. No
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Name
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Department
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Signature
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Date
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1.
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Head of Quality Assurance
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Attachments:
Cleaning validation visual inspection form:
Product cleaned
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Batch No.
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Cleaned by
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Date
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Cleaning SOP No.
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Date of revision
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Protocol No.
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No.
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Equipment inspected
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Result
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Inspected by
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Date
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Clean
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Not clean
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Remarks: ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Reviewed By: ……………………… Date……………………………..
Cleaning validation surface sampling form:
Product cleaned
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Batch No.
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Cleaned by
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Date
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Cleaning SOP No.
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Date of revision
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Name of the equipment
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Equipment No.
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Protocol No.
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No.
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Sample type
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Sample location
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Sample code
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Area (cm2)
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Sampled By
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Date
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1.
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Microbiological
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2.
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Microbiological
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3.
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Chemical
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4.
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Chemical
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Remarks: ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Reviewed By: ……………………… Date……………………………..
Cleaning validation final rinse sampling form:
Product cleaned
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Batch No.
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Cleaned by
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Date
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Cleaning SOP No.
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Date of revision
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Name of the equipment
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Equipment No.
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Protocol No.
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No.
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Sample type
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Which Part of the equipment to be use for sampling
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Sample code
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Quantity
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Sampled By
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Date
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Remarks: ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Reviewed By: ……………………… Date……………………………..
Cleaning validation monitoring form:
Product cleaned
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Batch No.
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Cleaned by
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Date
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Cleaning SOP No.
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Date of revision
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Name of the equipment
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Equipment No.
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Protocol No.
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No.
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Parameter monitored
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Sample location
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Result
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Monitored By
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Date
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1.
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Detergent
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2.
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Rinsing
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3.
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Final rinsing
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4.
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Mop
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5.
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drying
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Remarks: ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Reviewed By: ……………………… Date……………………………..
Submitted By:
Md. Abdul Bake
Product Development Officer
GonoShasthaya Pharmaceuticals Limited
Email - abdul.bake@yahoo.com
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Very informative article and helpful in developing in-house strategies... thanks!
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