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3 Critical Keys to Expediting CMC Development

3 Critical Keys to Expediting CMC Development

Written By
23 Jun 2023

Certain key strategies are imperative for establishing effective quality control (QC) systems in the development of new pharmaceuticals. The “Key 3” are implementing a QC process control strategy, creating a Standard Operating Procedure (SOP) manual, and partnering with experts.

Implementing a QC process control strategy ensures that quality is prioritized throughout all manufacturing processes. Simultaneously, the creation and use of an SOP manual around the complexities of the QC system ensure uniformity and compliance. Additionally, highly trained and experienced QC consultants provide valuable expertise and flexibility.

Key 1 – Develop and Implement a QC Process Control Strategy First

A QC process control strategy is vital. It establishes a system of policies based on the organization’s activities, including testing, calibration, validation, and verification. Process control strategies can be categorized as “retrospective feedback control,” monitoring quality within manufacturing processes and providing correctives, or “perspective feedforward control,” utilizing high-performing initiatives to prevent disruptions.

Key 2 – Create and Use a SOP Manual

Early creation and consistent use of SOPs are crucial. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Good Clinical Practice (GCP) guidelines detail global ethical and scientific quality standards for human trials. SOPs are written instructions for achieving uniformity in specific functions and ensuring compliance among all individuals responsible for these tasks. Obviously, SOPs must be clear, user-friendly, and unambiguous. They should also be revised as needed while remaining compliant with company standards and relevant legal, ethical, and regulatory requirements. SOPs are mandatory for implementing GCP and various Good x Practices (GxPs), notably Current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).

Key 3 – Partner with Experts

Consultants can be a valuable resource for smaller companies without a full-time QC specialist. Even larger companies can benefit from such partnerships when exploring new areas, or to complement existing internal capabilities. Consultants offer flexibility based on specific work requirements and financial considerations, so they are especially useful on an as-needed basis. Companies may also require one-off specialized skills and, when actions are taken against a company, regulatory bodies sometimes request or mandate that consultants review the organization’s quality systems and remediation plans. Consultants also provide a wide range of expertise throughout the various stages of development and testing, each with its own QC guidelines, plans, and requirements. Also, since engagements are contract-based, timelines are firmly established, keeping projects on track and within budget.

Solid QC process control strategies, SOP manuals and partnerships are vital components of a robust quality control system. Companies can ensure high-quality products by strategically monitoring and correcting manufacturing processes. The SOP manual is a comprehensive guide that elevates uniformity and compliance with all pertinent standards. Consultants bring specialized expertise, flexibility and fresh insights to smaller companies with intermittent needs and larger companies venturing into new areas. By following these keys, pharmaceutical organizations can optimize their operations, comply with regulations, and establish and – most importantly to all stakeholders – maintain a strong commitment to quality control.

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