Lecture 5

Question 1

What contents should a quality manual have if the QMS is based on the EU PQS?

Answer 1

Quality policy: Provides direction and vision for the organization.
Scope of the PQS: Defines the areas covered by the QMS.
Identification of PQS processes: Describes their sequence, linkages, and interdependencies.
Process maps and flowcharts: Visual depiction of PQS processes.
Management responsibilities: Clearly defined within the PQS.

Question 2

What should be included in the section on personnel in the quality manual?

Answer 2

The manual should explain how the organization ensures the suitability of personnel, aligning with Chapter 2 of EU GMP.

Question 3

What should be included in the section on premises and equipment in the quality manual?

Answer 3

The manual should detail how suitable premises and equipment are maintained, matching Chapter 3 of EU GMP.

Question 4

What should be included in the section on documents and records in the quality manual?

Answer 4

The manual should describe how documents and records are controlled, aligning with Chapter 4 of EU GMP

Question 5

On what should the typical structure of a quality manual be based?

Answer 5

It should be based on the standard it follows, such as EU GMP. For example, if following EU GMP, it should have sections corresponding to each of the nine chapters of the EU GMP.

Question 6

What are the advantages of having a quality manual?

Answer 6

Provides guidance and direction for personnel.
Offers insight into the organization.
Serves as a tool to promote the organization, highlighting its commitment to quality and its QMS.