good manufacturing practice

1. Collected by/ ph. Ahmed Elbaghdady

2. 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!

3. 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!

4. 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.

5. 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

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

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.