Giới thiệu về khóa học | Tài liệu GMP
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Tài liệu GMP được chia sẻ bởi GMPc Việt Nam - Nhà tư vấn Sáng tạo, Chuyên nghiệp, Toàn diện Dự án Nhà máy GMP (EU, PIC/S, WHO, ASEAN), ISO 13485:2012, ISO/IEC 17025:2005, ISO 15189:2012, ISO 15378:2011, ISO 9001:2008
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Giới thiệu về khóa học | Tài liệu GMP
- 2. Module 1 | Slide 2 of 17 January 2006 Basic Principles of GMP Introduction to the Training Course
- 3. Module 1 | Slide 3 of 17 January 2006 Introduction Objectives of this Introductory Session To outline the programme To introduce your trainers To introduce you to one another and to understand your objectives and background To understand the way these modules work
- 4. Module 1 | Slide 4 of 17 January 2006 Introduction Programme Overview – I Basic Principles of GMP WHO Technical Report Series, No. 908, 2003, Annex 4 1. Introduction to the training programme 2. Quality Management 3. Sanitation and hygiene 4. Qualification and Validation 5. Complaints and recalls
- 5. Module 1 | Slide 5 of 17 January 2006 Introduction Programme Overview – II Basic Principles of GMP 6. Contract production and analysis 7. Self Inspection and quality audits 8. Personnel 9. Premises 10. Equipment
- 6. Module 1 | Slide 6 of 17 January 2006 Introduction Programme Overview – III Basic Principles of GMP 11. Materials 12. Documentation 13. Good Practices in production and quality control 14. Sterile production 15. Active pharmaceutical ingredients
- 7. Module 1 | Slide 7 of 17 January 2006 Introduction Programme Overview – IV GMP Inspection Process 16. Introduction 17. The role of the inspector 18. Preparation for the inspection 19. Types of GMP inspection 20. The inspection Trainers’ notes
- 8. Module 1 | Slide 8 of 17 January 2006 Introduction Your Team Who are we? Trainers (Name) (Qualifications) (Experience) (Name) (Qualifications) (Experience)
- 9. Module 1 | Slide 9 of 17 January 2006 Introduction Who am I? Name Experience Objectives Not a lot of people know ………..
- 10. Module 1 | Slide 10 of 17 January 2006 Introduction Objectives of the training course To introduce general elements on quality management To train you in the WHO GMP texts for pharmaceutical products To bring in your own experience To develop your own action plan
- 11. Module 1 | Slide 11 of 17 January 2006 Introduction Our Way of Working A presentation on the subject of the module - usually about 60 minutes follows the WHO text as the basis of the module will have the WHO reference at the bottom of the slide A 30-60 minute group session discussing issues or a problem that will be set for you Group feedback in plenary session Multiple choice quiz
- 12. Module 1 | Slide 12 of 17 January 2006 Introduction How the Group Session and Feedback works Move to your area and select a group chairperson, a timekeeper, a recorder and reporter to present the group’s views to the combined meeting Identify the issues to be discussed Discussion: fundamental to the learning process needs enthusiastic participation needs a “brainstorming approach” Document the group’s views on 1 flip-chart page Maximum of 10 minutes for each group’s presentation
- 13. Module 1 | Slide 13 of 17 January 2006 Introduction Working in Groups Please accept shared responsibility in each group for: Dialogue Shared ideas Shared understanding Shared meaning Clarifying Participation Enabling others to participate Active listening Agreeing to disagree
- 14. Module 1 | Slide 14 of 17 January 2006 Introduction Working in Groups When someone says something which does not agree with your views …. or seems wrong to you .… Do not immediately say “That’s wrong” or “How stupid” Pause; Reflect “What do they really mean?” Say instead “An interesting idea” or “that’s a different way of looking at it”
- 15. Module 1 | Slide 15 of 17 January 2006 Introduction Group Session Discuss the GMP issues you each face in your own countries Identify key objectives to be achieved in attending this programme at a: Regional level National level Organizational level Personal level
- 16. Module 1 | Slide 16 of 17 January 2006 Introduction Group Session Identify key objectives to be achieved in attending this programme, at a Regional level, at a National level, at an Organizational level and at a Personal level. Set objectives using the SMART formula: Specific Measurable Action-oriented Realistic Time-related
- 17. Module 1 | Slide 17 of 17 January 2006 Introduction Group Session Identify key objectives to be achieved in attending this programme, at a Regional level, at a National level, at an Organizational level and at a Personal level. Objectives should be developed in the SMART format: Specific, Measurable, Action-oriented, Realistic, Time-related Identify 3 success criteria by which the objective will be measured. Please observe the times allowed: 1 hour maximum discussion 5 - 10 minutes maximum feedback for each group
Editor's Notes
- Welcome Good morning and welcome to all delegates to this training course offered by the World Health Organization to develop the practical implementation of the WHO GMP text of Good Manufacturing Practice for Pharmaceutical Products. Thanks Our thanks to ______________________ for the arrangements that have been made to accommodate us all for the duration of the programme. Housekeeping (cover fire or emergency procedures, and domestic arrangements including location of toilet facilities, tea or coffee breaks, meal breaks)
- Objectives I propose to review first of all the objectives that have been established for this training programme. These are to outline the programme and to describe the qualities that your team members bring to the programme. (Introduce trainers) We would also find it most valuable if we could understand something about you, why you are here and what you want to get from this training programme. In this way we hope to ensure that you get what you want from the programme. Additionally it will help us and your fellow trainees to know your area of expertise, so that we may all learn from one another. It is also important that you have an understanding of how the modules are constructed, and our way of working in groups. I will explain a little later about some team rules which are essential if you are to obtain the most benefit from this GMP course. My colleagues and I are also available to be consulted individually on any matter if you feel we can help in any way. Please make maximum use of the opportunity to exchange experiences with all of us.
- We shall start by reviewing the programme and introduce our interactive way of working together. We will explain the way the group discussions will work. Modules 1-14 cover the basic principles of GMP. There will be a half-day module on Quality Management and the requirements for a quality assurance unit. You will need to have a clear understanding of the organizational structures that must be in place if a pharmaceutical company is to have the product quality that is required by the National Health Regulator. We shall look at complaint handling procedures and product recall procedures that you should expect pharmaceutical companies to have. This ensures that complaints are properly handled and that patients are protected from dangerous or substandard medicines that have been placed on the market by a proper recall system. This will be followed by a half-day session on Sanitation and Hygiene. Next we will spend a half-day looking at Validation. We then have a half-day module on Contract Production and Analysis. This is becoming much more important all over the world as companies decide not to manufacture all their own products in their own factories or manufacturing sites. This means that companies are putting more and more work out to contractors. Companies are also contracting out analytical work as methods become more complex or use expensive equipment. All of this contract work requires careful your inspection.
- Next we will have a short session on Self-inspection. We then turn to the topic of Personnel. Personnel should be seen by the pharmaceutical manufacturer as its most valuable resource. It is sometimes its most difficult one to manage. Inspectors need to be sure that there are sufficient human resources, with people who have the correct qualifications and acceptable levels of experience. An important issue for you to check is the conflict of interest that can arise if Quality Control is not properly independent of Production. For this reason a full day is required for this subject. This will be followed by a half-day session on Equipment. If you would like to have any particular piece of equipment discussed please write its name down and hand it to me at the end of this module. If possible we will discuss the item during the Equipment module. We shall then spend a full day on Premises. Here we are going to be looking at some of the fundamental issues, including the effect of the external environment, on a company’s ability to manufacture products in the appropriate conditions. This will be followed by a half-day session on Materials. Experience has shown that many problems arise as a result of the selection of unsuitable or impure materials. Many developing countries have financial constraints that work against using materials of the right quality.
- Documentation: This short module covers the design and use of documentation -- often poorly done, especially in less developed countries. Correct recording of activities as they occur is vital for the production and testing of products to meet GMP standards. The full-day module on Sterile Production will look at the very demanding activities required to achieve the highest standards. There are special demands that these very important products make upon a company’s resources and systems. Companies are often tempted to take shortcuts because of the expense involved and you will have to know where to look to see if the companies are strictly following Good Manufacturing Practices. A half-day module on Active Pharmaceutical Ingredients is covered next. This is an area where regulatory authorities should be increasing their inspection activities. It is a vital area for proper drug efficacy. If poor quality actives are used then the drug attributes sometimes cannot be tested for later on when the material is compounded into product. A problem at a later stage is also more expensive to detect and correct. Personal objectives: On completion of the GMP Basic Training Modules, we shall distribute a Personal Action Plan form in order to check your understanding of the materials, and to give you the opportunity to develop your personal action plans.
- Modules 15-20 cover the G MP Inspection Process. Modules 15-19 consist of short sessions on: . an introduction to the topic . the role of the inspector . preparation for the inspection . types of GMP inspection . the inspection and will take approximately one-and-a-half days to complete. Module 20 provide trainer’s notes.
- THIS SLIDE (or overhead transparency) IS AN EXAMPLE ONLY AND HAS NOT BEEN PROVIDED IN THE PACK – YOU SHOULD PREPARE AN APPROPRIATE VERSION FOR EACH COURSE. First of all a few details about each of your team members. (The team members are to introduce themselves with a short review of their background and experience, giving training, qualifications, organizations worked with, and any other relevant details. Get them to also reveal something personal, such as a hobby.)
- (Note to the trainer: This is a good ice-breaker. Get the trainees used to speaking to the whole group. Give each trainee only 2 or 3 minutes each, a little longer if at all possible. You may need to allow a little for time depending on the language ability of the participants.) In order that we can all become better acquainted, I would like you to tell us your name, your experience to date in manufacturing and/or GMP inspection, your objectives for attending this training programme and a little something about you that no one else in the room knows – YET!
- When we were preparing for this training programme, we were aware that it had to be of value to you, our participants. We felt very strongly that it must provide information and experience sharing in a form that you will want to take away with you and use again and again. These are the objectives that we have for this programme: We aim to provide you with a training programme to ensure that you have an understanding of all aspects of the WHO recommendations on GMP for pharmaceutical products. However, these recommendations have to be applied in the real world in which you live. For this reason we have developed the programme in such a way that your input will be an important element. The programme has been designed to enable you to bring in your real life experiences, so that we can see how you will respond to these real challenges. A training programme is only of value if, as a result of the training, you change your behaviour. To encourage such a change, we will be asking you to prepare your own personal action plan as we work through the training. Note for the trainer: The form for the action plan should be contained in the trainee’s registration material. It is suggested that you have an overhead of this and go through its layout at this point You have each been provided with a form for your own personal action plan: things to do as a result of this training programme. If any of you would like help in creating this action plan please see any member of the team during training. We would recommend that you compile this plan as we go along and not leave it all to the end. You will be expected to discuss this action plan with your supervisor on your return to your office and then regularly to review your progress with him or her.
- The modules start with a presentation which follows the WHO text. A reference number to the WHO text is always given in a text box at the bottom of the slide. There follows a group discussion. We have placed you into small groups and designated a room or an area for you to work in. On the next slide we will talk about the most effective ways to have a group discussion. Each group will be asked to present its findings before the other groups in what is sometimes referred to as a plenary session. We will allow 5 - 10 minutes for each group to make its presentation. At the end of each of the modules on Basic Principles of GMP (except this one) there is a set of simple multiple choice questions to complete. We will then go through the answers with you and discuss any questions you may have about them. Many previous groups have found test answer session one of the most informative parts of the programme.
- At the end of each session on the theory of the WHO text, we will put up an overhead to remind you which group you are in, which area or room you should go to, and the key issues to be discussed. Please help us to keep to time by moving quickly to your area. Your group must first appoint a chairperson, a timekeeper to keep you on track, a recorder and someone to present your conclusions. Then discuss the issues. These group discussions are considered to be: fundamental to the learning process need enthusiastic participation needs a “brainstorming approach We recommend the technique of “brainstorming” using a flip-chart to get all the issues out into the open quickly. I should just like to check if everyone is familiar with brainstorming and the rules that apply to it. (Note to the trainer: If necessary advise how brainstorming is undertaken using a flipchat.) At the end of your group discussions, you will come back here for a session at which the conclusions from each group will be presented to everyone. This will last at the most, 30 minutes.
- Some trainees may get suppressed by more dominating trainees. A few group rules are useful. Trainers tip: Provide slides 11 and 12 as fullpage handouts. Dialogue: make sure that the groups are not monopolized by one participant Shared ideas: encourage participants to share experiences or to advance their ideas even if they seem a little silly. Make sure that they record all ideas, no matter how strange they may seem. Some explanation of brainstorming may be needed. Shared understanding: some participants in each group may have a good understanding of the subject and should be encouraged to explain the concepts. Shared meaning: If some of the group has a better understanding of the meaning of a concept, encourage them to share this with the group. Clarifying: make clear the meanings Participation: Each person should be encouraged to participate in the groups work. Enabling others to participate: Some participants through shyness of language barriers may feel left out. It is important that the groups draw these people into the discussions as much as possible. Active listening means concentrating on what they are saying, asking questions such as “I take it that you mean … by your statement”, or “I see” or “could you explain that another way perhaps” Agreeing to disagree: sometimes, inevitably, there comes a time when some people within a group just cannot agree. This is sometimes quite acceptable because GMP is not a black and white subject. However, it is important that when this situation arises that the people respect that the other person has a right to hold a certain interpretation and so still agree to disagree.
- Its OK to disagree within a group. However, try to understand the other person’s point of view.
- Trainer’s tip: this slide may have to be ordered with the Personal level coming first, depending on the nature and background of the participants. The Regional and National level may have to be explained or a global perspective can sometimes be encouraged where there are countries with factories are exporting (or want to export) products around the world. For our first group session we want to you to familiarize yourself with the brainstorming technique and the way of working in groups. You need to learn how to work with your groups members to achieve a good result together. Please use this session to start this process. Your task in your groups is to to discuss the current GMP situation in your country. We wish to know the following: 1. What do you consider to be your key objectives for this programme? 2. What you will use to measure the success or otherwise of the whole programme?
- Discuss the SMART approach to setting objectives. Example: I want to prepare two GMP training modules for use in my own country by the year 2003. Show how this is specific, measurable, action-oriented, realistic and time based.
- Identify 3 criteria by which you will measure the effect. You have 1 hour for this activity and you should return with 1 flip-chart sheet to be presented in a maximum of 5 - 10 minutes (Note: you may have to allow a little longer for discussion or for other matters such as language problems) in the plenary session. Here is a list of the members of each group and your group room numbers. You have one hour for the discussion and then we shall meet back here for the group feedback session. We hope that you will enjoy our training programme and gain valuable insights that will help you in your work in the future.