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GXP ACADEMY · PHARMA ROLES & CAREERS
Explore the responsibilities, capabilities and operational challenges faced by pharmaceutical professionals. Content designed to help you understand your role, make stronger decisions and build the next step in your career.
ARTICLES & INSIGHTS
Roles, quality systems, operational activities and regulatory topics explained with a practical approach.
The fachtechnisch verantwortliche Person (FvP) is the Responsible Person required by Swissmedic for manufacturing, importation and wholesale of medicinal products in Switzerland. MPLO requirements, education, experience, presence and...
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How to get into quality assurance in the pharmaceutical industry: starting degrees, the GMP skills that matter, entry-level roles and the career path up to QA Manager and...
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How to build an audit-ready E&L dossier: documentation structure, risk assessment template, inspection checklist and answers to typical questions.
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How to implement Annex 1 §8.136 on E&L in single-use systems: risk-based strategy, supplier data, gap analysis, documentation and audit readiness.
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Complete guide to the VMP: why it is a governance document, what it must contain according to Annex 15, how to define scope and attachments, with a practical...
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Calibration certificates and logbooks: how to avoid uncontrolled Excel files, ensure ALCOA+, and implement CMMS/Part 11 systems without findings.
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How to build Continued Process Verification (Stage 3): parameters, control charts, Cp/Cpk, data stratification, golden batch, and governance. With practical examples from the shop floor.
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Operational FMD playbook for wholesalers: when to verify or decommission, how to manage NMVS alerts, quarantine workflow, and the Italian DataMatrix + bollino dual system.
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The fachtechnisch verantwortliche Person (FvP) is the Responsible Person required by Swissmedic for manufacturing, importation and wholesale of medicinal products in Switzerland. MPLO requirements, education, experience, presence and batch release...
The fachtechnisch verantwortliche Person (FvP) is the Responsible Person required by Swissmedic for manufacturing, importation and wholesale of medicinal products in Switzerland. MPLO requirements, education, experience, presence and batch release...
How to get into quality assurance in the pharmaceutical industry: starting degrees, the GMP skills that matter, entry-level roles and the career path up to QA Manager and Qualified Person,...
How to get into quality assurance in the pharmaceutical industry: starting degrees, the GMP skills that matter, entry-level roles and the career path up to QA Manager and Qualified Person,...
How to build an audit-ready E&L dossier: documentation structure, risk assessment template, inspection checklist and answers to typical questions.
How to build an audit-ready E&L dossier: documentation structure, risk assessment template, inspection checklist and answers to typical questions.
How to implement Annex 1 §8.136 on E&L in single-use systems: risk-based strategy, supplier data, gap analysis, documentation and audit readiness.
How to implement Annex 1 §8.136 on E&L in single-use systems: risk-based strategy, supplier data, gap analysis, documentation and audit readiness.
Complete guide to the VMP: why it is a governance document, what it must contain according to Annex 15, how to define scope and attachments, with a practical template.
Complete guide to the VMP: why it is a governance document, what it must contain according to Annex 15, how to define scope and attachments, with a practical template.
Calibration certificates and logbooks: how to avoid uncontrolled Excel files, ensure ALCOA+, and implement CMMS/Part 11 systems without findings.
Calibration certificates and logbooks: how to avoid uncontrolled Excel files, ensure ALCOA+, and implement CMMS/Part 11 systems without findings.
PRACTICAL GMP TOOLS FOR PHARMA
GuideGxP turns complex GMP requirements into operational guides, editable templates and practical insights for pharmaceutical professionals.
