If you need QA advice, or complete design and management of your QA systems, or something in between, Draco can help.
QA & QM - Quality Management / Lot Release
Set-up, training, and ongoing management or management support of quality assurance processes, including product release
Standard Operating Procedures
Expert development of Standard Operating Procedure documents (SOPs) and related staff training, and/or review of existing SOPs to ensure that they meet current standards and regulatory requirements
Quality Assurance Systems
Development of compliant quality assurance plans for
- complaint handling
- returned goods handling
- validation
- recalls
- document control
Facilities & Temperature Control
Facilities auditing, and development of compliant quality assurance programs and systems for
- warehousing & storage
- temperature mapping & monitoring
- transportation procedures and documentation
Good Manufacturing Practice Audits / GMP Audits
- Thorough internal GMP self-inspections to GMP standards
- Quality assurance inspections
- Quality assurance surveillance plans
- Surveillance audits and/or support during government audits of contractors and suppliers
Documentation Management
- Creation and managment of quality assurance documents
- Detailed specification development
- Preparation of regulatory documentation
- Development of document control systems
GMP Training
Effective customized GMP training programs for experienced and new employees
On-Site Support
Available on-site support ensuring operations compliance and available on-site support during inspections by regulatory officials
