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 addresses professionals in Quality Assurance, Qualified Persons and GMP Representatives in the pharmaceutical and API industry. It is free of charge and available at www.gmp-journal.com.

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:

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

Please find all articles of the GMP Journal at www.gmp-journal.com.

These topics are covered in GMP Journal

February/March 2024 issue

February/March 2024 issue

Cover Story

  • GMP Update 2023/2024

Background

  • The FDA Warning Letter Report 2023
  • Continuous Tableting and the Road to Global Adoption
  • Self-Inspections
  • Questions and Answers to Cloud Computing in a GxP Environment - Part 3
  • Conference report on the ECA GMP & GDP Forum - Day 1 & 2
  • Conference report on the ECA GMP & GDP Forum - Day 3
October/November 2023 issue

October/November 2023 issue

Cover Story

  • Quality Standards for Medical Cannabis – Update on Pharmacopoeial Monographs

Background

  • Are Data Quality and ALCOA attributes equivalent?
  • FDA 483s and Warning Letters concerning Stability Testing
  • ICH Q7 Training Week 2022
  • Safe Handling of Highly Potent Substances
June/July 2023 issue

June/July 2023 issue

Cover Story

  • GDP Update 2022/2023

Background

  • QPs in a Time of Electronic Data
  • Advanced Data Analysis as an enabler to near real-time Contamination Control Strategy Evaluation
  • New Code of Conduct developed for QPs
  • 30 Years of APIC - Highlights of the "25. APIC/CEFIC Global GMP & Regulatory API Conference"
  • Air-tightness of Cleanrooms and Containment Solutions - Classification, Planning & Testing
  • Extended QP responsibilities based on national legislation
February/March 2023 issue

February/March 2023 issue

Cover Story

  • GMP Update 2022/2023

Background

  • The Ideal Managed Access / Compassionate Use Legislation
  • Pharma Congress 2022
  • Reusable wipe covers - GMP-compliant and process-safe in use
  • ECA Qualification and Validation Forum
  • Questions and Answers to Cloud Computing in a GxP Environment - Part 2
  • Questions and Answers about Cleaning Validation - Part 2
October/November 2022 issue

October/November 2022 issue

Cover Story

  • Annex 1 Revision

Background

  • Questions and Answers on (Reduced) Sampling
  • Cross-contamination and Sustainability: The Trouble with Contamination
  • Data flows, Data Lifecycle, and ALCOA+
  • GMP for APIs - Live Online ICH Q7 Training Week - Interviews
  • Developments on GMP Classification of Fiscal Imports
  • GMP-compliant equipment design: The GMP Equipment Design Guide
  • Questions and Answers about Cleaning Validation - Part 1
  • Questions and Answers to Cloud Computing in a GxP Environment
June/July 2022 issue

June/July 2022 issue

Cover Story

  • Stability testing for medical Cannabis – What needs to be considered

Background

  • Common and Typical GDP Violations
  • Highlights of the 24th Active Pharmaceutical Ingredients Conference of APIC
  • Q&A from European GMP Conference: “Bioburden – Regulatory Expectations and Practical Experiences”
  • The Present and Future of Remote Audits
  • The most Frequent GMP Deficiencies in Quality Control
February/March 2022 issue

February/March 2022 issue

Cover Story

  • GMP Update 2021/2022

Background

  • QP Qualification Requirements in different Member States
  • ICH Q12 Pharmaceutical Product Lifecycle Management – Part II
  • Ventilation and Air-Conditioning Systems
  • New Publication – ECA's Good Practice Guide Integrated Qualification and Validation
  • Trends Identification and Anaysis
  • Microbiological Suitability Tests of Non-Sterile Preparations
  • ICH Q7 Training Week
October/November 2021 issue

October/November 2021 issue

Cover Story

  • ICH Q12 Pharmaceutical Product Lifecycle Management

Background

  • Compassionate Use and other Managed Access Concepts
  • Demonstrating Method Suitability for an ATP-bioluminescence Rapid Microbial Detection Method for Biologic Products
  • Cell by Design (CbD)
  • What makes a good GMP Auditor?
  • Successful Communication in Audits
June/July 2021 issue

June/July 2021 issue

Cover Story

  • Good Manufacturing Practice and the Marketing Authorisation Holder

Background

  • Prescription medicines in Japan
  • Highlights of the 23rd Active Pharmaceutical Ingredients Conference of APIC
  • Frequently Asked Questions by QPs – the EQPA Discussion Forum
  • Quality culture
  • Validation of disinfection procedures in aseptic manufacturing
February/March 2021 issue

February/March 2021 issue

Cover Story

  • Is Real Time Release Testing and Certification by the QP the next Generation Process?

Background

  • E-records Vulnerabilities
  • GMP Update 2020/2021
  • FDA finds most basic GMP quality control and quality assurance violations
  • Preparing for a data integrity inspection
  • The long and winding Road of the Annex 1 Revision
  • Cleaning Validation Q&A
  • European GMP & GDP Forum – the largest Conference of its Kind in Europe
  • How to safe Time and Money in International Equipment Qualification Projects?
November/December 2020 issue

November/December 2020 issue

Cover Story

  • Final Version: ECA´s Good Practice Guide Integrated Qualification and Validation

Background

  • Blind trust in supplier certificates and inadequate final testing
  • Pharma Congress 2020: Exchanging ideas and experiences online
  • Particularities of Russian GMP inspections from a specialist interpreter's point of view
  • GDP for APIs
August/September 2020 issue

August/September 2020 issue

Cover Story

  • GMP-Update – What's new in Germany and the EU? – Part 2

Background

  • Benchmark of Industry Practices: Surface Cleanliness Monitoring
  • Data Integrity & Data Governance - Part 2
  • GDP: the growing issue of theft
  • Covid-19: What Does Lockdown Mean for Chromatograph Qualification and Calibration?
  • Focussing on Quality – Critical aspects for auditing IT suppliers and service providers
  • Nitrosamine Impurities - A Global Challenge for API Manufacturers and Pharmaceutical Companies
  • Travel Restrictions: Are Remote Audits an Option?
  • Do you know the ECA Visual Inspection Good Practice Guide?
January/February 2020 issue

January/February 2020 issue

Cover Story

  • Medical Cannabis – How to get GMP-ready?

Background

  • GMP-Update – What's new in Germany and the EU? – Part 1
  • Supplier Qualification
  • Cold WFI Manufacture – Two Years after the Change in the Pharmacopoeia
  • FDA/GMP trends in production & technology - Part 2
September/October 2019 issue

September/October 2019 issue

Cover Story

  • Data Integrity and Data Governance - Part 1: What is Data Governance?

Background

  • Round table discussion on GMP for ATMPs in Vienna
  • FDA/GMP trends in production & technology - Part 1
  • Conference Report on GMP for ATMPs
January/February 2019 issue

May/June 2019 issue

Cover Story

  • When Things go wrong: is Whistleblowing an Option?

Background

  • Knowledge Management
  • GMP Inspections at API Manufacturers in the EU and Asia
  • Continuous Processing in the Biopharmaceutical Industry
January/February 2019 issue

January/February 2019 issue

Cover Story

  • GMP UPDATE - WHAT'S NEW IN THE EU?

Background

  • INADEQUATE HANDLING OF LABORATORY DATA AND OOS RESULTS
  • GMP MEETS CAPA

Conference Reports

  • WHAT'S NEW IN THE GMP ENVIRONMENT?
  • GMP DOCUMENTATION 
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

 

To-Top
To-Bottom