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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.

Regulations of Raw Materials Used During Production Process

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
New Emprove® Product Nr Product Name Manufacturing Site Target Emprove® Category
12063 137123 Benzalkonium Chloride Buchs, Switzerland Expert
76857 137124 aq. Benzalkonium Chloride Solution Buchs, Switzerland Expert
15702 108637 Tropolone Buchs, Switzerland Evolve
76078 104309 L-Methionine Sulfoximine Buchs, Switzerland Essential
80443 105477 Sodium Pyruvate Buchs, Switzerland Essential
02712 108318 Cystamine Dihydrochloride Buchs, Switzerland Essential
ARK2163 137120 Benzyl Alcohol, USP/NF, EP Arklow, Ireland Expert
ARK2176 137129 Galactose Arklow, Ireland Expert
ARK2183 137130 Acetic acid, Glacial, USP, JP, Ph Eur Arklow, Ireland Expert
ARK2161 137127 Sodium Butyrate Arklow, Ireland Expert
ARK2174 137148 Triethanolamine, USP Arklow, Ireland Expert
ARK2169 137133 Ethanolamine Arklow, Ireland Expert
53729 137139 Cysteamine Hydrochloride Buchs, Switzerland Essential
07604 137151 2-Mercaptoethanol Buchs, Switzerland Evolve
11317 137152 Methanesulfonic Acid Buchs, Switzerland Essential
56454 108704 1-Thioglycerol, USP Buchs, Switzerland Essential
ARK2151 137126 Hexylene Glycol Arklow, Ireland Expert
C1231 137132 SyntheChol™ Synthetic Cholesterol Arklow, Ireland Expert
39269 137153 Linoleic Acid Buchs, Switzerland Evolve
52983 137141 Spermine tetrahydrochloride Buchs, Switzerland Evolve
91541 104415 Oleic Acid Buchs, Switzerland Evolve
93792 103893 Benzenesulfonic Acid Buchs, Switzerland Essential
G0674 137268 GlycylGlycine Cherokee, St. Louis MO Expert
PHG0001 137270 HEPES Cherokee, St. Louis MO Evolve
PHG0002 108319 TRIS hydrochloride Cherokee, St. Louis MO Evolve
PHG0003 137271 MES hydrate Cherokee, St. Louis MO Evolve
PHG0004 137276 BIS-TRIS Cherokee, St. Louis MO Evolve
PHG0005 137269 BIS- TRIS propane Cherokee, St. Louis MO Evolve
PHG0006 137272 Guanidine hydrochloride Cherokee, St. Louis MO Evolve
PHG0007 137273 MOPS Cherokee, St. Louis MO Evolve
PHG0008 137274 MES sodium salt Cherokee, St. Louis MO Evolve
PHG0016 137275 Glycine Hydrochloride Cherokee, St. Louis MO Evolve
M8439 137250 L-Methionine, Ajinomoto Amino Acid, EP/JP/USP Cleveland, Ohio Expert
RES0113M-A7 137256 MES Cleveland, Ohio Evolve
RES0114M-A7 137257 MES, Sodium Salt Cleveland, Ohio Evolve
RES0197M-A7 137258 MOPS, Sodium Salt Cleveland, Ohio Evolve
RES0704P-A7 137259 PIPES, Disodium Salt Cleveland, Ohio Evolve
RES10070-A7 137251 L-Asparagine Monohydrate, FCC Cleveland, Ohio Evolve
RES1161B-A7 137260 BIS TRIS Cleveland, Ohio Evolve
RES1164B-A7 137252 BIS TRIS Hydrochloride Cleveland, Ohio Evolve
RES1513C-A7 137253 L-Cystine Dihydrochloride, Non-Animal Derivative Cleveland, Ohio Evolve
RES2029D-A7 137261 Dextran sulfate sodium salt Cleveland, Ohio Evolve
RES3077T-A7 137262 Tricine Cleveland, Ohio Evolve
RES3098T-B7 108315 TRIS hydrochloride Cleveland, Ohio Evolve
RES3156T-A7 137254 L-Tyrosine, Disodium Salt Dihydrate Cleveland, Ohio Evolve
RES3193T-A7 137263 Tromethamine, USP, EP, JPC, BP Tested Cleveland, Ohio Evolve
RES5063G-A7 137255 L-Glutamic Acid, Mono Sodium Salt, Low Endotoxin Cleveland, Ohio Evolve
RES6003H-B7 137264 HEPES Cleveland, Ohio Evolve
RES6007H-A7 137265 HEPES, Sodium Salt Cleveland, Ohio Evolve
RES6008H-A7 137266 HEPES, Hemisodium Salt Cleveland, Ohio Evolve
RES6104H-A7 137267 Hypoxanthine, Sodium Salt Cleveland, Ohio Evolve

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