Biotechnology Unit 1 Introduction, Slides of Biotechnology

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Pharmaceutic

al Quality and

cGMP

Learning Objectiv

Biotechnology Unit

One Learning

Objectives

Flashcar ds

Set one

Set two

Set three

Set Four

Set Five

Set Six

La b

Lab

Lab

Documents

Lectur Biotechnology Unit One Lecture

Lecture Section One: Introduction and History

Lecture Section Two: Regulation, QC, and Personnel

Lecture Section Three: Documentation

Lecture Section Four: Facilities, Equipment, and

Material Controls

Lecture Section Five: Procedures, Lab, and Electronic Records

Lectur Lecture Section One: Introduction and History Warm-up: Take 20 minutes to find dirt on pharmaceutical companies. The juicer the better. Be sure to include the source of your information Be sure to include FACTS NOT OPINIONS

Lectur Lecture Section One: Introduction and History Practice Take 15 minutes to read and take notes for section 1. Pages 1-4 to the top of page 1-6. Stop at Section 1. Use the blank student learning objectives as a guide

Lectur Lecture Section One: Introduction and History

• (^) Students will be able to describe the price of poor quality (pages 1-4 and 1-5).
• (^) Students will be able to explain how to prevent poor quality by applying the concept of quality by design and by being able to recall the definitions of the following words: safety, efficacy, current good manufacturing practices, and quality biopharmaceutical product (pages 1-4 and 1-5).
• (^) Students will be able to explain what the cGMP mindset is and how the cGMP mindset affects the actions of the process technician (page 1-6).

Lectur Lecture Section Two: Regulation, QC, and Personnel Where does the authority of the FDA come from? What specific law allows the FDA to take legal action?

Lectur Lecture Section Two: Regulation, QC, and Personnel The FD&C’s goal is to take legal action against adulterated or misbranded medicines.

Lectur Lecture Section Two: Regulation, QC, and Personnel

Responsibilities of the FDA :

● Review and approve or reject applications for new drugs, biologics, and

medical devices.

● Oversee manufacturing and distribution activities, including facility

inspections

● Review and approve or reject marketing materials

● Perform research, independent laboratory testing, and technical

development

of knowledge and information about specific drugs in support of public

health.

Lectur Lecture Section Two: Regulation, QC, and Personnel

FDA On-Site Inspections

● General CGMP inspections are regularly scheduled audits the FDA

conducts at a company every 2–5 years to ensure the company remains

compliant.

● Pre-approval inspections (PAI) are product-specific inspections the FDA

performs before approving new drugs for market.

● For-cause audits occur when the FDA inspects companies in response

to

identified issues, such as specific complaints, concerns about the

stakeholders involved in the research process, multiple deviations, or

FDA-

identified events of special interest.

Lectur Lecture Section Two: Regulation, QC, and Personnel

Mandatory Systems - cGMP

• Current Good Manufacturing Practices

(cGMP)

is a set of minimum standards for

manufacturing set by the Food and Drug

Administration (FDA) to ensure the safety and

purity of drug products made in the USA.

• GMPs are always being revised, the FDA

expects companies to follow current practices.

Lectur Lecture Section Two: Regulation, QC, and Personnel

21 CFR is a portion of the Code of Federal Regulations

that

outlines all cGMP for drug, medical device, and

biological

industries.

It includes rules for every aspect of manufacturing

from labeling

to release of product for distribution.

Similar guidelines for other countries must be followed

if the

product is shipped outside the USA.