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 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

Who Will Benefit:

This topic applies to personnel/companies in the Pharmaceutical, Biotechnology and Medical Device Industries. The employees who will benefit most include:

• Quality Control Analysts and Management
• Senior Management
• Manufacturing Associates and Management
• Shipping, Receiving, Warehouse Personnel and Management
• Raw Material Receipt and Testing Personnel
• Quality Assurance Analyst and Management
• Quality Engineering Personnel and Management
• Supplier Quality and Auditors
• However, if you are already familiar with the Designing the Receipt, Handling and Processing, Specification, Inventory Tracking, and Qualification of a cGMP Controlled Raw Materials you may recommend this webinar to anyone in your company that has questions about the this subject.