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“EVALUATION AND COMPARISON OF CLEANING METHOD VALIDATION TECHNIQUES” MASTER OF PHARMACY DISSERTATION PROTOCOL SUBMITTED TO THE RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA, BANGALORE BY PATEL SWETA NAVINBHAI Under The Guidance of MR. KRISHNANANDA KAMATH K. M.PHARM. DEPARTMENT OF QUALITY ASSURANCE, SRINIVAS COLLEGE OF PHARMACY, MANGALORE – 574143 2010 – 2012 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA ANNEXURE - II REGISTRATION OF SUBJECT FOR DISSERTATION 1.0 NAME OF THE CANDIDATE ADDRESS PATEL SWETA NAVINBHAI. DEPARTMENT OF Q.A., SRINIVAS COLLEGE OF PHARMACY, VALACHIL,POST PARENGIPITTE, MANGALORE -574143 2.0 NAME OF THE INSTITUTION 3.0 COURSE OF STUDY & SUBJECT 4.0 DATE OF ADMISSION 5.0 TITLE OF THE TOPIC: SRINIVAS COLLEGE OF PHARMACY, VALACHIL, MANGALORE. MASTER OF PHARMACY (QUALITY ASSURANCE) 31/05/2010 “EVALUATION AND COMPARISON OF CLEANING METHOD VALIDATION TECHNIQUES” 6.0 BRIEF RESUME OF THE INTENDED WORK: 6.1 NEED FOR STUDY: Good manufacturing practices require the pharmaceutical industries to strive for the highest manufacturing standards. All phases of manufacturing process must be controlled for predictability and for final production of a product that consistently meets predetermined quality standards and specifications. Cleaning processes for manufacturing equipment are closely inspected because inadequate cleaning procedures, method of sampling analysis can result in adulterated or contaminated products. An important factor in that control is validating cleanliness of equipment. Cleaning validation is primarily applicable to cleaning process of manufacturing equipment in the pharmaceutical industry. The scope of cleaning validation is that cleaned surfaces, if inadequately cleaned, could potentially contaminate the product subsequently manufactured in that same equipment.1 This should be performed to provide documented evidence that the procedure being followed for cleaning of equipment and accessories is effective and removes residues of previous product up to an acceptance level, using a well-defined protocol. To check the efficiency of cleaning two methods are widely employed for sampling during cleaning validation. They are rinse method and swab method. The study involves comparing the cleaning method validation by Rinse and Swab Sampling techniques. The API used is practically insoluble and more potent. 6.3 OBJECTIVE OF THE STUDY: To compare the swab and rinse sampling techniques of cleaning method validation. The study also involves finding out criteria for visual cleanliness limit for selected drug by impregnating known amount of drug on SS. Plates. Drug is selected based upon the solubility of drug in water, because water is major solvent used for cleaning of equipment. 6.3 REVIEW OF LITERATURE: A Review of literature on cleaning method validation was carried out in bellow manner. The collection of references are reproduced below: Current Practices: Various approaches are used for cleaning validation, including a widely used technique called swab testing. Clean wet, swabs are applied to areas that have been cleaned and an extract of that swab is analyzed to show the effectiveness of that cleaning. Swab testing, however, is expensive and time consuming, but sampling does not represent the entire part of equipment, subject to errors caused by factors such as incomplete removal of contaminants. Cross-contamination can result from handling and treatment of samples between swab collection and subsequent analytical work. Unfortunately, no infallible algorithm has been identified for either cleanliness validation or contaminant detection in final products, and validation practices normally depend on previous experience. The most effective way to prevent the presence of a contaminant in a finished product is to develop increasingly reliable and foolproof cleaning validation methods. Julie Thomas A.2 developed A Cleaning Validation Master Plan for Oral Solid Dose Pharmaceutical Manufacturing Equipment. Validation are state-of-the-art is to assemble a multi-discipline team from the Appropriate manufacturing sites that can review and revise all components associated with cleaning validation. What follows are excerpts from a cleaning Validation master plan that was painstakingly composed and has now become the standard for planning and executing cleaning validations at several manufacturing site. Robert kirsch B.3 developed Validation of Analytical Methods Used in Pharmaceutical Cleaning Assessment and Validation.Validation of cleaning process following production of pharmaceutical products has received much industry and regulatory attention, because companies are increasingly using multipurpose process equipment and automated clean-in-place procedures, it has become even more important to establish evidence that product is not contaminated. This method discusses requirements for validating a Chromatographic procedure for assessing cleaning efficiency and for cleaning validation purpose. Recovery experiments are particularly important because firms must demonstrate removal of analytes at low level from potentially active stainless steel and glass surfaces as well as from polyester swabs to ensure the accurate evaluation of the cleaning process. Pei Yang, Kim Burson, Debra Feder, and Fraser Macdonald4 developed Method Development of Swab Sampling for Cleaning Validation of a Residual Active Pharmaceutical Ingredient. Cross contamination with active ingredients is a real concern. A swab-sampling method was developed for cleaning validation of a residual active pharmaceutical ingredient in samples collected after cleaning of the equipment. A summary of the strategies and results of the method development is presented. The developed extraction method produced an acceptable level of recovery and precision. ICH Q2 guideline analytical method validation5, The discussion of the validation of analytical procedures is directed to the four most common types of analytical procedures: Identification tests, Quantitative tests for impurities' content, Limit tests for the control of impurities, Quantitative tests of the active moiety in samples of drug substance or drug product or Other selected component(s) in the drug product. Typical validation characteristics which should be considered are Accuracy, Precision, Repeatability, Intermediate Precision, Specificity, Detection Limit, Quantitation Limit, Linearity, and Range for rinse and swab sampling techniques. Ruey Ching Hwang6 developed how to establish an effective Maintenance Program for Cleaning Validation Completing a cleaning validation study is a major task. When a minimum of three cleaning validation runs are completed and the results meet the acceptance criteria, the cleaning procedures are demonstrated to sufficiently and consistently remove. 7.0 MATERIALS AND METHODS: 7.1 Source of Data: Data will be obtained from the publication of USFDA Guidelines, Health Canada as well as from Srinivas college of pharmacy library, Helinet, Science Direct and other internet facility. Consultation with Industrial experts. www.sciencedirect.com www.pharmaifo.com www.pubmed.com www.jpronline.info www.google.com ANALYTICAL METHODS: The analytical methods should be validated before the Cleaning Validation Study is carried out. The analytical methods used to detect residual or contaminant could be specific for the substance to be assayed and provide a sensitivity that reflects the level of cleanliness. 7.2 Method The suitability of the material to be used for sampling and of the sampling medium should be determined. The ability method to recover residue samples accurately. It is important to ensure that the sampling medium and solvent are satisfactory and can be readily used. A. Swab sampling After cleaning the equipment, product contact surface could be swabbed to evaluate surface cleanliness. Swabs used should be compatible with the active ingredients and should not interfere with the assay. They should not cause any degradation of the compound and should not encourage degradation. This shall be evaluated during method validation stage. B. Rinse Samples Rinse samples allow sampling of a large surface area. In addition, inaccessible areas of equipment that cannot be routinely disassembled can be evaluated. A direct measurement of the product residue or contaminant in the relevant solvent should be made when rinse samples are used to validate the cleaning process. In method validation suitability of rinse method for cleaning of active residue shall be evaluated. C. Visual cleaning method It is important to use visual inspection in addition to analytical methodology to ensure the cleaning process is acceptable. The study involves finding out criteria for visual cleanliness limit for selected drug by applying known amount of drug on SS plate before taking swab samples for chemical analysis. 7.3 Does the study require any investigation to be conducted on patients or animals? No 7.4 Has the ethical clearance been obtained from your institution in case of 7.3? Not applicable REFERENCES: 1. Destin LB, The applicability of cleaning validation. Cleaning Validation Technologies cleaning memo October. 2000 http://www.cleaningvalidation.com 2. Thomas AJ. A Cleaning Validation Master Plan for Oral Solid Dose Pharmaceutical Manufacturing Equipment. Journal of Validation Technology 2000; 6(2):522-530. 3. Robert KB. Validation of Analytical Methods Used in Pharmaceutical Cleaning Assessment and Validation. Pharm Technol 1998; 40-46. 4. Yang P, Burson K, Feder D, Macdonald F. Method Development of Swab Sampling for Cleaning Validation of a Residual Active Pharmaceutical Ingredient. Pharm Technol 2005;84-94. 5. International Conference on Harmonisation (ICH). Harmonised tripartite guideline: validation of analytical procedures: text and methodology Q2(R1). Geneva, Switzerland: ICH; 2005. Available at http://www.ich.org/LOB/media/MEDIA417.pdf. 6. Hwang RC. How to establish an Effective Maintenance Program for Cleaning Validation. Pharm Technol 2000; 62-72. 7. Prabhu LS, Suriyaprakash TNK. Cleaning Validation and its importance in pharmaceutical Industry. Pharma Times 2010; 40(7):21-25. 8.0 SIGNATURE OF THE CANDIDATE Patel Sweta Navinbhai. 9.0 10.0 REMARKS OF THE GUIDE NAME AND DESIGNATION OF GUIDE Forwarded for approval Mr. Krishnanand Kamath K. Assistant Professor 11.0 SIGNATURE Dr. E.V.S. Subrahmanyam, 12.0 HEAD OF THE DEPARTMENT Professor and Head, Dept. of Quality Assurance 13.0 SIGNATURE 14.0 REMARKS OF THE PRINCIPAL 15.0 SIGNATURE Dr. Ramakrishna Sharbaraya A. Principal, Srinivas College of Pharmacy, Valachil, Mangalore.