Professional Documents
Culture Documents
Cannaflos - Auditplan BG Labs 2022-04!13!15 - Final Draft - CP
Cannaflos - Auditplan BG Labs 2022-04!13!15 - Final Draft - CP
Cannaflos - Auditplan BG Labs 2022-04!13!15 - Final Draft - CP
Inspection Standards
GACP – Guideline on Good Agricultural and collection Practice for Starting Materials of
herbal origin, adopted by HMPC under the European Medicines Agency
EU-GMP Vol. 4 Part I – Good Manufacturing Practice – Basic Requirements for Medicinal
Products (European Commission)
EU-GMP Vol. 4 Part II – Good Manufacturing Practice – Basic Requirements for Active
Substances as Starting Materials (European Commission)
EU-GMP Vol. 4 Part III – EMA ICH guideline Q9 on quality risk management
EU-GMP Vol. 4 Part III – EMA ICH guideline Q10 on pharmaceutical quality system
Quality Manual
SOP list
A Site Master File (incl. material and personnel flow in GACP and GMP area) according to
EU-GMP Vol. 4 Part III – “Explanatory Notes on the preparation of a Site Master File” should
be prepared and presented to Cannaflos in good time before a regulatory inspection or a
final audit by Cannaflos.
Introduction of participants
BG Labs presentation
o BG Labs Company history
o Organizational chart
o Rules and laws relevant to the handling of Cannabis in Colombia as a
producer.
o Certificates / licenses / inspection history
o Overview of site
o Site security
o Layout of all functions (incl. material and personnel flow, cleanroom classes)
o Production process
o Business Continuity & Disaster Recovery
o Upcoming Improvements and Business Development
Cultivo y Post
cosecha
Dir técnica calidad
Asuntos regulatorios
Admon y finanzas
Quality Audit_BG Labs_2022-04-20_22_Agenda Page 5 von 6
Gestión de proyectos