Documentation in cleaning validation

1.0 Detailed cleaning procedure(s) are to be documented in SOPs

2.0 A Cleaning Validation Protocol is required to define how the cleaning process will be validated. It should include the following:

• The objective of the validation process;
• Responsibilities for performing and approving the validation study;
• Description of the equipment to be used;
• The interval between the end of production and the beginning of the cleaning procedure;
• The number of lots of the same product, which could be manufactured during a campaign before a full cleaning is done
• Detailed cleaning procedures to be used for each product, each manufacturing system or each piece of equipment;
• The number of cleaning cycles to be performed consecutively;
• Any routine monitoring requirement;
• Sampling procedures, including the rationale for why a certain sampling method is used;
• Clearly defined sampling locations;
• Data on recovery studies where appropriate;
• Validated analytical methods including the limit of detection and the limit of quantitation of those methods;
• The acceptance criteria, including the rationale for setting the specific limits;
• Other products, processes, and equipment for which the planned validation is valid according to a “bracketing” concept;
• Change Control/ Re-validation.

3.0 Depending upon the complexity of the system and cleaning processes, the amount of documentation necessary for executing various cleaning steps or procedures may vary.

4.0  When more complex cleaning procedures are required, it is important to document the critical cleaning steps. In this regard, specific documentation on the equipment itself which includes information about who cleaned it, when the cleaning was carried out, the product which was previously processed on the equipment being cleaned should be available. However, for relatively simple cleaning operations, the mere documentation that the overall cleaning process was performed might be sufficient.

5.0 Other factors such as history of cleaning, residue levels found after cleaning, and variability of test results may also dictate the amount of documentation required. For example, when variable residue levels are detected following cleaning, particularly for a process that is believed to be acceptable, one must establish the effectiveness of the process and of the operator performance. Appropriate evaluations must be made, and when operator performance is deemed a problem, more extensive documentation (guidance) and training may be required.

6.0 A Final Validation Report should be prepared. The conclusions of this report should state if the cleaning process has been validated successfully. Limitations that apply to the use of the validated method should be defined (for example, the analytical limit at which cleanliness can be determined). The report should be approved by management.