FDA Regulated Facility Using cGMP Principles
CWS Contract Packaging is and has been a FDA Regulated facility since January 2000 and holds compliances to the following FDA Regulations:
- 21 CFR Part 210 & 211 cGMP in Manufacturing Practice, Packing, or Holding of Drugs
and Finish Food
- 21 CFR Part 110, Current Good Manufacturing Practice, Packing, or Holding Human Food
- 21 CFR Part 820 Quality Systems Regulation, Good Manufacturing Practice for the
Medical Devices
- 21 CFR Part 701, Cosmetic Labeling
- 21 CFR Part 101, Food Labeling
CWS Contract Packaging has approximately 50,000 square feet dedicated to Pharmaceutical packaging for all types of industry secondary packaging applications. We can provide front to end services for our customers requirements.
ISO 9001: 2000 Certification
CWS Contract Packaging holds certification to ISO 9001:2000 Standard (ANSI/ISO/ASQ Q9001:2000).
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies. The adoption of this Quality Management System at CWS Contract Packaging is a strategic method adopted to give our customers the highest possible product and services found in the industry for Commercial and Pharmaceutical.
It is our aim to enhance customer satisfaction through the effective application of the ISO Standard principles that include processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements such as FDA, UL, CSA, DOD, USDA etc...
Statistical Analysis Capabilities
CWS Contract Packaging can validate processes and products through the use of Statistical Analysis and performance studies if required by its customers. CWS Contract Packaging utilizes QI Analysis 3.0 software to perform capability studies as a requirement for the validation of methods, processes and products. Past and present capability and performance studies have shown CWS performing to Six-Sigma capabilities within many areas of our business.
Product and Processes Research, Development and Design Capabilities
CWS Contract Packaging is a full Research, Development and Design company with experience and knowledge to take a product from design to the manufacturing floor. CWS Contract Packaging Engineers using the latest technology and software can professionally develop product, processes etc... per the specifications and requirements of its customers.
Through the use of the latest software such as AutoCAD 2005 we can design the manufacturing processes and equipment that is efficient and cost effective.
Prototyping and tooling requirement capabilities are within CWS Contract Packaging. We have a complete Tool Room within our facility and can perform most machining requirements as requested by our customers.
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