1 Define the scope

The first step is to define the scope of your cleaning program. This means identifying the areas, equipment, surfaces and materials that need to be cleaned and sanitized, as well as the frequency, duration and methods of cleaning. You should also consider the types and levels of residues that may be present, such as active ingredients, excipients, solvents, detergents and bioburden. The scope should be documented in a cleaning master plan that outlines the objectives, responsibilities, procedures and acceptance criteria of your cleaning program.

2 Select the agents

The next step is to select the appropriate cleaning and sanitizing agents for your cleaning program. You should choose agents that are effective, compatible, safe and environmentally friendly. You should also verify that the agents are suitable for the intended use and do not leave any harmful or unacceptable residues. You should conduct compatibility tests to ensure that the agents do not damage or corrode the equipment or surfaces. You should also evaluate the stability, shelf life and storage conditions of the agents.

3 Establish the procedures

The third step is to establish the detailed cleaning and sanitizing procedures for your cleaning program. You should specify the steps, parameters, equipment and tools required for each cleaning operation. You should also define the roles, qualifications and training of the personnel involved in the cleaning process. You should document the procedures in standard operating procedures (SOPs) that are clear, consistent and compliant with the GMP requirements. You should also provide instructions for recording, reporting and reviewing the cleaning activities and results.

4 Validate the process

The fourth step is to validate the cleaning and sanitizing process for your cleaning program. Validation is a systematic and documented way of demonstrating that the process consistently meets the predetermined specifications and quality attributes. You should design and execute a validation protocol that includes the rationale, scope, criteria, methods, data and conclusions of the validation. You should also perform sampling and testing to verify the removal or reduction of the residues to acceptable levels. You should document the validation results in a validation report that confirms the effectiveness and reliability of the process.

5 Monitor the performance

The fifth step is to monitor the performance of your cleaning and sanitizing process for your cleaning program. Monitoring is a continuous and proactive way of ensuring that the process remains in a state of control and compliance. You should implement a monitoring plan that includes the frequency, methods, indicators, limits and actions of the monitoring. You should also collect and analyze data to evaluate the trends, variations and deviations of the process. You should document the monitoring results in a monitoring report that identifies and addresses any issues or opportunities for improvement.

6 Review and update

The final step is to review and update your cleaning and sanitizing process for your cleaning program. Reviewing and updating is a periodic and reactive way of adapting to the changes and challenges that may affect the process. You should conduct a review at regular intervals or whenever there is a significant change in the product, process, equipment, agent or regulation. You should also update the relevant documents, such as the cleaning master plan, SOPs, validation protocol and report, and monitoring plan and report. You should document the review and update results in a change control record that justifies and approves the changes.

7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?