QUALITY SYSTEM 2018-09-19T20:12:15+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

GMP QUALITY PROCESS

General:

Quality Policy Manual
GMP/OTJ Training program
Product Coding System and Lot Numbering System (unless using contractor’s system.  Should have procedures to assure that consistent lot numbers are used in all of the documentation)
Specifications and Certificates of Analysis – describe how specifications are established & made effective, generation and approval of a certificate of analysis
Qualifying Contractors
Quality Agreement between CMO and Sponsor Company
Audit Program – must include audits of CMO’s and other contract organizations
Planned Deviation system
Deviation (Discrepancy/Quality Investigation) System
Out of Specification procedures
Non-conforming Material Review system – for failing materials
Material Review Board
Corrective and Preventive Actions (CAPA)
Change Control Procedure
Stability Testing Guideline
Product Specific Stability SOPs – Bulk and Final Product
Stability Protocol for Master/Working Cell Bank
Reference Material – how established, characterized and stability program
Analytical Standards – how established, characterized and stability program
Requesting Drug Product from a Contract Manufacturer
Recall and Withdrawal of Product
Product Complaint System
Adverse Event Reporting Procedures
Development Report Preparation
QA Reserve Sample file

Documentation:

Controlled Documents (Standard Operating Procedures) – a document to describe what these 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

Review of Product Documentation and Release of Materials:

Review and Approval of Contract Manufacturing Batch Record
Review and Approval of Testing Data
Disposition of bulk Product for Further Processing – necessary for API (bulk drug substance) to be shipped to fill/finish facility
Disposition of Product –product release procedure and documentation

CBD INC QUALITY CONTROL

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