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Quality Assurance The primary objective of the MPL quality system is to assure compliance with the FDA's current Good Manufacturing Practices 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 MPL, quality begins with the Design Control Process. Prospective products are reviewed by the Design Control team, which focuses on three key areas:
1. Comparing the requirements of the project with the company capabilities. 2. Clarifying customer specifications and expectations. 3. 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, MPL has a well-established internal audit program. Auditors have been trained in ISO auditing techniques, and audits are conducted to assure compliance with cGMP and conformance with ISO 9001:2000 and ISO 13485:2003 standards.
Registrations and Certifications Medical Products Laboratories, Inc. has been registered for drugs and devices with the United States Food and Drug Administration for more than 60 years. Recently MPL systems were evaluated by KEMA and found to conform to ISO 9001:2000 and ISO 13485:2003 CMDCAS standards. For your convenience, registration information is provided below:
FDA Labeler Code: 010733 FDA Device Registration: 2513595
MSDS Sheets for all General Product Lines FDA Drug Registration Document FDA Device Registration Document Last FDA Establishment Inspection Report MPL Catalog of Product Capabilities Form 1 Online Version for New Business Requests
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Please
click each link below to download a PDF: 
