Quality Assurance
BioTechLogic can perform Quality System Assessments in accordance with the FDA's Quality Systems for the 21st Century Initiative and ICH directives Q8 (Pharmaceutical Development), Q9 (Risk Management) and Q10 (Quality Systems). BioTechLogic will perform Quality Systems Evaluations and Audits, develop detailed recommendations, and outline mitigation strategies and plans where deficiencies have been identified.
BioTechLogic’s team has developed and implemented Quality System Programs for Biopharmaceutical products, Medical Devices and Combination Products. Our team has also provided regulatory support for U.S., Canada, and EU products, and supplier management including assessment of quality systems in compliance with 21 CFR 820, 21 CFR 210/211, ISO13485, Medical Device Directives 93/42/EEC, Canadian Medical Device Regulations, and EU-GMP.
Examples of Our Quality Assurance Services:
BioTechLogic assessments focus on the following areas:
- Quality Policy and Objectives
- Quality Manual
- Quality Plan
- Quality System Procedures and Instructions
- Corrective Action and Preventative Action (CAPA)
- CAPA Data Sources
- CAPA Data
- Failure/Deviation/OOS Investigations
- Management Review Program
- Organizational Structure
- Manufacturing and Process Controls
- Resource Management
- Continual Improvement and Evaluation – Quality Audits
- Quality Risk Management
BioTechLogic can support a client's Quality Assurance department by reviewing documents and identifying actions required to meet regulatory requirements and ensure product quality.