What is a Process Validation Review?

Why is it needed?

Process Validation Review is an essential part of the manufacturing process of human and veterinary medicinal products, testing they consistently meet expected results and quality requirements.

Pharmaceutical product manufacture is a complex process that must align with the regulatory requirements at the place of manufacture, the intended market, and all relevant Good Manufacturing Practices (GMP) guidelines.

For producers this combines not only product safety aspects but also financial operating aspects. Manufacture requires expensive materials, sophisticated facilities and equipment, and highly trained personnel, so the cost of manufacturing failure is high, and this is why systematic Process Validation Review is such an important, valuable, and necessary part of operations.

Typical Process Validation Review process.

A Process Validation Review usually requires a minimum of three consecutive batches produced under regular operating conditions. An alternative number of batches may be justifiable, considering factors such as the use of standardized manufacturing methods and the existence of comparable products or processes on site.

There may also be a requirement for additional data from subsequent batches as part of an ongoing process verification process.

In all cases, it is essential to prepare a thorough process validation protocol that clearly outlines Critical Process Parameters (CPP), Critical Quality Attributes (CQA), and any other associated acceptance criteria. The protocol should be supported with development data or existing process knowledge documentation.

The Process Validation Review protocol.

The European Commission provides the following guidelines for what should be included or considered within a review protocol:

A concise process description along with a reference to the corresponding Master Batch Record.
A clear delineation of functions and responsibilities.
An overview of the Critical Quality Attributes targeted for investigation.
A summary of the Critical Process Parameters and their associated limits.
A summary of all other (non-critical) attributes and parameters slated for investigation or monitoring during the validation activity, along with the rationale for their inclusion.

A comprehensive list of equipment/facilities to be employed (inclusive of measuring/monitoring/recording equipment) and their calibration status.
A catalogue of analytical methods used, accompanied by appropriate method validation.
The proposed in-process controls featuring acceptance criteria and the rationale for selecting each in-process control.
Any additional testing to be conducted, with acceptance criteria.
A defined sampling plan, along with the underlying rationale.
Approved methods for recording and assessing results.
The process for releasing and certifying batches, if applicable.

Why choose Aegisana for Process Validation Review support?

Process expertise.

Our GMP Compliance team has the experience and expert knowledge to support you with your Process Validation Review procedures, with the production understanding required of how this works within your Quality System, and operational efficiency.

Typically, but not exclusively, we support clients in the following areas,

The review or creation of Process Validation Protocols and Reports.
Critical analysis of the Validation Process.
Recommendations for improvement of the manufacturing process.

Supported by our robust Quality Management System (QMS), we can seamlessly and efficiently adapt to the compliance needs of your manufacturing site.

Safety & insights.

Our goal is to provide you with peace of mind and confidence by providing a comprehensive Process Validation Review support service that thoroughly assesses/defines your review process and provides you with actionable insights that provide value.

We consider both safety and efficiency and are fully cognisant of the importance of both to your operations.

Through effective communication, reliability, and trust, we aspire to establish a successful and robust strategic compliance and auditing partnership throughout the manufacturing and packaging of your human and animal products.

All of our services adhere to the regulations and principles of the EMA’s guidelines on compliance.