Cleaning Validation in Pharmaceutical Industry

Cleaning validation is a process that is gaining more & more attention day by day in the pharma industries.

  • The reason behind its highest demand is that most of the regulatory bodies are now strict on the process of cleaning validation.
  • Cleaning validation is the process of validating the cleaning method or process.

What Is Cleaning?

The process of removing residues of previous products from any equipment used for manufacturing/packaging or area.

The pharmaceutical products or area can be contaminated by one of the following:

  • API of Previous Product
  • Excipients of Previous Product
  • Microbes
  • Airborne Particles
  • Residues of Detergents

What Is Cleaning Validation?

Cleaning validation is the process of ensuring that the equipment used in pharmaceutical manufacturing is free of any residues that could compromise the quality, safety, or efficacy of the products. 

It ensures cleaning is so accurate that it removes not only residues of previous product, APIs & excipients but also removes microbes, chemicals & residues of the detergent up to defined limits.

Principle Of Cleaning Validation

The basic principle of cleaning validation is as follows:

To give assurance that the performed cleaning activity is done in such a way that it removes all carryover or residues of previous product, microbes or detergents or all above mentioned are removed up to the acceptance criteria.

Cleaning Validation Strategy

One of the key aspects of cleaning validation is choosing the appropriate analytical methods to detect and quantify the residues on the equipment surfaces. Here is the brief strategy of cleaning validation:

1. Define the acceptance criteria

When conducting a cleaning validation investigation, the first step is to define your acceptance criteria. These are the limits of contamination or residues that are acceptable for your products and processes. The criteria should be based on scientific rationale, risk assessment, and regulatory guidance. Additionally, you should consider the type and nature of the product and contaminant, the potential impact on product quality, safety, and efficacy, the sensitivity and specificity of analytical methods used to detect and quantify the contaminant, and the worst-case scenario of contamination or residue levels.

2. Select the sampling methods

When selecting sampling methods for collecting samples from your equipment and facilities for testing, you should consider two main types: direct and indirect. Direct sampling involves physically contacting the surface of the equipment or facility with a swab, a wipe, or a rinse, while indirect sampling involves testing the final product or the process stream for the presence of the contaminant or residue. Factors to consider when choosing your sampling method include accessibility and representativeness of the sampling location, compatibility and recovery of the sampling material and solvent, stability and transport of the sample, as well as validation and verification of the sampling method.

3. Design the sampling plan

When designing your sampling plan, the strategy used to determine the number, frequency, and location of the samples to be collected and tested should be based on statistical principles, risk analysis, and process understanding. Additionally, you should take into account the objective and scope of the cleaning validation investigation, the variability and uncertainty of the sampling and testing process, the confidence and reliability of the sampling and testing results, as well as the worst-case scenario of the sampling and testing outcome.

4. Perform your sampling and testing

When performing your sampling and testing, you should adhere to the standard operating procedures (SOPs) and good laboratory practices (GLPs). Additionally, you should consider the qualification and calibration of the equipment and instruments, the training and competency of the personnel, the documentation and traceability of the data and records, as well as the quality control and assurance of the methods and results.

5. Evaluate your results and conclusions

The fifth step is to evaluate your results and conclusions, which involves analyzing and interpreting the sampling and testing data to determine whether the acceptance criteria are met or not. Statistical tools and methods should be used to evaluate the results, while considering factors such as the significance and relevance of the data and results, sources of errors and deviations, root cause of failures, non-conformities, justification of conclusions, and rationale for recommendations.

6. Report your findings and recommendations

The final step is to report your findings and recommendations, which involves communicating and documenting the cleaning validation investigation process and outcome. The format and content requirements of the cleaning validation report (CVR) should be followed, as it is the official record of the cleaning validation investigation. Additionally, factors such as the summary and overview of the cleaning validation investigation, details and evidence of acceptance criteria, sampling methods, sampling plan, sampling and testing results, results and conclusions, deviations, failures, non-conformities, root causes, corrective actions, preventive actions, limitations, assumptions, uncertainties and risks of the cleaning validation investigation should all be taken into consideration when reporting your findings and recommendations. Lastly, suggestions for improvement and best practices for future cleaning validation activities should also be included.

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