Quality System

The more complex the organization – the more interdependencies between the various links – the smaller number of independent chains it’s composed of.

E.M. Goldratt and J. Cox in The Goal, 3rd Edition (2004)

The Quality System is the totality of all of the integrated purposes and functions needed to build and maintain a facility to the expectations outlined in published cGMP / GMP standards.  With senior management’s commitment and the acquisition of necessary resources, the Quality System will be argyle and capable of responding to manufacturing issues as well as to the rigors associated with sourcing qualifying raw materials.  In turn, the Quality System houses and supports corporate policies, procedures, and processes – all with an aim to aid in preventing product defects.  By fostering a culture of quality, senior management and staff will periodically complete performance assessments to determine what areas within the Quality Systems will benefit from further improvements or expansions.

The following are a few additional subject areas that are relevant as part of the implementation and maintenance of the Quality System:

A) Planning

  • communications – these are critical operations that apply at both the intradepartmental level as well as the voice of the customer
  • product design / product optimization – in the early stages of a product development project, often during the benchtop stage, negative issues can be identified and remediated (thereafter maintaining cost effectiveness)
  • traceability at all stages of production – not only is this a tool for demonstrating the inherent safety of the products manufactured at Viva, it also establishes the evidence trail as to how the product was produced
  • servicing / maintenance for the facility and equipment – an ongoing program for maintaining optimal levels

B) Controlling

  • documentation – consisting of distant phases, namely, the document’s creation, its issuance, staff accessibility, and archiving
  • supplier qualification – an important step in maintaining consistency over the quality of the raw materials, packaging materials, and processing aids
  • process – were the performance markers can be measured, systematically reviewed, and, as required, the process itself can be updated
  • nonconforming product – the establishment of manufacturing targets, reproducible operations, robust inspections, and finished product specifications all aid in reducing product defects
  • labels, packaging materials and other printed items – a compressive series of reviews have been established where comparisons are made to the product’s market authorization as well as advertisement law

C) Improving

  • personnel training and qualifications – having knowledgeable staff employed is an integral part that leads to the overall success in maintaining the customer’s expectation of product quality
  • validating processes – an ongoing program that builds improvements of process, and control of variables, into the equipment trains that have been selected for product manufacturing
  • trending – statistical techniques are used to track longer timelines for the identification and correction of quality issues that may appear in either the process or the product
  • quality audits – internal and third party audits help to identify areas that need attention in order to maintain compliance to cGMP / GMP requirements and contractual obligations