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The primary objectives of the PJN quality system are to insure 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 P. J. Noyes, 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; and
- 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.
Other documents generated during production are added to this packet to capture a complete history of the product.
In addition, all inventory transactions are recorded electronically in our
Enterprise Resource Planning system, which gives complete and quick lot traceability.To
ensure continuous improvement and confidence in its quality system, P.J. Noyes
has a well-established internal audit program. Four lead auditors have been
trained in ISP auditing techniques, and regular audits are conducted with teams
of volunteers from throughout the company.
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