Emprove® Program

 

Explore Transparency

The Emprove® Program provides full supplier transparency at your fingertips, anticipating industry expectations not yet covered by regulation. Find comprehensive regulatory documentation for filters, single-use components and raw and starting materials to simplify your qualification, risk assessment and process optimization.

It helps you meet the latest regulatory requirements 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
 

 

Emprove® Portfolio

Our Emprove® portfolio spans products from approximately 400 chemicals to various filtration and single use devices and components.

 

 

Emprove® Dossiers

To support you throughout different stages of your operations: qualification, risk assessment, and optimization we have created three different types of dossiers.

 

Glance of Emprove® Chemicals quality attributes:

 
Product Quality Attributes Emprove® Evolve Emprove® Essential & Emprove® Expert
Regulatory
  • Non-GMP: Manufactured utilizing GMP concepts and elements; ISO9001 or equivalent
  • Supply chain transparency and control
  • No defined industry standards or regulations
  • Non-compendial; not for direct human use
  • GMP: IPEC/EXCiPACT™ plus elements of ICH
  • Defined regulations and GMP standards
  • Compendial compliance; intended as suitable for human use
Examples of use/Application
(Examples only: customers’ responsibility to assess and decide on appropriate quality of raw materials for their use)
  • Process chemicals & clean-in-place
  • Upstream, early downstream, early synthetic steps
  • Higher risk applications, close to final drug product & patient
  • Formulation, late downstream & purification
Product shelf-life/stability
  • Shelf-life based on analysis of 3 batches/historical data/retests
  • Summary statement in Emprove® dossier
  • Long-term stability studies according to ICH Q1A requirements
  • Detailed stability study data in Emprove® dossier
Supplier qualification
  • High
  • Paper assessment mandatory
  • On-site audit preferred; exceptions possible under certain conditions
  • Change agreement
  • High
  • On-site audit mandatory
  • Quality/change agreement
Change control
  • High
  • High

 

Learn more about  our SAFC PharmaGrade™ Portfolio integration into the Emprove® Program

Our PharmaGrade™ product portfolio of specialty chemicals, buffers, and amino acids is being integrated into the Emprove® Program.

The PharmaGrade™ portfolio of biopharma raw materials was developed to resolve a fundamental bioprocess challenge: sourcing specialized raw materials with transparent and consistent supply chains, without adding unnecessary cost or complexity.

Following a thorough review process, the PharmaGrade™ portfolio is being integrated into our Emprove® Program either as Emprove® Essential, Emprove® Expert, or included in our NEW Emprove® Evolve category.

What will change?

In order to meet our exacting Emprove® standards, each PharmaGrade™ product will be requalified according to harmonized definitions and robust processes.

Our PharmaGrade™ product documentation will be upgraded and expanded from the current single dossier to the three-dossier Emprove® format, increasing the quality and quantity of information available for each product.

In addition, some technical features of the products will also be upgraded to meet the higher standards of the Emprove® program.

 

 
Will Change
Won’t Change

Product/Article number

X  
Product name (to reflect the Emprove® category Expert, Essential or Evolve) X  
Manufacturing site   X
Manufacturing process   X
Raw materials / sources   X*
Increased product dossier content X  
Primary packaging volumes or material of construction   X*
Existing specification parameters   X*
New tests added to product specification (in some cases) X  
Extended impurity profiling (eg. elemental impurity information, bioburden, volatile impurity profiles) X  
Addition of improved stability and shelf-life data X  
Layout and wording of certificates and statements as a result of harmonization X  
Label format and branding X  
Distribution / supply chain / ordering process   X
*No intended change: Change only to be made when necessary to meet higher Emprove® standards

Phases of integration

The integration of the PharmaGrade™ portfolio is taking place in several phases. The table below shows those products which are prioritized for phase one, started in 2018. Formal change notifications for each product will be issued in due course, according to our quality procedures.

 

PharmaGrade™ Product Number Product Name Manufacturing Site PharmaGrade™ Quality Level Target Emprove® Category
ARK2163 Benzyl Alcohol, USP/NF, Ph.Eur Arklow, Ireland GMP PharmaGrade™ Expert
ARK2161 Sodium Butyrate, USP/NF Arklow, Ireland GMP PharmaGrade™ Expert
ARK2176 Galactose, USP/NF, Ph.Eur Arklow, Ireland GMP PharmaGrade™ Expert
C1231 SyntheChol™ Synthetic Cholesterol, USP/NF, Ph.Eur Arklow, Ireland GMP PharmaGrade™ Expert
ARK2183 Acetic acid, Glacial, USP, JP, Ph.Eur Arklow, Ireland GMP PharmaGrade™ Expert
12063 Benzalkonium Chloride, Ph.Eur, USP, JP Buchs, Switzerland GMP PharmaGrade™ Expert
76857 aq. Benzalkonium Chloride Solution, Ph.Eur, USP Buchs, Switzerland GMP PharmaGrade™ Expert
15702 Tropolone Buchs, Switzerland Elite PharmaGrade™ Evolve
76078 L-Methionine Sulfoximine Buchs, Switzerland GMP PharmaGrade™ Essential
80443 Sodium Pyruvate Buchs, Switzerland GMP PharmaGrade™ Essential
ARK2151 Hexylene Glycol, USP/NF Arklow, Ireland GMP PharmaGrade™ Expert
ARK2169 Ethanolamine, USP/NF Arklow, Ireland GMP PharmaGrade™ Expert
02712 Cystamine Dihydrochloride Buchs, Switzerland GMP PharmaGrade™ Essential
56454 1-Thioglycerol, USP Buchs, Switzerland GMP PharmaGrade™ Essential
91541 Oleic Acid Buchs, Switzerland Elite PharmaGrade™ Evolve
93792 Benzenesulfonic Acid Buchs, Switzerland GMP PharmaGrade™ Essential

We are committed to supporting our customers through this process and to avoiding any supply disruption as a result of this integration.

 

Subscribe to the Emprove® Suite

In addition to buying single dossiers, you can use the new Emprove® Suite online to find all our Emprove® dossiers. The Suite is constantly updated and is optimized for targeted search. It provides online access to all dossiers of the entire Emprove® portfolio for two years.

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