Meeting regulatory requirements to ensure the quality and safety of excipient in pharmaceutical products.
Aiming at Quality: An Industrial Commitment
The pharmaceutical and excipients world perpetually and rigorously seeks quality. This need becomes even more relevant for products and components used in drug formulations, such as excipients. Glycerol, widely utilized across various sectors, including the pharmaceutical industry, falls into this category, revealing appreciated and necessary multi-functionality. “Glycerol Eur. Ph. min. 99.5% vegetable origin – Excipient,” distributed and produced by Spiga Nord, emerges as an excellent potential excipient candidate, meeting stringent criteria and raising the bar for productive quality.
The product claims adherence to monograph 0496 of the European Pharmacopoeia. It also boasts production and distribution in line with Good Manufacturing Practices (GMP). These practices are essential for pharmaceutical excipients. In the pharmaceutical industry, compliance and safety are crucial. Spiga Nord’s glycerol emphasizes a strong commitment in this regard. The aim is to meet the required criteria and exceed them when possible.
Validated Tools for Optimal Management
Beyond the intrinsic quality of the product, robust and reliable systems for managing business activities and analytical data are crucial. In this context, using an Enterprise Resource Planning (ERP) and a Laboratory Information Management System (LIMS) is desirable and often essential. Validated according to applicable Good Automated Manufacturing Practice (GAMP) requirements, this last tool further reinforces the reliability of Spiga Nord’s glycerol as a pharmaceutical excipient.
Ensuring Consistency and Safety in the Production of Excipients
Ensuring a meticulous adherence to regulations and utilizing validated management and analytical systems places Spiga Nord’s glycerol prominently in the pharmaceutical excipient sphere. This amalgamation guarantees the finished product’s quality and paves the way towards sustainable production. It ensures optimization and compliance with required standards at every stage, from raw material to finished product. Spiga Nord does not produce Glycerin API – the active ingredient. In an era with health at the forefront of global discussion, the quality of components used in pharmaceutical products cannot be compromised.