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Nirav Rajendrakumar Soni Cleaning validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes. All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product and the quality of future products using the equipment, to prevent cross-contamination and as a GMP requirement. The U.S. Food and Drug Administration (FDA) has strict regulation about the cleaning validation. For example, FDA requires firms to have written general procedures on how cleaning processes will be validated. Also, FDA expects the general validation procedures to address who is responsible for performing and approving the validation study, the acceptance criteria, and when revalidation will be required. FDA also require firms to conduct the validation studies in accordance with the protocols and to document the results of studies.The valuation of cleaning validation is also regulated strictly, which usually mainly covers the aspects of equipment design,cleaning process written, analytical methods and sampling. Each of these processes has their related strict rules and requirements. Regarding to the establishment of limits, FDA does not intend to set acceptance specifications or methods for determining whether a cleaning process is validated. But some limits that have been mentioned by industry include analytical detection levels such as 10 PPM, biological activity levels such as 1/1000 of the normal therapeutic dose and organoleptic levels.〔FDA guidance Validation of Cleaning Processes〕 Cleaning Validation in the context of Active Pharmaceutical Ingredient manufacture may be defined as: "The process of providing documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels". It is necessary to Validate Cleaning procedures for the following reasons: 1. It is a customer requirement - it ensures the safety and purity of the product. 2. It is a regulatory requirement in Active Pharmaceutical Ingredient product manufacture. 3. It also assures from an internal control and compliance point of view the quality of the process. PRINCIPLES The objective of the cleaning validation is to verify the effectiveness of the cleaning procedure for removal of product residues, degradation products, preservatives, excipients, and/or cleaning agents as well as the control of potential microbial contaminants. In addition one needs to ensure there is no risk associated with cross-contamination of active ingredients. � Cleaning procedures must strictly follow carefully established and validated methods. � Appropriate cleaning procedures must be developed for all productcontact equipment used in the production process. Consideration should also be given to non-contact parts into which product may migrate (e.g., seals, flanges, mixing shaft, fans of ovens, heating elements, etc.). � Relevant process equipment cleaning validation methods are required for biological drugs because of their inherent characteristics (proteins are sticky by nature), parenteral product purity requirements, the complexity of equipment, and the broad spectrum of materials which need to be cleaned. � Cleaning procedures for products and processes which are very similar do not need to be individually validated. This could be dependent on what is common, equipment and surface area, or an environment involving all product-contact equipment. � It is considered acceptable to select a representative range of similar products and processes. The physical similarities of the products, the formulation, the manner and quantity of use by the consumer, the nature of other product previously manufactured, the size of batch in comparison to previously manufactured product are critical issues that justify a validation program. � A single validation study under consideration of the worst case can then be carried out which takes account of the relevant criteria. � For biological drugs, including vaccines, bracketing may be considered acceptable for similar products and/or equipment provided appropriate justification, based on sound and scientific rationale, is given. Some examples are cleaning of fermenters of the same design but with different vessel capacity used for the same type of recombinant proteins expressed in the same rodent cell line and cultivated in closely related growth media; a multi-antigen vaccine used to represent the individual antigen or other combinations of them when validating the same or similar equipment that is used at stages of formulation (adsorption) and/or holding. Validation of cleaning of fermenters should be done upon individual pathogen basis. edited by https://www.google.co.in/?gfe_rd=cr&ei=NPb2VaKyDqjG8Ae1nYGwAw&gws_rd=ssl#q=nirav+rajendrakumar+soni ==References== 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「cleaning validation」の詳細全文を読む スポンサード リンク
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