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SOP for Cleaning Validation- Step by Step Procedure

SOP for Cleaning Validation: Discover a straightforward guide for cleaning validation tailored for the pharmaceutical industry. This SOP for Cleaning Validation simplifies the process of ensuring all cleaning procedures effectively remove residues and contaminants, helping you meet quality and safety standards with ease.

SOP for Cleaning Validation- Step by Step Procedure
SOP for Cleaning Validation- Step by Step Procedure

SOP for Cleaning Validation- Step by Step Procedure


The aim of this SOP for Cleaning Validation is to describe the process of cleaning validation for pharmaceutical manufacturing or laboratory settings. 

Cleaning validation is necessary because cleaning processes between the production of different products or batches should be clean. it should be free from all residues of APIs, excipients, detergents and any possible microbial contamination to defined levels that ensure product quality and safety.


This SOP for Cleaning Validation covers all cleaning processes used for all equipment that directly contacts pharmaceutical products and includes reactors, mixers, conveyors, and filling and packaging machines. 

It includes validation of manual as well as automated cleaning processes to meet regulatory standards and guidelines.

Responsibilities– SOP for Cleaning Validation

  • Validation Team: Responsible for planning, executing, and documenting the cleaning validation studies.
  • Quality Assurance (QA): Responsible for reviewing and approving the validation protocol, reports, and ensuring that the validation process meets regulatory requirements.
  • Production and Cleaning Personnel: Responsible for implementing the cleaning procedures as defined in the validation protocol.

Materials and Equipment– SOP for Cleaning Validation

  • Sampling tools: Swabs, rinse water collection containers
  • Analytical equipment: HPLC, TOC analyzer, microbial culture plates
  • Cleaning agents and solvents
  • Personal Protective Equipment (PPE)

Procedure- SOP for Cleaning Validation

Step 1: Cleaning Validation.

Objective: Cleaning Cleaning validation is about proving the ability of cleaning procedures to remove residues down to a defined level of acceptance.

Importance: Cleaning validation is recognized as necessary to prevent cross-contamination and maintain product purity.

Step 2: The validation team is formed

Composition: A cross-functional team should incorporate the members of QA, Production, QC, and Engineering.

Responsibilities: A list of responsibilities of team members should be formulated so that all validation aspects are covered.

Step 3: A clean validation protocol is developed

Content: The protocol should specify the goals, coverage, cleanliness processes to be validated, equipment and surfaces involved, sampling, analytical methods, and acceptance criteria.

Approval: First, be sure the protocol is reviewed and signed off by QA before implementation.

Step 4: Equipment and Surface Selection for Validation.

Criteria: Identify and record the equipment and surfaces that are essential to product quality and those that are challenging to clean.

Justification: This is to justify the choice for the choice, discussing the risk of contamination and effects on product quality.

Step 5: Cleaning Procedures Definition

Detailing: The cleaning procedure for each equipment should be mentioned, the disassembly, cleaning agents used, their concentration, temperature, contact time and reassembly.

Standardization: Procedures must be standardized and documented.

Step 6: Performing Cleaning Procedures

Perform Cleaning: It is cleaning process procedure according to the documents.

Documentation: Cleaning protocol deviations should be documented, mentioning the details of the cleaning process.

Step 7: As for validation sampling

Methods: A decision should be made on the sampling methods (swab, rinse, or both) and the sampling locations that can be regarded as the most difficult areas to clean should be defined.

Collection: Aseptic sampling should be done to prevent contamination.

Step 8: Analytical Testing

Analytical Methods: As per the validated analytical methods that are compatible with the detection and quantification of the specific residues of concern.

Results: The analytical results should be documented and compared with the predetermined acceptance criteria.

Step 9: The evaluation of results

Assessment: Cleaning process validates whether it is able to reduce the residue levels below the acceptance criteria consistently.

Actions: If the requirements are not met, determine the source, take corrective action and revalidate as required.

Step 10: The documentation and reporting

Validation Report: Set up a detailed report on the validation activities, results, and conclusions.

Review and Approval: The report should be QA reviewed and approved, in line with regulatory requirements and internal policies.

Evaluation and Conclusion

  1. Review Data: Compare the results with the predefined acceptance criteria.
  2. Determine Validity: Conclude whether the cleaning process is verified by the data.
  3. Recommendations: If required, propose any modifications to the cleaning procedure or revalidation needs.

Documentation and Reporting- SOP for Cleaning Validation

  1. Prepare Validation Report: The validation study should be summarized, indicating the protocol, implementation, outcomes, and conclusion.
  2. QA Review and Approval: Get the validation report reviewed and signed by the QA department.

Revalidation- SOP for Cleaning Validation

  1. Define Revalidation Criteria: Cleaning process revalidation conditions (e.g. new products, formulation changes, major changes in cleaning process).
  2. Schedule Periodic Revalidation: For continual adherence to the acceptance criteria.

Safety Precautions

  1. In handling cleaning agents, samples, and analytical tests, use the right PPE.
  2. All instructions for safety and handling of cleaning chemicals and pharmaceutical residues must be observed.

Maintenance and Troubleshooting

  1. All equipments used during cleaning and validation studies should be maintained as per the instructions of the manufacturer.
  2. Any observed deviations or failures in the cleaning process should be addressed right away, identifying the source and taking corrective action.


Cleaning validation is a critical component of quality assurance in pharmaceutical manufacturing, requiring meticulous planning, execution, and documentation.

By following this detailed procedure, individuals new to cleaning validation can gain a comprehensive understanding of the process, ensuring that they can effectively contribute to the validation efforts within their organization.

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