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Questions and Answers
What are the five critical values for CGMP?
What does IND stand for?
Investigational New Drug
CGMPs apply to the manufacturing of investigational new drugs.
True
Who enforces GMPs?
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What does FDA Form 482 represent?
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What is meant by 'Quality by Design'?
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The FDA expects that 'quality should be built into the product, and testing alone cannot be relied on to ensure product ___.
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What are the two approaches the FDA uses for prioritizing inspections?
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What does CQA stand for?
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Part 4 of EUDRALEX covers ___.
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What is the purpose of a CMP?
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Study Notes
CGMP Overview
- Five critical values for CGMP: Safety, Identity, Strength, Purity, and Quality (SISPQ).
- CGMP regulations ensure pharmaceutical products meet safety and effectiveness standards.
Safety
- Safety measures include toxicology studies, clinical trials, and batch testing to ensure product safety for patients.
Identity
- Product identity must match labeling; involves proofreading, destroying unused labels, and maintaining accurate documentation.
Strength
- Ensures correct dosage and potency through repeatable production processes and potency testing.
Purity
- Protects product purity from contamination; focuses on proper storage and manufacturing practices.
Quality
- Achieved by adhering to SISPQ, meeting customer and regulatory standards, and following registered specifications.
FDA Quality Expectations
- Quality is built into the product; reliance on final testing is not sufficient.
Areas Affected by CGMP
- CGMP applies to procurement, testing, storage, and distribution of pharmaceutical products.
Active Pharmaceutical Ingredient (API)
- Defined as ingredients that provide a pharmacological effect, classified as biological or chemical.
Investigational New Drug (IND)
- CGMP applies to IND production for clinical studies involving humans and animals.
FDA Enforcement
- FDA enforces GMP regulations under the Food, Drug, and Cosmetic Act and conducts inspections without notice.
FDA Forms
- Form 482: Notice of Inspection.
- Form 483: Documents Inspectional Observations.
Inspection Protocol
- Investigators must present a Form 482 at inspection start and a Form 483 upon concluding if there are issues.
Firm Responsibilities Post-Inspection
- Recipients of Form 483 are encouraged to respond, addressing observations within 15 days.
FDA Action Classifications
- VAI: Voluntary Action Indicated.
- OAI: Official Action Indicated.
- NAI: No Action Indicated.
FDA Warning Letters
- Issued when violations of cGMP are confirmed post-inspection.
Regulatory Actions for Non-compliance
- Possible actions include product recall, withholding approval, facility closure, or legal action.
FDA Inspection Approaches
- Two main approaches: risk-based and quality systems-based for prioritizing inspections.
Six-Systems Inspection Model
- Focuses on quality, facilities, production, materials, lab control, and packaging systems.
Quality by Design (QbD)
- Integrates quality into the development process rather than just testing finished products.
Certifications and Agreements
- GMP certifications confirm compliance; Mutual Recognition Agreements (MRA) facilitate inspections and compliance.
European Regulatory Framework
- EUDRALEX governs EU medicinal products, equivalent to U.S. Title 21 CFR.
Pharmacovigilance
- Collaborative efforts to monitor drug safety and evaluate side effects for improved safety measures.
New Pharmacovigilance Legislation
- EU regulations established for improved drug safety monitoring, effective July 2012.
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Description
This quiz focuses on the critical values of Current Good Manufacturing Practices (CGMP) in the pharmaceutical industry. Test your knowledge on concepts such as safety, identity, strength, purity, and quality as well as regulatory guidance for industry standards.
