Quality In Investigational Drugs Presented by: Larry Parker, BSMT (ASCP), MHSA, ASQ CQA American Society for Quality Central Arkansas Section 1407
Dec 26, 2015
Quality In Investigational Drugs
Presented by: Larry Parker, BSMT (ASCP), MHSA,
ASQ CQA
American Society for Quality Central Arkansas Section 1407
What do you expect from the medicines that you take?
What do you expect from the medicines that you take?• Expect them to work.
What do you expect from the medicines that you take?• Expect them to work.• Expect them to be safe.
How does FDA make sure that medicines used in the United States are safe and effective?
How does FDA make sure that medicines used in the United States are safe and effective?• Regulations based on scientific quality.
How does FDA make sure that medicines used in the United States are safe and effective?• Regulations based on scientific quality.• Inspections based on the regulations.
How does FDA make sure that medicines used in the United States are safe and effective?• Regulations based on scientific quality.• Inspections based on the regulations.• Enforcement actions for companies and
individuals based on public health law.
Safety First
The first thing FDA requires is that you show a drug product is safe.
Safety First
The first thing FDA requires is that you show a drug product is safe.• FDA will almost always require that there are
animal safety studies done before a new drug can be given to a human.
Safety First
The first thing FDA requires is that you show a drug product is safe.• FDA will almost always require that there are
animal safety studies done before a new drug can be given to a human.
• Animal studies are regulated under the Good Laboratory Practices (GLPs) found in 21 CFR 58
Safety First
Quality in the GLPs is insured in the following ways:
Safety First
Quality in the GLPs is insured in the following ways:1. Facilities that conduct GLP studies must allow
FDA to inspect them.
Safety First
Quality in the GLPs is insured in the following ways:1. Facilities that conduct GLP studies must allow
FDA to inspect them.2. Each animal facility must have a quality
assurance unit that inspects all it studies
Safety First
Quality in the GLPs is insured in the following ways:1. Facilities that conduct GLP studies must allow
FDA to inspect them.2. Each animal facility must have a quality
assurance unit that inspects all it studies3. Written protocols are followed by the facility
for the conduct of each study
Safety First
Quality in the GLPs is insured in the following ways:1. Facilities that conduct GLP studies must allow
FDA to inspect them.2. Each animal facility must have a quality
assurance unit that inspects all it studies3. Written protocols are followed by the facility for
the conduct of each study4. Equipment used in each study is validated for
use in the study prior to the start of the study
Safety First: On to humans
Before FDA will allow use of a new drug in human studies you must file an Investigational New Drug (IND) application for their review.
Safety First: On to humans
Before FDA will allow use of a new drug in human studies you must file an Investigational New Drug (IND) application for their review.INDs contain:• The clinical protocol that is intend for use in
humans
Safety First: On to humans
Before FDA will allow use of a new drug in human studies you must file an Investigational New Drug (IND) application for their review.INDs contain:• The clinical protocol that is intend for use in
humans• Animal Safety Data
Safety First: On to humans
Before FDA will allow use of a new drug in human studies you must file an Investigational New Drug (IND) application for their review.INDs contain:• The clinical protocol that is intend for use in
humans• Animal Safety Data• Drug product manufacturing information
Safety First: On to humans
Before FDA will allow use of a new drug in human studies you must file an Investigational New Drug (IND) application for their review.INDs contain:• The clinical protocol that is intend for use in
humans• Animal Safety Data• Drug product manufacturing information• All references intended to support the application
INDs
What does FDA expect you to know about a new drug that is going to be used in Humans?
INDs
What does FDA expect you to know about a new drug that is going to be used in Humans?• Identity
INDs
What does FDA expect you to know about a new drug that is going to be used in Humans?• Identity• Strength
INDs
What does FDA expect you to know about a new drug that is going to be used in Humans?• Identity• Strength• Potency
INDs
What does FDA expect you to know about a new drug that is going to be used in Humans?• Identity• Strength• Potency• Purity
INDs
What does FDA expect you to know about a new drug that is going to be used in Humans?• Identity• Strength• Potency• Purity• Quality
INDs
What does FDA expect you to know about a new drug that is going to be used in Humans?• Identity• Strength• Potency• Purity• Quality
Everything!
GMPs
You know everything about a investigational drug product based on the Good Manufacturing Practice Regulations (cGMPs) found in 21 CFR 210 & 211
GMPs
The GMPs:• Define the responsibilities of a companies
Quality Control Unit
GMPs
The GMPs:• Define the responsibilities of a companies
Quality Control Unit• Define the minimum qualifications for QA
personnel
GMPs
The GMPs:• Define the responsibilities of a companies
Quality Control Unit• Define the minimum qualifications for QA
personnel• Define the minimum specifications for
facilities and equipment
GMPs
The GMPs:• Define the responsibilities of a companies
Quality Control Unit• Define the minimum qualifications for QA
personnel• Define the minimum specifications for facilities
and equipment• Provide requirements for control of
components and products
GMPs
The GMPs:• Define the responsibilities of a companies Quality Control
Unit• Define the minimum qualifications for QA personnel• Define the minimum specifications for facilities and
equipment• Provide requirements for control of components and
products• Provide for controls on processing, production, packaging,
labeling, holding, and distribution of drug product
GMPsThe GMPs:• Define the responsibilities of a companies Quality Control
Unit• Define the minimum qualifications for QA personnel• Define the minimum specifications for facilities and
equipment• Provide requirements for control of components and
products• Provide for controls on processing, production, packaging,
labeling, holding, and distribution of drug product• Also provides minimum requirements for laboratory
controls, records and reports
But does it work?
But does it work?
• Phase II clinical trials involve drugs that have successfully completed safety testing and start to look and see if a drug is effective and why it is effective.
But does it work?
• Phase II clinical trials involve drugs that have successfully completed safety testing and start to look and see if a drug is effective and why it is effective.
• Phase III clinical trials use all the information found in the earlier phases and expand it to large numbers of subjects in different locations to verify that the data is still the same.
Marketing a drug
• After you have completed the Phase III trials you can file for marketing clearance with FDA in order to be able to sell the drug.
Marketing a drug
• After you have completed the Phase III trials you can file for marketing clearance with FDA in order to be able to sell the drug.
• Quality doesn’t stop there! FDA requires “post-marketing” studies usually called Phase IV studies that are on going as long as the drug is on the market.
Questions:
Quality Workshop
Quality By Design:
What is QbD?
What is QbD?
• FDA push to improve the drug development process
What is QbD?
• FDA push to improve the drug development process
• Seeks to reduce the cost of product development due to low efficiencies, waste, and manufacturing time requirements due to testing
What is QbD?
• FDA push to improve the drug development process
• Seeks to reduce the cost of product development due to low efficiencies, waste, and manufacturing time requirements due to testing
• FDA states that you can’t test quality into a product, it must be designed there
What is QbD?
• A scientific, risk-based, holistic and proactive approach to pharmaceutical development.
What is QbD?
• A scientific, risk-based, holistic and proactive approach to pharmaceutical development.
• A deliberate design effort from product conception through commercialization.
What is QbD?
• A scientific, risk-based, holistic and proactive approach to pharmaceutical development.
• A deliberate design effort from product conception through commercialization.
• Manufacturer’s should have a full understanding of how product attributes and process relate to product performance
QbD System
Better View
Another Flow Chart