Merck

Emprove® Program – Help Maintain Compliance with Current Good Manufacturing Practices

Emprove® Program: The smart way to master compliance and control.

THE SMART WAY TO MASTER COMPLIANCE AND CONTROL

Maintaining compliance with current Good Manufacturing Practices (cGMP’s) at any given time in your drug manufacturing process can be a complex and challenging task – especially in a global, dynamic environment. As a drug manufacturer, you need to compile a vast amount of information from your suppliers to ensure that the raw materials and components you purchase continue to meet the technical, regulatory and supply needs for your designated use and function. This can be resource- and time-intensive, as well as expensive.

To help facilitate and accelerate this risk assessment continuum process, we have developed the Emprove® Program.  Offering convenient access to reliable information for a broad portfolio of high-quality products, the Emprove® Program enables you to:

  • make more agile, risk-based decisions
  • maintain compliance and
  • demonstrate control – saving you time and money

There are three pillars of the Emprove® Program:



YOUR EMPROVE® PRODUCT PORTFOLIOS

We’ve continued to expand the scope of the Emprove® Program beyond Emprove® Chemicals. The Emprove® Program now covers more than 500 raw materials, 1,100 Filtration SKU’s and 450 Single-Use Components. Although some of these product portfolios do not contain the Emprove® Name in their brand name, they have been qualified into the Emprove® Program and their respective Emprove® Dossiers are included in the Emprove® Suite.

We leverage our biopharma and pharma regulatory intelligence and participation in industry associations to stay abreast of constantly evolving regulatory requirements, advancing industry guidance, and increasing customer expectations to determine which products would benefit from the Emprove® Program and what additional information would be of value to you. Then, we qualify those products into the Emprove® Program and add new content to our Emprove® Dossiers by proactively developing, obtaining, and compiling the information needed to address the specific requirements of the different product portfolios – giving you peace of mind.

YOUR TECHNICAL, REGULATORY AND SUPPLY INFORMATION

The Emprove® Qualified Product Portfolios are supported with reliable information in the Emprove® Dossiers, which have been compiled in line with the ICH Common Technical Document (CTD) Chapter 3 format. The Emprove® Dossiers are designed to support different steps in your raw material and component risk assessment continuum – streamlining your supplier selection, material qualification, process optimization, patient safety evaluation and more.

Choose from over 1,500 Emprove® Dossiers covering hundreds of raw and starting materials, filter products, single-use components, chromatography resins and cell culture media.

*Disclaimer: The API Information Package is not intended to be used as an official document for registration by the authorities. The registration procedure for active pharmaceutical ingredients in final drugs is strictly regulated. The CEP and DMF/ASMF procedures enable API manufacturers to protect their intellectual property. Access to CEPs and LoAs for US DMFs (and other DMFs) and ASMF applications can be provided on request to support drug applications using our Emprove® API.


The new Emprove<sup>®</sup> Suite

THE NEW EMPROVE® SUITE: SPEED THROUGH COMPLEXITY WITH CONFIDENCE

Compliance with current Good Manufacturing Practices is a continuum. Changes are inevitable. Audits and periodic reviews are necessary.

Take a seat: The Emprove® Suite is here to improve your risk assessment journey. This  Information-as-a-Service digital platform is your co-pilot to support your need for convenient access to reliable information – anywhere, anytime. A subscription helps you stay current:  You can  not only easily find, view and download Emprove® Dossiers, but also to “opt-in” to notification updates to be informed of changes to documents. You can also generate Emprove® Dossier download metrics and reports, and so much more.

Ultimately, a subscription to the Emprove® Suite empowers you to:

  • take advantage of everything the Emprove® Program has to offer
  • collaborate and share information globally
  • speed your way through the complexity of compliance with confidence

Related Product Resources



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