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Basic Training Good Manufacturing Practices (GMP)

 

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Basic Training Good Manufacturing Practices (GMP)

Basic Principles of 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

GMP Inspection Process

Introduction

The role of the inspector

Preparation for an inspection

Types of GMP inspection

The inspection

 

 

 

The following documents have been used as the basis of the course material:

 

Quality assurance of pharmaceuticals – A compendium of guidelines and related materials Volume 1, Geneva, World Health Organization, 1997

Quality assurance of pharmaceuticals – A compendium of guidelines and related materials Volume 2: Good manufacturing practices and inspection, Geneva, World Health Organization, Updated edition, 2004

WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-Ninth Report, Geneva, World Health Organization, 2005 (WHO Technical Report Series, No. 929)

Annex 2: Good Manufacturing Practices: requirements for the sampling of starting materials (amendment)

Annex 3: WHO Good Manufacturing Practices: water for pharmaceutical use

WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fortieth Report, Geneva, World Health Organization, 2006 (WHO Technical Report Series, No. 937)

Annex 2: Supplementary guidelines on GMP for heating, ventilation and air-conditioning systems

Annex 3: Good manufacturing practices: supplementary guidelines on GMP for the manufacture of herbal

medicines

Annex 4: Good manufacturing practices: validation

Additional Reading Material

WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-third Report, Geneva, World Health Organization, 1993 (WHO Technical Report Series, No. 834)

Annex 3: Good Manufacturing Practices for biological products

WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fourth Report, Geneva, World Health Organization, 1996 (WHO Technical Report Series, No. 863)

Annex 7: Good Manufacturing Practices: supplementary guidelines for the manufacture of investigational pharmaceutical products for studies (clinical trials) in humans

WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-sixth Report, Geneva, World Health Organization, 2002 (WHO Technical Report Series, No. 902)

Annex 8: Quality systems requirements for national good manufacturing practices inspectorates

 

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quality assurance1) Quality of our services confirmed by audits.

2) International level of GCP / GMP / ISO trainers and auditors.

3) You can check at any time any GCP / GMP / ISO certificate for authenticity.

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06 July 2010

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Gift for each medical conference participant: Flash drive 2 GB Kingston DataTraveler (DTI / 2Gb) !

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