Gerresheimer database solution accelerates market launch of new drugs

Comprehensive documentation of Gerresheimer primary packaging made of plastic

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Gerresheimer's web-based, audit-proof product database contains relevant information and up-to-date documentation of the entire product portfolio.
Gerresheimer's web-based, audit-proof product database contains relevant information and up-to-date documentation of the entire product portfolio.

Gerresheimer, an innovative systems and solutions provider and global partner for the pharma and biotech industry, underlines its expertise in selecting the right primary plastic packaging with its database. Thanks to the comprehensive packaging documentation, customers can register new medications more easily and quickly, accelerating the market launch process.

The web-based, audit-proof product database contains relevant information and up-to-date documentation of the entire product portfolio. The online product catalog on the Gerresheimer website is based on the product database and facilitates the pre-selection of suitable primary packaging. Access to approval-relevant documentation is only available to Gerresheimer customers.

”With the push of a button, our customers have access to a toolbox with complete documentation of all our products. This simplifies and supports product registration in every country”, says Christian Haas, vice-president Sales Europe Primary Packaging Plastic at Gerresheimer. ”Our database highlights our extensive experience and deep understanding of patient safety and our customers’ requirements. It is constantly updated with new content and functionality to meet current and future needs.”

Solution provider for solid, liquid and ophthalmic packaging

Gerresheimer is the leading solution provider for plastic packaging for solid, liquid and ophthalmic products. The product range includes the leading brands Duma, Dudek and Triveni for solid dosage forms, PET bottles under the edp brand for liquid dosage forms and products for ophthalmic applications. The broad standard range includes a wide variety of containers and closures, PET bottles, eye droppers, nasal sprays, nebulizers, applicators and accessories, as well as countless customer-specific innovative developments, which also include sustainable solutions made from 100% recycled PET or sugar cane. All these products are comprehensively documented in the product database for registration and approval of new drugs or formulations.

Reduced time to market with audit-proof information

From the beginning, the goal of developing the database was to simplify and speed up the registration process for customers by giving them direct online access. All relevant information is kept up to date and includes a revision date for any changes. Customers can exchange the required data with their teams and the respective authorities. Customer-specific files can also be uploaded. Thus, the database supports customers’ internal documentation, testing, and approval processes with all relevant certificates and test results. In addition, a complete overview of all standard products, including full documentation, is available at any time.

Complete documentation simplifies work for many departments

In addition to reducing time-to-market through thorough documentation, an increasing number of customer departments are taking advantage of the Gerresheimer product database. The R&D department can access information on the dimensions and properties of the packaging solution for their new products. They can also find regulatory and standard drawings, as well as USP (United States Pharmacopeia) test results such as water vapor and light transmission. The quality department can access descriptions of quality control and the most common types of defects, along with their corresponding AQL (Acceptable Quality Level) values. The approval department can view raw material supplier declarations, declarations of compliance, and information on registrations and certifications. The Purchasing Department can identify packaging solutions for new and existing applications for comparison. The production department can use the database to determine the most suitable packaging for their filling line, including packaging and labeling. The sustainability department can use the database to identify the most sustainable packaging solutions for their applications.

The Gerresheimer online product catalog

The online product catalog on the Gerresheimer website is based on the product database and contains information on the entire Primary Packaging Plastic portfolio. It facilitates the pre-selection of suitable primary packaging and can be accessed by customers and interested parties here.

Access to the complete and approval-relevant documentation is only available to Gerresheimer customers through their assigned Gerresheimer Sales representative.

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