Emprove

Legacy SAFC PharmaGrade Portfolio
to be integrated into the Emprove® Program.

Please contact your sales representative to discuss your needs during the integration process

Our PharmaGrade™ product portfolio – which includes 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. With controlled manufacturing processes, optimized quality attributes and analytical specifications, and readily available quality documentation packages, PharmaGrade™ products provide efficiency and reliability for biopharma raw material qualification.

Following a thorough review process, the PharmaGrade™ portfolio is being integrated into our industry-leading Emprove® Program. The Emprove® Program supports your risk assessment and offers assistance in developing more robust processes. It not only covers the latest regulatory requirements, but also anticipates industry expectations not yet covered by regulation. The PharmaGrade™ products will be integrated into our Emprove® Program either as Emprove® Essential, Emprove® Expert, or included in our NEW Emprove® Evolve product line.

Emprove® Evolve products address applications with a need for supply chain transparency and control, as well as detailed documentation to support risk assessments, but where no specific regulatory standard exists. Some examples of such an evolving regulatory environment are upstream and early downstream bioprocessing, clean-in-place, and early synthetic steps in small molecule drug manufacture.

Evoloving Regulation

To support drug manufacturers’ risk assessments and decisions on raw materials, the different Emprove® categories are designed to provide manufacturers with the ability to select the appropriate quality raw materials for their specific application.

A glance at our Emprove® Program product categories:

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/ ongoing 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

What will change as a result of this integration?

With this integration, PharmaGrade™ products will benefit from being part of the established industry-leading Emprove® Program for raw and starting materials. In order to meet our exacting Emprove® standards, each PharmaGrade™ product will be requalified according to harmonized definitions and robust processes.

More information on the Emprove® Program can be found here.

The Emprove® Program also provides comprehensive and thorough documentation, via our extensive dossier library and Emprove® Suite.

Within the Emprove® program there are 3 different supporting Emprove® dossiers which accompany each product:

Material Qualification Dossier

  • General information
  • Manufacture
  • Characterization
  • Container closure system
  • Stability/shelf-life summary

Information to start a material qualification

Quality Management Dossier

  • Quality Self-Assessment
  • Audit report summary
  • Supply chain Information
  • Stability data

Answers questions during risk assessment

Operational Excellence Dossier

  • Product quality report
  • Elemental impurity information
  • Analytical procedures

Supports process optimization

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.

Sigma-Aldrich Pharmagrade to Emprove

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

First phase of PharmaGrade™ products to be addressed

The integration of the PharmaGrade™ portfolio is taking place in several phases. The table below shows those products which are prioritized for phase one, starting in 2018. Detailed planning for these products has started but this list should be considered for information purposes only at this time. Formal change notifications for each product will be issued in due course, according to our quality procedures. In the interim we encourage all customers to discuss with their sales representative their demand and qualification requirements for these products. In each case there will be a period of time where both the legacy PharmaGrade™ product and new Emprove® product will be available in parallel, to provide supply security and allow time for customers to perform their change management activities.

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, Switz. GMP PharmaGrade™ Expert
76857 aq. Benzalkonium Chloride Solution, Ph.Eur, USP Buchs, Switz. GMP PharmaGrade™ Expert
15702 Tropolone Buchs, Switz. Elite PharmaGrade™ Evolve
76078 L-Methionine Sulfoximine Buchs, Switz. GMP PharmaGrade™ Essential
80443 Sodium Pyruvate Buchs, Switz. 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, Switz. GMP PharmaGrade™ Essential
56454 1-Thioglycerol, USP Buchs, Switz. GMP PharmaGrade™ Essential
91541 Oleic Acid Buchs, Switz. Elite PharmaGrade™ Evolve
93792 Benzenesulfonic Acid Buchs, Switz. 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.