Standard

ISPE ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing of Oral Solid Dosage Forms

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Abstract

Continuous Manufacturing (CM) has become a well-established approach that offers multiple benefits in the production of pharmaceutical oral solid dosage forms as compared to traditional batch manufacturing. CM continues to offer opportunities for faster development and time to market, enhanced process robustness, improved quality assurance, and greater operational efficiency.To achieve successful implementation of these technologies and result in successful commercial manufacturing of drug products requires a deliberate focus on control strategy throughout the product lifecycle. While several approved drug products are already manufactured using this technology, this Guide will contextualize and provide a practical approach for both scientific and regulatory consideration and basis for establishing a fit for purpose CM control strategy. Beyond technical guidance, the document explores lifecycle management and novel considerations that arise in CM environments. Through practical examples and clear recommendations, the Guide aims to reduce barriers to CM adoption, streamline development efforts, and support successful commercialization across the industry.

Document information

  • Standard from ISPE
  • Published:
  • Version: 0
  • Document type: IS