Quality Management (QM) / Processes & Good Practices

CSO Pharma offers set-up, optimisation and consolidation as well as maintenance of your Quality Management (QM) system.

We implement your QM system according to current regulatory requirements and your individual needs. This includes in particular:

• GDP, wholesale license
• GVP, GCP
• GMP, GLP or ISO 9001, ISO 13485

We are at your service especially when an inspection or certification is required (i.e. wholesale licence).

We additionally support you if time matters, lack of resources or capacity constraints or if you just would like to outsource parts of your QM system for strategic reasons.    

QM-System

• Development of an efficient QM system / GxP processes
• Interface management
• Technology for lean management of quality systems / GxP processes
• Preparation of contracts, supplier and contract management

SOPs (Standard Operating Procedures)

• Preparation and/or review and update of SOPs (Standard Operating Procedures)
• Professional process development / flowcharts
• Planning and realisation of suitable SOP training considering content, topics, methods and media including success control (e.g. MC-test, question list, group test, electronic testing)

Audits

• Auditplans
• Support of self inspections / friendly audit
• Audits / 3rd Party Audits
• Preparation of corrective action plan (CAP)
• Follow-up

Product Quality Reclamations, Quality complaints

• Initial receipt of pharmaceutical complaints
• Processing and management of product quality complaints
• Analysis

Establishment of QM tools

• Risk management
• Management review
• Training system
• Validation, Qualification
• Continuous improvement, KPI establishment

If desired we take over continuous maintenance, timely update and implementation of your SOPs according to regulatory requirements. Your needs and objectives are our central focus during implementation.

Please feel free to contact us. We are looking forward to support you.