This comprises all the documents that form part of the company’s quality management system. This includes documents such as the quality policy, quality procedures, work instructions, and records. These documents are arranged in a definite hierarchy based on their scope.
Fig.: Quality Documentation Pyramid
Quality policy/ Manual: Describes the quality system
and what is to be done as an organization to implement it. Also answers the
question of why this quality system is being implemented. In the pharmaceutical
industry, this part will include the regulations to be followed by the company
such as USFDA guidelines/ICH guidelines/Schedule M requirements/WHO-GMP
requirements, etc.
Quality Procedures: Describes how the quality system
will be implemented, methods to be used, who should do what, when, and where.
More detailed than a policy document.
Work Instructions: Specific to departments, and spell
out details of how each task is to be done. Detailed instructions are given,
and may include diagrams, job sheets, etc. In the pharma industry, this is
represented by SOPs.
Records: Evidence documents that prove that quality
policy, procedures, and work instructions have been implemented as directed. In
the pharmaceutical field, this includes batch manufacturing records, QC test
reports, validation documents, etc.