QUALITY AUDIT

General Information Auditor

Company: CANNAFLOS – Gesellschaft für medizinisches Cannabis mbH

Vogelsanger Straße 348
50827 Köln / Germany

Lead-Auditor: Dr. Wolfgang Stock / Qualified Person

TEL: +49 170 380 7679
EMAIL: wolfgang@cannaflos.de

Co-Auditor: Maximilian Schmitt / Managing Director – Head of QM

TEL: +49 178 811 4520
EMAIL: max@cannaflos.de

General Information Auditee

Company: BG Labs SAS

Head Office Cannabis Facility
Finca El Manzano
Av. Carrera 9 No. 110 – 51 In. 111 Vereda Soconsuca de Blancos
Bogotá – Colombia Sotaquirá, Boyacá – Colombia

Contact: Claudia Puentes V. / CEO

TEL: +57 318 803 25 23
EMAIL: c.puentes@bglabs.com.co

Date and Purpose of the Audit

Date: April 20 - 22, 2022

Purpose: Verification of GACP / GMP compliance to act as manufacturer for

Cannabis flowers as intermediate medicinal products

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Contracted Activities (this list is not conclusive):

Cultivation, harvesting, processing, manufacturing, testing and supply of medicinal Cannabis

flowers manufactured from Cannabis sativa L. of jointly agreed origin

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 Annex 7 – Good Manufacturing practice – Manufacture of Herbal Medicinal

Products (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

Other documents acc. to Document review

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.

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Agenda Day 1 (April 20,2022)

11:30 p.m. Welcome and Introduction

 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

12:30 p.m. Lunch break

13:00 p.m. Site tour acc. to material flow (Part 1 - GACP)
 General precautions for handling of narcotic substances
 Handling and registration of incoming goods
 Propagation
 Cultivation (incl. soil, irrigation, fertilisation, pest control)
 Harvest (cutting of stems)
 Intermediate packaging and transport from greenhouses
to post-harvest area
 Building construction and pest controls
 Facilities – Utilities, Water supply etc.

15:00 p.m. GACP / Annex 7 Document review

 GACP / Annex 7 in general
 Specification of starting materials
 GACP process documentation
 GACP batch documentation
 Development and validation of cultivar
 Pest control of cultivars
 Use of fertilizers

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  Review of the SAS Auditreport (open points)

16:30 p.m. Preparation wrap-up meeting

16:45 p.m. Wrap-up meeting and outlook day 2
17:00 p.m. End of audit day 1

Agenda Day 2 (April 21,2022)

09:00 a.m. GMP opening / Document review

 Pharmaceutical Quality system (ICH Q10)

 Quality Risk management (ICH Q9)
 Deviation Control and CAPA-Management
 Internal audits
 Product Quality Review
 Change Control

 Qualification Personnel / Training documentation

 Rooms (design, maintenance, conditions, cleaning etc.)

 Utilities (HVAC, water, lightning, sanitation, maintenance etc.)
 Process Equipment (design, construction, calibration etc.)
 Qualification and Validation (VMP)

 Documentation (specifications, manufacturing instructions

and protocols, archiving, batch record review etc.)

12:30 p.m. Lunch break

13:00 p.m. Document review (cont.)

 Production (general, flow-chart, CCP’s)
 Material management, receipt, quarantine, sampling, storage
 Production operations, IPC, contamination control
 Packaging and Labelling
 Storage and Distribution
 Process validation
 (Quality control – exempted / ref: third party management)

14:30 p.m. Site tour acc. to material flow (Part 2 - GMP)

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  GMP Production (trimming, drying, milling, homogenization etc.)
 Storage of materials and products
 Bulk storage under frozen conditions
 Filling / primary packaging, labelling and final packaging
 In-process control and (internal) analytical testing
 Supply of products

16:00 p.m. Document review (cont.)

 Batch Record Review
 Stability Testing (Protocol and record)
 Third party management (Qualification of analytical laboratories,
testing of starting and packaging materials

 Rejection and Reuse of Material

 Complaint and Recall

17:00 p.m. Preparation wrap-up meeting

17:30 p.m. Wrap-up meeting and outlook day 3
18:00 p.m. End of audit day 2

Agenda Day 3 (April 22, 2022)

09:00 a.m. Document review (cont.)

 Open points

09:30 p.m. Preparation wrap-up meeting

10:00 p.m. Final wrap-up meeting
11:00 p.m. End of audit

Cultivo y Post
cosecha
Dir técnica calidad
Asuntos regulatorios
Admon y finanzas
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 Gestión de proyectos

Quality Audit_BG Labs_2022-04-20_22_Agenda Page 6 von 6