Basic GMP Training

WHAT IS GOOD MANUFACTURING PRACTICES

Good Manufacturing Practice (GMP) Is A System For Ensuring

That Products Are Consistently Produced And Controlled

According To Quality Standards. It Is Designed To Minimize The

Risks Involved In Any Pharmaceutical Production That Cannot Be

Eliminated Through Testing The Final Product.

 TEN RULES OF GMP
1. Having Detailed Written Procedures Before Any Job Is Started.
•Make Sure You Know What You Are Doing
•Procedure In Place
•Specification In Place
2. Following Those Instructions Exactly With No “Cutting Corner”.
If It Calls For A Record Of Temperature, Time, Date Then Record It.
3. Do Not Start Without Reading The Documents
•Do Not Assume
•Ask- Make Sure
 TEN RULES OF GMP
4.Ensure That The Correct Product And Materials Are Being Used
• Check Against Pick List
• Follow Inspection Procedure
5. Ensure That Correct Equipment Is Being Used And That Is Clean.
• Line Clearance
6. Preventing Contamination And Mix-up
• Line Clearance Checks
• Physical Segregation
• Correct Uniform
• Keep Doors Shut
• Maintain Positive Pressure
 TEN RULES OF GMP
7. Always guard against labeling errors
• Largest single source of product recall
• Mistakes are expensive and dangerous
• Follow coding procedures
8. Always work accurately and precisely
• Temperature
• Measurement
• Quantities
9. Keeping things (including yourself) clean & Tidy.
• Good housekeeping
• Reduces the risk of microbial contamination
 TEN RULES OF GMP
10. Always Be On The Look-out For Mistakes ,Errors & Bad Practices And
Report Them Immediately

• Vigilance Is All Important

• Report The Use Of Bad Practice
• Covering Up Could Cost Lives
• Think GMP

Make Clear, Accurate Record Of What Has Been Done And Checks
Carried Out.
 GMP AREAS
Any Area Used In The Manufacture, Processing, Packaging, Testing,
Holding Of Pharmaceutical Product, Raw Material Or Component
• All Production Facilities.
• All Corridors In The Manufacturing Area.
• All Packaging Areas.
• Warehouses.
• Laboratories.
 GMP AREAS
Types of areas (Based on Access levels)
General Access
• Public entrances
• Administrative offices, etc.
Controlled Access
• Laboratories
• Secondary packaging
• warehouses, etc.
Restricted Access
• Manufacturing area
 Dress Codes
• All Personnel Must Use Proper Dress To Protect Drug Products From
Contamination And Protect Themselves From Exposure To Harmful
Conditions.

• All Personnel Involved In The Processing Of A Drug Product Must

Wear Clean Clothing Appropriate For Their Function.

• Appropriate Safety Equipment And Protective Garments Must Be

Worn.
 Dress Codes
Rules For Wearing Protective Clothing In GMP Areas

• Wear A Clean Garments And Changed Regularly . If Contaminated

During Work They Should Be Changed Immediately.

• Use Appropriate Clothing, Full Sleeves Are Worn In Dispensing,

Granulating, Coating ,Filling Etc. And Any Operation Where Direct
Contact With Product Occurs.

• All Buttons Are Fastened Up To The Neck.

 Dress Codes
Rules For Wearing Protective Clothing In GMP Areas
• Appropriate Dress ,Shoes (Or Shoes Covers) Are Worn. These Are To
Be Kept In Good Condition And Replaced As Necessary.
• Production Dress ,Shoe & Other Coverings Are Not To Be Worn
Outside The Production Area.

• Hair Completely Covered. Beard Or Moustache Cover Is Also Worn.

• Disposable Gloves Are Worn At All Times When Dispensing Raw

Material Or Handling Naked Tablets.

• Jewelry, Watches, Chains, Earrings, Are Not Be Worn In Any GMP

Designated Areas.
 Dress Codes
Hair net
Beard cover and face mask
2 piece suit /Lab Coat/Dungaree
Gloves, if required
Shoe or Shoe covers
 Dress Codes
PROPER DRESS

PROTECT YOU FROM THE PRODUCT

&
PROTECT THE PRODUCT FROM YOU
Thanks