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 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 Includes the March 2026 FDA Draft Guidance requirements and warning letter escalation risk factors.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.
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.