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Quality manuals and quality policies in pharmaceuticals are developed in a structured way. Any quality manual has a similar structure that includes all the necessary elements of a quality manual. A good quality manual should contain the following:
1. Table of Contents
List of components and headings of various topics in the manual with the numbers of the pages where the sections are found. The table of contents is the most important element of a quality manual because it indicates the summary of the elements.
2. Background information
It describes the location, name, purpose, scope, aims and objectives, strategy and history of pharmaceutical services and products.
3. Purpose and scope
Quality management is achieved at certain times within certain norms to ensure how the quality manual will be used in the pharmaceutical industry. Also explains and justifies why regulations need to be followed and why others are not followed in the pharmaceutical industry.
4. Quality policy
Statement on how the pharmaceutical industry works to ensure that quality of service to customers and employees is met and that set objectives are met. It provides assurance and sets the expectations of the company’s stakeholders.
5. Products, Responsibilities and Roles
Roles and responsibilities if various stakeholders in the pharmaceutical industry. Description of products available in pharmaceutical industry, usage, general prescription and distribution strategy for marketing. Flow chart diagrams can be used to describe responsibilities and roles.
