What is Proven Acceptable Range (PAR)?

A Proven Acceptable Range (PAR) refers to a defined range of a process parameter within which, when other parameters are held constant, the manufacturing process consistently produces a product that meets predefined quality criteria. Establishing a PAR is a fundamental aspect of the Quality by Design (QbD) approach in pharmaceutical development, as outlined in the International Council for Harmonisation's ICH Q8(R2) guidelines.

What is its significance of Proven Acceptable Range (PAR) in pharmaceutical development?

• Ensuring Product Quality: By defining a PAR, manufacturers can operate within a scientifically justified range, ensuring that the final product consistently meets quality standards.
• Regulatory Compliance: Demonstrating a well-established PAR aligns with regulatory expectations, facilitating smoother approval processes and ensuring adherence to Good Manufacturing Practices (GMP).
• Process Flexibility: A PAR allows for controlled variability in process parameters, providing flexibility in manufacturing operations without compromising product quality.

What are the key features of Proven Acceptable Range (PAR)?

• Characterization: The PAR is established through comprehensive studies that assess the impact of process parameter variations on product quality.
• Parameter Specificity: Each PAR pertains to a specific process parameter, such as temperature or pH, and is defined based on its influence on critical quality attributes.
• Controlled Variability: Operating within the PAR allows for natural process variability, enabling manufacturers to adapt to minor fluctuations without affecting product quality.
• Regulatory Documentation: PARs should be documented in the marketing authorization dossier, providing evidence of process understanding and control.

DDReg’s capability-

At DDReg, we are committed to helping pharmaceutical companies navigate the complexities of the Proven Acceptable Range (PAR) in manufacturing. Our deep understanding of Quality by Design (QbD) principles and ICH Q8(R2) guidelines empowers you to establish scientifically justified ranges that ensure consistent product quality and compliance with regulatory standards.