Prescription Process Validation of Generic Drug

During the manufacturing of pharmaceuticals, each of the different production steps needs to be well controlled to ensure the consistency and repeatability throughout the manufacturing process. The purpose of prescription process validation is to prove the feasibility of the prescription process on the production scale, so as to ensure the stability of product quality. Generally, the validation process is completed in a regulated operating space and pilot scale, and scientists collect and evaluate the data to provide the final result. Prescription process validation is an important step before generic drugs enter into process scale-up and commercial production. The FDA therefore encourages drug manufacturers to employ necessary process validation strategies to determine the robust of their prescription process. Alfa Chemistry provides process validation services for a wide range of generic pharmaceuticals, ensuring the final results demonstrate the good control of the manufacturing process.

Figure 1. The comparison between the generic and brand-name medicines. (Yeotikar, S. 2020)

Purpose of Process Validation

• Demonstrate the repeatability and stability of your prescription process in the consistency evaluation
• Provide adequate proof of the feasibility of the process at the production scale
• In-process control of the production conditions
• Provide strong guarantee for the product quality

What We Deliver?

• Identify key parameters for the process validation
• Necessary documentation of validation methods and results
• Complete at least three consecutive batches of successful process validation
• SOPs for the whole validation of prescription process

Figure 2. A example of the validation process flow. (Crasto, A. M. 2013)

Alfa Chemistry's Services

Validation of the prescription process flow

Pharmaceutical process validation includes the evaluation of all critical process steps that affect product quality. Our services include:

• Our manufacturing team defines the unit operations, and perform the validation of all critical process parameters and steps
• Process validation batches and sampling plans are defined according to quality risk management principles
• High frequency sampling at multiple points in the validation process to obtain sufficient information to demonstrate the stability and reproducibility of the prescription process
• A complete description of the process is documented in a report and included as part of the technology transfer package

Risk assessment and control measures for the process

In general, the purpose of the risk assessment is to determine the scope and depth of process validation. We perform the risk assessment based on the impact of each process parameter on product quality. Prior to drug process validation, our risk control team establishes a risk failure model (FMEA) for detailed analysis of risk factors.

Pharmaceutical process validation program

Based on the results of the risk assessment, we provide different solutions for the subsequent process validation:

• Appropriately reduce the number of validation batches to save your money and time
• Process stability study: consistency analysis of samples from different locations and times between batches using statistical analysis