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GMP Presentation.pptx
- 1. GMP Good Manufacture Practices Trainername Anas Awad
- 2. Quality: Is theculture, procedures and methodology to obtain, maintain , sustain , and improve good and standard products, that assure customer and consumer satisfaction, and environmental friend , safe on health, compliant with law, and satisfy company profit. 2
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- 5. What is GMP "Goodmanufacturing practices" or "GMP" refers to the Quality Control of manufacturing for foods, pharmaceuti cal products, and medical devices. GMPs are guidelines that outline the aspects of production that would affect the quality of a product 5
- 6. What are the10 golden rules? Golden Rule #1 Get the facility design right from the start Golden Rule #2 Validate processes Golden Rule #3 Write good procedures and follow them Golden Rule #4 Identify who does what Golden Rule #5 Keep good records 6
- 7. Golden Rule#6 Train and develop staff Golden Rule #7 Practice good hygiene Golden Rule #8 Maintain facilities and equipments Golden Rule #9 Build quality into the whole product lifecycle Golden Rule #10 Perform regular audits 7
- 8. Golden Rule #1 Getthe facility design right from the start 8
- 9. Every food,drug, and medical device manufacturer aims to operate their business in accordance with the principles of Good Manufacturing Practice (GMP). It’s much easier to be GMP compliant if the design and construction of the facilities and equipment are right from the start. 9
- 10. الدفاع خط االول ترابيةغير ، المحيطة المنطقة , وال مائية وال اشجار الخارجية الحاويات , مستوية ارض على معدن , تنظف مغلقة اسبوعيا ارتفاعه رصيف حوله المصنع مبنى 10 سم ( يستطيع ال الجرذون حفره الرمبات مقعرة في والحفر الفتحات االسوار ممنوعة االضاءة للداخل توجه الخارجية لالرض وليست لالعلى وليست صوديوم اللمبات زئبق حتى التجذب الحشرات التوالف في مؤقتا تخزن اماكن ومرتفعة معزولة خارجية 10
- 11. الثاني الدفاع خط االبواب , كامال محيطها على مطاط لها يوضع االبواب للداخل تفتح ال مناطق في الهوائية الستارة االنتاج ليس مترين ارتفاع على فعالة اكثر عملية البالستيكية الستائر Self closing االبواب دائما مغلقة الخارجية ( رداد ) 11
- 12. الثالث الدفاع خط PestControl Integrated Pest Management • الدفاع خطوط ( دخولها منع اصال التصميم طريق عن ) • الحياة مثلث كسر 12
- 13. ميكانيكية وقاية للحشرات الصواعق وليس المصائد وارتفاعها خارجية بشرط الصواعق 1.6 الى 1.8 م اللواصق والمبيدات للكيماويات ال 13
- 14. Pest Control Criteria Place Design Raw materials Final product 14
- 15. الشحن سيارات فحص األالمواد تنزيل قبل تفحص أن يجب الشاحنات كل ولية النهائي بالمنتج تحميلها أو ،منها حشري نشاط أي وجد إذا رفض
- 16. المكافحة متعهدي نشاطمتابعة المراقبة إستعمال المعتمدة الكيماويات النشاط عن مفصل تقرير المعنيين األفراد مع النتائج مناقشة
- 17. المصنع تصميم االنارة قويةالصناعية ( 550 لوكس , شمعة ) المواد لون توضح بحيث واالصباغ والمنتجات فاتح زيتي الجدران دهان , ملساء الجدران , التمتص الرطوبة , التنظيف سهلة , من خالية النتوءات والزوايا توفر التواليت العدد حسب : لكل حمام 20 شخص شوار لكل 25 شخص لكل مغسلة 10 اشخاص في االنتاج كل مغسلة 6 م ( مسافة المغسلة وقاع الحنفية بين ) انحدار االرضيات المناهل نحو 2.5 سم , لكل 3 م االرضيات اللون فاتحة و تتأثر ال موادها باالحماض والقلويات اذا شباك وجد , يجب ان بدون يكون ارفف , دقيق منخل وله والمنتجات والمواد الهواء تدفق واالشخاص من االماكن المتسخة نحو النظيفة , والعكس ممنوع الصحي الصرف شبكة عن الصناعية المياه شبكة فصل 17
- 18. Cross Contamination 18 Anas Awad(GMP& ISO)
- 19. Production Layout I L U Anas Awad(GMP& ISO) 19
- 20. Work flow Shouldbe linear, sequence, continuous, progressing from raw material (delivery ) to finished product (service), with the shortest distance, and ensuring no contact between raw and RTE Anas Awad (GMP& ISO)) 20
- 21. Facility layout Lay out the production area to suit the sequence of operations. The aim is to reduce the chances of cross contamination and to avoid mix-ups and errors. For example, don’t have final product passing through or near areas that contain intermediate products or raw materials. A logical and well-planned layout will improve productivity. Sometimes you need to step back and reconsider the whole production area rather than applying quick fix solutions. remove unnecessary traffic in the production area which could result in a hazardous environment segregate materials, products, and their components to minimize confusion and potential for mix-ups and errors. ‘Sometimes you need to step back and reconsider the whole production area’ 21 Anas Awad (GMP& ISO)
- 22. Example: A company, throughpoor planning, failed to keep the product manufacturing process linear. As the product moved through the factory, it was zigzagged from one area to another. This meant that near-final product was exposed to early-stage product with the potential of contamination. Before making any changes, the company should have stepped back and reviewed the layout as a whole. 22 Anas Awad (GMP& ISO )
- 23. Environment It’s important tocontrol the air, water, lighting, ventilation, temperature, and humidity within a plant so that it does not impact product quality. You should design facilities to reduce the risk of contamination from the environment. Make sure that: lighting, temperature, humidity and ventilation are appropriate interior surfaces (walls, floors and ceilings) are smooth, free from cracks and do not shed particulate matter interior surfaces are easy to clean pipe work, light fittings, and ventilation points are easy to clean drains are sized adequately and have trapped gullies. 23 Anas Awad (GMP& ISO)
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- 26. Golden Rule #2 Validateprocesses 26
- 27. Equipment Design,locate, and maintain equipment to suit its intended use. Make sure that equipment is: easy to repair and maintain designed and installed in an area where it can be easily cleaned suitable for its intended use not reactive, additive or absorptive calibrated at defined intervals (if necessary) clearly labeled. 27
- 28. Validation is : "Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre- determined specifications and quality attributes.“ Validation usually involves: Design Qualification, or DQ, which is testing to verify that the equipment dimensions are suitable to the place Installation Qualification, or IQ, which is testing to verify that the equipment is installed correctly Operational Qualification, or OQ, which is testing to verify that the equipment operates correctly Performance Qualification, or PQ, which is testing to verify that product can be consistently be produced to specification. 28
- 29. Why to Validate? To prove that equipment and processes consistently do what they are supposed to do, testing and documentation is required. Consistent performance is the key to maintaining safety and effectiveness of every product and enhances a company’s reputation for quality and reliability. 29
- 30. المستقبلية المتوقعة للعملياتالتأكيدية اإلجراءات Prospective Validation ت في البدء قبل عملها يتم التي اإلجراءات هي وزيع ر َمطو أو جديد منتج . التالي ستحوي الوثائق : المنتج تركيبة التصنيع تعليمات الرئيسية التصنيع سجالت لإلنتاج الرئيسية العوامل تحديد العينات أخذ خطة و تحليلها 30
- 31. Change control Once testing is complete and the equipment or process is known to be controlled, it’s important to maintain its ‘validated state’. Achieve this by correctly following written procedures, and properly maintaining and calibrating equipment. If a change to the validated state is required then it must be subject to change control. A change control system should be in place to document all changes to facilities, equipment, or processes that may have an impact on product quality. You should evaluate the impact of the change and define the extent of re-validation. 31
- 32. Example: Acomputer system was validated after it was first installed on site. Some years later an auditor discovered that changes had been made to the system. No re-validation work had been performed and the system was no longer in its validated state. How did the company know that the system was operating in a controlled and consistent manner? The answer is they didn’t. The oversight was due to a weak change control system that allowed changes to be made without formal evaluation and re-validation. 32
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- 34. َفاألك الجودة أفراد ي اء + الالتحاليل طرق صحيحة = للجودة تنظيم 34
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- 36. المختبر تنظيم إجراءات الحسيةالتقييمات (SOPs and TMs) حفظ الكواشف الكيماويات و و البيولوجية األوساط (GLP) السجالت حفظ و الوثائق والدقة التحقق درجة قياس نظام (Accuracy and Precision) الحدود خارج النتائج مع التعامل (OOS) CoA Lab Accreditation 36
- 37. Golden Rule #3 Writegood procedures and follow them 37
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- 41. S O P StandardOperating Procedure 41
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- 44. ‘Procedures should beclear, concise, and logical’ 44
- 45. Some operatorsresist following procedures because they think they have a ‘better’ way of working. Introduce a “Better Operating Procedures” system within the work group where the team meets to discuss procedures that are not followed. Allow operators to suggest how they think a task should be performed and act on it as necessary 45
- 46. It isa GMP requirement to regularly review documentation to ensure that it’s up to date. Most companies have a three-year review cycle for their documents however this can be set according to the likelihood of change in the process that the document relates to. 46
- 47. Golden Rule #4 Identifywho does what 47
- 48. All employeesshould clearly understand what they have to do each day. It avoids misunderstandings and minimizes the risk to product quality. You should create a Job Description for each role to define: job title job objective duties and responsibilities skill requirements. 48
- 49. Example: Duringa validation batch a series of samples were not taken as the operators thought that validation staff would take them, whilst validation thought that the operators would take them. The sampling responsibilities should have been detailed in sampling procedures and the validation documentation. 49
- 50. Golden Rule #5 Keepgood records 50
- 51. Good recordsenable you to track all activities performed during batch manufacture from the receipt of raw materials, to the final product release; they provide a history of the batch and its distribution. It is an essential part of GMP to keep accurate records, and during an audit, it helps convey that you are following procedures. It also demonstrates that processes are known and under control 51
- 52. ‘If it’snot written down then it didn’t happen!’ If it’s not written then it’s a roomer 52
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- 55. 11080962 11080926خطأ المواصفة رقمنقل تم ABC 55
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- 57. Good recordkeeping Follow these guidelines to ensure that good record keeping is part of your everyday culture: Record all necessary information immediately upon completion of a task. Never trust your memory or write results on loose pieces of paper. Write your name legibly in ink. Remember that by signing records you are certifying that the record is correct and that you have performed the task as per the defined procedure. 57
- 58. Draw asingle line through any mistakes, and initial and date the correction. Include a reason for the correction at the bottom of the page. Record details if you deviate from a procedure. Ask your supervisor or the Quality Department for advice should a deviation occur. Don't document someone else's work unless you are designated and trained to do so. Never assume that undocumented work has been properly completed – if it’s not written down then it didn’t happen! 58
- 59. Signature fatigueis a problem in the pharmaceutical world. Employees are asked to sign so many records and can become complacent about what their signature actually means. Review your procedures to reduce the number of signatures to critical steps only. Include a ‘checked by’ signature when it’s required by a predicate rule. 59
- 60. Retention requirements: You should keep records for every stage of the manufacturing process. Some required records include: product master records batch or manufacturing records material / component control records personnel records training records equipment logs cleaning logs. 60
- 61. Keep documentsthat form GMP records for one year past the expiry date of the product or three years past the distribution date of the product, whichever comes later. You can define your own retention period for other documents and files. If you follow these guidelines, you will easily be able to examine each step of the manufacturing process should you need to. 61
- 62. Golden Rule #6 Trainand develop staff 62
- 63. To meetGMP requirements it’s essential to have the right people to do the right job. Do your employee’s have the skills and knowledge to complete their job? Have you equipped them with the right tools? If so, then you can be proud that your people are doing the right thing to make GMP a culture. 63
- 64. You shouldprovide training for all employees whose duties take them into production areas or laboratories, and whose activities could affect the quality of the product. It’s also important to ensure that training requirements are highlighted as part of the change control system. If you install a new piece of equipment then employees must know how to use it. Annual performance reviews are also a great way to formally discuss an employee’s development and performance. It’s a great way to review what the employee has achieved and to identify any gaps or areas for further development 64
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- 68. Golden Rule #7 Practicegood hygiene 68
- 69. It’s criticalto reduce the risk of product contamination to a minimum by putting in place a sanitation program. Develop a program to meet the standards of cleanliness necessary for the product. 69
- 70. Cleaning ,sanitization, disinfection Detergents , MSDS 70
- 71. To convincestaff of the importance of washing their hands after toileting, ask the microbiology department to take fingerprint samples from each operator after they have washed their hands. They can then see how much bacteria is present on their ‘clean’ hands. 71
- 72. الجيد التصنيع قواعد مكانه في شيء وكل مكان شيء لكل شائعة فهو يكتب لم ما بالطريقة منك مطلوب هو ما اعمل االفضل دائما النظافة وابدا 72
- 73. على حافظ االدوات حياتك نمط الجودة اجعل 73
- 74. أ المخاطر نواع ( التلوث ) فيزيائية:شعر ،معدنية قطع ،شوائب كيميائية : انسكابات جانبية تفاعالت ، بيولوجية : الطفيليات ،الفيروسات ،البكتيريا 74
- 75. المخاطر على السيطرة الجيدة الشخصية النظافة المنتج بتداول األصحاء لألشخاص فقط السماح . 75
- 76. الشخصي السلوك يجوز الالمنتج مع التعامل عند : التدخين ؛ البصق ؛ المضغ أو األكل ؛ العطس أو الكحة 76
- 77. الخاطئة السلوكيات بعض والساعات والحلي اإلكسسوارات لبس 77
- 78. الخاطئة السلوكيات بعض التجميل مستحضرات وضع 78
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- 80. اليدين غسل تكمن المنتجوسالمة صحة يديك في .... Product Safety Is In Your Hands… 80
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- 82. اليدين؟؟؟ غسل يجبمتى بالعمل البدء قبل التدخين بعد والشرب األكل بعد المياه دورة من الخروج بعدW.C النفايات من التخلص بعد القفازات تغيير بعد مع التعامل بعد االغذية النيئة 82
- 83. اليدين لغسل العالمياليوم 83
- 84. عن الناجمة التلوثمصادر اإلنسان الفم األنف البشرة الشعر األذن اليدين األظافر 84
- 85. القفازات اليدين لغسيلًالبدي القفازات تعتبر ال 85
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- 87. الصحية الحالة ... يجب ابعاد عليهتظهر العمل عن عامل أي أ عراض مرضية . إعالم العامل على يجب مسؤوله إصابته عند المباشر بالمرض 87
- 88. والجروح األمراض إلجراءاإلدارة إلى إبالغها ينبغي التي الصحية الحاالت تشمل الالزم الطبي الفحص و / إبعاد ضرورة مدى في النظر أو يلي ما ،األغذية تداول عن المصاب: اإلسهال القيء الحمى الحرارة درجة في بارتفاع المصحوب الحلق التهاب الظاهرة الجلدية االلتهابات ( والجروح ،الدمامل ... األنف أو العين أو األذن من إفرازات حدوث 88
- 89. الجروح الجروح تغطيةيجب No open cuts… 89
- 90. بالعاملين توافرها الواجبالصحية االشتراطات سارية صحية شهادات على العاملين حصول يجب المعدية األمراض من خلوهم تثبت المفعول 90
- 91. Golden Rule #8 Maintainfacilities and equipment 91
- 92. It’s important tohave a maintenance schedule for facilities and equipment: Regular equipment maintenance prevents equipment breakdowns, which can be costly. It also reduces the risk of product contamination . Maintains the ‘validated state’ of the facility or equipment. Sometimes an unexpected event may affect the facility or equipment and under such circumstances, you need to carry out repairs immediately 92
- 93. When writingmaintenance procedures consider whether the work can be performed outside the manufacturing area so that it doesn’t affect the remainder of the facility. If this can’t be achieved, remember to detail the cleaning requirements to get the plant back to a GMP standard. 93
- 94. Maintenance Records GMPrequires you to keep accurate records relating to maintenance activities. Use equipment logs to record information such as: when the equipment was last used what it was used for when it was cleaned when it was last inspected or repaired when it was last calibrated 94
- 95. Walk aroundyour plant and check all the calibration stickers you can see. If they are out of date then your maintenance process is not being controlled properly. 95
- 96. Golden Rule #9 Designquality into the whole product lifecycle 96
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- 98. By workingin food, drug, and medical device industry you know that the health and safety of the customer depends on the quality of the product. The QC department can only inspect for quality so it’s critical that you build quality into the product lifecycle. four critical areas: 1. Components (Raw Material) 2. Manufacturing Process (IPC) 3. Packing, Packaging and Labeling 4. Holding and Distribution (Storage, Market) 98
- 99. 1. Receiving ofraw material األولـيـــة المواد Raw Materials Packing Material 99
- 100. الصحيحة المواصفات + الصحيحة المواد = الصحيحةالمنتجات 100
- 101. المبادىء العامة اإلدارة و للموردين االعتمادية Supplier Qualification الموردمن المواد مواصفات Supplier Specification المواصفات مع التوافق Sampling & Testing المرجع العينات ية Standard Samples 101
- 102. المواد الستالم إجراءاتوجود Receiving Procedures Deviation Report 102
- 103. 2. Manufacturing Process الجيدةالمواد + الجيدة العمليات = الجيد المنتج 103
- 104. المعدات تمييز و المعدات تعريف و الرئيسية الخطوط المعايرة الضبط القياسيةالتشغيل حدود عند (Centerlining) 104
- 105. الخطوط تحضير إجراءات (Line Clearance) المواد القياسيةاإلجراءات تطابق العملية التصرفات الموضوعة (SOP) مع التعامل الحيود والمخالفات non conformity 105
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- 107. إستعداد المنتج + العمليات في للتحكمجيدة أنظمة = جــيـــد منـتــج 107
- 108. ؟ العمليات فيالتحكم لماذا IPC التشغيل جودة لضمان التذبذبات على القضاء و من التغيرات تشغيل ة ألخرى تطوير و الجودة تحسين و التشغيل دائمة بصورة للمواصفات مطابق منتج إنتاج ومس تمرة 108
- 109. ماهي ؟ التحكم فكرة العملياأن يضمن تكتيك هو العمليات في التحكم ت باستمرار تنتج التصنيعية م توقع يحقق نتج المستهلك ات و المو التصميم وفق إنتاجه يتم وأيضا ،يرضيه ضوع دائمة بصورة التركيبة في ومستمرة 109
- 110. تـعــريــفــــات نقاط السنترالين (Centerlining) الضبط نقاط و (Set points) : فمتغير لكل التشغيل مدى في المحددة المثالية النقاط هي العملية ي التشغيلية و باستمرار الهدف المنتج ستعطي التي . ع و فإن ادة نقاط السنترة ،التعبئة خطوط على محددة تكون و الض نقاط بط التصنيع عمليات في تكون . التباين تقلل النقاط هذه و و التفاوت نوبة بين و ،أخرى و شخص بين و آخر 110
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- 113. 3. Packing, Packagingand Labeling line clearance Receiving from warehouse Mix up 113
- 114. األكــــواد موحد نظام لألكواد موقع األكواد و وضوحها الثانية للكود التفسير Batchand lot تاريخ اإلنتاج و الصالحية انتهاء Shelf life Stability study 114
- 115. TAMU Target Accepted Marginal Unaccepted 115
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- 119. 4. Holding andDistribution (Storage, Market) المنتجات تصنيف مع التعامل تنظيم التوالف المعدات وصيانة تشغيل ( الرافعات ) البيئية النظم في والتحكم الصيانة ( ورط حرارة وبة ) 119
- 120. FIFO First In ,First Out 120
- 121. األسواق من المرتجعةالمنتجات المرتجعة المنتجات تنظيم إتخاذ النهائي القرار والفسح أرقام متابعة التشغيالت المرتجعة للبضائع اإلرتجاع الوهمي (Mock test) Recall Shipping Form 121
- 122. Golden Rule #10 Performregular audits 122
- 123. ISO 22000 InternalAudit K.E.# 16 برنامج التطوير الذاتي الداخلي التدقيق الـتــطـــويـــر الــذاتـــي = تـحــســيــن مـســتــمــر 123
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- 131. Written Procedures Arethere procedures that provide "step by step instructions" to perform my job? Do I know and understand these procedures and do I carefully follow them? Do I regularly review my procedures to make sure they are accurate and up-to-date? Do I refrain from deviating from my written procedures? When I see an easier or better way to do my job do I discuss this with my supervisor? 131
- 132. Job Competence DoI have the necessary education, training, and on-the- job experience to perform my assigned function? Have I identified and acquired the necessary skills (i.e. been trained) that relate to my job? Do I perform my job right the first time and every time? 132
- 133. Documentation and Validation Do I carefully document my work by recording all necessary information immediately? Do I sign my name legibly and in ink, when and where a signature is required? If required, do I mark down the date and the time I started or completed the job? Do I check and double-check all critical operations to make sure there are no errors? 133
- 134. Sanitation and Cleanliness Do I always practice good personal hygiene? Do I always wear the proper garments in the workplace? Do I wear the garments correctly? Are my equipment and tools clean? Do I store them in the proper place? Do I report any conditions in the plant or equipment that could be potential sources of product contamination? 134
- 135. Maintenance of theWorkplace Is there adequate space in my work area to safely and effectively perform my job? Do I minimize the chance of product contamination, mix-ups, and errors by helping to control the plant environment? Do I perform routine maintenance on my equipment? Do I check to see if my measuring and testing equipment is calibrated? Do I keep an accurate equipment log? Do I promptly report any maintenance problems to the supervisor? 135
- 136. Quality Control DoI carefully control the components used in the manufacture of our products? Do I pay close attention to the lot numbers assigned to components and finished products? Do I know and understand what responsibility the Quality Assurance/Quality Control Department has for assuring Product Quality? Do I know and understand my responsibility to build quality into our products? 136
- 137. If youhave answered "no" to any of these questions, then raise a corrective action. Auditing is an important tool to help evaluate your progress toward the goals of GMP. If you have answered "yes" to these personal audit questions, your work practices are compliant with the requirements of GMP. 137
- 138. GMP 10 GoldenRules 138
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