2 - Emprove - w305116 - Flyer - EN - MRK - Sep 2016 - Low

YouR
FasT
Track
through regulatory
challenges
The Emprove® program
The life science business of Merck operates

as MilliporeSigma in the U.S. and Canada.
Filtration and
single-use
As the biopharmaceutical industry evolves, it also shapes the need
for higher transparency along the supply chain and standardization.
Information is crucial for manufacturers when selecting filtration
and single-use technologies and other materials. The more you know
about your materials and the risks involved, the more confidence
you can have to move forward with your product development.
After all, careful assessment ensures manufacturers select the
right materials from dependable suppliers.
Regulatory guidelines surrounding chemicals continue to direct

and alter the flow of information between supplier and end user.
Industry-wide demands and expectations are pushing for the same
level of transparency for devices used in the manufacturing process.
With these demands in mind, we are extending
the Emprove® program to include filtration
and single-use, starting with sterile and virus
filters as well as single-use components used
at the major steps of the biopharmaceutical
process.
An overview of products available with

Emprove® documentation can be
found at www.merckmillipore.com/emprove
Dossier Library
With the new Emprove® program, we address tomorrow’s regulatory questions today. Three different
types of dossiers will support you throughout the different stages of your operations: qualification,
risk assessment, and process optimization.
Emprove® dossier library
Material Qualification Dossier Quality Management Dossier Operational Excellence Dossier

Information to start a material Answers questions during Supports process optimization
qualification risk assessment
• General information • Quality self assessment • Product quality report

• Manufacturing flow chart • Audit report summary • Element impurity
• Product characterization • Supply chain information information
Raw and starting materials
and qualification • Stability data • Analytical procedure

• Control of drug substance
• Reference standard
• Materials
• Container closure systems
• Stability summary
• General information • Quality self assessment • Extractable report*

• Manufacturing flow chart • Audit report summary • Elemental impurity
• Product characterization • Supplier and CMO information
Filtration and single-use
and qualification management • Analytical procedure

• Specification, release criteria • Supply chain information
• Materials of construction • Shelf life testing and results
• Extractables summary* • Critical raw materials
• Residual solvents statement
• Regulatory statements
(Animal origin, allergens...)
* Standardized Extractable Protocol,

BPOG, published in Pharmaceutical
Engineering, 11.2014
Raw and Starting
Materials
Risk levels vary depending on your product and its application. Our Emprove® portfolio
of raw and starting materials, which includes excipients, is divided into three categories
to help simplify and streamline the selection process.
EMPROVE® ESSENTIAL product line is designed for moderate risk

levels. The best-in-class regulatory support is combined with our high
quality standards.
EMPROVE® EXPERT product line addresses higher risk applications,

where the lowest microbiological and endotoxin levels are of utmost
importance. These products are documented as being manufactured
with low microbiological and endotoxin levels.
EMPROVE® API product line provides the right quality and regulatory
documentation required for active pharmaceutical ingredients. All the
products in this line are manufactured in Europe and comply with the
ICH Q7 requirement.
Following the acquisition of Sigma Aldrich we aim to integrate the

well-known PharmaGrade portfolio of SAFC into the Emprove® program.
Updates on the progress can be found at
www.merckmillipore.com/emprove and
www.sigmaaldrich.com/safc/bioprocess/pharmagrade.html
Qualification
made easy
Emprove® program now includes
raw materials, filters
and single-use components
The innovative Emprove® program has been

providing efficient regulatory documentation to the pharma and
biopharma industry for over a decade, even as the number of regulations
has increased. Now we’re broadening our scope by expanding our portfolio
and providing detailed information on filters and single-use components
for biopharma production.
The Emprove® program simplifies your processes by:
• Expediting approval preparation and extending compliance

• Facilitating qualification processes
• Supporting risk assessment, management and mitigation
• Increasing supply chain transparency
• Saving you time and money
Comprehensive
regulatory
information
at your fingertips
Accessibility to relevant information is essential. The new Emprove® Suite is
Full
access to all
your online gateway to conveniently access all of our Emprove® dossiers on
dossiers of the
demand. The Suite is always up to date and optimized for any targeted search.
Emprove® library
• One time registration
Subscribers with a two-year license can navigate regulatory challenges
• Includes 5 email
with access to dossiers from our entire portfolio. The Material
addresses per company
Qualification Dossier is available free of charge on our website.
• Access for 2 years
For more information on how to subscribe, visit:

www.merckmillipore.com/emprovesuite
We provide information and advice to our customers on application technologies and regulatory matters to the best of our knowledge and
ability, but without obligation or liability. Existing laws and regulations are to be observed in all cases by our customers. This also applies
in respect to any rights of third parties. Our information and advice do not relieve our customers of their own responsibility for checking
the suitability of our products for the envisaged purpose.
Merck KGaA, Darmstadt, Germany

Corporation with General Partners
Frankfurter Str. 250
64293 Darmstadt
Germany
Phone: +49 6151 72-0

Email: pcs.salessupportEU@merckgroup.com
www.merckmillipore.com
w305116
Merck and the vibrant M are trademarks of Merck KGaA.

Emprove is a registered trademark of Merck KGaA.
Copyright © 2016 Merck KGaA. All Rights Reserved. PS-16-12892 09/2016

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YouR

The life science business of Merck operates

Regulatory guidelines surrounding chemicals continue to direct

An overview of products available with

Emprove® dossier library

Material Qualification Dossier Quality Management Dossier Operational Excellence Dossier

• General information • Quality self assessment • Product quality report

and qualification • Stability data • Analytical procedure

• General information • Quality self assessment • Extractable report*

and qualification management • Analytical procedure

* Standardized Extractable Protocol,

EMPROVE® ESSENTIAL product line is designed for moderate risk

EMPROVE® EXPERT product line addresses higher risk applications,

Following the acquisition of Sigma Aldrich we aim to integrate the

The innovative Emprove® program has been

The Emprove® program simplifies your processes by:

• Expediting approval preparation and extending compliance

For more information on how to subscribe, visit:

Merck KGaA, Darmstadt, Germany

Phone: +49 6151 72-0

Merck and the vibrant M are trademarks of Merck KGaA.

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