The pharmaceutical process validation is a must for accomplishing the GMP regulations. It is an effective way to evaluate the different processes, identify error or fails in the systems, develop the documentation related and determine the corrective actions to be implemented to guarantee the regulation compliance.
Qualipharma has a team of experts with deep experience on process validation. We master the production process validation with the aim to set and establish stable and reliable systems and process.
The main objective of the production process validation is to demonstrate the ability of the system to produce, in a continuous and sustainable way, homogeneous products according to the standards and regulations. Therefore, is a must to deeply know the process specifications in order to carry out the risk assessment and identify the critical points that can affect the quality of the product.
The main priorities to be considered when defining the which processes must be validated are:
- New production process. Every new project must be validated before its implementation.
- Existing production processes.
a) Processes designed for sterile products production. Every process that has an impact on the product sterility must be validated, been the sterilization phase the priority number.
b) Processes designed for non-sterile products production. On pharma production, specifically in the systems for capsule and tablet format, the priority for validation is for mixing, granulation and filling processes.
- Processes based on scientific knowledge and risk assessment
- We provide constant support with the updated regulatory requirements and applicable regulations
- Project involvement