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 Good Practices in Production and Quality Control |
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Good Practices in Production and Quality Control Related Guidelines
содержание презентации «Good Practices in Production and Quality Control Related Guidelines.ppt»| Сл | Текст | Сл | Текст |
| 1 | Good Practices in Production and | 15 | recorded protocol which demonstrates with |
| Quality Control. Related Guidelines John | a high degree of probability that any | ||
| Startup. Good Practices in Production and | activity will repeatedly produce a result | ||
| Quality Control Related Guidelines. JOHN | within a pre determined | ||
| STARTUP. Training workshop: Training | specification/requirement. ” All aspects | ||
| workshop on regulatory requirements for | of pharmaceutical manufacture require | ||
| registration of Artemisinin based combined | validation. Sufficiently important to be | ||
| medicines and assessment of data submitted | referred to throughout the guidelines. eg. | ||
| to regulatory authorities, February 23-27, | WHO 1 appendix 6 Normally states the | ||
| 2009, Kampala, Uganda. | requirement (not negotiable) but rarely | ||
| 2 | Basic Principles of GMP. Good | “how to”. | |
| Practices in Production and Quality | 16 | Basic Principles of GMP. TRAINING WHO | |
| Control. Related Guidelines. | 1.10 and EEC 2.8 to 2.12 Detail training | ||
| 3 | Basic Principles of GMP. The Ten | requirements General company culture On | |
| Commandments of GMP. Section 16 and 17. | the job Outside courses Tests for | ||
| 4 | Basic Principles of GMP. The Ten | proficiency Authorisation Training | |
| Commandments of GMP 1 Build Adequate | records. | ||
| Premises Equip Your Premises with plant | 17 | Basic Principles of GMP. RECORDS Found | |
| and services fit for purpose. Maintain | in the documentation chapters of the | ||
| your premises and equipment Write | guidelines. Examples Analytical test | ||
| procedures Validate your work/procedures. | records Batch manufacturing documents | ||
| Section 16 and 17. | (BMR) Cleaning records. | ||
| 5 | Basic Principles of GMP. The Ten | 18 | Basic Principles of GMP. CLEANLINESS |
| Commandments of GMP Train your workforce | AND HYGIENE Fleeting reference in EEC and | ||
| Record your work 8 Be clean in all things | WHO Guidelines PIC gives better | ||
| 9 Test for Quality 10 Audit for | information #. | ||
| compliance. | 19 | Basic Principles of GMP. QUALITY | |
| 6 | Basic Principles of GMP. The WHO | Quality Assurance Both OG and WHO describe | |
| Guidelines EEC Guidelines(ORANGE GUIDE | in detail the elements of a robust quality | ||
| Eudralex Guidelines FDA Guidelines(CFR) | system. Emphasises its all embracing | ||
| MHRA Specific Topics. | function. | ||
| 7 | Basic Principles of GMP. Well | 20 | Basic Principles of GMP. QUALITY |
| documented and respected guidelines. Most | Quality Control Quality control of raw | ||
| available on the internet (OG is the | materials Components Intermediates and | ||
| exception). | finished products. Microbiology. | ||
| 8 | Basic Principles of GMP. Do not forget | 21 | Basic Principles of GMP. QUALITY |
| EP, BP,USP Setting standards as opposed to | Quality Control WHO 1.17 EEC 12.6 Quality | ||
| guidelines. | control of raw materials Components | ||
| 9 | Basic Principles of GMP. PREMISES EEC | Intermediates and finished products. | |
| 1.3 Specifically Annexe 1 Sterile | Microbiology $ #. | ||
| Manufacture WHO Chapter 1 .12 HVAC Chapter | 22 | Basic Principles of GMP. AUDITING FOR | |
| 3 Sterile Manufacture. Eudralex Monograph. | COMPLIANCE WHO 1.8 EEC2.9 Describes the | ||
| 10 | Basic Principles of GMP. EQUIPMENT EEC | procedures Aspects of pharmaceutical | |
| 3 and 5 (production) Specifically Annexe 1 | production to be assessed. Includes audits | ||
| Sterile Manufacture WHO Chapter 1 | of suppliers. | ||
| (includes HVAC) Chapter 3 Sterile | 23 | So what else is there? ??? Basic | |
| Manufacture. Eudralex Guideline. Also | Principles of GMP. ISO9000. GAMP. HTM 2010 | ||
| Sterile Manufacture. | Validation of Autoclaves BS 6001. | ||
| 11 | Basic Principles of GMP. CARE and | 24 | Basic Principles of GMP. OTHERS ISPE |
| MAINTENANCE EEC 3.34 to 3.44 Cleaning and | Publications on good Pharma Practice HTM | ||
| maintenance. WHO 1.13 Company SOP for | 2010 Validation of Autoclaves. | ||
| service schedule and pre programmed | 25 | Basic Principles of GMP. WHAT ELSE IS | |
| Maintenance (PPM). | THERE Contract manufacture. Technical | ||
| 12 | Basic Principles of GMP. WRITE | agreements. WHO 1.7 EEC 2.7 Both define | |
| PROCEDURES Addressed in the Documentation | contract giver and acceptor And their | ||
| chapters of the guidelines EEC 4.19 to | individual and shared responsibilities. | ||
| 4.29 Include but not limited to Inventory | 26 | Basic Principles of GMP. WHAT ELSE IS | |
| control Sampling Testing and status | THERE Complaints Recalls Returns Stability | ||
| control Manufacture and packaging Hygiene | programmes. | ||
| /environmental monitoring & control. | 27 | Basic Principles of GMP. All the | |
| 13 | Basic Principles of GMP. WRITE | guidelines presented are objectives which | |
| PROCEDURES Addressed in the Documentation | are not negotiable Nowhere does it say if | ||
| chapters of the guidelines WHO 1.15 | it costs too much one can ignore the | ||
| Eudralex PIC Annexe 13. | guideline Nowhere does it say if the | ||
| 14 | Basic Principles of GMP. VALIDATION | resources are unavailable the guideline | |
| Validation protocols usually have a | can be ignored. Whist not negotiable, the | ||
| generic format # See WHO 1 appendix 6 | means /ways of achieving the objectives | ||
| Validation Master Plan PIC guideline | are a matter of company style” one man’s | ||
| 10063. | solution is another man’s disaster. | ||
| 15 | Basic Principles of GMP. VALIDATION “A | ||
| Good Practices in Production and Quality Control Related Guidelines.ppt | |||
Good Practices in Production and Quality Control Related Guidelines
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