PQ Forum #21 - Validation Initiation Document Template

Validation documents are key documents in a pharmaceutical manufacturing facility. Validation documents must be carefully written for internal and external review including audit by regulatory inspectors; they may be accessed numerous times during a product lifetime. The most frequently reviewed validation documents are Stage 2 Process Performance Qualification documents.

Qualification of the water for injection treatment system for GMP

The proper functioning of the water treatment system is a key area of quality assurance in pharmaceutical manufacturing. Qualification of the water for injection treatment system is a complex multi-stage process required a competent approach and careful preparation. The main requirements for the quality of water for injection and the elements of the water treatment system guided by the qualification of such a system are described in this article. The most important aspects of the project, installation, operation and performance qualification are considered. The presented methodological provisions will be useful for pharmaceutical enterprises implementing the good manufacturing practice in terms of qualification of the water for injection treatment system.

A Novel Digital Design Approach for Metal Additive Manufacturing to Address Local Thermal Effects

The reliability and performance qualification of additively manufactured metal parts is critical for their successful and safe use in engineering applications. In current powder-bed fusion type metal additive manufacturing processes, local thermal accumulations affect material microstructure features, overall part quality and integrity, as well as bulk mechanical behavior. To address such challenges, the investigation presented in this manuscript describes a novel digital design approach combining topology optimization, process simulations, and lattice size optimization to address local thermal effects caused during manufacturing. Specifically, lattices are introduced in regions of topology optimized geometries where local thermal accumulations are predicted using the process simulations with the overall goal to mitigate high thermal gradients. The results presented demonstrate that the proposed digital design approach reduces local thermal accumulations while achieving target mechanical performance metrics. A discussion on how post-manufacturing heat treatment effects could be also considered, as well as comments on the computational implementation of the proposed approach are provided.