PREM-01 / WEIGHING
Weighing Room
Raw materials are weighed under a laminar flow hood, the first controlled step in every batch.
- Laminar flow hood
- Controlled, contamination-limited environment
Our Premises
A facility built room by room for compliance — not added on after the fact.
Every weighing station, airlock, and storage area at Medicka Lab exists for one reason: to keep your product controlled, traceable, and compliant from raw material to finished batch.
GMP
21 CFR Part 111
FSSC
22000 certified
100%
First audit score, 2024
3
Dedicated airlocks
2
QC laboratories
Inside Our Facility
Seven zones, each with one job.
From the moment a raw material enters the building to the moment a finished batch leaves it, every step happens in a room built specifically for that stage.
PREM-02 / MANUFACTURING
Manufacturing Rooms
Two dedicated rooms keep dry and liquid production fully separated.
- Powder Mixing room
- Liquid Mixing room
PREM-03 / PRIMARY PACK
Primary Packaging Rooms
Product meets its first packaging layer in a room matched to its format.
- Powder Primary Packaging
- Liquid Primary Packaging
PREM-04 / SECONDARY PACK
Secondary Packaging Room
Cartoning and labeling finish the product for shipment.
- Cartoning & labeling
- Final, shelf-ready presentation
PREM-05 / AIRLOCKS
Airlocks & Flow Control
Three separate airlocks keep clean and non-clean flows apart at every transition.
- RM/AC — raw materials & auxiliary components
- RM/AC return & waste
- Personnel airlock
PREM-06 / STORAGE
Storage Areas
Materials and finished goods are kept separated at every stage of release.
- Raw Materials Storage
- Packaging Materials & Released Finished Products Storage
- Quarantine Storage for finished products & in-use packaging
PREM-07 / LABORATORIES
Laboratories
Two dedicated labs test every batch before it's released for shipment.
- Physicochemical Analysis & Development Lab
- Microbiological Analysis Lab
Certifications & Compliance
Independently audited, not self-declared.
Our facility was first certified GMP-compliant in January 2024 with a 100% audit score, and holds current international certifications across food safety and dietary supplement manufacturing.
Valid to Aug 2027
GMP Certification — 21 CFR Part 111
Certificate of Conformity · Eurofins Healthcare Assurance (ANAB-accredited, ISO/IEC 17065)
Covers GMP for Dietary Supplements under 21 CFR Part 111, including Part 121, Part 117 (Subparts A, B, F), and Part 1.511. Certificate No. ACCB8AAA720_1, issued July 8, 2026.
Product categories
CapsuleIngestible liquidIngestible oil
PowderTablet
Manufacturing technologies
Dry formulationLiquid formulationMixing
Tablet compressionPackaging & labelingWarehousing
Valid to Sep 2027
FSSC 22000 — Food Safety System Certification
DQS CFS GmbH (DAkkS-accredited) · ISO 22000:2018 + ISO/TS 22002-1:2009 + FSSC 22000 v6
Covers subcontracted manufacturing and packaging of dietary supplements: oral solutions and suspensions (glass/PET bottles, drops, sprays, sticks, unidoses), dry forms (capsules and tablets in blisters or bottles), and fractionated powders. Category K. Registration No. 40551161 FSSC V6.
First certifiedSept 2, 2024
Valid untilSept 1, 2027
First audit · Jan 2024
GMP for Dietary Supplements — Initial Audit
Audit Recognition · Eurofins Food Assurance
Per requirements listed in 21 CFR Part 111. Certificate No. 01192024_1, audited January 19, 2024, with a 100% audit score — Medicka Lab's first formal GMP recognition, now followed by our current Certificate of Conformity (ACCB8AAA720_1, valid to Aug 2027).
Audit dateJan 19, 2024
Audit score100%
StatusSuperseded by current certificate
Why Our Facility Design Matters
Layout is a quality control, not just an operations choice.
The way a facility is laid out determines what contamination risks are even possible in the first place.
Segregated production flow
Dedicated airlocks keep raw materials, waste, and personnel apart.
Full traceability
Quarantine and released storage are always kept separate.
Dual quality laboratories
Every batch is tested for both chemical and microbiological safety.
Internationally recognized standards
GMP 21 CFR Part 111 and FSSC 22000 certified.
FAQ
Common questions on our facility & certifications.
If your question isn't covered here, request a consultation and we'll answer it directly.
GMP certification under 21 CFR Part 111 for Dietary Supplements (Eurofins Healthcare Assurance, ANAB-accredited) and FSSC 22000 food safety certification (DQS CFS GmbH, DAkkS-accredited), covering capsules, tablets, powders, and liquid formulations.
Three separate airlocks — for incoming raw materials and auxiliary components, for returns and waste, and for personnel — keep contamination risks controlled and separate clean and non-clean flows.
Weighing is done under a laminar flow hood, manufacturing and packaging are split into dedicated rooms by format, and dedicated airlocks separate raw materials, waste, and personnel flows.
Our physicochemical analysis and development laboratory and our microbiological analysis laboratory test raw materials and finished products before release.
Quarantine storage holds finished products and in-use packaging materials separately until quality control confirms they meet specification and can be released to general storage.
Yes. Contact us to schedule a facility visit or to request copies of our current GMP and FSSC 22000 certificates.