EUDRALEX training

EudraLex – Volume 4 ممارسات التصنيع الجيدة (ممارسات التصنيع الجيدة) Guidelines.

مقدمة

• • Replacement of Commission Directive 91/356/EC of 13 يونيو 1991 to cover good manufacturing practice of investigational medicinal products.
  • Commission Directive 91/412/EEC ل 23 يوليو 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products.
• Commission Directive 2003/94/EC, ل 8 أكتوبر 2003, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use

Part I – Basic Requirements for Medicinal Products

• Chapter 1 Quality Management (revision February 2008)
• Chapter 2 الموظفين
• Chapter 3 Premise and Equipment
• Chapter 4 التوثيق (Revision January 2011) – Coming into operation by 30 يونيو 2011
• Chapter 5 إنتاج
• Chapter 6 Quality Control
• Chapter 7 Contract Manufacture and Analysis
• Chapter 8 Complaints and Product Recall
• Chapter 9 التفتيش الذاتي

Part II – Basic Requirements for Active Substances used as Starting Materials

• Basic requirements for active substances used as starting materials

Part III – GMP related documents

• Site Master File
• Q9 Quality Risk Management
• Q10 Note for Guidance on Pharmaceutical Quality System
• MRA Batch Certificate

Annexes

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تدريب GMP

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برنامج:

 المبادئ الأساسية لبرنامج الرصد العالمي    

Introduction to the training course
Quality management
Sanitation and hygiene
Qualification and Validation
Complaints and recalls
Contract production and analysis
Self-inspection and Quality Audits
Personnel
Premises
Equipment
Materials
Documentation
Good Practices in Production and Quality Control
Sterile production
Active Pharmaceutical Ingredient

 عملية التفتيش GMP 

Introduction
The role of the inspector
Preparation for an inspection
Types of GMP inspection
The inspection

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اتصل بفريقنا للحصول على المعلومات السريرية والبحثية

أرسل استفسارك عبر البريد الإلكتروني