The Ten Principles of GMP

Collected by/ ph. Ahmed Elbaghdady

BIOTECHNOLOGY DEPTARTMENT

Principle #1Writing detailed step-by-step procedures that provide a roadmap for controlled and consistent performance

Written procedures are essential to the consistent functioning of your company. When you write them, make sure that they are clear, concise, easy to understand, and logical .

Having well conceived, well written, and well packaged procedures is the first step toward GMP compliance, and controlled and consistent performance!

Principle #2 - Carefully Following Written Procedures To Prevent Contaminations, Mixups, and Errors

The written procedure is the most valuable tool that you have at your disposal to ensure product quality.

A written procedure is a well thought out plan to help you attain the consistent quality in your work in which you can take pride.

Written procedures are as important to the experienced veteran as they are to the newly hired employee

The written procedure is your key to ensure compliance with the Good Manufacturing Practice Regulations. Remember, the next time somebody asks you "what's the best way to insure compliance with the GMP regulations, you can answer "by carefully following each step of our company's written procedures." Written procedures are your roadmap to quality. Don't take a shortcut!

Principle #3Promptly and accurately documenting work for compliance and traceability.

Before any product is released to the market, a complete check of your records is made to make sure the product meets our high quality standards.

When you sign your name on the appropriate records, you are, in essence, becoming an historian for that product .

Should you receive a customer complaint, the product history records become very important documents. They allow you to carefully examine each step of the manufacturing process to determine the seriousness of

the complaint and decide what action should be taken .When you care enough to make GMP a lifestyle, not just a

regulations, you do more than sign records - we put our name on a job well done .

So remember: Write it Down - Keep Good Records.

Principle #4 - Proving That Systems Do WhatThey Are Designed To Do By Validating Work

The factors we have just discussed all affect the consistent quality of our products. We can

summarize these factors as the 3 P's of GMP . They are:

Performance

Pride

Proof

Principle #5 - Integrating Productivity, Product Quality, and Employee Safety Into the Design and Construction of Facilities and Equipment

when you properly maintain your workplace you are helping to assure company productivity, employee safety and product quality.

Principle #6 - Properly Maintaining Facilitiesand Equipment

It is everyone's responsibility to follow established maintenance schedules, and to be on the lookout for new evidence of necessary maintenance. By doing this you can help your company maintain its good image and stay profitable.

Principle #7 - Clearly Defining, Developing, and Demonstrating Job Competence

It is important to remember that competence takes on a different meaning for every person,

depending on the jobs, duties, and responsibilities he has. Therefore, your challenge is to clearly

identify, define, develop, and demonstrate the individual job competencies that relate to your job.

Principle #8 - Protecting Products Against Contamination By Making Cleanliness a Daily Habit.

The Plant Sanitation Program is the best defense you have to defend your products against contamination .

When you think about it, all the defensive "must do's" of good sanitation practice are really nothing more than common sense. Your goal, then, is to make "cleanliness" a part of the GMP

"lifestyle ".When you do, you are meeting your personal responsibility to

defend your products against contamination.

Principle #9 - Building Quality Into Products By Systematically Controlling Components and Product Related Processes Such As Manufacturing, Packaging, and Labeling, Testing, Distribution, and Marketing

Through GMP we can identify four critical areas in our manufacturing

operation where you must establish effective controls to assure product

quality.

There are key elements in each of these critical control areas that help you build quality into your products. Let's briefly examine them.

Principle #10 - Conducting Planned and Periodic Audits

Auditing is an important tool to help you evaluate your progress toward the goals of GMP. The FDA externally audits your compliance with the GMP Regulation and your company's internal audits measure the success of our GMP Lifestyle. But most important, it's your personal responsibility to evaluate how well you are living up to the standards of GMP. Make a personal GMP audit part of your daily work habit today.

Special thanks for all