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Indian pharma sees immense relevance to US FDA Continuous Manufacturing norms as companies shift from batch production, which is multi-step and a lengthy process, to a quicker, and resourceful process which is continuous manufacturing. The recent norms of the global regulatory authority titled as Q13 Continuous Manufacturing of Drug Substances and Drug Products applies to new drugs, generic drugs, biosimilars and the conversion of batch manufacturing to continuous manufacturing for existing products.
The pharma industry observers pointed out that there is a visible shift towards moving away from batch manufacturing to a quicker, and resourceful process which is continuous manufacturing. To this end, the global regulator during the Covid pandemic phase took pre-emptive moves to enable the pharma industry’s implementation of emerging technologies, including continuous manufacturing, to improve product quality and address many of the underlying causes of drug shortages and recalls.
The principles described in this guidance may also apply to other biological/biotechnological entities. Continuous manufacturing involves the continuous feeding of input materials into, the transformation of in-process materials within, and the concomitant removal of output materials from a manufacturing process. While this description may apply to an individual unit operation like process chromatography, tableting, perfusion cell culture, this guidance focuses on the integrated aspects of a continuous manufacturing system in which two or more unit operations are directly connected, said US FDA.
Changes made in a unit operation of a continuous manufacturing system will have impact on downstream and upstream unit operations. These include back pressure resulting in forward mixing and output material quality. Fundamental aspects of continuous manufacturing that are generally not specific to technology, dosage form, or molecule type are described within the main body of this guidance. Annexes are provided to augment the main body of the guidance by providing illustrative examples and considerations specific to certain modalities which are chemical entities, therapeutic proteins, technologies, and production methods. These cover integration of drug substance and drug product manufacturing.
The regulatory authority stated that continuous manufacturing can be applied to some or all unit operations in a manufacturing process. Examples of CM modes include: A manufacturing approach in which some unit operations operate in a batch mode while others are integrated and operate in a continuous mode. It could also be an approach in which all unit operations of a drug product manufacturing process is integrated and operate in a continuous mode. In addition, it can also be a manufacturing approach in which drug substance and drug product unit operations are integrated across the boundary between drug substance and drug product to form a single continuous manufacturing process. These cover the drug substance which is continuously formed and processed into the product through integrated unit operations.
The pharma industry in the country contended that there are many companies in India which have found optimal efficiency with continuous manufacture. This is because the production is nonstop reducing hold times between steps. It saves time, decreases human error, and running the machine for a longer period of time reduces drug shortages as speed of production allows meeting deadlines. With the production linked incentive (PLI) scheme for pharma, companies have made a transition to continuous manufacture as it enables easier trace and track during a product failure.
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