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
+49 6221 84 44 21
heimes@concept-heidelberg.de

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

These topics are covered in GMP Journal

October/November 2024 issue

Cover Story

Development of modern Pharmaceuticals, Vaccines and more - Part 2

Background

CTR Implementation – A QP's Perspective
Real-World Data (RWD) and Real-World Evidence (RWE) to Support Medicinal Product Development
Product, Process, People
Handling external Personnel in the GMP Environment
Valsartan
GMP Hot Spots as seen in the Warning Letters
ICH Q7 Training Week
Analytical Instrument Qualification and System Validation

May/June 2024 issue

Cover Story

Development of modern Pharmaceuticals, Vaccines and more - Part 1

Background

GDP Update 2023/2024
Use of Artificial Intelligence in the 100% Visual Inspection of Parenterals
Pharmaceutical Contracts and their Importance for the Qualified Person
Audit Trail in EU GMP Annex 11 and EMA Concept Paper on Annex 11
26th APIC / CEFIC Global GMP & Regulatory API Conference
GMP Hot Spots as seen in the Warning Letters - Stability Testing

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Cover Story

GMP UPDATE WHAT IS NEW IN THE EU

Background

FIVE YEARS EUGDP 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

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

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

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

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

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

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

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

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