GMP十项基本原则.docx

1、GMP十项基本原则TEN PRINCEPLE OF GMP1. Writing Step By Step Procedures That Provide a Roadmap For Controlled and Consistent Performance 21.1. Introduction 2What Are Written Procedures? 2Why Are Written Procedures Important? 32. Carefully Following Written Procedures To Prevent Contaminations, Mixups, and E

2、rrors 43. Promptly and Accurately Documenting Work For Compliance and Traceability 54. Proving That Systems Do What They Are Designed To Do By Validating Work 75. Integrating Productivity, Product Quality, and Employee Safety Into the Design and Construction of Facilities and Equipment 96. Properly

3、Maintaining Facilities and Equipment 107. Clearly Defining, Developing, and Demonstrating Job Competence 118. Protecting Products Against Contamination By Making Cleanliness a Daily Habit 139. Building Quality Into Products By Systematically Controlling Components and Product Related Processes Such

4、As Manufacturing, Packaging, and Labeling, Testing, Distribution, and Marketing 1410. Conducting Planned and Periodic Audits 151. Writing Step By Step Procedures That Provide a Roadmap For Controlled and Consistent Performance 1.1. IntroductionIt is estimated that 90-95% of all our daily activities

5、are habit. Our days are filled with eating habits, work habits, sleeping habits, etc. Stop and think about it for a moment. compare your daily routine from one day to the next. Is it pretty much the same? Do you follow the same procedures throughout the day? Day-in and day-out? Its not surprising if

6、 you do, most of us are creatures of habit.Our lives are governed by procedures. For example: What is your procedure when you first get up in the morning? Do you put on the coffee? Shower? Dress? Read the paper? Whats your procedure when you first arrive at the plant?Yes, whether we like it or not,

7、our lives are governed by procedures. The main difference between the procedures we follow in our personal lives and the procedures we follow at work is the word written. Because of the critical nature of your industry, you cant take any chances. You must put your procedures in writing. Written proc

8、edures form the backbone of your business operation and are the key to Good Manufacturing Practice.What Are Written Procedures?Well, written procedures are important tools, and, like any tool, have value only when properly used. For example, the blueprints that a carpenter follows when building a ho

9、use are his written procedures, his controls. If he doesnt follow his blueprints, the finished house wont turn out as planned. Likewise, your written procedures provide you with detailed step-by-step instructions for executing or controlling the important parts of your business. Each step must be wr

10、itten in a clear and logical sequence. All steps should lead to our final goal - a safe and effective product. Another way you might think of written procedures is as a roadmap, which when carefully followed, help you avoid wrong turns - wrong turns that could put you on the road to mix-ups, errors,

11、 and recalls.So, just as you frequently check your roadmap on a trip, to be sure you are on the right road and headed in the right direction, written procedures need to be checked regularly to stay on the road to quality.Why Are Written Procedures Important?Lets examine quickly why written procedure

12、s are so important to your operations. Written procedures serve six important functions in your company:Standards of performance - Written procedures are important in establishing and enforcing work standards. Where required, written procedures help to ensure that the same job is consistently perfor

13、med the same way each time. Instruction - Written procedures help instruct employees at all levels of the company. For example, if you are a new employee trying to learn the job, or an experienced employee assigned to a different job, written procedures serve as a training guideline. Reference - It

14、is difficult to remember every step involved in manufacturing a quality product. Written procedures provide a time-saving checklist needed to make sure each step is carefully followed. Control - Written procedures, when well developed, have important control characteristics. They tell you what to lo

15、ok for when auditing and how to evaluate results for compliance. Review - Putting your procedures down on paper provides you with the opportunity to see how you can improve your operations and plan for performance improvement. Documentation - Finally, written procedures are a record of how you do ce

16、rtain operations. They are basic business documents which are critical to success. For example, when a complaint is received concerning a product, written procedures help document what happened and identify potential causes of the complaint. TipsUse these helpful hints for developing well-written pr

17、ocedures and getting them followed: Outline the Job.Outlining the job before you begin writing the procedure will help you to approach it in an organized fashion. You can do this by creating a brief breakdown of the important steps and the key points to remember when performing the job. Write For th

18、e Reader.Be sure that you use language that the reader will understand. Addtionally, you can increase the readability of the procedure by using short, simple sentences, using familiar, strong and short words, and writing in a conversational style. Use Pictures To Punctuate!A picture is worth a thous

19、and words, and it is therefore very important to use pictures to punctuate procedures. A picture can be any type of illustration or example which clarifies, supports, or reinforces the critical information in a procedure. Put Procedures In a PackageIn retail, you can have a great product at a great

20、price, but if you dont package and merchandise it properly, it wont sell. Selling written procedures (getting employees to follow them) is no different. The procedures may be well-written, but unless you package them in a way that relates to the needs of employees, you wont get them followed. Pay at

21、tention to the following things when packaging procedures: page design, instructions, table of contents, index, dividers, visual layout, and the type of binder you use. SummaryWritten procedures are essential to the consistent functioning of your company. When you write them, make sure that they are

22、 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! 2. Carefully Following Written Procedures To Prevent Contaminations, Mixups, and Errors How would yo

23、u answer this question - What is the best way to ensure compliance with the Good Manufacturing Practice Regulation? Hopefully, your answer would be, By carefully following each step of your companys written procedures.Why? Because the heart of GMP is the establishment of well written procedures for

24、each step of our manufacturing and quality operations. These written procedures provide the controls necessary to minimize the chance of mixups and errors in the manufacture of products. When you carefully follow written procedures, you not only ensure compliance with the GMP regulation, but, more i

25、mportantly, you ensure the consistent quality of your companys products.Shortcuts or DeviationsSometimes it seems that the steps described by the written procedures are not the most efficient way to do the job. If you are an experienced employee, you may see shortcuts that appear to save the company

26、 time and money or may make your job easier.Even so, never deviate from your written procedure without the approval of your supervisor. First, many apparent shortcuts have pitfalls that can be costly in the long run. Second, each step in a well written procedure has a purpose. This may not effect yo

27、u directly but may be there as a check or balance to another phase of the operation. Only those designated persons with a view of the total process can approve shortcuts or deviations in following written procedures.If you do have an idea for improving an operation, talk to your supervisor. If your

28、ideas is a good one, it should become part of the written procedure so that everyone can benefit.SummaryThe 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

29、 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 whats the be

30、st way to insure compliance with the GMP regulations, you can answer by carefully following each step of our companys written procedures. Written procedures are your roadmap to quality. Dont take a shortcut!3. Promptly and Accurately Documenting Work For Compliance and Traceability A record is a doc

31、ument that recalls or relates past events. It is a body of known facts. The records your company keeps to comply with the GMP regulations concern the people, the equipment and the step-by-step processes of manufacturing a quality processes of manufacturing a quality product. These records provide a

32、complete history of your product and provide a means of evaluating the source of any complaints regarding your products.The records you keep on the job are like the records doctors keep in a hospital. Patient charts record current condition and medical history records are reviewed to ensure quality health care. These records relate the exact activities that were performed on the patient. Your records also relate the exact steps that were completed to manufacture the product.Accurate Records Are ImportantAlthough it may seem unnecessary to