صناعة الأدوية

ja'far abu shaikha

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السلام عليكم ورحمة الله وبركاته

أنا مشترك جديد إسمي جعفر أبوشيخه من الأردن

ارجو مساعدتي بأية أمور تخص السلامة والصحة المهنية التي تعنى بمجال صناعة الأدوية

ولكم جزيل الشكر
 

مواضيع مماثلة

almasry

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أخي العزيز حدد نوع النشاط أولاً . تصنيع الأدوية أم المستلزمات الطبية ؟
 

ja'far abu shaikha

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أخي العزيز

صناعة الأدوية وما يخصها من أمور تخص السلامة والصحة المهنية.

وشكراً جزيلاً
 

نبيل عواد الغباري

مشرف الهندسة الكيميائية
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السلام عليكم ورحمة وبركاته
اهلا وسهلا بك هل انت من العقبة ؟
 

ibrahim Abass

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HACCP - Food and Pharmaceutical Safety
(Hazard Analysis and Critical Control Points)
HACCP is a systematic preventive approach to food safety and pharmaceutical safety that addresses physical, chemical, and biological hazards as a means of prevention rather than finished product inspection. HACCP is used in the food industry to identify potential food safety hazards, so that key actions, known as Critical Control Points (CCPs) can be taken to reduce or eliminate the risk of the hazards being realized. The system is used at all stages of food production and preparation processes including packaging, distribution, etc.
The HACCP Seven Principles :
1.Conduct a hazard analysis. The organisation determines the food safety hazards and identify the preventive measures are identified and applied to control these hazards. A food safety hazard is any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.

2.Identify critical control points. A Critical Control Point (CCP) is a point, step, or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to an acceptable level.

3.Establish critical limits for each critical control point. A critical limit is the maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level.

4.Establish critical control point monitoring requirements. Monitoring activities are necessary to ensure that the process is under control at each critical control point. Each monitoring procedure and its frequency may be listed in the HACCP plan.

5.Establish corrective actions. These are actions to be taken when monitoring indicates a deviation from an established critical limit. The final rule requires a organisation's HACCP plan to identify the corrective actions to be taken if a critical limit is not met. Corrective actions are intended to ensure that no product injurious to health or otherwise contaminated as a result of the deviation enters commerce.

6.Establish record keeping procedures. The HACCP regulation requires that all organisations maintain certain documents, including its hazard analysis and written HACCP plan, and records documenting the monitoring of critical control points, critical limits, verification activities, and the handling of processing deviations.

7.Establish procedures for ensuring the HACCP system is working as intended. Validation ensures that the organisations do what they were designed to do; that is, they are successful in ensuring the production of safe product. Organisations will be required to validate their own HACCP plans.

The seven HACCP principles are included in the international system ISO 22000. This standard is a complete food safety management system incorporating the elements of prerequisite programmes for food safety.

HACCP Verification
For each company, an audit checklist is drawn up based on the seven principles listed above. ISOQAR would audit an organisation against this checklist to determine whether they meet the requirements of HACCP. Verification ensures the HACCP plan is adequate, that is, working as intended. Verification procedures may include such activities as review of HACCP plans, CCP records, critical limits and microbial sampling and analysis.
 

ja'far abu shaikha

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السلام عليكم ورحمة الله وبركاته

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