Free pharmaceutical procedural maps built from primary regulatory sources. Every decision point. Every regulatory citation. Designed to be used - in training sessions, at your desk and on the manufacturing floor.
The free maps on this page cover the full procedural workflow. GMPify subscribers get access to the Enhanced Edition of each map on learn.gmpify.com, with deeper detail built for daily use and inspection prep.
The complete two-phase FDA OOS investigation framework. Phase I laboratory investigation through Phase II full manufacturing investigation. Every decision point, timeline and scope extension requirement from 21 CFR 211.192 and FDA OOS Guidance 2022.
From problem identification through root cause analysis, corrective action implementation and effectiveness verification to closure. Includes VOE design requirements and the 2026 warning letter case patterns.
Deviation classification, impact assessment, root cause methodology selection and CAPA integration. Includes the Apotex 2025 warning letter pattern and 5 Why versus Ishikawa selection criteria.
From change proposal through risk assessment, regulatory classification and implementation to post-implementation review. Includes PAS, CBE-30 and CBE-0 decision logic and ICH Q12 PACMP pathway.
Cleanroom monitoring programme design, alert and action level setting, exceedance investigation and trend analysis. Built from EU GMP Annex 1 2022 and FDA aseptic processing guidance.
From 483 receipt through observation assessment, response drafting, CAPA commitment and follow-up. Includes the March 2026 FDA Draft Guidance requirements and warning letter escalation risk factors.
Three-stage cleaning validation lifecycle from cleaning process design through qualification and continued verification. Includes MACO calculation pathway and HBEL versus legacy limit decision logic.
From batch completion through quality unit review, specification assessment, deviation and OOS status review to release or rejection decision. Covers both FDA and EU GMP qualified person release frameworks.
From supplier identification through qualification assessment, approval, quality agreement and ongoing monitoring. Includes the 2026 contract manufacturing enforcement framework and audit programme requirements.
From product classification through study design, storage condition selection, time point planning and shelf life determination. Built from ICH Q1A(R2) and the 2025 Draft ICH Q1 revision.
From design and specification through testing and certification, documentation and release, to requalification and maintenance. Includes the full ISO class to GMP grade equivalence table. Built from ISO 14644-1:2015, ISO 14644-2:2015, EU GMP Annex 1 2022 and 21 CFR 211.42.
From design and qualification through sampling and testing, trending and review, to maintenance and recertification. Covers PW, WFI and Pure Steam grade requirements. Built from USP <1231>, USP <645>, EU GMP Annex 1 2022 and 21 CFR 211.42.
From sample selection and preparation through test execution, result interpretation and investigation, to release decision and documentation. Covers membrane filtration vs direct inoculation. Built from USP <71>, USP <1071>, EU GMP Annex 1 2022 and 21 CFR 211.167.
From sample and method selection through test execution, result interpretation and trending, to investigation and release decision. Covers the complete USP <1111> product category structure. Built from USP <61>, USP <1111>, EU GMP Annex 1 2022 and 21 CFR 211.113.
From design and planning through execution, incubation and reading, to evaluation and requalification. Covers worst-case design requirements and acceptance criteria. Built from EU GMP Annex 1 2022, FDA Aseptic Processing Guidance 2004, PDA TR 22/28 and ISO 13408-1.
From risk assessment and strategy development through control implementation, monitoring and verification, to review and continuous improvement. Includes the full eight-component CCS framework. Built from EU GMP Annex 1 2022 Section 2.2, ICH Q9(R1) and ICH Q10.
From data collection and baseline through statistical analysis and limit setting, ongoing trend review, to signal response and adjustment. Covers control charts, percentile methods and run rules. Built from EU GMP Annex 1 2022, ICH Q10, USP <1116> and PDA TR 13.
From initial assessment and laboratory investigation through manufacturing and process investigation, root cause and impact assessment, to CAPA and closure. Built on the two-phase model from the Barr decision. Built from 21 CFR 211.192, FDA OOS Guidance 2006 and ICH Q10.
From isolate recovery and triage through method selection and testing, result interpretation and risk assessment, to library management and trending. Covers phenotypic vs genotypic methods. Built from USP <1113>, EU GMP Annex 1 2022 and PDA TR 13.
From detection and criteria through laboratory assessment, process and product investigation, to disposition and programme adjustment. Covers regression analysis, control charts and percent change criteria. Built from ICH Q1E, USP <1010>, 21 CFR 211.166 and 211.192.
From receipt and initial triage through investigation and classification, root cause and impact assessment, to response, CAPA and closure. Covers critical, major and minor complaint classification. Built from 21 CFR 211.198, EU GMP Chapter 8 and ICH Q10.
From audit planning and scheduling through execution, findings documentation and classification, to CAPA and follow-up verification. Covers auditor independence and risk-based scheduling. Built from EU GMP Chapter 9, ICH Q10 and 21 CFR 211.22.
From initiation and planning through identification and analysis, evaluation and control, to communication and review. Covers FMEA, HACCP, Fault Tree Analysis and risk ranking tools. Built from ICH Q9(R1), ICH Q10 and EU GMP Annex 20 / Part III.
From data collection and scope definition through compilation and trend analysis, evaluation and conclusion, to reporting, CAPA and follow-up. Covers required APR content per 21 CFR 211.180(e). Built from 21 CFR 211.180(e), EU GMP Chapter 1 and ICH Q10.
Print or display any map during team training to walk through the correct procedural sequence step by step. Every decision point references the applicable regulation so your team understands the why not just the what.
Review the relevant map before an FDA or EU GMP inspection to confirm your procedures align with the regulatory expectations shown at each decision point. Identify gaps before the investigator does.
Each map corresponds to a GMPify course that covers the regulatory content in depth. The map gives you the procedural framework. The course gives you the understanding behind every step.
Each procedural map is built from the same primary regulatory sources as the corresponding GMPify course. The map gives you the framework. The course gives you the regulatory depth, case examples and knowledge checks that prepare you for inspection.