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

September/October 2018 issue

September/October 2018 issue

Cover Story

  • THE VALSARTAN CONTAMINATION: CONTEXT AND IMPLICATIONS

Background

  • ANALYTICAL PROCEDURE LIFECYCLE MANAGEMENT (APLM) – THE CHANGING FACE OF VALIDATION

Conference Reports

  • ANNEX 1 - CLARIFICATION NEEDED
  • TRENDS IN THE GMP/FDA COMPLIANT PHARMA PRODUCTION
  • GLASS PACKAGING: USP, EDQM AND ECA CONFERENCE COVERS CENTRAL ISSUES

 

May/June 2018 issue

May/June 2018 issue

Cover Story

  • GMP UPDATE  WHAT IS NEW IN THE EU

Background

  • CLEANING AND DISINFECTION – A RISK BASED VS AN ARBITRARY APPROACH
  • MRA – STRENGTHENING THE COLLABORATION OF FDA AND EU
  • RISK MANAGEMENT IN ICH Q12 – SUPPORTING QUALITY, COMPLIANCE & CULTURE EXCELLENCE OVER THE LIFECYCLE
  • FDA AND EU-GMP – ALWAYS IN BALANCE?
January/February 2018 issue

January/February 2018 issue

Cover Story

  • GMP UPDATE  WHAT IS NEW IN THE EU

Background

  • FIVE YEARS EU GDP GUIDE LINES  A SUCCESS STORY?
  • CAPA  SEVEN STEPS FOR AN EFFECTIVE PROCESS
  • CLEANING AND DISINFECTION - A RISK BASED VS AN ARBITRARY APPROACH
  • CONTI MANUFACTURING - THE CONTINUOUS MANUFACTURE OF TABLETS
September/October 2017 issue

September/October 2017 issue

Cover Story

 

  • CYBER SECURITY – IS IT TIME TO RECONSIDER THE IT LANDSCAPE AND THE DESIGN OF INDUSTRIAL COMPUTERISED EQUIPMENT?

Background

  • ANALYSIS OF BIOPHARMACEUTICALS – AUTHORITY EXPECTATIONS
  • SERIALISATION: WHAT IS THE QUALIFIED PERSON'S (QP) ROLE?

Conference Reports

  • TECHNICAL AND REGULATORY DEVELOPMENTS IN THE PHARMACEUTICAL INDUSTRY
May/June 2017 issue

May/June 2017 issue

Cover Story

  • GMP UPDATE – WHAT IS NEW IN THE EU

Background

  • WARNING LETTERS: DRAMATIC INCREASE TO CHINESE COMPANIES
  • DATA GOVERNANCE: ROLES AND RESPONSIBILITIES

Conference Reports

  • QUALITY MANAGEMENT AND DATA INTEGRITY IN API PRODUCTION
January/February 2017 issue

January/February 2017 issue

Cover Story

  • GMP UPDATE – WHAT IS NEW IN THE EU

Background

  • PACKAGING UPDATE: REQUIREMENTS ON PACKAGING AND MATERIALS

Conference Reports

  • TRENDS IN LABORATORY INFORMATICS
  • CURRENT DEVELOPMENTS IN GMP COMPLIANCE
  • PHARMA CONGRESS: INNOVATIONS IN PRODUCTION AND PROCESS TECHNOLOGY
October/November 2016 issue

October/November 2016 issue

Cover Story

  • GOOD DISTRIBUTION PRACTICE: DISTRIBUTION CONCEPTS AND LEGAL RELATIONSHIPS

Background

  • IMPACT OF THE CHANGES TO THE EUROPEAN GMPs ON CLEANING VALIDATION – PART II
  • ICH Q7 GUIDE – QUESTIONS AND ANSWERS ON GMP FOR ACTIVE PHARMACEUTICAL INGREDIENTS
  • PACKAGING UPDATE: REQUIREMENTS ON PACKAGING AND MATERIALS

Conference Reports

  • CONSEQUENCES OF ANNEX 1 REVISION FOR INDUSTRY
April/May 2016 issue

April/May 2016 issue

Cover Story

  • GMP UPDATE – WHAT’S NEW IN EUROPE?

Background

  • IMPACT OF THE CHANGES TO THE EUROPEAN GMPs ON CLEANING VALIDATION
  • FDA READINESS: WHAT EXACTLY IS THAT?
  • GMP UPDATE – WHAT’S NEW IN EUROPE?
  • SELF INSPECTION – A CERTAIN KIND OF INSPECTION

Conference Report

  • API SUMMIT – 18TH EUROPEAN ACTIVE INGREDIENTS' MANUFACTURERS MEETING
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

 

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