Operational Excellence: A Model Pathway to Improve Yield and Productivity of the Pharmaceutical Tablet Manufacturing Process

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Background: Operational Excellence (OE) is a management principle widely adopted in the pharmaceutical industry to optimize manufacturing processes and to improve yield and productivity up to 20%. OE was based upon a few principles, tools, and techniques such as Lean, Six Sigma, JIT, FIFO, FEFO, statistical analysis, etc. Lean and Six Sigma (LSS) will reduce production defects by 30–50%, shorten batch release time by 25–40% in the pharmaceutical manufacturing company. Objective: This review aims to correlate the key process parameters of manufacturing with the application of OE tools to improve Overall Equipment Effectiveness (OEE) by 15–35% and reduce process variability (σ) by 40–60%. Also, provide a framework to the industry to implement OE with statistical tools. Method: In this review, DMAIC methodology is used to demonstrate the process flow of change and improvement. OE is a continuous process that ensures quality compliance, improved yields, and robust processes. OE highly impacts the 4 M’s, i.e., Material, Method, Money, and Manpower. An example of a bilayer tablet has been considered for study purposes. However, this technique is widely applicable to all types of dosage forms. Findings: OE is gaining larger importance in the pharmaceutical industry as manufacturers focus on issues like cost-cutting (by15%), quality improvement, and customer satisfaction (20-30%). This study indicates that understanding the manufacturing process from the perspective of OE is vital before initiating any change in the process, which will directly affect yield and the overall industrial environment. Novelty: This review focuses on the application and implementation of various OE tools at the industrial and/or commercial level without compromising with the cGMP criterion, which are defined by the regulatory authorities. This will allow the manufacturer to focus on quality improvement in crucial products in terms of quality, large commercial volume, and market value. Keywords: Operational Excellence (OE), Lean Six Sigma (LSS), Bilayer Tablet (BT), Lean Manufacturing (LM), Pharmaceutical Manufacturing

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