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20 July 2017 Tablets & Capsules which should give you a product that can be manufac- tured over and over again to its defined quality standard. Quality by Design (QbD) for product development and manufacture is a concept that states that quality can be planned and that most quality problems relate to the way in which quality was planned. QbD principles have been used to advance product and process quality in many industries. In fact, almost all commercial products outside pharma use manufacturing techniques that ensure product quality by building it into the process used to manufacture the product. Very few products are release- tested to ensure that they meet their design specifications prior to commercial distribution. If done properly, this same concept should work with pharmaceutical products. Thus, in last decade or so the FDA has promulgated QbD as part of its 21st Century Initiative as a vehicle for trans- forming how drug products are developed and manufac- tured. The FDA's 2004 "Guidance for Industry: PAT–A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance" introduced the concept of building quality into the preparation of drug products through the use of Process Analytical Technology (PAT). The goal was to replace end-product testing as a means of ensuring that a product met its speci- fications. The International Committee on Harmonization (ICH)—with the help of pharma and global health authorities—has also issued guidance documents, Q8 through Q11, that describe how QbD concepts apply to the lifecycle of a drug product. See Table 1. In short, quality can be designed into tablet and capsule products if you follow well-defined development practices. It starts with gaining product and process understanding, followed by identifying, evaluating, and minimizing risk. To achieve the required safety, efficacy, manufacturability, and stability using QbD, follow these steps: • Define the QTPP, which describes the design profile of the product and forms the basis for the development of the quality attributes that ensure clinical safety and efficacy. The QTPP also forms the basis for the control strategy. • Review prior knowledge, including the scientific lit- erature and any experience with similar dosage forms and/or with APIs that have similar properties. • Evaluate the physicochemical properties of the API and how potential excipients could affect the dosage form. • Conduct an assessment to identify, understand, and minimize the potential risks associated with the prepara- tion that may affect manufacturability, safety, or efficacy. • As needed, conduct studies to facilitate and under- stand the product's design and the manufacturing process. • Develop a control strategy to ensure that the prod- uct will have the required quality attributes and be con- sistently produced. This control strategy will be derived from product and process understanding and should ensure that the process performs as designed and gives the specified product quality. Table 1 ICH quality guidances ICH Q8 (R2)–Pharmaceutical Development Current Step 4 ver- sion, August 2009 ICH Q9–Quality Risk Management Current Step 4 version, November 2005 ICH Q10–Pharmaceutical Quality System Current Step 4 ver- sion, June 2008 ICH Q11–Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Current Step 4 version, May 2012 Pharmaceutical Quality Training Program for Q8/Q9/Q10 Quality Implementation Working Group on Q8, Q9 and Q10: Questions & Answers (R4) Current version, November 2010 ICH Quality Implementation Working Group Points to Consider (R2), ICH- Endorsed Guide for ICH Q8/Q9/Q10 Implementation Current version, December 2011