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Role of FDA FDA was designed to promote and protect the public’s health FDA was designed to promote and protect the public’s health Food and Drug Cosmetic.

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Presentation on theme: "Role of FDA FDA was designed to promote and protect the public’s health FDA was designed to promote and protect the public’s health Food and Drug Cosmetic."— Presentation transcript:

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2 Role of FDA FDA was designed to promote and protect the public’s health FDA was designed to promote and protect the public’s health Food and Drug Cosmetic Act first passed in 1906 to prevent the sale of unacceptable food and drugs Food and Drug Cosmetic Act first passed in 1906 to prevent the sale of unacceptable food and drugs

3 Role of FDA Minimum requirement for release of a drug is that it has to safe and effective Minimum requirement for release of a drug is that it has to safe and effective There are always risks and side effects There are always risks and side effects The FDA has to determine when the benefits out weigh the risks The FDA has to determine when the benefits out weigh the risks Vaccines and life threatening diseases Vaccines and life threatening diseases Clinical trials: when is enough enough? Clinical trials: when is enough enough? Thalidomide incident Thalidomide incident

4 Center for Drug Evaluation & Research CDER CDER Group which assures the safety and effectiveness of drugs available in the U.S. Group which assures the safety and effectiveness of drugs available in the U.S. Monitors for adulterated or contaminated drugs Monitors for adulterated or contaminated drugs Adulterated: drug or food produced by methods which do not conform to cGMP Adulterated: drug or food produced by methods which do not conform to cGMP

5 Center for Biologics Evaluation and Research CBER CBER Reviews applications for new biologics produced from microbes and viruses Reviews applications for new biologics produced from microbes and viruses Examples: vaccines, allergens, monoclonal antibodies Examples: vaccines, allergens, monoclonal antibodies Regulates all aspects of the process from mfg. to QC, to labeling and advertising Regulates all aspects of the process from mfg. to QC, to labeling and advertising

6 Center for Devices & Radiologic Health CDRH CDRH Regulates medical devices and some in vitro diagnostic kits Regulates medical devices and some in vitro diagnostic kits Examples of devices: Examples of devices: Pace maker, ultrasonic cleaners for cleaning medical instruments, insulin monitors, thermometers Pace maker, ultrasonic cleaners for cleaning medical instruments, insulin monitors, thermometers Examples of in vitro diagnostic kits Examples of in vitro diagnostic kits CK-MB kits CK-MB kits

7 Center for Food Safety & Applied Nutrition Protects and promotes health & economic interests by ensuring that foods are safe, nutritious, and honestly labeled Protects and promotes health & economic interests by ensuring that foods are safe, nutritious, and honestly labeled Also oversees cosmetics Also oversees cosmetics

8 FDA Actions Facility Inspections Facility Inspections 483: inspector’s note documenting a deficiency 483: inspector’s note documenting a deficiency Not following procedure Not following procedure Incomplete records Incomplete records Warning letter: written letter citing cGMP violations. Requires a written response of corrective actions to be implemented. Warning letter: written letter citing cGMP violations. Requires a written response of corrective actions to be implemented.

9 FDA Actions If a company does not comply with FDA requests the FDA can do any and all of the following: If a company does not comply with FDA requests the FDA can do any and all of the following: Take the product(s) off of the market Take the product(s) off of the market Sue and or arrest executives Sue and or arrest executives Detain imports / exports Detain imports / exports FDA cannot do nothing when they know there are issues at a company FDA cannot do nothing when they know there are issues at a company

10 Product Development: Ideas to Market Computer Modeling Computer Modeling In vitro studies In vitro studies Pre-clinical Animal studies Pre-clinical Animal studies Investigation New Drug Application Investigation New Drug Application Clinical studies Clinical studies New Drug Application and Approval New Drug Application and Approval Manufacturing Manufacturing Marketing and Sales Marketing and Sales

11 GLP Good Laboratory Practices Good Laboratory Practices Prescribes practices for conducting non clinical lab studies that support or are intended to support applications for research or marketing of regulated products. Prescribes practices for conducting non clinical lab studies that support or are intended to support applications for research or marketing of regulated products. Required for research applications to be submitted to the FDA Required for research applications to be submitted to the FDA Intended to assure the quality and integrity of safety data filed Intended to assure the quality and integrity of safety data filed Does not include human studies or clinical studies Does not include human studies or clinical studies

12 Examples of what’s included Good lab practices Good lab practices Labeling reagent bottles w/ proper info. Labeling reagent bottles w/ proper info. Reagent name, date, initials or name of who prepared it Reagent name, date, initials or name of who prepared it Equipment monitoring Equipment monitoring Calibrated, cleaned and verification logs Calibrated, cleaned and verification logs Written procedures Written procedures Filled out, reviewed by QA, and maintained Filled out, reviewed by QA, and maintained Personnel should be qualified or at least knowledgeable Personnel should be qualified or at least knowledgeable

13 Standard Operating Procedures: SOPs Procedures for the following: Procedures for the following: Manufacture the product Manufacture the product Test and release the product Test and release the product Train personnel Train personnel Label and packaging the product Label and packaging the product How to handle non conforming product How to handle non conforming product How to design new products How to design new products

14 Standard Operating Procedures Good SOPs contain the following: Good SOPs contain the following: Purpose or scope Purpose or scope Materials Materials Procedure Procedure Must be written in proper order Must be written in proper order Must include sufficient detail for operator to follow Must include sufficient detail for operator to follow Should include “checkers” for calculations Should include “checkers” for calculations Must include initials and signature of operator Must include initials and signature of operator Must have Supervisors review and sign off\ Must have Supervisors review and sign off\ Should be reviewed and updated as needed Should be reviewed and updated as needed

15 Clinical Investigation Definition: any experiment that involves a test article and one or more human subjects and that is either subject to requirements for submission to FDA or is not subject for submission but results are intended to be submitted later. Definition: any experiment that involves a test article and one or more human subjects and that is either subject to requirements for submission to FDA or is not subject for submission but results are intended to be submitted later.

16 Phases of Clinical Trials Phase 1: small number of patients, (10-20) Phase 1: small number of patients, (10-20) Can take 9-18 months to complete Can take 9-18 months to complete May continue with animal studies for long term data May continue with animal studies for long term data Phase 2: continues to test safety and evaluates how well the new drug is working. More patients enrolled ( ) Phase 2: continues to test safety and evaluates how well the new drug is working. More patients enrolled ( ) May take 1-2 years to complete May take 1-2 years to complete Phase 3: most extensive study,1-3 years Phase 3: most extensive study,1-3 years Fully assess safety and effectiveness of drug Fully assess safety and effectiveness of drug patients involved, diverse group, multiple sites patients involved, diverse group, multiple sites May compare old and new drug treatments May compare old and new drug treatments Evaluating side effects Evaluating side effects Phase 4: long term side effects and effectiveness Phase 4: long term side effects and effectiveness

17 Single and Double Blinded Study Single-Blind study: clinical trial study in which the human subjects do not know if they are receiving the active product or a placebo. Single-Blind study: clinical trial study in which the human subjects do not know if they are receiving the active product or a placebo. Double-Blind study: study in which neither the subject nor the investigator knows the treatment assigned. (usually subjects, investigators, monitors and data analysts are unaware) Double-Blind study: study in which neither the subject nor the investigator knows the treatment assigned. (usually subjects, investigators, monitors and data analysts are unaware)

18 Participants in clinical trials Investigator Investigator Sponsor Sponsor Sponsor Investigator Sponsor Investigator Human Subject Human Subject Institution Institution Institution Review Board Institution Review Board

19 Clinical Trial Data Analysis Data analyzed by Statistics or Biostatistics group Data analyzed by Statistics or Biostatistics group Use well defined, accepted and pre-determined data analysis formulas and methods. Use well defined, accepted and pre-determined data analysis formulas and methods. Looking for levels of significance 99% still means 1% error possible of 1/100 (0.01). Looking for levels of significance 99% still means 1% error possible of 1/100 (0.01). Is that good enough? Is that good enough? How do you balance the data with the delay in releasing a product? How do you balance the data with the delay in releasing a product? Outlier: data point outside of the average range and is usually larger or smaller than the rest of the points Outlier: data point outside of the average range and is usually larger or smaller than the rest of the points

20 Clinical Trial Data Analysis INCLUSION/EXCLUSION CRITERIA: The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe. INCLUSION/EXCLUSION CRITERIA: The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe.

21 Institutional Review Board Definition: any board, committee or group formally designated by an institution to review biomedical research involving human subjects Definition: any board, committee or group formally designated by an institution to review biomedical research involving human subjects IRB approval MUST be obtained before an investigator can begin a study IRB approval MUST be obtained before an investigator can begin a study

22 Institutional Review Board Usually comprised of medical and lay persons (at least 5 members, no conflict of interest) Usually comprised of medical and lay persons (at least 5 members, no conflict of interest) Established to protect the human subjects and ensure fair enrollment Established to protect the human subjects and ensure fair enrollment Review and Approve Informed Consent Review and Approve Informed Consent Conduct periodic reviews to ensure integrity of the study Conduct periodic reviews to ensure integrity of the study

23 What are cGMP’s Designed To Do? Protect consumers from adulterated product Protect consumers from adulterated product Protect consumers from products that do not contain what is claimed on the label Protect consumers from products that do not contain what is claimed on the label Provide consistent industry-wide requirements Provide consistent industry-wide requirements Ensure quality of product not safety or efficacy of dietary ingredients Ensure quality of product not safety or efficacy of dietary ingredients

24 Operations responsibilities This is where cGMP comes into play

25 General Provisions cGMP should apply to activities associated with cGMP should apply to activities associated with manufacturing manufacturing packaging packaging holding holding distributing distributing Manufacturer would need to comply with requirements applicable to operations performed Manufacturer would need to comply with requirements applicable to operations performed

26 Components of a cGMP Personnel Personnel Physical plant internal environment Physical plant internal environment Equipment and utensils Equipment and utensils Production and process controls Production and process controls Records and Recordkeeping Records and Recordkeeping

27 QSR QSR: Quality System Regulations QSR: Quality System Regulations Standard produced by the FDA which companies MUST follow Standard produced by the FDA which companies MUST follow Include standards such as training, document control, process control, design control Include standards such as training, document control, process control, design control cGMP and QSR are essentially the same cGMP and QSR are essentially the same Mandated by FDA; only in US

28 ISO Similar to QSR Similar to QSR International standard International standard Voluntary Voluntary Provides marketing edge and is well received by customers Provides marketing edge and is well received by customers Risks: failure or loss of certification, add’tl expense Risks: failure or loss of certification, add’tl expense ISO 9001 ISO 9001

29 Batch Records FDA Requirement FDA Requirement cGMP requirement cGMP requirement QSR requirement QSR requirement ISO requirement ISO requirement Failing to do so can get you into a heap of trouble! Failing to do so can get you into a heap of trouble! Used to ensure consistent product Used to ensure consistent product

30 Batch Record: Record Keeping What are some record keeping requirements? What are some record keeping requirements? Black ink Black ink No white out No white out Single line, date, initial Single line, date, initial No blanks, N/A any lines which do not apply No blanks, N/A any lines which do not apply Legible Legible

31 Label Approval and Control Regulatory, Quality Assurance and Marketing are the groups who “approve” the final label Regulatory, Quality Assurance and Marketing are the groups who “approve” the final label Materials, QA, QC, and Mfg. “control” the label from receipt, through inspection to application to product, through finished product inspection. Materials, QA, QC, and Mfg. “control” the label from receipt, through inspection to application to product, through finished product inspection.

32 Labeling and Packaging Control Why would this be an area to be audited? Why would this be an area to be audited? Label text: pre-approved and inspected Label text: pre-approved and inspected Label adhesion: pre-approved and inspected Label adhesion: pre-approved and inspected Label accountability: verified at every step Label accountability: verified at every step Package insert content: pre-approved and inspected Package insert content: pre-approved and inspected Package insert accountability: verified at every step Package insert accountability: verified at every step CONTROLLED TO PREVENT MIXUPS CONTROLLED TO PREVENT MIXUPS

33 Label Text Fixed Text Fixed Text Text that does not change with each lot Text that does not change with each lot Company name, address, Company name, address, Product Name, storage temp, ingredients Product Name, storage temp, ingredients Variable Text Variable Text Text that does change with each lot Text that does change with each lot Lot number and or serial number Lot number and or serial number Expiration Date Expiration Date Concentration or Potency Concentration or Potency

34 Marketing Information Labels and Package inserts are highly controlled Labels and Package inserts are highly controlled Marketing information such as product informational flyer Marketing information such as product informational flyer Approved by Regulatory and Marketing Approved by Regulatory and Marketing Marketing distributes w/out control Marketing distributes w/out control

35 Audits The evaluation of the company, the process, and the product to assure quality and reliability The evaluation of the company, the process, and the product to assure quality and reliability Management Responsibility Management Responsibility Auditing (internal and external) Auditing (internal and external) Design Control Design Control Document Control Document Control Purchasing Control Purchasing Control Identification and Traceability Identification and Traceability

36 Process of Auditing Meeting to review process and timing Meeting to review process and timing Tour of company Tour of company Ask for records Ask for records Review records Review records Ask for interviewees if necessary Ask for interviewees if necessary Write preliminary report Write preliminary report Review prelim report w/mgmt Review prelim report w/mgmt


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