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Research Journal of Pharmaceutical Dosage Forms and Technology
ISSN: 0975-4377(Online), 0975-234X(Print)
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Cleaning Validation of Paracetamol Tablets as a Dosage Formulation
Hapse S.A.*, Bhagat B.V., Wagh V.S. and Kadaskar P.T.
Department of Quality Assurance Technique, Padmashree Dr. Vithalrao Vikhe Patil College of Pharmacy, Ahmednagar. Maharashtra. 414111.
Cross1 contamination is one of the major problems focused in manufacturing of drugs utilizing common facility which leads to inferior quality of final product and cause considerable loss to the company. Contamination of one batch product with significant levels of residual active ingredients from a previous batch and contamination by microorganisms are the real concern. Cleaning and decontamination is one of the major and critical activity in pharmaceutical operations. The concept of purity and safety are directly related to the cleaning operations. Cleaning programmers are necessary simply to prevent our manufactured products from being contaminated. These are cross-contamination of one product into another , product contamination by a foreign material and microbial contamination The cleaning validation is a documented process that proves the effectiveness and consistency cleaning of pharmaceutical equipments to meet the regulatory requirements. Manufacturing of paracetamol and other tablets utilizing common facility, where paracetamol could be a possible cross contaminant. Hence the present study was carried out to validate the cleaning activity from both regulatory and quality prospective. Visual inspection, Swab sampling for chemical residue and for microbiological analysis were carried out to validate cleaning activity and results from all methods were complying with acceptance criteria.
Paracetamol, sodium lauryl sulphate; Cross contamination; Cleaning validation
Hapse S.A., Bhagat B.V., Wagh V.S. , Kadaskar P.T.. Cleaning Validation of Paracetamol Tablets as a Dosage Formulation. Research J. Pharma. Dosage Forms and Tech. 2011; 3(5): 215-219 .
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