Complete Quality Management System Documentation Package (Draft Framework)
Full set of core QMS SOPs and templates.
38 500 Skr
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Purpose:
This documentation package provides a comprehensive draft framework of core Quality Management System (QMS) SOPs intended to support the establishment or enhancement of a pharmaceutical quality system.
Regulatory Alignment:
EU GMP pharmaceutical quality system principles and commonly applied quality system expectations. This package is provided as a draft framework and requires company-specific adaptation prior to implementation.
Included Files:
• Draft SOPs covering core QMS processes, including document control, training and competence management, deviation and non-conformance management, CAPA, change control, quality risk management, internal audit, management review, and supplier qualification and oversight
• Supporting templates and forms associated with each SOP
Format:
Microsoft Word (fully editable)
Intended Users:
Pharmaceutical companies, marketing authorisation holders, manufacturers, distributors, and quality assurance teams seeking to establish or structure a compliant pharmaceutical quality management system.