CGMP controlled Raw Materials

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:

1. Regulatory Requirements for all Incoming cGMP Controlled Raw Materials:
1. What does the regulation say about raw materials that are received for cGMP use
2. Receipt and Storage of cGMP Controlled Raw Materials
1. Delineation of Raw Materials
1. Critical
2. Non-critical
2. Acceptable Storage of cGMP Controlled Raw Materials
1. Control of Conditions (Temperature and Humidity Control)
2. Control of Location (Lock and Key)
3. Quarantine, Segregation and Labeling Requirements
4. Testing and Qualification
5. Approval and Release for use
6. Disposition and Release for Use Requirements
7. Dispensing and Traceability (Tracking)
8. Discarding and Reconciliation
3. Processing New cGMP Controlled Raw Material Specification
1. Receiving and Handling of cGMP Controlled Raw Materials
2. Processing the cGMP Controlled Raw Material Specification
3. Changing cGMP Controlled Raw Material Specification
4. Retiring cGMP Controlled Raw Material Specification
4. Procedure for Raw Material Initial Receipt
1. When Quality Control Sampling is Required
2. Processing cGMP Controlled Raw Materials
3. Assessment and Determination of the Criticality of the cGMP Controlled Raw Materials
4. Performing the Verification Checks
5. Testing Requirements for all Incoming cGMP Raw Materials
1. New and Unqualified cGMP Controlled Raw Materials (Initial Qualification)
2. Acceptable Testing Programs and Frequency
6. Test Requirements for Routine and Confirmatory Testing of Qualified cGMP Controlled Raw Materials
1. Already qualified cGMP Controlled Raw Materials (Subsequent Qualification)
2. Acceptable Testing Programs and Frequency
7. Routine and Yearly Confirmatory Testing for Suppliers and Manufacturers of Qualified cGMP Controlled Raw Controlled Materials
1. Acceptable Testing Programs and Frequency
2. Review of Supplier Approved Status
3. Review of Initial Qualification
4. Review of Quality History
5. Review of Comparison Criteria
6. Review of Appropriate Intervals
8. Evaluation of Suppliers and Manufacturers of cGMP Controlled Raw Materials after Approved Specification Changes
1. Review of Previous acceptance of affected cGMP controlled raw materials.
2. Review of the affected change and potential product impact and batch
9. Disqualification of cGMP Controlled Raw Materials Test Parameters
1. When can a cGMP Controlled Raw Material Testing test parameters be disqualified.
10. Requirements for the Comparison Criteria Used in the Confirmatory Yearly Testing
1. When comparison criteria can be used in lieu of a full qualification.
2. How to establish and document comparative analysis in lieu of full controlled material testing.
11. cGMP Controlled Raw Material Confirmatory Testing Process
1. Outline of the process for completing the yearly controlled material confirmatory testing.
12. Issuing and Approving cGMP Controlled Raw Materials Specification
1. How cGMP Controlled Raw Materials are issued and release
13. Processing Failed cGMP Controlled Raw Materials
1. How to handle a cGMP Controlled Raw Material with a failed result.
14. Documentation of cGMP Controlled Raw Materials
1. Documentation Practices and Required Documentation to Satisfy Qualification
2. Issuance of Specifications
15. Investigating OOS Associated with Rejected cGMP Controlled Raw Materials
1. How to investigate a failed cGMP controlled raw material initial and subsequent qualification testing.
2. Documentation the OOS Investigation of Rejected cGMP Controlled Raw Materials
3. 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.

Charity Ogunsanya
Director of Quality Control, Pharmabiodevice Consulting LLC

Charity Ogunsanya, is the CEO and founder of Pharmabiodevice Consulting LLC. Ms. Ogunsanya has over 23 years of extensive practical and management experience in various Fortune 100 pharmaceutical, biotechnology, biologics, cell therapy, diagnostics, research and development, radio-pharmaceutical, Contract Manufacturing Organization (CMO) and medical device/IVD companies.

She has been a much sought after SME to assume key roles specifically related to remediation and difficult quality and compliance related deficiencies associated with FDA’s Consent Decree, FDA’s Warning Letters and other regulatory bodies’ inspectional findings. Her remediation work has constantly resulted in several successful national and international regulatory bodies’ inspections, re-inspections and new product approvals.

Her technical expertise covers and goes beyond interpretation, administration and set up of quality assurance, quality/compliance, quality engineering, aseptic processing, contamination control, quality control, microbiology, sterility assurance, stability, vaccine development, new product design, product release testing and medical device sterilization (ethylene oxide (EtO), gamma, radiation, VHP sterilization) systems and operations for compliance to various regulations.

She has a keen working knowledge of the requirements and regulations guiding new and existing products from planning through design, proof of concept, research and development, technology transfer, pre-clinical, clinical, commercial manufacturing, supply chain, regulatory filings, pre-approval inspections, licensure, government affairs, commercialization and post-approval inspections.

She is a member of the Parenteral Drug Association (PDA), American Society of Microbiologists (ASM), and other Scientific Forums and Industry Expert Network. She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and she is currently attaining her Masters in Biotechnology (Biodefense Concentration) at the Johns Hopkins University Advanced Academic Program.

Frequently Asked Questions:

1. What is your opinion or thoughts on the current FDA guidance implying that 95% Ethanol MUST have methanol and all other impurities tested by my internal QC. That it is not acceptable to accept the COA, even though the manufacturer /distributor is a reputable, global supplier?
2. An additional related question is concerning 99% Glycerin, with reference for the agency enacting mandatory testing for ethylene glycol and DEG, again not being able to accept the manufacturer/supplier COA, another global leader in the chemical and pharmaceutical industry.
3. If qualified reference materials are not available for a raw, how could you go about qualifying one in-house ?

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