The primary objective of the SWEETCON quality system is to assure compliance with the FDA's current Good Manufacturing Practices


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Quality System And Quality Assurance

Home • Quality System And Quality Assurance

The primary objective of the SWEETCON quality system is to assure compliance with the FDA's current Good Manufacturing Practices (cGMP) and to meet customer specifications. Written Standard Operating Procedures are maintained and followed for receipt, testing and storage of raw materials and packaging components, production and packaging, in-process checks and cleaning, and release of finished product to the customer. In addition there are procedures for ancillary processes such as stability testing, process validation, controlling documents, laboratory processes, calibration protocols, etc.

At SWEETCON, quality begins with the Design Control Process. Prospective products are reviewed by the Design Control team, which focuses on three key areas

Comparing the requirements of the project with the company capabilities.

Clarifying customer specifications and expectations.

Designing the process flow to control and accomplish the project on a timely basis.

The Design Control Process culminates in the production of a Master Formula Record, which accompanies the product through the system. Another output of the design control process is the Product Master File, a complete manufacturing specification and instruction set which becomes the foundation of our Validation Processes.

To ensure continuous improvement and confidence in its quality system, SWEETCON has a well-established internal audit program. Auditors have been trained in ISO auditing techniques, and audits are conducted to assure compliance with cGMP, ISO 9001:2000 and other regulatory requirements.