GMP Journal

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

This 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, EMA, 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 ECA Academy, 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.

ECA Academy Members can access all issues of the GMP Journal in the ECA Academy Members Area.

Advertising in the GMP Journal

Introduce your business, technologies, products and services with an ad in the GMP Journal. For detailed information please contact:

Mr Wolfgang Heimes
Telefon   +49 6221 84 44 21
Mail   heimes@concept-heidelberg.de

 

These topics are covered in GMP Journal

October/November 2015 issue

October/November 2015 issue

Cover Story

  • THE NEW ANNEX 15: A COMPREHENSIVE ANALYSIS

Conference Reports

  • GMP TRENDS: ANNEX 1, CONTINUOUS MANUFACTURING AND CONTROL OF PARENTERALS
  • THE NEW TREND IN THE GMP ENVIRONMENT: TRENDING
  • THE SPECIFIC CHALLENGES FOR THE IMP QP
April/May issue 2015

April/May issue 2015

Cover Story

  • A NEW CHANCE FOR AN MRA?

Background

  • GMP UPDATE: WHAT'S NEW IN THE EU?
  • UPDATE: THE VISUAL INSPECTION OF PARENTERALS
  • ICH Q10: IMPLEMENTATION THROUGH TOTAL PROCESS QUALITY IMPROVEMENT

Conference Report

  • PULLING TOGETHER: API CONFERENCE AS INITIATOR FOR MORE HARMONISATION
October/November 2014 issue

October/November 2014 issue

Cover Story

  • ECA/PQG GUIDELINE FOR THE INTERPRETATION OF GOOD DISTRIBUTIOJN PRACTICES (GDP)

Background

  • THE MOPST FREQUENT GMP VIOLTIONS IN THE MIRROR OF THE FDA WARNING LETTERS
  • PHARMA WATER: SAVING POTENTIAL FOR ENERGY COSTS
  • ANALYTICAL QUALITY CONTROL: ECA WORKING GROUP DEVELOPS SOP ON OOE AND OOT
  • PARTICULATE MATTER GUIDANCE: COMMENTARY REGARDING NEW USP CHAPTERS <787> AND <1787>

Conference Report

  • MICROBIOLOGY CONFERENCE AND BIOBURDEN WORKSHOP PROVIDE FOOD FOR THOUGHT

 

April/May issue 201$

April/May issue 2014

Cover Story

  • ACTIVE INGREDIENTS: SIDE EFFECTS CLEARLY WANTED

Conference Reports

  • FDA/GMP TRENDS IN THE MANUFACTURE OF ASEPTIC AND SOLID DOSAGE FORMS
  • QbD AND PAT – CURRENT STATUS OF THE PHARMACEUTICAL INDUSTRY

Background

  • THE NEW CHANGES TO USP CHAPTERS FOR PARTICULATE MATTER GUIDANCE
  • TABLETING PROBLEMS – CAUSES AND REMEDIES

 

October/November issue 2014

October/November issue 2013

Cover Story

  • THIRD PARTY GMP AUDITS: WHICH REPORTS CAN BE USED – WHICH CAN’T?

Background

  • CHALLENGE for the qp: THE CHINESE MARKET
  • VISUAL INSPECTION OF PARENTERALS: control of particulate matter
  • COMPLIANCE IN THe LAB: INFORMED PERSONNEL INDISPENSABLE
  • ICH Q10: IMPLEMENTATION THROUGH TOTAL PROCESS QUALITY IMRPOVEMENT
April/May issue 2013

April/May issue 2013

Cover Story

  • eTACT PROJECT: INTERVIEW WITH DR SUSANNE KEITEL, DIRECTOR OF THE EDQM

Background

  • WRITTEN CONFIRMATIONS: TIME IS RUNNING OUT!
  • 5TH EUROPEAN GMP CONFERENCE DEDICATED TO 50 YEARS OF GMP
  • THE NEW EU GMP GUIDE ANNEX 2: GOOD THINGS COME TO THOSE...
  • ECA VALIDATION GOOD PRACTICE GUIDE: A VALUABLE SOURCE OF INFORMATION
  • CLOUD COMPUTING FOR REGULATED GXP ENVIRONMENTS

 

October/November 2012 issue

October/November 2012 issue

Cover Story

  • THE CHALLENGE OF DEVIATION MANAGEMENT

Background

  • THE STANDARD DIN ISO 14644-1:1999: PROGRESS OF THE REVISION
  • CLOUD COMPUTING FOR REGULATED GxP ENVIRONMENTS

Q&As

  • cGMP COMPLIANCE QUESTIONS TO AUTHORITY REPRESENTATIVES AND INDUSTRY EXPERTS
April/May issue 2012

April/May issue 2012

Cover Story

  • THE 2011 FDA WARNING LETTERS REPORT

Background

  • GOOD DISTRIBUTION PRACTICES: THE NEW GUIDELINE AND ITS CONSEQUENCES FOR INDUSTRY

Conference Reports

  • QbD IN THE LIGHT OF THE CURRENT PROCESS VALIDATION GUIDANCE
  • QUALITY AND SECURITY OF ACTIVE SUBSTANCES: HIGHLIGHTS OF THE 14TH EUROPEAN APIC CONFERENCE
  • THE ANTI-FALSIFICATION LEGISLATION: POTENTIAL CONSEQUENCES FOR QPs

Q&As

  • cGMP COMPLIANCE QUESTIONS TO AUTHORITY REPRESENTATIVES AND INDUSTRY EXPERTS

 

October/November issue 2011

October/November issue 2011

Cover Story

  • EUROPEAN PHARMACEUTICAL INDUSTRY DEFINES EXPECTATIONS WITH REGARD TO EU PROCESS VALIDATION GUIDANCE

Conference Reports

  • EUROPE’S LARGEST PHARMA CONGRESS WITH COMPREHENSIVE EXHIBITION BRINGS TOGETHER INDUSTRY
  • EUROPE’S ANSWER TO COUNTERFEITING OF MEDICINAL PRODUCTS: DIRECTIVE 2011/62/EU
  • BIO PRODUCTION FORUM MOVES R&D CLOSER TO INDUSTRIAL MANUFACTURING

Background

  • EVOLUTION: NEW ANNEX 11 SUPPORTS A RISK-BASED APPROACH

Q&As

  • cGMP COMPLIANCE QUESTIONS TO AUTHORITY REPRESENTATIVES AND INDUSTRY EXPERTS
April/May issue

April/May issue

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

 

To-Top
To-Bottom