CGMP training english

The FDA website can be accessed anywhere in the world anytime by anyone

(central site)
/cdrh/index.html

TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION


(1) The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. (2) The provisions of this part shall be applicable to any finished device as defined in this part, intended for human use, that is manufactured, imported, or offered for import in any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.
The Rules are titled “21 CFR Part 820. and apply to all medical products intended for human use.
21 CFR (Code of Federal Regulations) part 820
“The quality system regulation includes requirements related to the methods used in and the facilities and controls used for: Designing, purchasing, manufacturing, packaging, labelling, storing, installing, and servicing of medical devices intended for human use.”

§820.3 – Definitions (exactly) §820.5 - Quality system.

Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.

FDA is organized into Centers which are responsible for each type of product.



Center for Food Safety and Applied Nutrition Center for Drug Evaluation and Research Center for Devices and Radiological Health Center for Biologics Evaluation and Research Center for Veterinary Medicine Office of Regulatory Affairs National Center for Toxicological Research
This is a basic overview, it is up to the individual to read and understand the complete rule!

Who are these guys?!

US FDA CDRH
The U.S. Food and Drug Administration (FDA) is the U.S. Government agency that oversees most foods and medical products. Its job is to make sure that:
Why do these rules apply to S&N here in Suzhou?
S&N Suzhou will export direct to the US market. All products entering the US market that are regulated by the US FDA must comply regardless of the country of origin. If we don’t meet, we don’t compete.
processes.
What is the outcome of following CGMP?

The assured ability to consistently produce the same product to meet the same specifications time after time! Increase production, lower cost, reduce price to customer, faster delivery times, etc. . . Are NOT part of GMP!


DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES PART 820 QUALITY SYSTEM REGULATION

Rules Subpart A--General Provisions

§820.1 - Scope.
Subpart B--Quality System Requirements

When do the rules apply?

Research – do not, not in compliance
Development – some do, compliance is considered


Manufacturing – compliance is required

Now for the fun part..............

On the next series of slides we will cover who is the FDA and what is the intent of each sub-part of the rules we must comply with at all times
food is safe, healthy, and clean medicines and medical devices are reasonably safe and effective cosmetic products are safe animal foods and drugs are safe food and medical products have proper labels
Assure that correct and APPROVED procedures are always followed. Provide controlled documentation, traceability, and accurate history records.



Overall Intent: To assure Quality is “built in” to the product and

CGMP and CGLP

CGMP: (Current Good Manufacturing Practice)

Protect the integrity and quality of manufactured product intended for human use.

CGLP: (Current Good Laboratory Practice)

Protect the integrity and quality of laboratory data used to support a products release to the customer.
Current Good Manufacturing Practices (CGMP)

US FDA CGMP INDUCTION TRAINING
GMP stands for “Current Good Manufacturing Practices” and is the bases for the US FDA Rules of Conduct for ALL medical device manufacturers that import or sell products to the US market.
Manufacturing
Must be even more Controlled . . .

CGMP takes priority
Quality and Control are critical