SGD launches digital guide for non-compliance

The digital tool is due to a development project between SGD Pharma quality and marketing departments. Its USP is: identifing non-compliances that may be discovered during an incoming inspection or during on-line inspection at client’s side.

The SGD Pharma app aims at optimising and harmonising exchanges with quality controllers and technical staff by making it easier to identify non-compliances that could be present in moulded glass bottles intended for pharmaceutical use.

The app can be downloaded for free from the App Store as well as Google Play and one can register with a few clicks. It provides 2D visual compilation of the most frequently encountered forms of non-compliance. Users can refine their searches by administration method (parenteral, oral or nasal), by location or non-compliance types corresponding to various effects on the patients or on filling lines (critical, major or cosmetic).

Once a non-compliance has been identified, the user accesses a dedicated page including a visual, a definition, the type of non-compliance and its associated acceptable quality level (AQL) in conjunction with the international standard ISO 2859-1. As an added benefit, the SGD Pharma standards are cross-referenced with the two quality benchmarks recognised and accepted by the pharmaceutical industry: technical report 43 from the Parenteral Drug Association (PDA) and the list of moulded glass container non-compliances from Edito-Cantor-Verlag (ECV).

According to Quentin Ritter, quality project manager at SGD Pharma: "This application project was initiated in response to our customers’ increasing demand for glass non-conformities training. It is crucial for them to identify and recognise non-conformities quickly in order to improve inspection processes and make the right decision."

Emmanuel Lepitre, head of development and quality said, "SGD Pharma app answers to the growing zero tolerance trend, including cosmetic quality, by hospital staff. With this application, open to all professionals in the industry, designed upstream with its customers in mind, SGD Pharma aims to support the pharmaceutical industry to protect patient health."