Highlights of our Quality Control Systems
Raw Materials
Only FDA approved raw materials are used in the manufacturing process.
Raw material data sheets and Certificates of Analysis are available
to our customers upon request.
Specifications
Every component we manufacture must conform to our rigid manufacturing
specifications. These standards are used to prepare our equipment
for production, and used continuously during the manufacturing process,
to insure compliance to the specifications.
Training
We provide ongoing and documented SOP training programs for all
employees. We monitor and enforce our quality procedures and policies
throughout our manufacturing and warehousing operations.
Preventive Maintenance Program
A rigid preventive maintenance program is in place to ensure the
highest level of efficiency and quality from our equipment with
less down time. This program helps to eliminate manufacturing defects
due to equipment failure or malfunction, prior to production.
Calibration
Our quality system includes calibration of our QA lab equipment
on a regular basis as a further means of quality assurance.
First Piece Approval
Production start-up is regulated by a series of checks to insure
proper machine settings and production to approved specifications.
Once the equipment has been properly adjusted, the first few bottles
are immediately inspected. We also document machine #, lot #, 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 visual.
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 Quality 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 XXIII Testing
• Certificates of Compliance
• Traceability of Production
Questions ?
Should you have additional questions or comments about our quality
programs/systems, please contact:
Mr. Shane Jordan
Phone: 800-421-4772 or 314-427-4300
Fax: 314-427-5445
Email: quality@alphaplastic.com |
