Protocol Development

A cleaning validation protocol will be developed for each worst-case product per equipment train identified from the matrix incorporating the guidelines and requirements. These protocols will also be used to define specific sampling locations for each of the equipments included within the equipment train for the particular product under study.

The protocol must be prepared prior to the initiation of the study and must include all other documentation required to provide the following information.

• Objective of the study: The objective of the protocol should clearly refer to the cleaning procedure that is to be validated. If the study is employed to demonstrate the acceptability of the cleaning procedure for a group of products, the rationale for doing so will be detailed here.

• Scope of the study: The validation professional will evaluate the process and determine the residues (including cleaning agents) to be tested.

• Listing of the process parameters to be verified: This is particularly necessary when automated or semiautomated cleaning techniques are employed.

• Sampling and inspection procedures: Types of sampling methods, number of samplings, and sites of sampling will be described. Any particular requirements should also be stated, that is, for sterile sampling or sampling light-sensitive products. An equipment-sampling diagram should be referenced.

• Personnel responsibilities during the study: The designations and details of the responsibilities of personnel involved in the validation study will be included in this part.

• Test methods to be used: All the test methods used in the study will be indicated here.

• Acceptance criteria: The rationale for this criterion should be given along with a calculation step.

• Change control

• Approval of protocol before the study: Managers of the respective areas, including the validation manager and the director of Quality Assurance, will duly sign off the protocol before execution.

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