Practical pharma quality & compliance
Field-tested guidance on audits, Qualified Person duties, quality systems and inspection readiness — written by a senior QP.
How the MHRA Inspection Process Works (and Timelines)
A senior QP's guide to the MHRA inspection process: inspection types, stage-by-stage flow, how deficiencies are classified, realistic timelines and readiness.
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MHRA Inspection Types Explained
A senior QP guide to the main MHRA inspection types - pre-approval, routine, for-cause and follow-up - and how to make your MIA or WDA site ready for each.
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Premises and Facility Requirements for an MIA
A senior QP guide to MIA premises requirements: EU GMP layout, segregation, Annex 1 cleanrooms, utilities and the ALCOA+ evidence MHRA inspectors expect.
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Mock Inspections: How a Dry Run Prevents Real Findings
A mock inspection pharma dry run simulates an MHRA or EU GMP inspection so you catch and fix findings privately, before a regulator ever writes them up.
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Named Persons on a Licence: QP, RP and Production
Named persons licence guide: how the QP, RP, RPi and production roles work on a UK MIA or WDA, their eligibility, scope, authority and inspection readiness.
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Naming a QP on Your Manufacturing Licence
How to name a QP on a licence the right way: eligibility, scope, MHRA variations and governance for your UK or EU MIA, with employed or contract QPs.
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Setting Up a New Pharma Site: A Readiness Roadmap
A senior QP's phased roadmap for new pharma site setup: scope, MIA/WDA licensing, building an operating quality system, qualification and MHRA readiness.
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Pre-Application Readiness: What to Do Before You Apply
A senior QP's guide to licence readiness before an MIA or WDA application: scope, an operating quality system, named persons and a mock inspection.
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How to Prepare for an FDA Inspection from the UK
FDA inspection preparation for UK and EU sites: map 21 CFR 211 to EU GMP, ready your site, rehearse the team and respond to a Form 483 with confidence.
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