bio 221regulatory compliance in biomanufacturing chapter summaries
TRANSCRIPT
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BIO 221 REGULATORY COMPLIANCE IN BIOMANUFACTURING
CHAPTER SUMMARIES
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DRUGS
MEDICAL DEVICES
BIOLOGICS
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CHAPTER 1 - THE HISTORY OF THE DEVELOPMENT OF REGULATORY
AGENCIES
I. State versus Federal Powers and the Regulation of Commerce
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Versus
Georgia State Capitol
The United States Capitol
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CHAPTER 1 - CONTINUED
• The United States is a federal system of government with powers divided between the states and the federal government.
• The United States Constitution grants to the federal government the power to regulate international and interstate commerce. Hence food and drug laws require that the product, or at least one of its ingredients, travel in interstate commerce.
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CHAPTER 1-CONTINUED
II. Separation of Powers
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CHAPTER 1-CONTINUED
III. History of Key Regulatory Agencies and Legislation Underpinning Regulation
• USDA (formed in 1862), FDA (formed in 1931) & EPA (formed in 1970).
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CHAPTER 2 - EVOLUTION AND SCOPE OF THE FDA
I. FDA HistoryA. Basic timeline: 1848-1968B. Events and Legislation Underlying
the Evolution and Scope of the FDADrug Importation Act (1848)>>>> Bioterrorism Act (2002)
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CHAPTER 2 - CONTINUED
II.What the FDA RegulatesA. Food
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CHAPTER 2 - CONTINUED
II. What the FDA Regulates – Continued
B. Drugs
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CHAPTER 2 - CONTINUED
II.What the FDA Regulates – Continued
C.Medical DevicesE.g. Contact Lenses
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CHAPTER 2 - CONTINUEDII. What the FDA Regulates –
ContinuedD. Biologics
E. Veterinary Products
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CHAPTER 2 - CONTINUED
II. What the FDA Regulates – Continued
F. Cosmetics
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CHAPTER 2 - CONTINUED
II. What the FDA Regulates – Continued
G. Radiation-Emitting Products
III.What the FDA Does Not Regulate
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CHAPTER 2 - CONTINUED
IV.Summary of the Mission and Fundamental Activities of the FDA
FDA Website: http://www.fda.gov/
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CHAPTER 3 - ORGANIZATION OF THE FDA
I. BackgroundFDA is a federal science-based law
enforcement agency within the US Department of Health and Human Services (HHS)
II. OrganizationFDA consists of six centers and several
offices
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CHAPTER 4 - PROCESS OF DRUG DEVELOPMENT
I. Introduction Definition of new drugII. Requirements
a.Preclinical Investigationb.INDc.Phase I clinical trialsd.Phase II clinical trialse.Phase III clinical trialsf.NDA
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CHAPTER 4 - CONTINUEDIII.Notes• Biologics (BLA vs NDA; CDER or CBER): i. Vaccines, antitoxins, sera, blood and
blood products. ii. Therapeutic protein drugs derived
from natural sources, e.g. anti-thrombin III, or biotechnology, e.g. proteins derived using recombinant DNA technology.
iii. Gene or somatic cell therapies.
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CHAPTER 5 - FORMAT, ASSEMBLY AND SUBMISSION OF
IND
I. IntroductionA submission to the FDA that requests
permission to initiate a clinical study of a new drug in the United States
II. Requirement for an INDNew drug or change in use of old drug
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CHAPTER 5 - CONTINUEDIII. Pre-IND MeetingBetween sponsor and FDAIV. Format of an INDV. Assembly and Submission of an
INDVI.Overview of Review Process
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CHAPTER 6 - FORMATTING, ASSEMBLING AND
SUBMITTING THE NEW DRUG APPLICATION (NDA)
I. IntroductionApproval of NDA (BLA for biologics)
required for marketing and sale of drug
II. Format, Assembly and Submission of NDA
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CHAPTER 6 - CONTINUEDIII. Overview of Review Process
NDA Review Chart
The New Drug Development Process:Steps from Test Tube to New Drug Application Review
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CHAPTER 7 – MEDICAL DEVICES
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CHAPTER 7 – CONTINUEDI. IntroductionII. Classification of a Medical
DeviceIII. Regulatory Requirements for
Medical Devices
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CHAPTER 8 - MEETING WITH FDA
I. IntroductionII. Types of FDA MeetingsIII.Categories of FDA Meetings
Type A, Type B and Type CIV.Preparing for FDA MeetingsV. Conduct at FDA Meetings
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CHAPTER 9 - GOOD CLINICAL PRACTICES
I. IntroductionII. Regulations and Guidance for
GCPs
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CHAPTER 10 - THE ROLE OF GOOD MANUFACTURING PRACTICES
I. IntroductionA. Regulations for Good Manufacturing
Practices (GMP)B. Current Good Manufacturing
Practices (cGMP)
II. RegulationsA. BasisB. Code of Federal Regulations (CFR)
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CHAPTER 11 - POST-MARKETING REGULATION
• Adverse drug reports are required to be reported to FDA
• Post-Marketing Surveillance is an ongoing process by FDA for monitoring the safety of medical products
• MedWatch, the FDA Medical Products Reporting Program, was established to facilitate post-marketing surveillance
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• Inspection: investigators look for evidence of non-compliance with
• Various types of inspections• Documentation: 482, 483, 484, EIR• Warning Letters
cGMP
CHAPTER 12 - FDA INSPECTION AND WARNING LETTERS
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CHAPTER 13 - RISK-BASED APPROACH TO FDA REGULATION OF GMP
• GMP regulations broad and open to some interpretation
• Risk-based approach• Initiative: Pharmaceutical Quality for
the 21st Century: A Risk-Based Approach
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CHAPTER 14 – PATENTS AND THEIR ROLE IN DISCOVERY AND MARKETING
I. The PatentII.How an Invention is PatentableIII.The Role of Patents
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CHAPTER 15 - APPLICATION OF CURRENT GOOD
MANUFACTURING PRACTICES
I. IntroductionII. CGMP
Procedures
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CHAPTER 16 - BUILDINGS AND FACILITIES FOR GMP
I. Design and Construction
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CHAPTER 16 - CONTINUED
II. Plant Materials
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CHAPTER 16 - CONTINUED
III. Ventilation, Air Filtration; Air Heating and Cooling
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CHAPTER 16 - CONTINUED
IV. PlumbingV. LightingVI. Sewage and RefuseVII. SanitationVIII. Maintenance
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CHAPTER 17 - RECEIVING AND QUARANTINE
OPERATIONS
I. IntroductionII. General RequirementsIII.Receipt and Storage of Untested
Components, Drug Product Containers and Closures
IV.Testing and Approval or Rejection of Components, Drug Product Containers and Closures
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CHAPTER 17 - CONTINUED
V. Use of Approved Components, Drug Product Containers, and Closures
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CHAPTER 17 - CONTINUED
VI.Retesting of Approved Components, Drug Product Containers, and Closures
VII.Rejected Components, Drug Product Containers, and Closures
VIII.Drug Product Containers and Closures
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CHAPTER 18 - CLEAN ROOMS
I. IntroductionII. Design
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CHAPTER 19 - EQUIPMENT PREPARATION AND ASSEMBLY
I. IntroductionII. Equipment CleaningIII.Sanitary Versus Non-Sanitary
FittingsIV.Notes on Selected Equipment
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CHAPTER 20 - CLEANING, DECONTAMINATION AND
SANITATION (CDS)
I. IntroductionII. CDS of the General
Manufacturing AreaIII.CDS of Process
Equipment
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CHAPTER 20 - CONTINUED
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CHAPTER 21-STERILIZATION OF PROCESS EQUIPMENT
I. IntroductionII. Methods of Sterilization
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CHAPTER 21- CONTINUED
III. Validationa) Introductionb) Qualification and Validationc) Equipment Controls and
Instrument Calibration
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CHAPTER 22 - PRODUCT FORMULATION AND FILLING
OPERATIONS
I. IntroductionII. Bulk Freeze-ThawingIII.Formulation ProcessIV.Sterile Filtration
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CHAPTER 22 - CONTINUED
V. FillingLiquid Filling Machine with 40 to 55 Bottles/Minute Capacities and 90 to 520mL Filling Range
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CHAPTER 23 - HOLDING AND DISTRIBUTION
I. IntroductionII. Warehousing ProceduresIII.Distribution Procedures
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THE ENDTHANK YOU!