Overview of Validation in Pharmaceutical Production

More than a normal inspection process, validation in pharmaceutical manufacturing is a relentless pursuit of quality, including the assessment, verification of every stage of production, from raw materials to systems, machinery, production process to the final product.

The goal is to ensure that pharmaceutical products are produced consistently and continuously, with quality, effectiveness, and safety for users. The following article aims to give an overview of validation in pharmaceutical production.

Validation processes in pharmaceutical production

Validation Master Plan: This is an important document that covers all aspects of the process. It defines the objective, scope and methods to be used.
Process Validation: This is the stage where the manufacturing process is tested and verified to ensure that the manufacturing process is suitable and can continuously produce products that meet quality requirements. stated quantity.
Equipment Validation: Equipment used in production needs to be assured that they are designed (DQ – Design qualification), installed (IQ – Instal qualification), operated (OQ – Operational qualification ) is suitable and ensures performance (PQ – Performance qualification) according to user requirements.
Computer System Validation: Computer systems used to monitor and control the production process need to ensure accuracy, data integrity and security. As eQMS gradually becomes mainstream, CSV becomes increasingly necessary to ensure requirements from regulatory agencies.
Analytical Method Validation: Analytical methods used to check product quality need to ensure accuracy, precision, repeatability, and roughness.
Cleaning Validation: This is the process of ensuring that equipment and product contact surfaces are properly cleaned to avoid cross-contamination or microbiological contamination. Evaluate storage time for equipment to ensure equipment remains clean after a period of non-use.

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) positions on validation in pharmaceutical manufacturing are focused on ensuring that manufacturing processes meet regulatory requirements, high standards of quality, safety and efficiency. Both agencies require pharmaceutical companies to conduct detailed and comprehensive validations to confirm that manufacturing processes can consistently produce products and meet regulatory standards.

This includes managing risks, complying with strict regulations, maintaining detailed records and continuously improving processes. The FDA and EMA both emphasize the need to protect public health by ensuring that pharmaceutical products on the market are safe and effective for consumers.

Advantages and Disadvantages

Advantages:

Ensure uniformity of output products.
Minimize rejected defective products and reworks.
Reduce utility costs.
Avoid large investment costs.
Fewer complaints about process-related errors.
Minimize inspection of processes and finished products.
Quickly and accurately investigate process deviations.
Boot new devices faster and more reliably.
Easily expand production scale from development stage.
Easier to maintain equipment.
Raise employee awareness of the process.
Automate faster

Disadvantages:

Time-consuming process.
The production process is often complex and expensive.
Validation also has practical limitations and associated costs

Conclude:

Validation is an essential component of GMP, helping to ensure products meet standards for quality, safety, effectiveness, purity and potency. This activity is commonly used in drug development, manufacturing and final product specifications. This activity also eliminates the possibility of manufacturing defects because the product is manufactured according to a stage-by-stage optimization process; Helps reduce quality risk costs and bring the best quality products. This process includes a series of activities that take place during the life cycle of the product and production process. Ultimately, pharmaceutical validation helps provide positive assurance regarding batch uniformity and the integrity of the final product manufactured in accordance with GMP rules and regulations.

In addition, validation activities can also help raise employee awareness of product quality, motivate employees to strictly comply with production processes, and contribute to improving quality culture in the business career. This process requires accuracy and strict compliance with international standards and regulations, however, the benefits that validation brings to manufacturers and consumers are huge. Therefore, performing pharmaceutical validation is an indispensable part of the pharmaceutical industry.

Nguồn https://www.researchgate.net/publication/363403367_A_Brief_Review_on_Pharmaceutical_Validation