CGMP controlled Raw Materials

This webinar will help the attendee gain an understanding of the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. cGMP Raw materials that are used for product manufacturing has to be released for use in the production process. Guidance will be given as to the steps that every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials which includes the release for use in the manufacturing of products.
Why Should You Attend:

cGMP raw materials are the most critical ingredient of any product manufacturing step hence they must be controlled as stipulated in 21 CFR 110.80 Processes and Controls as well as applicable FDA regulations. Some manufacturers of drug products have received FDA 483’s and lost several batches of product due to lack of a defined raw material processing that showed acceptability through qualification tests, traceability, consistency and control of the incoming raw materials. Raw material control is therefore a very critical part that ensures drug product quality, purity and potency. Drug product manufacturers must have a clear understanding in preventing loss of expensively manufactured drug product because of the use of an adulterated raw material through a defined procedure that clearly shows how raw materials are received, stored, labeled, quarantined, tested, qualified, tracked, used, and discarded at the end of expiry.
This webinar will provide such guidance as to the process of ensuring that there all the steps are followed to avoid producing an adulterated product as defined by the 21 CFR 110.80 Processes and Controls. This webinar will provide a great resource to Pharmaceutical, Biotechnology and Medical Device Industries personnel that will like to have a clear understanding of the Designing the Receipt, Handling and Processing, Specification, Inventory Tracking, and Qualification of a cGMP Controlled Raw Materials.

Areas Covered in the Webinar:

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