Quality Systems

SAFC® has multiple cGMP manufacturing locations worldwide for biochemical production and manufacturing of complex organic APIs and key intermediates. Therefore SAFC must meet many different regulatory requirements globally.  Our Quality Systems are designed to meet stringent regulatory requirements, but flexible enough for us to customize many specific items for your needs.

Quality Records and Batch Documentation

Product Specifications & Certificate of Analysis
Certificates of Analysis (CofA) report batch specific information and are available for all of our products. A CofA for your product may be available at Sigma-Aldrich Technical Services, or requested from our Technical Service group, and/or included with your shipment.

Our extensive Quality Control capabilities allow us to integrate custom testing and special statements on our CofA’s in order to comply with individual customers' regulatory and technical needs.

Analytical Test Methods
A number of the analytical methods used by the Quality Control groups to test SAFC products are available for your review. Specific analytical methods can be found at Sigma-Aldrich Technical Services or can be requested from our Technical Service groups. Depending on the request, SAFC reserves the right to disclose certain information under a Confidentiality Disclosure Agreement.  SAFC is able to develop custom analytical methods and to integrate additional testing for custom-made or customized products in order to tailor the testing to best fit your needs.

Product Information Sheets
Standard products include a product information sheet, which provides general product information or specific product usage instructions.

Product Information Sheets can be found at Sigma-Aldrich Technical Services, requested from our Technical Service group or may be included in the shipment.

Certificate of Origin
Origin information is available for the majority of the materials we offer. Information regarding the origin of a particular product is provided on a Certificate of Origin. Information can include:

• Source: Animal, Plant, Synthetic, etc.
• Country of Origin of biological material
• Biologic species
• Tissue used
• Additional source information as required by regulations

Review Sigma-Aldrich Certificate of Origin Policy (198 Kb PDF) (TSE/BSE) and Frequently Asked Questions.

BSE/TSE Declarations
Sigma-Aldrich has established an approach to assisting customers in assessing the risk regarding BSE/TSE, and when Animal Component Free is applicable: Sigma-Aldrich Certificate of Origin Policy (198 Kb PDF) (TSE/BSE) and Frequently Asked Questions.

Certificate of Suitability (CofS)
When the details are known regarding potential exposure to animal origin materials during a product’s manufacturing process, and the procedures are in-place to reduce the risk of cross contamination, SAFC will determine if a dossier will be filed with the European Directorate for the Quality of Medicines (EDQM) for that specific product. If requested, additional administration processing fees will apply. SAFC currently holds 19 TSE Certificates of Suitability at EDQM. SAFC is able to share our knowledge and expertise regarding Certificates of Suitability with customers whenever the need for a high TSE risk material is identified.

Product Labeling
Product information provided on the standard container label include:

• Product and Batch number
• Product Name
• Physical chemical properties
• Risk and safety statements in multiple languages with pictograms
• Regulatory information incl. country of origin, usage claim
• Storage and handling information

If you need additional label information, we may be able to customize it for your specific products or for your custom formulations. Contact your sales contact for details.

Drug Master Files
DMF’s are available for many of our products that have a significant potential to be used in a drug or regulated manufacturing environment by our customers. Access to these DMF’s is available by requesting an Authorization Letter. For your custom products, we can completely manage the process of filing a new DMF, or guide and assist you in the filing of your own DMF’s with the FDA. For submission to European Authorities (EMEA), the DMF can be developed under the CTD format.

MSDS
Material Safety Data Sheets are available for our standard products and can be found at Sigma-Aldrich Technical Services.

Technical Resources
A wide range of technical resource documents including catalogs, data sheets, citations, structures, formulations, and brochures are available from our Sigma-Aldrich Technical Services or by contacting your local SAFC office.

SAFC's Technical Services
SAFC provides a Technical Services Team to specifically address SAFC's customers. This team consists of highly skilled scientists concentrating on Regulatory Support and Customer Support. Specific technical documents are also available.

Customer Audits

At SAFC we are proud of our facilities and welcome Quality audits by our customers.  Your feedback helps us to continuously improve our Quality Systems.

1. Scheduling
   We request that adequate notification be provided (30-days prior to visit) and that an agenda be sent from the customer within 2-weeks of the requested audit date(s).
2. Review & Evaluate
   During your audit we invite you to review and evaluate our many Quality System programs that are designed to maintain product control and allow us to produce high quality products consistently lot after lot.
   
   • Design Control
   • Validation
   • Change Control
   • Supplier Qualification
   • Document Control
   • Comprehensive Training
   • Corrective and Preventive Action
   • Process Control
   • Equipment Qualification
3. Contact Information
   Contact your local SAFC office for further information about scheduling an audit

Regulatory Affairs

SAFC offers a deep knowledge of all relevant international guidelines and regulations and is committed to stay at the forefront of the evolving regulations. SAFC is also ready to provide regulatory guidance to our customers.

SAFC has an experienced regulatory team that works to aid customer requirements for development programs such as Drug Master File (DMF) submissions, CE Mark technical files and Certificate of Suitability (C of S) declarations etc. to the appropriate governing body when applicable.

SAFC has a solid regulatory history and maintains multiple FDA inspected facilities around the world. SAFC is willing to offer full cooperation to all requests for Government or regulatory audits of our cGMP facilities.

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