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:

  • REDUCE COSTLY ERRORS

    Translate complex regulations into clear procedures. Avoid non-compliance, findings, and penalties with practical, ready-to-use tools.

  • SAVE PRECIOUS TIME

    Editable checklists, flowcharts, and templates allow you to immediately apply the rules without rewriting procedures from scratch.

  • ALWAYS READY FOR AUDITS

    Content aligned with the latest EMA, EU GMP, ICH and GVP revisions, tested in real cases and approved in inspections.

Targeted guides for each key role

Qualified Person (QP)

OPERATIONAL ANNEX 16: STRATEGIC MANUAL FOR AUDIT-PROOF BATCH RELEASE

EU GMP Annex 16 – Certification by a Qualified Person and Batch Release

Directive 2001/83/EC (Art. 48–52) – QP requirements and responsibilities

EU GMP Part I & Part II – Manufacturing of medicinal products and active ingredients

GDP Guidelines (2013/C 343/01) – For the release and distribution of batches

QA Manager

QUALITY MASTERY – CHECKLIST AND PROCEDURES FOR CAPA, DEVIATION AND AUDIT READINESS

EU GMP Part I – Quality Management System (Chap. 1) and production controls

EU GMP Annex 1 – Aseptic production

ICH Q9 – Quality Risk Management

ICH Q10 – Pharmaceutical Quality System

ISO 9001 – Quality Management Systems

Regulatory Affairs

RA Toolkit – Practical Guide to CTD, AIC Changes, and ICH Q12

Regulation (EC) 726/2004 – EMA centralised procedures

Directive 2001/83/EC – Community pharmaceutical legislation

ICH M4 – Common Technical Document (CTD)

Variations Regulation (EC) 1234/2008 – Management of variations

EudraLex Volume 2 – Guidelines for the Submission of Dossiers

Pharmacovigilance

PV COMPLIANCE – ERROR-FREE GVP, PSUR, AND RMP FORMS

Regulation (EU) 1235/2010 and Directive 2010/84/EU – New pharmacovigilance legislation

Good Pharmacovigilance Practices (GVP Modules I–XVI) – EMA

ICH E2A–E2E – International Guidelines on Safety

Regulation (EU) 520/2012 – Practical implementation of the PV

GDPR Responsible Person

OPERATIONAL GDP – SERIALIZATION, WAREHOUSE AND DISTRIBUTION
IN COMPLIANCE WITH EU

GDP Guidelines (2013/C 343/01) – Guidelines on Good Distribution Practice

Directive 2001/83/EC – Requirements for the distribution of medicinal products

EU GMP Part II – For distributed APIs

WHO GDP Guidelines – For non-EU markets

Manufacturing Manager

GMP PRODUCTION – ANNEX 1, CLEANING VALIDATION AND OPTIMIZED BATCH RECORDS

EU GMP Part I – Manufacturing and Quality Control

EU GMP Annex 1 – Manufacture of sterile medicinal products

ICH Q7 – GMP for APIs

OSHA / Occupational Safety Guidelines – Health and Safety in Production

EU GMP Annex 15 – Qualification and Validation

Validation & Calibration Expert

VALIDATION PRO – ISO 17025, IQ/OQ/PQ AND PROCESS VALIDATION IN THE COMPANY

EU GMP Annex 15 – Qualification and Validation

EU GMP Annex 1 – For sterile environments

ISO 17025 – Competence of testing and calibration laboratories

ICH Q8/Q9/Q10 – Pharmaceutical Development, Risk Management, Quality System

GAMP 5 – Good Automated Manufacturing Practice

FIND THE GUIDE FOR YOUR ROLE

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What they say about us

  • "Finally, a guide that combines standards and practice. We used it for an EMA inspection: zero critical observations."
    Maria R. – QA Manager, CDMO in Italy

  • “The conditional release section of Annex 16 has allowed us to formalize clear and auditable procedures.”

    Thomas K. – Qualified Person , German Pharma

  • “The AIC variation templates have saved us days of work and reduced submission errors.”
    Laura P. – Regulatory Affairs Officer , UK biotech company
DISCOVER ALL THE GUIDES

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.

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