Our manufacturing process integrates the finest FDA-approved raw materials with state-of-the-art equipment and stringent quality control procedures at every station on the line. All manufacturing and warehousing is conducted in a sealed, clean, air-conditioned environment.

Come for an Audit; Here's What You'll Find

Raw Materials: We use only FDA-approved raw materials in our manufacturing processes. Raw material data sheets and Certificates of Analysis are available to our customers upon request.

Specifications: Rigid manufacturing standards ensure compliance to every specification. Standards apply across the entire manufacturing process, from preparing equipment for production to finished product quality control.

Training: Ongoing and documented training programs ensure compliance to standard operating procedures by all associates. We monitor and enforce our quality procedures and policies throughout our manufacturing and warehousing operations.

Preventive Maintenance Program: Efficient, well-maintained equipment produces higher-quality products. Alpha Packaging's rigid PM program reduces down time as it ensures the highest level of efficiency from our equipment.

Calibration: Regular calibration of lab equipment helps us sustain the highest levels of quality assurance.

First Piece Approval: A series of checks at production startup ensures proper machine settings and production to approved specifications. Once the equipment has been adjusted, we inspect the first few bottles. We also document machine number, lot number, bottle code, raw material sources, label information, packaging parameters, label panel diameter and land area analysis.

Hourly Checks: The following areas are evaluated every hour, 24 hours/day: gram weights, neck dimensions, taper/concavity, wall thickness, overall dimensions, surface treatment, short shot, leak check, cycle time, color and appearance.

Internal Audit: Our audit team continuously oversees and critiques all of our manufacturing and warehousing operations. Irregularities are documented and addressed immediately.

Corrective Action: Should we receive a customer complaint, Alpha's Corporate Quality Assurance Manager, Shane Jordan, personally intervenes on the client's behalf, communicating with the client and ensuring the problem does not recur. In addition to the above outlined procedures, we also provide:

• Drug Master File
• Compliance to USP XXVI Testing
• Certificates of Compliance
• Traceability of Production

Questions? Planning your visit?

Please contact our Corporate Quality Assurance Manager, Shane Jordan.

Toll-free in the United States: 800-421-4772 x103 or 314-427-4300 x103 Fax: 314-427-5445 Email: shanej@alphap.com