{ENGLISH} CHAPTER 3 QUALITY SYSTEM AND GMP – PART 2 (END)

CHAPTER 3 QUALITY SYSTEM AND GMP – PART 2 (END)

 

4. Pharmaceutical Quality System (PQS)

ICH introduced PQS in 2010 as an independent system for the first time.

The objective is to improve the quality assurance level of pharmaceutical products by promoting improvements in manufacturing and quality control methods.

 

PQS emphasizes the importance of specific systems throughout a drug’s development and use. These systems serve a dual purpose: verifying control over the product and enabling continuous quality improvement.

Process and Product Monitoring System:

This system continuously tracks raw materials, equipment conditions, process control parameters, and finished product quality. This vigilance ensures the manufacturing process remains under control and identifies any potential deviations that might trigger corrective and preventive actions (CAPA).

Corrective and Preventive Action (CAPA) System:

This system tackles issues like deviations from specifications, customer complaints, product recalls, and observations from inspections. Its goal is to prevent these problems from happening again and continuously improve the manufacturing process.

Change Control System:

When advancements in technology or CAPA activities suggest improvements, this system provides a framework for evaluating, approving, and implementing those changes in a controlled manner.

Management Review System:

This system empowers management to review quality-related information gathered from the other three systems. This allows them to identify trends, prioritize issues, and direct the necessary countermeasures to maintain and enhance overall product quality.

 

2. PQS and GMP

A key shift from the traditional view is that process validation is no longer a single act of proof. Instead, it’s a continuous process that gathers and evaluates data across the entire product lifecycle. This ongoing analysis ensures the process remains appropriate for…