Follow
A Cleaning Validation Protocol is required laying down the procedure on 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 procedures;
– 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 equipment;
– Sampling procedures, including the rationale for why a certain sampling method is used;
– Clearly defined sampling locations;
– Data on recovery studies where appropriate;
– 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 the “bracketing” concept; and
– When Re-validation will be required.
The Cleaning Validation Protocol should be formally approved by the Plant Management, to ensure that aspects relating to the work defined in the protocol, for example personnel resources, are known and accepted by the management. Quality Assurance should be involved in the approval of protocols and reports.
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 the Plant Management.
The cleaning process should be documented in an SOP.
Records should be kept of cleaning performed in such a way that the following information is readily available:
– The area or piece of equipment cleaned;
– The person who carried out the cleaning;
– When the cleaning was carried out;
– The SOP defining the cleaning process; and
– The product, which was previously processed on the equipment being cleaned.
The cleaning record should be signed by the operator who performed the cleaning and by the person responsible for Production and should be reviewed by Quality Assurance.
