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

Published: October 2025
Pages: 72

• Table of Contents
• Special Pricing for Emerging Economies

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.

Guide Core Team

Alexandre Bonnassieux

Senior Manager, Technical Operations

Vertex Pharmaceuticals Incorporated

Anthony Tantuccio

Fellow Scientist of Continuous Tableting

Hovione L.L.C.

Kim Boué

Senior Principal Scientist CMC Regulatory Affairs

Johnson & Johnson Innovative Medicine

Gabriella Dahlgren, PhD

Director, Strategy Deployment and Excellence, PQM

Johnson & Johnson Innovative Medicine

Melanie Dumarey

Director Product and Process Control

AstraZeneca

Katherine Giacoletti

Principal Scientist

Merck & Co Inc

Robert Meyer, PhD

Principal Scientist

Pharmaceutical Commercialization Technology, Merck & Co., Inc.

Elisabeth Peeters, PhD

Principal Scientist

Pfizer

For the full list of contributors to this Guide see Guidance Document Teams