GMP Inspections - Hungary

Greetings & Thanks of HungaryCommon Aim of Supervisory Authorities Clear, rational, harmonized regulation Product quality Patient safety

Ágnes Szabó – GMP Inspector NIPN

Hungarian Institute of Drug and Nutrition

EMMI (Ministry) – NIPN/OGYÉI – Directorate of Technology & Supervision – Drug Inspectorate GMP/GDP/GCP/GLP/PhV Inspections & Quality Complaints ~ 100 Medicinal Product & ~ 50 API manufacturers 8 GMP Inspectors Steps of Inspection:

1. Notification – 2. Inspection – 3. Inspection Report – 4. CAPA –5. CAPA evaluation – 6. Decision on closure – 7. GMP Certificate

1. Notification Performed based on request or routine, regulare inspection Legal basis: EU legislation - 2001/83/EC (community code),

2003/94/EC (GMP) and national law Risk based approach – Compilation of Community Procedures on

Inspections and Exchange of Information (CoCP) Preparation

• Inspection team – rapporteur inspector• Inspected fields – different elaboration• SMF, Agenda/Documents readily available

2. Inspection Deficiencies presented and discussed when they are identified Daily wrap up, close out meeting Classification of deficiencies Field Report referring to critical deficiencies only

3. Inspection Report Internal deadline: 30 days Stucture and content according to CoCP – MIA, manufacturing

activities, SMF, changes, unanbiguous presentation of deficiencies withreferences, description part indicating the reviewed documentsDeadline for CAPA

4. CAPA submission5. CAPA evaluation

Performance, efficiency Decision on checking Request for additional activities/documentation

6. Decision on closure Statement on CAPA acceptance and closure of procedure

7. GMP Certificate Uploaded into the EudraGMDP database and released on paper

Documentation Electronical doketing system All steps documented chronologically under defined sub-numbers of

the same main procedure ID

Post Inspection Activities QRM – Intrinsic risk, product criticality, inspection findings The QRM serves as a basis to schedule the yearly plan

THANK YOU!