At CPhI WW 2019, SGD Pharma will be launching the first application to identify non-compliances inmolded glass bottles intended for the pharmaceutical industry
Resulting from a development project between SGD Pharma Quality and Marketing departments, this new
digital tool makes it possible to identify non-compliances that may be discovered during an incoming
inspection or during on-line inspection at client’s side. The SGD Pharma App is a testament to our
commitment to continuous improvement. It also demonstrates transparency in working with customers
toward the mutual objective of safeguarding patient health.
As a leader in molded glass pharmaceutical packaging for the healthcare sector, SGD Pharma makes product quality an essential part of its mission. The SGD Pharma App aims at optimizing and harmonizing exchanges with quality controllers and technicalstaff by making it easier to identify non-compliances that could be present in molded glass bottles intendedfor pharmaceutical use. Available for free from the Apple Store and the Play Store, it only takes a few clicks for users to create their account and have unlimited access to a 2D visual compilation of the most frequently encountered forms ofnon-compliance. Users can refine their searches by administration method (parenteral, oral or nasal), bylocation 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 then accesses a dedicated page including a visual, adefinition, the type of non-compliance and its associated acceptable quality level (AQL) in conjunction withthe international standard ISO 2859-1. As an added benefit, the SGD Pharma standards are then cross-referenced with the two quality benchmarks recognized and accepted by the Pharmaceutical industry: technical report 43 from the Parenteral Drug Association (PDA) and the list of molded glass container non-compliances from Edito-Cantor-Verlag (ECV).
According to Quentin Ritter, Quality Project Manager at SGD Pharma: “This application project was initiatedin response to our customers’ increasing demand for glass non-conformities training. It is crucial for them tobe able to identify and recognize non-conformities quickly in order to improve inspection processes and make the right decision.” The application is intuitive and comprehensive and offers reliable practical
information. "The mission of SGD Pharma,” adds Emmanuel Lepitre, Head of Development and Quality, “isto improve safety for the end user. SGD Pharma App answers to the growing zero tolerance trend, includingcosmetic quality, by hospital staff. With this application, open to all professionals in the industry, designedupstream with its customers in mind, SGD Pharma aims to support the Pharmaceutical Industry to protectpatient health."
About SGD Pharma
SGD Pharma has a unique know-how and offers innovative and premium quality glass packaging solutionsconsistent with international pharmacopoeias. SGD Pharma places the quality and safety of the patient atthe center of its concerns. Our 5 manufacturing sites are totally dedicated to Pharmacy, certified ISO 15378.All our bottles are controlled and packaged in clean room ISO 8. SGD Pharma is implementing a quality policy both homogeneous and effective on all its sites of production, based on the respect of Good Manufacturing Practices. In the drug industry more than elsewhere, the security of the supply chain is a vitalelement. We carry out every effort to ensure a continuous supply and protect the client and patient. SGDPharma provides back-up solutions between its different manufacturing sites for all types of glass. Our group's mission, aligned with its DNA, is to improve and protect patient's health by providing high quality,innovative and reliable primary glass packaging to our pharmaceutical customers.