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48 October 2017 Tablets & Capsules As you'd expect, a validation expert's work includes preparing and executing a range of protocols, such as installation qualification (IQ), operational qualification (OQ), per- formance qualification (PQ), analyti- cal method validation (AMV), clean- ing validation (CV), process validation (PV), computer system validation (CSV), etc. But these protocols are just the means to an end: preventing situations that may lead to your drug products being deemed adulterated. No one wants to read "drug deemed adulter- ated" in an FDA 483 letter. How can that happen? It's spelled out in Section 501 (a)(2)(B) of the Federal Food, Drug and Cosmetics Act: [A] drug is deemed to be adul- terated if the methods used in, or the facilities or controls used for its manufacture, processing, pack- ing, or holding do not conform to or are not operated or adminis- tered in conformity with the Current Good Manufacturing Practices (CGMPs). This definition establishes links to most of the systems that require vali- dation: equipment, utilities, facilities, materials, analytical methods, manu- facturing processes, cleaning processes, computer systems, etc. And testing these systems, sites, and methods requires you—or your vali- dation expert—to generate docu- mentary evidence that they consis- tently and reliably perform as intended and that cGMPs are fol- lowed throughout the product's life- cycle. The ultimate goal of all valida- tion activities is to ensure drug products have the strength, identity, safety, purity, and quality (SISPQ) that the law requires. Although validation is a regulatory requirement, the FDA only outlines how to perform it. There is no clear description of the specifics or the extent of the validation activities the FDA expects companies to perform. That raises the risk of doing too much or too little, especially if you're new to validation. Someone with validation expertise, however, can tell you what to validate, to what extent, and how much documentation to generate. To start, a validation expert relies on a risk- and science-based rationale to formulate the validation strategy and to tailor the plan to your com- pany's specific needs. Avoid using a one-size-fits-all approach as a short- cut. That can lead to major compli- ance issues and technical failures. It's better to spend the time and money to develop a scientifically sound vali- dation approach. That investment will pay big dividends in terms of meeting regulators' expectations and operating a better business, because it optimizes use of your equipment, materials, utilities, facilities, processes, etc. When performed on a scientific basis, validation can offer a tremendous reduction in process fail- ures, product rework, rejects, recalls, and lawsuits. That means a more profitable operation. A true validation expert uses a val- idation master plan (VMP) to develop and document a validation strategy that ensures GMP compli- ance throughout a product's lifecycle. A well-developed, clear, and concise VMP goes a long way toward clarify- ing and defending your validation approach when customers or regula- tors perform quality audits. But we shouldn't become compla- cent thereafter. Even when operations start with adequate validation, unin- tended and unexpected changes may creep into the systems. This can hap- pen despite having the mandatory change-management system in place, and it can degrade the state of control over time. A validation expert can help you return operations to a state of con- trol by performing a validation-gap analysis—delineating "as-it-is" versus "as-required"—and by developing and implementing remedial actions. At every step, the recommenda- tions must be practicable, economi- cal, and sustainable. The life sciences industry needs a validation expert not only to achieve compliance with FDA regulations, but also to gain a technical and business lead over competitors. With the FDA's ever- increasing emphasis on Quality by Design (QbD) and on using a risk- and science-based approach, the role of validation experts has gained sig- nificance. By helping you meet the expectations of today's regulators, a validation expert can help your com- pany design and build quality, safety, and efficacy into products. It's short- sighted to rely only on testing the finished product. Again, invest wisely to realize the best returns. Don't rely on cookie- cutter validation protocols. They might patch you up, but they won't help you accomplish your long-term goals in regulatory compliance or business competitiveness. T&C P a r v e e n Bh a n d o l a , PhD, is president and principal consultant at Validation Edge, 9022 M a r t i n d a l e St r e e t , Lenexa, KS 66220. Tel. 732 322 4743. Website: www.validationedge.com. b a c k p a g e What does a validation expert do and why do I need one?