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all the elements of validation are inter-dependent and each can affect the effectiveness of the validation program. Can you imagine performing effective PV using poorly designed, inadequately qualified process equipment? Impossible. A validation program should not only focus on the initial validation, but should include a mechanism to ensure that the validation state is maintained throughout commercial production. That's where change control comes in. Unfortunately, most change-control systems assess changes one by one before and after implementation to see how they affect the state of validation. A better approach is to perform periodic evaluations collectively so that all the changes implemented over a certain period are evaluated to gauge the effect of their interaction. Last, never forget the human factor when developing validation programs. Some of the best processes, even when performed on the best equipment, can fail purely due to the human factor. Call it human error if you like, but the experience of operators and/or the level of care they show in performing their job are often a significant factor in the variation of process performance. Whether operators work a day or night shift can also influence the process, as can the length of their shift. Changes in their physical health and emotional state can also contribute to variation. Conclusion Validation is a legally enforceable regulatory require- ment, so there's no option: You must implement compliant validation programs. But keep in mind that compliance is just the minimum requirement. If you want a competitive edge, the programs must also be effective and efficient. Effective means that the validation program meets most of the process goals. How much you invest initially and how much you spend operating the program, as well as the process cycle times, figure prominently in how efficient the validation program is. To be deemed a success, the valida- tion program must be all three: compliant, effective, and efficient. But the real benefit of validation comes from developing innovative and efficient manufacturing processes through continuous improvement, as noted in the FDA's 2011 PV Guidance. The lifecycle approach and general principles outlined in that Guidance are applicable not only to the validation of manufacturing processes, but also to other components of validation, including computer systems and cleaning methods. Apply the four fundamental principles discussed in this article—which essentially recapitulate the FDA's current thinking from the Guidance—and you will have compliant, effective, and efficient validation programs. T&C References 1. FDA. Process Validation: General Principles and Practices. Guidance for Industry, January 2011. 2. FDA-ICH. Q8 (R2) Pharmaceutical Development. FDA/ICH Guidance for Industry, November 2009. 3. FDA-ICH. Q9 Quality Risk Management. Guidance for Industry, June 2006. 4. FDA-ICH. Q10 Pharmaceutical Quality System. Guidance for Industry, May 2007. Parveen Bhandola, Ph.D., is president of Validation Edge, 9022 Martindale Street, Lenexa, KS 66220. Tel. 732 322 4743. E-mail: pbhandola@validationedge.com. He earned his Ph.D. in chemical engineering from ETH, Zurich, Switzerland, and has more than 30 years' experience in academia and the pharmaceutical industry. Val- idation Edge provides consulting and support services in all aspects of pharmaceutical validation and regulatory compliance. Its spe- cialty is offering cost-effective solutions through systematic gap analyses to ensure validation programs and quality systems are compliant, effective, and efficient. His article "Implementing cleaning validation requires process understanding" appeared in T&C's Octo- ber 2012 issue. 14 October 2015 Tablets & Capsules 9_MVYWOHYTHOHUKSPUN The material matters in material handling 4-.=0(3;9(@ Won't bend, dent or deflect under heavy loads Smooth surface is easily cleaned Easy integration with process equipment More economical than metal; more durable than plastic Reinforced composites bring a whole new level of performance to the pharmaceutical industry. And the leading name in FRP is MFG. Call toll-free (800) 458-6050 or visit www.mfgtray.com. 4-..,3*(7;9(@ mat atte te te te te te ters rs rs rs rs rs in ma ma ma ma m te te teri rial a han