Preventive maintenance is the base of the entire maintenance strategy for every pharmaceutical industry. One of the frequent problems that PM programs may confront is to maintain equally every equipment or parts involved in the pharmaceutical manufacturing. A safer path is to apply a risk-based approach that separates each equipment or parts of equipment in terms of their direct contact with product and possible defects on possibly affecting product quality . It is useful to apply a risk-based approach to prioritize and organize the documentation needed. PM activities are more vulnerable to risks in the period of time of parts changes, including scheduled shutdowns or special projects. Complete process documentation and operating procedures, including organizational policies should exist for all maintenance activities .
As part of the process of developing an effective preventive maintenance program, it is also needed to change the whole organization mind-set, about maintenance. There are several steps involved in the implementation of preventive main...
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...hing versus very expensive unscheduled repairs that may be required under troublesome conditions causing production to stop and loss of revenue. Good PM saves money over a product’s life cycle.
 Worsham W. C. (2005). Is preventive maintenance necessary? Reliability Center, Inc. Retrieved from http://www.reliability.com
 White paper 10 common GMP challenges facing maintenance departments in pharmaceutical plants, (2013). Retrieved from http://www.pharmout.net
 Clarke, G., Mulryan, G., & Liggan, P. (2010).Lean maintenance- a risk based approach. Pharmaceutical Engineering, the official magazine of ISPE,30(5),1-5 Retrieved April1, 2014, from http://www.ispe.org
 Gross, J.M. (2002) Fundamentals of preventive maintenance. Amacon: New York
 Maintenance, 21 C.F.R. 211.58 (2013).
 Equipment cleaning and maintenance, 21 C.F.R. 211.67 (2013).
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