cGMP Controlled Raw Material Testing Program

This webinar will help in understanding the proper design of cGMP controlled raw material processing for drug product manufacturing. This session covers a wide scope, including the receipt, testing, specification issuance, and processing of changes or retirements for controlled raw materials. Ensuring the release of cGMP raw materials for production is essential, and our guidance will walk you through the necessary steps every drug product manufacturer should follow.

cGMP raw materials are pivotal in the manufacturing process and must adhere to 21 CFR 110.80 Processes and Controls and FDA regulations. Some drug product manufacturers have faced FDA 483 observations and product batch losses due to undefined raw material processing, lacking qualification tests, traceability, consistency, and control of incoming materials. Effective raw material control is critical for product quality, purity, and potency, preventing costly losses.

Our webinar provides a clear roadmap for preventing the use of adulterated raw materials, guiding you through the receipt, storage, labeling, quarantine, testing, qualification, tracking, usage, and disposal of raw materials. We ensure compliance with 21 CFR 110.80 Processes and Controls, safeguarding product integrity.

This webinar is an invaluable resource for professionals in the Pharmaceutical, Biotechnology, and Medical Device industries seeking a comprehensive understanding of cGMP Controlled Raw Material design, receipt, handling, specification, inventory tracking, and qualification.

 Areas Covered in the Session :

PART 1:

• 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

PART 2:

• 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.

PART 3:

• 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 Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Warehouse Personnel
• Raw Material Testing Personnel
• Quality Engineers
• Supplier Quality and Auditors

Course Director: KELLY THOMAS

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.