Project Evaluation

During the project evaluation phase, the main parameters of validation activities and the system's lifecycle are determined, specifically:

Independent parts of the system that cannot affect product quality/safety are excluded from the validation scope.
Hardware and software categories are defined to optimally scale validation activities.
The extent/rigor of supplier qualification is determined.
The computerized system's lifecycle is defined, reflecting the strategy for achieving GxP compliance.

The Project Evaluation stage can be compared to a Basic Risk Analysis (BRA) within traditional validation structures.

When determining GxP coverage, the system components (modules, parts) are evaluated to assess their potential impact on product quality/safety:

Can the component have a direct or indirect impact on the product (comparable to an impact assessment according to ISPE Guide Volume 5, Commissioning and Qualification)?
Do the outputs of functions performed by the component serve as inputs for other GxP-critical functions?
Can the component indirectly influence other GxP-critical functions by utilizing/loading/blocking system resources of the shared hardware or software infrastructure?

If there is no direct or indirect impact, the component can be excluded from GxP coverage.

Hardware Categories

Hardware is divided into two categories:

Category 1 – Standard hardware components
Category 2 – Custom-made hardware components

With rare exceptions, all hardware used in pharmaceutical manufacturing belongs to Category 1.

Software Categories

Software in GAMP 5 is divided into four categories:

Category 1 – Infrastructure software
~~Category 2~~ ~~(which existed in GAMP 4) is no longer present~~
Category 3 – Non-configurable products
Category 4 – Configurable products
Category 5 – Custom applications

Supplier Evaluation (Qualification)

GAMP 5 provides three main types of supplier evaluation activities:

Basic evaluation based on available information
Postal audit using a questionnaire
On-site audit at the supplier's facility, conducted by an appropriate specialist, auditor, or audit team

In general, systems with low impact on product quality/safety may only require a basic evaluation, while systems with higher impact may require a formal audit. Postal audits (Questionnaire-based audits) are typically used for suppliers of standard and configurable products and services.

Compliance Strategy/System Lifecycle

The final activity of Stage 2 "Project Evaluation" is to define the strategy for achieving compliance/system lifecycle, specifically:

Based on the system architecture study, GxP coverage determination (extent of system components' impact on quality/safety), hardware and software category identification, and supplier evaluation, the lifecycle steps are determined, including validation activities, and the type of V-model validation per GAMP 5.
Lifecycle steps related to system operation, potential migration, decommissioning, storage, and disposal are also determined.
The developed compliance strategy/system lifecycle is preliminary and may change following a detailed risk assessment at Stage 3, and as a result of resolving deviations during the Design Review at Stage 4.

The specialists at Tarqvara Pharma Technologies have years of experience in conducting qualification, validation, and acceptance tests within the pharmaceutical industry, in full compliance with international, European, and national GMP/GxP regulations and standards.