QUALITY SYSTEM 2018-10-03T20:27:18+00:00

GMP QUALITY PROCESS

General:

Quality Policy Manual
GMP/OTJ Training program
Product coding System and Lot numbering system
Planned Deviation system
Deviation (Discrepancy/Quality Investigation) System (timely customer notification)
Out of Specification procedures (timely customer notification)
Non-conforming Material Review system (timely customer notification)
Material Review Board – Should include customer participation
Change Control Procedure (timely customer notification)
Corrective and Preventive Actions (CAPA)
Supplier Qualification
Contract Testing Laboratory Qualification
Manufacturing Hold System

Documentation:

Controlled Documents (Standard Operating Procedures )- describe what they are, how they are generated, controlled and used.
Test Methods – format, content, control and use
Document Approval Policy
Document Coding System
Document Change Review and Approval
Storage of Records

Facilities and Equipment:

Validation Master Plan
Routine and Preventative Maintenance
Calibration System
Temperature Monitoring
Environmental Monitoring

Labeling:

Printed Material Coding system
Generation, Ordering and Inspection of Clinical Labels and Labeling – describe procedures for label generation, inspection and release of labeling materials.  Must include Customer approval of label copy and proofs.
Labeling and Packaging of API/Bulk Materials
Labeling and Packaging of Drug Product

Review of Product Documentation and Release of Materials:

Batch Record Review and Approval
Testing Data Review and Approval
Disposition of Product (copies of completed records to customer)
Certificate of Compliance
Certificate of Analysis (if applicable)

Material Handling:

Component and Raw Material Receipt, Quarantine and Release procedures
Transfer of bulk to Fill/finish Facility
Transfer of Labeled and Packaged Material to Distribution Facility
Dispensing and Shipping of Drug Product for Investigational Use and Clinical
Trials

CBD INC QUALITY CONTROL

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