Pharmaceutical regulations explained in a practical way
GxP regulations made simple: Checklists, tables and operating diagrams integrated into easy-to-consult digital guides.
Based on internationally recognized standards
Our guides are based on the regulations and guidelines issued by leading bodies and organizations in the pharmaceutical sector.
Why Pharmaceutical Professionals Choose Us:
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REDUCE COSTLY ERRORS
Translate complex regulations into clear procedures. Avoid non-compliance, findings, and penalties with practical, ready-to-use tools.
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SAVE PRECIOUS TIME
Editable checklists, flowcharts, and templates allow you to immediately apply the rules without rewriting procedures from scratch.
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ALWAYS READY FOR AUDITS
Content aligned with the latest EMA, EU GMP, ICH and GVP revisions, tested in real cases and approved in inspections.
FIND THE GUIDE FOR YOUR ROLE
The Most Purchased Guides
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Operational Guide to GMP Cleaning Validation
Regular price €149,00 EURRegular priceSale price €149,00 EUR -
USP 382 – Implementation Guide for Parenteral Closure Systems
Regular price €199,00 EURRegular priceSale price €199,00 EUR -
Operational Guide to GMP Annexes 1, 15, 16 and 20 – With Best Practices
Regular price €89,00 EURRegular priceSale price €89,00 EUR -
Application Guide to the ISO 14644 Series for the Pharmaceutical Industry
Regular price €49,00 EURRegular priceSale price €49,00 EUR
Data Integrity: everything you need to know
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ALCOA+ & Data Governance – The Definitive Operational Guide for Pharmaceutical Data Integrity
Regular price €49,00 EURRegular priceSale price €49,00 EUR -
Audit Trail Review Step-by-Step – The Definitive Operational Guide for QC and Manufacturing
Regular price €49,00 EURRegular priceSale price €49,00 EUR -
Data Integrity in QC Labs – HPLC, GC, Empower, LIMS, ELN
Regular price €49,00 EURRegular priceSale price €49,00 EUR
ICH Guidelines – Q, S, E, M: Basic Guides
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ICH Quality Guidelines Q – The Complete Guide to Q8, Q9, Q10, Q12
Regular price €89,00 EURRegular priceSale price €89,00 EUR -
ICH Safety Guidelines – Toxicology, Genotoxicity, Carcinogenicity & Risk Assessment
Regular price €89,00 EURRegular priceSale price €89,00 EUR -
ICH Efficacy Guidelines E – Clinical Studies, GCP, E6(R3) & Global Structure
Regular price €89,00 EURRegular priceSale price €89,00 EUR -
ICH Multidisciplinary Guidelines M – CTD/eCTD, Stability, Bioequivalence & Global Submissions
Regular price €89,00 EURRegular priceSale price €89,00 EUR
PIC/S Collection – Aide-Memoire, PI Documents
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Introduction to PIC/S: Structure, Functioning, Documents and Aide-Memoires
Regular price €49,00 EURRegular priceSale price €49,00 EUR -
PIC/S PI Documents, Aide-Memoires and Operational Guidelines: How to Read, Interpret and Apply Them
Regular price €49,00 EURRegular priceSale price €49,00 EUR -
How to Prepare for a PIC/S Inspection – Operational Audit-Ready Guide
Regular price €49,00 EURRegular priceSale price €49,00 EUR
Computer System Validation (CSV)
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Computer Software Assurance (CSA) – Operational GxP Guide
Regular price €99,00 EURRegular priceSale price €99,00 EUR -
Operational Guide to Computer System Validation (CSV) in the GxP Environment
Regular price €99,00 EURRegular priceSale price €99,00 EUR
Annex 1 EU GMP - 2022
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Aseptic Process Simulation (Media Fill) – Practical Guide according to EU GMP Annex 1
Regular price €129,00 EURRegular priceSale price €129,00 EUR -
Contamination Control Strategy (CCS) – Operational Guide according to EU GMP Annex 1
Regular price €129,00 EURRegular priceSale price €129,00 EUR -
Operational Guide to the Implementation of EU GMP Annex 1 (Rev. 2022)
Regular price €129,00 EURRegular priceSale price €129,00 EUR
Key Roles in the Pharmaceutical Industry
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Qualified Person (QP) Operational Guide – Annex 16 / Batch Release
Regular price €149,00 EURRegular priceSale price €149,00 EUR -
The GDP Responsible Person: A Complete Guide to Good Pharmaceutical Distribution
Regular price €149,00 EURRegular priceSale price €149,00 EUR -
Technical Guide for Manufacturing Managers in Pharmaceutical Companies
Regular price €149,00 EURRegular priceSale price €149,00 EUR -
QA Manager Operational Guide – Deviation, CAPA, and Audit Readiness
Regular price €149,00 EURRegular priceSale price €149,00 EUR -
A Complete Guide to Regulatory Affairs in the Pharmaceutical Industry
Regular price €149,00 EURRegular priceSale price €149,00 EUR
MAKE YOUR JOB SIMPLE
Download the guide for your role now and implement audit-ready procedures.
Have questions? Check out our FAQs.
What are the GxP Guides?
GxP Guides are digital operational manuals for pharmaceutical industry professionals. We transform complex regulations (EMA, EU GMP, ICH, GVP) into ready-to-use checklists, templates, and procedures.
Who are they aimed at?
They are designed for several key roles: Qualified Person, QA Manager, Regulatory Affairs, Pharmacovigilance, GDP Responsible Person, Manufacturing Manager, Validation & Calibration Expert. They are useful for both those new to the industry and those with years of experience.
In what format will I receive the guides?
The guides are provided in professional PDF format, optimized for reading on PCs, tablets, and mobile devices. You'll receive them immediately after purchase.
Are they based on official regulations?
Yes. All content is based on official regulations (EMA, EU GMP, ICH, GVP, ISO) and recognized guidelines. We always include up-to-date references to ensure reliability.
Can I also use them for internal training?
Absolutely. The guides can be used as support materials for training, audit readiness, and onboarding new colleagues.