GMP JOURNAL

The GMP environment is continuously experiencing profound changes. With the new GMP Journal we want to accompany this process.

This new periodical will provide detailed information on current developments in the area of Good Manufacturing Practices (GMP), valuable background information and analyses. The Journal will not only pick up regulations from FDA, EMEA, ICH and PIC/S, though. It will also cover inspectors' lectures during international conferences, reports from working groups, making it a unique source. Moreover, in no other publication you will be able to find excerpts from the FDA Warning Letters.

The GMP Journal will be published twice a year (April and October) and addresses professionals in Quality Assurance, Qualified Persons and GMP Representatives in the pharmaceutical and API industry. It is free of charge and will be distributed exclusively to members of the European Compliance Academy (ECA), which is one of the co-operation partners of Concept Heidelberg.

If you have any comments relative to the new journal or articles, we will be looking forward to receiving your note at info@concept-heidelberg.de.

Advertising in the GMP Journal

Introduce your business, technologies, products and services with an ad in the GMP Journal. For detailed information please contact Wolfgang Heimes at heimes@concept-heidelberg.de

 
GMP Journal issue 6.  

In the April/May issue of the GMP Journal you will read the following articles:
 
Cover Story

FDA INSPECTIONS: PAST, PRESENT AND FUTURE

Background
CHARTS: FDA WARNING LETTERS REPORT 2010

QUALITY BY DESIGN – THE REINVENTED WHEEL?

PERFORMANCE: HOW MUCH CONTAINMENT IS NEEDED?

CAPA AS A CENTRAL SYSTEM FOR IMPROVEMENT PROCESSES

Background
INITIATIVES: QUALITY ASSURANCE FOR ACTIVE PHARMACEUTICAL INGREDIENTS

  

GMP Journal issue 5.  

The fifth issue of the GMP Journal of October/November 2010 includes:
 
Cover Story

INFORMATION EXCHANGE: PHARMA CONGRESS PRODUCTION & TECHNOLOGY 2011

Conference Reports
BIO PRODUCTION FORUM: BRIDGING RESEARCH AND INDUSTRY

NEW STRATEGIES: THE FIGHT AGAINST COUNTERFEIT MEDICINES

Background
COUNTERFEIT MEDICINES: THE NECESSITY FOR A HARMONISED EUROPEAN APPROACH

IMPACT: THE MONOCYTE ACTIVATION TEST (MAT) REDUCES THE RISK OF PYROGENICITY

POINT OF VIEW: CHANGES IN THE CHAPTER ON TESTING NON-STERILE DOSAGE FORMS

  

GMP Journal issue 4.  

The fourth issue of the GMP Journal of April/May 2010 includes:
 
Cover Story

INCREASE: FDA ISSUES MORE WARNING LETTERS THAN IN PREVIOUS YEARS

Conference Reports
REVIEW: THE 12TH EUROPEAN CONFERENCE ON ACTIVE PHARMACEUTICAL INGREDIENTS

CONTROVERSIAL DISCUSSION: REQUIREMENTS OF ANNEX 1 CRIMPING/CAPPING

Background
GAMP®5: COMPUTER SYSTEM VALIDATION IS UNDERGOING CHANGE

WEIGHTING: DISADVANTAGES AND ADVANTAGES OF ELECTRONIC BATCH RECORDS

PAEDIATRICS: CONSEQUENCES OF THE EU REGULATION

THE NEW PHARMA PACKAGE: FAR REACHING CONSEQUENCES FOR THE GMP ENVIRONMENT

  

GMP Journal issue 3.  

The third issue of the GMP Journal of October/November 2009 includes:
 
Cover Story

DIALOGUE: INDUSTRY MEETS AUTHORITY

Conference Reports
FAST BREEDERS: RAPID MICROBIOLOGICAL METHODS (RMM)

SAFETY ISSUES: THE MANUFACTURE OF APIs IN THE FAR EAST AND ITS SURVEILLANCE

MEETING POINT: THE EUROPEAN QUALIFIED PERSON FORUM
  

GMP Journal issue 3.  

In the second issue of the GMP Journal from April/May 2009 you will find the following articles:

Cover Story
COUNTERFEIT - A GLOBAL ISSUE

GMP Inspections
FDA WARNING LETTERS REPORT

Validation
FDA'S NEW PROCESS VALIDATION GUIDANCE – THE INDUSTRY PERSPECTIVE

Confernce Reports
FDA'S JON CLARK INFORMS ABOUT THE AGENCY'S CURRENT INITIATIVES

THIRD EUROPEAN GMP CONFERENCE – A UNIQUE FORUM

Background
RISK-BASED QUALIFICATION OF SUPPLIERS, CONTRACT MANUFACTURERS AND CONTRACT LABS
  

GMP Journal issue 1.  

In the first issue of the GMP Journal from October/November 2008 you will find the following articles:

Cover Story
COUNTERFEIT DRUG PRODUCTS - ACTION IN DEFAULT?

IDEAS FOR THE BETTER PROTECTION OF EU PATIENTS AGAINST THE RISK OF COUNTERFEIT MEDICINES

Conference Reports
GMP UNDER RECONSTRUCTION

FDA'S NEW REQUIREMENTS ON PROCESS VALIDATION - AN OUTLOOK ON THE NEW FDA GUIDANCE
(Parts I and II)

QUALITY BY DESIGN - AN INTERDISCIPLINARY SYSTEM FROM DEVELOPMENT TO REGISTRATION AND PRODUCTION

Q&As on cGMP
CGMP COMPLIANCE QUESTIONS TO AUTHORITY OFFICIALS AND INDUSTRY EXPERTS