One of the most daunting tasks performed by quality professionals is the prioritization of activities relating to “quality” or “FDA GMP Compliance”. Not only are there internal requirements from the various departments, there exists external demands from various customers and regulatory agencies. Everyone wants everything now and they all want it done correctly!
The purpose of a Quality Plan is to establish, evaluate and prioritize the company goals and include “Key Organizational Metrics.” Metrics are defined as projects performed to meet customer measurement requirements for quality. Keep in mind that customers should be defined as internal (interdepartmental, corporate, site to site, etc.) or external (regulatory agency, pharmaceutical customer, etc.).
This document is a GMP Compliance Guide for the formulation of a quality plan and the prioritization of the projects within the plan in order to meet FDA GMP Compliance. The plan should be dynamic – changing as warranted (e.g. – FDA requirements, as requested by new customers, following audits or as necessary due to expansion). Periodic meetings should be held with an applicable “quality plan team” to review the document and make any needed updates.
In order to gain an understanding of this process, it is necessary to have a rudimentary knowledge of the tool that is being incorporated to complete the plan.
GMP Compliance Guide – 5 KEYS TO SUCCESS
The initial meeting of this team should be to establish the basic outline of the project and set “rules” for the group. Rules may include time and dates for meetings, where to meet, how reports will be generated, etc.
An official “scribe” should be nominated to take notes that will be copied to each team member and to top management. The person leading the activities for the team should be established – usually this is done by top management and consists of either the Strategic Management Team Member or the representative from the quality unit.
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