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Sunday, May 22, 2011

Cleaning validation evaluation and general requirements


Evaluation of cleaning validation and its general requirements
Cleaning validation is very important and integral part in pharmaceutical validation, about cleaning validation all regulatory agencies around the world require that a pharmaceutical company should have a written standard operating procedure SOP for various cleaning validation of equipments and its pieces and premises. When ever there is a one cleaning for batch change over of same drug product and a different cleaning process for process for cleaning between different batches of the same product and use a different process for cleaning for different product FDA require a written procedure and SOP for to take care of these different product change over and same product batch change over cleaning process and its validation.
If there are two different cleaning procedures one adapted for removing water soluble residues and one for non water soluble residues it is required that pharmaceutical firm should have written procedure in place for both process and provide clear direction about the events of applications of these cleaning procedures or when to use these different cleaning procedures.
In case of bulk pharmaceuticals where certain equipments should be dedicated where ever there is difficulty due to product characteristics which make residue difficult to be removed from equipment parts. Similarly Fluid Bed Driers (FBD) bags are often dedicated to a particular product to avoid cross contamination, the cleaning procedure should ensure that the detergents and cleaning aid solvents and detergents are removed completely from the equipments.

FDA require a pharma company should have a written general procedures for validating cleaning procedures and process that is how to validate cleaning processes.
FDA require that the responsibility for performing and approving the cleaning validations and its acceptance standards or criteria and to decide re validation schedules should be delegated properly and effectively.
There should be a written validation protocol in advance for any cleaning validation to be performed on any type of equipment or its pieces or equipment systems. And the issues like sampling procedures and analytical methods and their sensitivity should be addressed properly in advance.
FDA requires that the cleaning validation studies should be carried out according to cleaning validation protocol and the results of the study should be documented to documented properly.
FDA require that the final validation report should be approved by the management and it should state clearly that whether the cleaning validation process is acceptable and valid or not in accordance with the sportive data suggesting that the residues of are cleaned or removed to the acceptable level.

EVALUATION OF CLEANING VALIDATION
Evaluation of cleaning validation is also a very important step, a pharmaceutical firm should focus on the objective of the validation process. There is no point in adapting extensive sampling and testing methodology unless the objective of cleaning validation process is set clearly and the steps in cleaning process are effective, therefore effectiveness of cleaning steps is important aspect as they will be required to be effectively achieve the objective of the cleaning process and its validation.
During evaluation of cleaning procedure for a equipment the methods applied for cleaning like scrubbing by hand or washing with solvent are also important variables which should considered properly in protocol, as the overall effectiveness of cleaning procedure depends very much on these variables. The number of cleaning processes required for the equipment or equipment pieces should be properly determined.

Following are some important factors in evaluation of cleaning procedures and cleaning validation
1. Equipment Design
2. Written Cleaning Process Procedure and Documentation.
3.Analytical Methods
4.Sampling :- a) Direct Surface Sampling b). Rinse Samples c). Routine Production In Process Control
Next series of articles on cleaning validation are focused on above points.
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Cleaning validation articles series:
Cleaning Validation Protocol

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Cleaning validation and equipment design.

Cleaning validation requirements

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Pharmaceutical Process Validation Series

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Pharma process validation and concurrent release of PPQ batches

Process validation aspects of Analytical Methodology.

Process Validation Stage 3 The Continued Process Verification.

Process Validation : Process Qualification and Process Performance Qualification (PPQ)

Process Design and Process Validation Recommendations

Process validation and its regulatory, statutory requirements.


Process Validation and Drug Quality Approach to Process Validation.


General Considerations for Process Validation and Recommendations


Terms used in pharma validations and their definitions

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