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The pharmaceutical industry is one of the fastest growing and sensitive sectors dealing with medicine, patients, medicinal drugs and pharmacists. It needs to be handled carefully to avoid risk to people at risk. Thus rules and regulations governing operations within the pharmaceutical industry are set and strictly followed to enhance service and product quality.
The introduction of quality manuals and quality policies in pharmaceuticals has helped maintain norms.
What is the Quality Manual?
It is simply a document that describes the quality management principles of a pharmaceutical company The document explains the various regulations, roles, responsibilities performed by the various parties and stakeholders that make up the pharmaceutical industry. This applies to externally affected workers such as patients and customers and to internal workers such as manufacturers and other workers.
The main purpose of the quality manual is to explain the scope of the total quality management program and the organization’s rationale, the interaction between the quality management system and the quality policy.
Quality manual structure
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 ingredients and headings of different subject sections in the manual with numbers where they 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. Objectives and scope: How the quality manual will be used in the pharmaceutical industry to ensure that quality management is achieved within specific norms at specific times. 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 implemented. 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.
6. References: List of regulations included in the manual.
