Sigma-Aldrich is a global company with sales, manufacturing, and distribution facilities in 38 countries. Many of these locations have quality systems that adhere to the requirements of ISO 9001 and have received third party accreditation. Sigma-Aldrich also operates many facilities in compliance with one or more current Good Manufacturing Practices regulation or guideline for APIs, Excipients, and Medical Devices. Other sites are currently working to enhance their current quality systems that would meet the requirements of a recognized standard.
The ultimate measure of our success can be found in the success of our Customers, Shareholders and Employees.
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Quality System Overview
Sigma-Aldrich is a global company with sales, manufacturing, and distribution facilities in 34 countries. Many of these locations have quality systems that adhere to the requirements of ISO 9001 and have received third party accreditation. In addition, Sigma-Aldrich has multiple manufacturing locations that are registered with the FDA and operate under cGMP. Other sites are currently working to enhance their current quality systems that would meet the requirements of a recognized standard.
ISO Quality Systems and Certificates
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Where it is necessary Sigma-Aldrich has the capabilities and resources needed to address regulatory requirements such as Drug Master File (DMF) submissions, CE Mark technical files and Certificate of Suitability ( C of S ) declarations to the appropriate governing body.
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Quality System Details
Strategic Plan and Management Review
Sigma-Aldrich has a comprehensive strategy plan which includes a comprehensive strategic plan which included an emphasis on enhancing the Quality Management System. This plan is continuously evaluated and adjusted to ensure Sigma-Aldrich objectives are achieved. In addition, many locations also conduct Management Reviews of their site Quality Management System at prescribed intervals.
The majority of locations within Sigma-Aldrich have a Quality Manual, which provides information on the elements of the Quality Management System for that location including the sequences and interactions of the primary processes.
Quality Management System policies and procedures are maintained under document control. Procedures include administration, manufacturing, analytical methods, equipment operation and others.
Sigma-Aldrich sites have established training programs that include core and job specific requirements. Core training can include quality system, safety and developmental topics. In addition to job training, each position has a written job description that describes the necessary educational and experience qualifications to adequately perform the required tasks.
Corrective and Preventive Action
Each site has established a Corrective and Preventive Action procedure to identify areas for improvement to current products and processes and to implement actions that will prevent issues from reoccurring or happening at all.
Customer complaints are communicated to the appropriate site for review and if necessary investigation. These locations have procedures that define how the complaint is investigated and, when applicable, the corrective actions implemented. The procedures define the actions necessary to accomplish field corrections or recall. In the event of a recall, affected customers will be identified and contacted.
Internal audit programs have been established at each location to ensure the integrity and continuous improvement of the Quality Management System.
Quality audits by our customers are permitted at our facilities. 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). Sigma-Aldrich reserves the right to cancel or revise the audit schedule.
Sigma-Aldrich is willing to offer full cooperation to all requests for Government or regulatory audits of our facilities.
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Our supplier's (materials & services) can be qualified using a combination of criteria such as, assessment questionnaires, on-site audits, historical performance (quality, on-time delivery) and/or third party accreditation. A supplier may become "Rejected" after non-compliance with the Sigma-Aldrich expectations. New and alternate suppliers are qualified as necessary to maintain product supply, purity and competitiveness.
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QA / QC Staffing
The Sigma-Aldrich Quality Assurance / Quality Control program staffs over 350 employees world-wide at 18 different sites.
||QA / QC Staffing
|Bellefonte, PA USA
|Miamisburg, OH USA
|Milwaukee, WI USA
|Natick, MA USA
|Saint Louis, MO USA
(in cooperation with Honeywell)
|Sheboygan Falls, WI USA
|The Woodlands, TX USA
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Documentation exists for providing appropriate instructions for producing and testing final product. If changes to the manufacturing or testing process is warranted the work instruction document(s) will reflect the procedural change and approval.
Critical equipment, defined as equipment where monitoring and output are controlled and recorded, is maintained in a calibration and testing program. Where applicable, traceable standards (e.g. NIST) are utilized. Documented procedures exist for equipment operation, calibration and maintenance, and can also include how equipment is cleaned. Equipment and usage records are maintained and available. Equipment tags are also employed to further indicate equipment calibration and maintenance status.
Where appropriate quality records for a product’s lifecycle within Sigma-Aldrich are maintained and available, quality records can include: customer inquiries including orders and complaints, raw material information, in-process manufacturing and testing data, packaging, final quality analysis, batch disposition, training and equipment. A product and batch numbering system is employed to allow for traceability throughout the entire process.
When a batch is determined to be nonconforming to product specifications, the batch is "flagged" in our electronic systems and may also be physically labeled and/or segregated to reflect this "blocked" status so as to prevent shipment. Procedures exist to describe this process.
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For most materials from our suppliers, Certificates of Analysis are received and reviewed. In addition if warranted, incoming materials may also pass through a physical quality inspection and review process. These materials will be maintained in a "Quarantined" status until the review is complete.
Research and Development, Manufacturing, Quality Control, Quality Assurance and Product Management/ Marketing functions are all involved with establishing product specifications. Customer and regulatory requirements, market demand, and process capability are considered in specification development.
Accessibility and Control
The majority of general catalog product's specifications are available to our customers and employees. A product specification is considered a controlled document, in either an electronic format and/or in hardcopy, and is handled as such, with revision control, approval and issuance. Any special customer specification(s) are maintained as confidential. Confidential specifications are disclosed only to personnel who are authorized access as part of their job function.
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Product / Batch Documentation
Product Specifications & Certificate of Analysis (C of A)
The majority of Sigma-Aldrich products have established product specifications. A product's specification information may be found on the Certificate of Analysis, catalog listing and/or on the label. Certificates of Analysis report batch level information including:
- Formula & formula weight
- CAS number
- Analytical test results
- QC release date
- Authorization signature from the site that released the batch.
Certificates of Analysis can be found at www.sigma-aldrich.com , requested from our Technical Service group and/or included in the shipment. Customers will need to contact Customer Service for further information on how to arrange receiving Certificates of Analysis in the product shipment.
Analytical Test Methods
Some of the analytical methods used by the Quality Control groups to test Sigma-Aldrich products are available.
Specific analytical methods can be found at www.sigma-aldrich.com or can be requested from our Technical Service group.
Product Information Sheets
Certain products include a product information sheet, which provides general product information or specific product usage instructions.
Product Information Sheets can be found at www.sigma-aldrich.com , requested from our Technical Service group or may be included in the shipment.
Certificate of Origin
Information regarding the origin of a particular product is provided on a Certificate of Origin. Information can include:
- Origination Country
- 2 Source: Animal, Plant, etc.
- Biologic species: e.g. Bovine
- Tissue used: e.g. Plasma
- Additional source information (e.g. Age of animal)
Certificates of Origin can be found at www.sigma-aldrich.com or by request from our Technical Service group.
2 Source definitions:
Animal - An organized living being endowed with sensation and the power of voluntary motion, and also characterized by taking its food into an internal cavity or stomach for digestion; by giving carbonic acid to the air and taking oxygen in the process of respiration; and by increasing in motive power or active aggressive force with progress to maturity.
Plant - A vegetable; an organized living being, generally without feeling and voluntary motion, and having, when complete, a root, stem, and leaves, though consisting sometimes only of a single leafy expansion, or a series of cellules, or even a single cellule.
Synthetic - Produced by synthesis, especially not of natural origin.
Synthesis - Formation of a compound from simpler compounds or elements.
Organic - Of or designating carbon compounds.
Inorganic - Of or relating to compounds not containing hydrocarbon groups.
Natural - existing in or produced by nature (e.g. NaCl).
Microbial - A minute life form; a microorganism, especially a bacterium that causes disease.
Fermentation - Any of a group of chemical reactions induced by living or nonliving ferments that split complex organic compounds into relatively simple substances.
Recombinant - An organism or cell in which genetic recombination has taken place. Material produced by genetic engineering.
BSE / TSE Declaration
Limited to specific products where specific details are known regarding potential exposure to human or animal origin materials during final product manufacturing process. If requested, additional administration processing fees will apply.
Certificate of Suitability (C of S)
When the details are known regarding potential exposure to human or animal origin materials during a product's manufacturing process and the procedures are in-place to reduce the risk of cross contamination, Sigma-Aldrich 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.
Product information provided on the container label include:
- Product and Batch number
- Product Name
- Physical chemical properties
- Risk & safety statements in multiple languages w/pictograms
- Regulatory information incl. country of origin, usage claim
- 3 Storage and handling information
- 4 Customer PO and / or product number
3 Sigma-Aldrich defines the following long-term storage conditions on the label:
Shipping Conditions & Recommended Long-Term Storage (38KB PDF)
4 This option is available for bulk orders only, contact the Sigma-Aldrich Fine Chemical Division for details.
Material is available for retest for those batches in stock. Sample quantity availability will vary depending upon the product. Certain products may have retained material from batches no longer available. Inquire on availability for specific products.
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