Q-People delivers tailored made solutions within Quality and Compliance projects. We design and develop Quality Management Systems to guarantee the quality and safety of drug products.
Our guidance describes a model for an effective Quality Management System for the Pharmaceutical industry, based on the ICH Q10 model.
ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) quality concepts. It includes applicable good manufacturing practice (GMP) regulations and complements ICH Q8 Pharmaceutical Development and ICH Q9 Quality Risk Management.
ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements. ICH Q10 is not intended to create any new expectations beyond current regulatory requirements. Consequently, the content of ICH Q10 that is additional to current regional GMP requirements is optional.
We are specialized in these four areas: (1) management responsibility; (2) resources; (3) product realization and (4) evaluation.
Management Responsibility
- Overall QMS-model
- Management Review
- Quality Risk Management (QRM)
- CAPA Management
- Change Control Management
- Documentation and Record Management
Resources
- Learning Management
- Qualification of facilities and systems
- Quality Agreements for outsourced activities
Product Realization
- Manufacturing Operations
- Packaging Operations
- Logistic Operations
- QC Operations
- Validation
- Technology Transfer
Evaluation activities
- Deviation Handling
- Stability Testing
- Trending
- Complaint Handling
- Auditing
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