Pozdravljeni,

sporočam vam, da bodo jutri z dne 7. 12. 2021 veljavne vse spodaj navedene verzije dokumentov. Zadnje spremembe so opisane pod nazivom dokumenta in v prilogi posameznega dokumenta. Veljavne verzije dokumentov se kot običajno nahajajo na Intranetu in zbirki dokumentov na strežniku. Nove verzije obrazcev so na voljo v rubriki Obrazci. Natisnjene originalne verzije dokumentov se nahajajo v arhivu v organizacijski enoti Kakovost (QMS).

NOVE IZDAJE

SOP LAB 001 Zagotavljanje Veljavnosti Rezultatov 06
Dodane odgovornosti za delovno mesto JLM. Ureditev kontrolnih vzorcev (imena in oznake) v poglavju 3.1. Dodan kriterij resolucije med CBD in CBG v kontrolnem vzorcu REF STD v poglavju 3.2. V poglavju 3.4 dodana zahteva po pripravi novega kontrolnega vzorca v primeru pojava trenda. Dodane odgovornosti za delovno mesto JLM. Natančnejše definiranje nadzora nad kompetentnostjo osebja. Dodana priloga 2 s seznamom udeležencev nadzora nad kompetentnostjo.

SOP LAB 007 Poročanje O Rezultatih 03
Dodane odgovornosti za delovno mesto JLM. V poglavju 3.2 dodana zahteva, da so informacije o imenu vzorca in številki serije, ki jih zagotovi odjemalec, jasno označene na poročilu o preskusu. V poglavju 3.4 dodano, da gre pri mnenjih in razlagah za neakreditirano dejavnosti in se morajo izdajati v ločenem dokumentu, brez sklica na akreditacijo.

SOP LAB 008 Obseg Zmogljivosti 04
Obravnava dejavnosti analitskega laboratorija v dokumentu – razdelitev dejavnosti na akreditirane, v postopku akreditacije in na neakreditirane ter vključitev podrobnosti vseh dejavnosti v LAB. Posodobitev obsega in zmogljivosti LAB na vse metode v postopku akreditacije (MET-LAB-001, MET-LAB-002 in MET-LAB-003). Dodana priloga 1 – dogovor z odjemalcem za možnost poročanja akreditiranih dejavnosti neakreditirano.

SPC LAB 001 Analitski Laboratoriji 03
Dodani CRM-ji v prilogi 2. Natančnejša obravnava CRM-jev v poglavju 4.2. Dodane dodatne zahteve oziroma merila sprejemljivosti za nabavo CRM-jev v prilogi 2. Posodobitev uporabljenih potrošnih materialov v prilogi 3. Naslov dokumenta spremenjen v »Analitski laboratoriji«.

MET LAB 001 Quantitative Determination of Cannabinoids by Reverse Phase Chromatography 06
Code of the document changed from MET-001 to MET-LAB-001. More detailed specifications were added for chemicals and reagents, CRMs, consumables and equipment/software; additional can be used in accordance to SPC-LAB-001. When different chemicals, reagents or CRMs is used their suitability must be confirmed by validation. Resolution tracking in REF STD was added, appendix 2 was corrected accordantly. Sample preparation instruction was updated to include the 10x and 100x concentrated sample preparation – 100x concentrated sample can be prepared only for certain matrices. The additional sample preparation protocols were updated for balms and gummies as confirmed during validation.

MET LAB 002 Quantitative Determination of Cannabinoids by Reverse Phase Chromatography Using HDR Detector 04
Code of the document changed from MET-002 to MET-LAB-002. More detailed specifications were added for chemicals and reagents, CRMs, consumables and equipment/software; additional can be used in accordance to SPC-LAB-001. When different chemicals, reagents or CRMs is used their suitability must be confirmed by validation. Resolution tracking in REF STD was added, appendix 2 was corrected accordantly. Sample preparation instruction was updated to include the 10x and 100x concentrated sample preparation – 100x concentrated sample can be prepared only for certain matrices. The additional sample preparation protocols were updated for balms and gummies as confirmed during validation.

MET LAB 003 Quantitative Determination of Cannabinoids by RPC with Shorter Analysis Time Using HDR Detector 02
Code of the document changed from MET-003 to MET-LAB-003. More detailed specifications were added for chemicals and reagents, CRMs, consumables and equipment/software; additional can be used in accordance to SPC-LAB-001. When different chemicals, reagents or CRMs is used their suitability must be confirmed by validation. Resolution tracking in REF STD was added, appendix 2 was corrected accordantly. Sample preparation instruction was updated to include the 10x and 100x concentrated sample preparation – 100x concentrated sample can be prepared only for certain matrices. The additional sample preparation protocols were updated for balms and gummies as confirmed during validation.

Lep pozdrav,

Tine Lavrič
Chief Quality Officer