Good Manufacturing Practices Introduction - GMP

Xin Chen and

Chris Lepine

Some questions to consider:

What are some good rules for manufacturing companies?

Do you usually trust people that you do not know with your life?

How well do people regulate themselves?

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FDA mission

Overview Protect public health Promote public health Coordinate regulatory requirements across

countries

How does FDA accomplish its mission?

Establishing and enforcing high product standards and other regulatory requirements

Regulating the labeling of products under its jurisdiction

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What products are regulated by FDA?

All foods except meat and poultry Prescription and non-prescription drugs Biologics Medical devices and radiological products Animal drugs and feed Cosmetics

FDA organization

O R AS u rve y a n d In sp ec tion

C F S A NF o o d a n d C o sm e tics

C D R HM e d ica l D e v ices

C B E RB io lo g ics

C V MA n im a l D ru g s a n d F e ed

C D E RD ru g s

N C T RS c ie n tif ic R ese a rch

F D AO ffice o f C o m m iss io n e r (O C )

C o m m issio n e r o f Fo o d a n d D ru gs

A question to consider:

Why do we have traffic laws?

What is cGMP?– Current Good Manufacturing Practice

Requirements that manufacturers of regulated healthcare products must follow so that the products they make have the safety, identity, strength, and quality that they purport or are represented to have.

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cGMP compliance

Ensure safety, quality, and effectiveness of drugs, biologics and medical devices

Non-compliance – Business failure – recall, seizure, fines,

imprisonment– Public health at risk

Evolution of cGMP

Early 1900’s: The Jungle 1906: Creation of FDA 1938: Creation of FD&C Act

– Requirement for pharmacological study to prove drug safety

1962: Drug Amendment – Requirement for testing on human subjects

Today: 21 CFR

Essence of cGMP

Protection from contamination Mix-ups prevention Know what you are to do before you do it Documentation Consistency and control Independent decision-making Continuous improvement

Other questions to consider:

Why do we want consistencies in our lives? How do you make sure your cakes turn out

right every time?

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Understanding SOP

Standard Operation Procedure– Written instruction

What to do How to do it

What is SOP for?– Provide consistency– Minimize mistakes

Where to find it?– Online– Check with your supervisor

Understanding SOP (contd.)

SOP is constantly changing SOP life cycle

SOP Status = Progress SOP Status = In Review

SOP Status = Effective SOP Status = Approved

Learner completes SOP Training SOP Status = In Training

Good Manufacturing Practices Introduction - GMP

Xin Chen and

Chris Lepine