During the course of our work we often find that there is little understanding of what a quality manual is and what should be in it.
Simply, the quality manual forms the basis for your quality system and is the ‘what you do’, whereas the SOPs are the ‘how you do it’.
As with all quality system documents, keep your quality manual to the point, avoiding lengthy preamble and long narratives. Remember your target audience, your quality manual should be accessible to all your staff.
Although not definitive, here are some suggestions for the contents of your quality manual:
o A brief introduction to your company.
o Company Profile – Scope of Activity, Exclusions, Quality System Objectives
o Process Flowchart – a simple flowchart showing the main activities of your company and how they interlink.
o Organisation Chart & Management Responsibility
• SECTION 1 – Quality Management
• SECTION 2 – Personnel
• SECTION 3 – Premises & Equipment
• SECTION 4 – Documentation
• SECTION 5 – Operations
• SECTION 6 – Complaints, Returns, Suspected Falsified Medicinal Product & Medicinal Product Recalls
• SECTION 7 – Outsourced Activities
• SECTION 8 – Self-Inspection
• SECTION 9 – Transportation
Within each section, address the points and clauses of the Guidance, giving a brief outline of what you do.
Example:
Clause 2.3
Other Personnel: There are adequate, competent, personnel involved at all stages of the activities carried out and an organisational chart has been set out. The roles and responsibilities and inter-relationships of the personnel has been clearly defined.
PCL can help you plan and write your Quality system. For further information, please contact us on +44(0) 1252 302 342