2018 - CGMP controlled Raw Materials

Regulatory Requirements for all Incoming cGMP Controlled Raw Materials:
What does the regulation say about raw materials that are received for cGMP use
Receipt and Storage of cGMP Controlled Raw Materials
Delineation of Raw Materials
Critical
Non-critical
Acceptable Storage of cGMP Controlled Raw Materials
Control of Conditions (Temperature and Humidity Control)
Control of Location (Lock and Key)
Quarantine, Segregation and Labeling Requirements
Testing and Qualification
Approval and Release for use
Disposition and Release for Use Requirements
Dispensing and Traceability (Tracking)
Discarding and Reconciliation
Processing New cGMP Controlled Raw Material Specification
Receiving and Handling of cGMP Controlled Raw Materials
Processing the cGMP Controlled Raw Material Specification
Changing cGMP Controlled Raw Material Specification
Retiring cGMP Controlled Raw Material Specification
Procedure for Raw Material Initial Receipt
When Quality Control Sampling is Required
Processing cGMP Controlled Raw Materials
Assessment and Determination of the Criticality of the cGMP Controlled Raw Materials
Performing the Verification Checks
Testing Requirements for all Incoming cGMP Raw Materials
New and Unqualified cGMP Controlled Raw Materials (Initial Qualification)
Acceptable Testing Programs and Frequency
Test Requirements for Routine and Confirmatory Testing of Qualified cGMP Controlled Raw Materials
Already qualified cGMP Controlled Raw Materials (Subsequent Qualification)
Acceptable Testing Programs and Frequency
Routine and Yearly Confirmatory Testing for Suppliers and Manufacturers of Qualified cGMP Controlled Raw Controlled Materials
Acceptable Testing Programs and Frequency
Review of Supplier Approved Status
Review of Initial Qualification
Review of Quality History
Review of Comparison Criteria
Review of Appropriate Intervals
Evaluation of Suppliers and Manufacturers of cGMP Controlled Raw Materials after Approved Specification Changes
Review of Previous acceptance of affected cGMP controlled raw materials.
Review of the affected change and potential product impact and batch
Disqualification of cGMP Controlled Raw Materials Test Parameters
When can a cGMP Controlled Raw Material Testing test parameters be disqualified.
Requirements for the Comparison Criteria Used in the Confirmatory Yearly Testing
When comparison criteria can be used in lieu of a full qualification.
How to establish and document comparative analysis in lieu of full controlled material testing.
cGMP Controlled Raw Material Confirmatory Testing Process
Outline of the process for completing the yearly controlled material confirmatory testing.
Issuing and Approving cGMP Controlled Raw Materials Specification
How cGMP Controlled Raw Materials are issued and release
Processing Failed cGMP Controlled Raw Materials
How to handle a cGMP Controlled Raw Material with a failed result.
Documentation of cGMP Controlled Raw Materials
Documentation Practices and Required Documentation to Satisfy Qualification
Issuance of Specifications
Investigating OOS Associated with Rejected cGMP Controlled Raw Materials
How to investigate a failed cGMP controlled raw material initial and subsequent qualification testing.
Documentation the OOS Investigation of Rejected cGMP Controlled Raw Materials
What to do with Existing cGMP Controlled Raw Materials in Quarantine