Quality

Quality Mission Statement:

The mission of Quality at P. J. Noyes is to provide customers, suppliers, regulatory agencies, and employees the tools, information, and support to ensure consistent output of quality products and services.

Objectives:

  • To ensure compliance with the FDA's current Good Manufacturing Practices
  • To meet customer specifications
  • To provide a high level of traceability for all materials used as well as every product manufactured and/or packaged by P. J. Noyes

Operating Procedures:

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.

Design Control Process:

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:

  1. Comparing the requirements of the project with the company’s capabilities
  2. Clarifying customer specifications and expectations
  3. Designing the process flow to control quality and complete 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 validated quality management software system, which gives complete and quick lot traceability.

Internal Audits:

To ensure continuous improvement and confidence in its quality system, P. J. Noyes has a well-established internal audit program. Lead auditors have received required training and are qualified to perform internal audits as scheduled by the P. J. Noyes audit manager. Audit teams are assembled and perform a minimum of five internal audits annually. Audit teams consist of a lead auditor as well as a team of trained auditors from departments throughout the company.