The QA group collaborates with BPDF production and Quality Control (QC) staff to generate technology transfer and method development documentation, oversees process and product qualification/validation protocols and reports, and develops the design and content of client manufacturing records. The QA group ensures that GMP activities meet client expectations by assessing the quality of incoming materials, monitoring manufacturing processes, and reviewing all production-related documentation prior to product release.
The BPDF Quality Assurance (QA) group ensures that activities are performed in compliance with the Quality System.
Responsibilities include:
- Maintenance and control of Quality System documents:
- Quality Manual
- Standard Operating Procedures
- Work Instructions
- Forms
- Master Batch Records
- Test Methods
- Specifications
- GMP Production Records
- Supply Chain/Materials Management
- Issuance and review of GMP Production Batch Records
- Process monitoring and improvement
- Personnel training and maintenance of training files
- Internal audits, investigations and CAPA
- External audits by clients and regulatory bodies
- Review and approval of process and analytical method qualifications
- Oversight of IQ, OQ, and PQ executions
- Calibration and maintenance of equipment used in GMP activities
- Oversight of facilities/utilities maintenance, cleaning, and environmental monitoring
The QA group collaborates with BPDF Production, Quality Control, and clients to develop client-specific documentation for each project. QA issues GMP production batch records, and QA and Production review them prior to transfer for client review and approval. Once records have been approved, QA releases the product with the appropriate certificate(s).