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
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
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
- Certificates of Compliance
- Traceability of Production
Questions? Planning your visit?
Please contact our Corporate Quality Assurance Manager, Shane
Toll-free in the United States: 800-421-4772 x103 or 314-427-4300
x103 Fax: 314-427-5445 Email: email@example.com