GMPReport Application
Report Application
Pharmaceutical Audit
Digitize your pharma audits. GMP, equipment qualification, process validation - complete checklist, photos, professional PDF report.
Free 7-Day TrialPharma Audit Types
GMP Audit
Good Manufacturing Practice, regulatory compliance.
Qualification
IQ, OQ, PQ for equipment and facilities.
Validation
Process validation, cleaning, analytical methods.
Supplier Audit
Raw material supplier qualification and monitoring.
Logistics
GDP, cold chain, traceability.
Laboratory
GLP, quality control, stability.
Features
Pharma Templates
Structured checklists based on GMP standards.
Documentation
Timestamped photos with data integrity.
CAPA Deviations
Deviation management, corrective actions, tracking.
Signatures
Audit trail, integrated electronic signatures.
Offline Mode
Audit in cleanrooms without connection.
PDF Report
Professional and structured report.
Other Regulated Sectors
Frequently Asked Questions
What are Good Manufacturing Practices (GMP) in pharmaceuticals?+
GMP (Good Manufacturing Practice) are regulatory requirements ensuring drug quality. In Europe: Eudralex Volume 4 (GMP). In France: ANSM decision. They cover: qualified personnel, qualified premises and equipment, controlled documentation, validated production, quality control, complaints and recalls, self-inspections.
What is equipment qualification (IQ/OQ/PQ)?+
A 3-step validation process. IQ (Installation Qualification): verification that equipment is installed according to specifications. OQ (Operational Qualification): verification of correct operation within planned usage ranges. PQ (Performance Qualification): verification that equipment operates reproducibly under actual production conditions.
What is the difference between an FDA audit and an EMA audit?+
The FDA (Food and Drug Administration) applies cGMP (21 CFR Parts 210-211) and can conduct unannounced inspections with observations (Form 483) and warning letters. The EMA relies on European GMP (Eudralex) with inspections by national authorities. Data integrity expectations are particularly strict on the FDA side (ALCOA+).
What does the ALCOA+ principle mean in data integrity?+
ALCOA+ is the acronym for data integrity principles required in regulated environments: Attributable (who?), Legible, Contemporaneous (when?), Original, Accurate. The '+' adds: Complete, Consistent, Enduring, Available. These principles apply to all GMP records, both paper and electronic.
How to manage deviations in pharmaceutical production?+
Any deviation from approved procedures must be documented, investigated (root cause analysis — Ishikawa methods, 5 whys), assessed for impact on product quality, and treated with CAPA (Corrective And Preventive Actions). Critical deviations can lead to batch rejection. The deviation register is systematically reviewed during inspections.