Practical tools to help you work faster — SOPs, checklists, calculators, and more
Ready-to-use regulatory affairs toolkit for RA professionals and job candidates. It has fillable PDFs to plan a regulatory pathway and coordinate a submission, plus 50 interview questions with model answers covering US FDA, EU and ICH requirements.
Ready-to-use USP–NF toolkit for QC, QA and compendial professionals and job candidates. It includes a 55-question interview handbook with model answers, scenarios and worked calculations, plus a 102-item checklist to assess the impact of USP–NF changes on products, methods and specifications.
Ready-to-use CSV toolkit for validation, QA and IT professionals and job candidates. It has 3 fillable PDFs to plan a risk-based validation, trace requirements to tests and evidence, and practise 60 interview questions aligned with 21 CFR Part 11, EU GMP Annex 11, GAMP 5 and FDA CSA.
Ready-to-use GMP toolkit for pharma professionals and job candidates. It has 4 PDF resources to self-assess inspection readiness against 80 evidence-based checks, practise documentation on realistic batch and lab records, and answer 80 interview questions aligned with EU GMP and 21 CFR 211.
Ready-to-use QMS toolkit for quality professionals and job candidates. It has 4 PDF resources to audit your quality system against 60 reference-mapped checks, decide between deviation, CAPA and change control, and practise 70 interview questions aligned with ICH Q10, EU GMP and 21 CFR 211.
Ready-to-use QA/QC toolkit for pharma professionals and job candidates. It has editable Word, PDF and Excel files to run quality investigations, review GMP records with a 45-item checklist, and practise 50 interview questions, all aligned with EU GMP, 21 CFR 211 and ICH.
Ready-to-use pharmacovigilance interview preparation pack for job candidates and hiring teams, including 2 editable Word documents to learn key PV terms, practice 300 interview questions, and review answer keys with clear explanations aligned with ICH and EU GVP.
Ready-to-use Market Complaint and Feedback Management pack for GMP, GxP, and QMS environments, including 3 editable Word documents to record, classify, evaluate, investigate, and close market feedback and product complaints.
Ready-to-use CAPA Management pack for GMP and GxP environments, including 4 editable Word documents to request, plan, execute, document, monitor, and close corrective and preventive actions.
What is the Pharmuni Toolkit?
Who are the tools designed for?
Are the tools free or do I need a subscription?
What is the difference between buying a single tool and subscribing to Pharmuni Pro?
In what formats are the tools provided?
Are the tools compliant with GMP and other regulations?
How often are the tools updated?
Can I keep the tools I have purchased after my subscription ends?