Quality policy
Describe the organisation’s quality commitments.
PHARMACEUTICAL DOCUMENT LIBRARY · QM
Pharmaceutical Quality Manual
Explore Quality Manual documents for describing your pharmaceutical quality system, its policy, responsibilities and connected processes. Review each published document’s contents and preview before choosing a template.
Quality Manual documents
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Quality Manual: purpose and scope
ICH Q10 describes a Quality Manual or equivalent documentation approach covering quality policy, system scope, linked processes and management responsibilities.
System scope
Identify the activities covered by the quality system.
Management responsibilities
Define ownership, authority and oversight.
Linked quality processes
Show process relationships and supporting procedures.
Monitoring and improvement
Describe monitoring, CAPA, change management and management review.
Document maintenance
Keep approved information current with the site’s operations.
Choose the right Quality Manual document
For QA teams, quality-system owners and site management.
Quality Manual template
Check scope, responsibilities and supporting references.
Quality Manual preparation SOP
Check how drafting, approval and maintenance are controlled.
Common questions
Is a Quality Manual the same as an SMF?
The manual describes the quality system; an SMF describes a specific manufacturing site.
Does a manual replace SOPs?
Reference the detailed procedures that implement the quality system.
Can I use a template immediately?
Complete site details and obtain the required review and approval first.