EUDRALEX training

EudraLex – Volumen 4 Buenas Prácticas de Fabricación (BPM) Pautas.

 

Introducción

• • Replacement of Commission Directive 91/356/EC of 13 Junio 1991 to cover good manufacturing practice of investigational medicinal products.
  • Commission Directive 91/412/EEC de 23 Julio 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products.
• Commission Directive 2003/94/EC, de 8 Octubre 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 Gestión de la calidad (revision February 2008)
• Chapter 2 Personal
• Chapter 3 Premise and Equipment
• Chapter 4 Documentación (Revision January 2011) – Coming into operation by 30 Junio 2011
• Chapter 5 Production
• Chapter 6 Quality Control
• Chapter 7 Contract Manufacture and Analysis
• Chapter 8 Complaints and Product Recall
• Chapter 9 Auto-inspección

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

Table Eudralex
Annex 1	Manufacture of Sterile Medicinal Products
Annex 2	Manufacture of Biological Medicinal Products for Human Use
Annex 3	Manufacture of Radiopharmaceuticals
Annex 4	Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
Annex 5	Manufacture of Immunological Veterinary Medicinal Products
Annex 6	Manufacture of Medicinal Gases
Annex 7	Manufacture of Herbal Medicinal Products
Annex 8	Sampling of Starting and Packaging Materials
Annex 9	Manufacture of Liquids, Creams and Ointments
Annex 10	Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
Annex 11	Computerised Systems (revision January 2011)
Annex 12	Use of Ionising Radiation in the Manufacture of Medicinal Products
Annex 13	Manufacture of Investigational Medicinal Products
Annex 14	Manufacture of Products derived from Human Blood or Human Plasma (Puede 2011) Deadline for coming into operation: 30 Noviembre 2011 Old Version
Annex 15	Qualification and validation
Annex 16	Certification by a Qualified person and Batch Release
Annex 17	Parametric Release
Annex 19	Reference and Retention Samples

 

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Capacitación en buenas prácticas de fabricación

 

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Programa:

 Principios básicos de GMP    

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

 Proceso de inspección GMP 

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

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