natgillin/translations-raw huggingface dataset:
It is necessary to lay down principles and guidelines of good manufacturing practice for active substances in a legally binding act.
Načela in smernice dobre proizvodne prakse za zdravilne učinkovine je treba določiti v pravno zavezujočem aktu.
In order to promote the use of harmonised standards at global level, principles and guidelines of good manufacturing practice for active substances should be laid down in line with the guidelines for active substances established by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
Da bi spodbudili uporabo usklajenih standardov na globalni ravni, bi bilo treba načela in smernice dobre proizvodne prakse za zdravilne učinkovine določiti v skladu s smernicami za zdravilne učinkovine, ki jih je določila Mednarodna konferenca o usklajevanju tehničnih zahtev za registracijo zdravil za uporabo v humani medicini.
Principles and guidelines of good manufacturing practice should be set out in relation to all issues, operations and processes that are key to determining the quality of active substances, such as quality management, personnel, premises and equipment, documentation, material management, production, in-process quality controls, packaging, labelling, laboratory controls, returns, complaints and recalls, contracting out and repackaging.
Načela in smernice dobre proizvodne prakse bi bilo treba opredeliti v zvezi z vsemi vprašanji, dejavnostmi in postopki, ki so ključni za določitev kakovosti zdravilnih učinkovin, kot so upravljanje kakovosti, osebje, prostori in oprema, dokumentacija, upravljanje materialov, proizvodnja, kontrola kakovosti med proizvodnjo, pakiranje, označevanje, laboratorijski nadzor, vračila, pritožbe in odpoklici, pogodbeno delo in prepakiranje.
In order to ensure compliance with those principles and guidelines, the manufacturers of active substances should be required to establish and implement an effective system for managing the quality of those substances.
Da bi zagotovili skladnost s temi načeli in smernicami, bi bilo treba od proizvajalcev zdravilnih učinkovin zahtevati, da vzpostavijo in izvajajo učinkovit sistem za upravljanje kakovosti teh snovi.
Personnel in unsanitary conditions, wearing unsuitable clothing or practicing potentially contaminating activities in the manufacturing area may compromise the quality of the active substance.
Osebje, ki dela v nehigienskih razmerah, nosi neprimerna oblačila ali morebiti onesnažuje proizvodno območje, lahko ogrozi kakovost zdravilne učinkovine.
This should be prevented by practicing sanitation and health habits that are appropriate to the manufacturing operations performed.
To bi bilo treba preprečiti z izvajanjem sanitarnih in zdravstvenih navad, ki so primerne za izvajane proizvodne dejavnosti.
Those practices should be provided for in the quality management system established by the manufacturer of the active substance.
Te prakse bi bilo treba določiti v sistemu upravljanja kakovosti, ki ga določi proizvajalec zdravilne učinkovine.
In order to ensure an adequate quality of the active substance, it is necessary to minimise potential contamination and cross-contamination by requiring the use of facilities, production processes and containers designed for this purpose, as well as appropriate contamination controls.
Da bi zagotovili ustrezno kakovost zdravilne učinkovine, je treba čim bolj zmanjšati morebitno onesnaženost in navzkrižno kontaminacijo, tako da se zahteva uporaba objektov, proizvodnih postopkov in zabojnikov, izdelanih za ta namen, ter ustrezen nadzor kontaminacije.
It is of particular importance to prevent cross-contamination when producing active substances harmful to human health.
Zlasti pomembno je, da ne pride do navzkrižne kontaminacije pri pripravi zdravilnih učinkovin, škodljivih za človekovo zdravje.
Contamination of other products with highly sensitising active substances could pose a serious threat to public health since exposure to these substances very often results in the development of hypersensitivity and allergic reactions.
Onesnaženje drugih izdelkov z zdravilnimi učinkovinami, ki povzročajo preobčutljivost, lahko pomeni resno tveganje za javno zdravje, saj izpostavljenost tem snovem zelo pogosto vodi v razvoj preobčutljivosti in alergijskih reakcij.
For that reason, manufacturing of those active substances should only be allowed to take place in separate production areas.
Zato bi morala proizvodnja teh zdravilnih učinkovin potekati zgolj v ločenih proizvodnih območjih.
The use of separate production areas may also be necessary for the production of active substances with the potential to be harmful to human health because of their potency or their infective or toxic nature.
Uporaba ločenih proizvodnih območij je lahko potrebna tudi pri proizvodnji zdravilnih učinkovin, ki so lahko škodljive za zdravje ljudi zaradi njihove potentnosti ali kužne oz. strupene narave.
For those substances, the manufacturer should perform an assessment of the risks to human health and the need for separate production areas.
Proizvajalec bi moral za te snovi opraviti oceno tveganja za zdravje ljudi in oceno potrebe po ločenih proizvodnih območjih.
In order to facilitate the tracing, identification and solving of potential quality problems as well as to verify compliance with good manufacturing practice, the manufacturer should keep detailed written records of all processes he performs that relate to the manufacturing of active substances, including of deviations from those processes.
Da bi olajšal spremljanje, prepoznavanje in reševanje morebitnih težav glede kakovosti ter preveril skladnost z dobro proizvodno prakso, bi moral proizvajalec voditi podrobno evidenco o vseh izvedenih postopkih, ki se nanašajo na proizvodnjo zdravilnih učinkovin, vključno z odstopanji od teh postopkov.
In order to ensure that medicinal products have the appropriate standards of quality, safety and efficacy and to protect public health, manufacturers of an active substance should communicate without delay any changes which may affect the quality of the active substance to manufacturers of medicinal products using the active substance.
Da bi zagotovili, da zdravila dosegajo ustrezne standarde kakovosti, varnosti in učinkovitosti, ter zaščitili javno zdravje, bi morali proizvajalci zdravilnih učinkovin nemudoma obvestiti proizvajalce zdravil, ki uporabljajo zdravilno učinkovino, o kakršnih koli spremembah, ki bi lahko vplivale na kakovost zdravilne učinkovine.
It is necessary to have in place appropriate procedures to record and investigate quality-related complaints and perform product recalls in order to rapidly address quality concerns and remove from the market active substances that do not meet quality standards or pose a serious threat to public health.
Treba je vzpostaviti ustrezne postopke za evidentiranje in preiskovanje pritožb glede kakovosti ter izvesti odpoklic izdelka, da bi se hitro odzvali na težave s kakovostjo in umaknili s trga zdravilne učinkovine, ki ne izpolnjujejo standardov kakovosti ali resno ogrožajo javno zdravje.
When the manufacturer of the active substance entrusts any part of the manufacturing to another party, it is important to clarify in writing the responsibilities of that other party with regard to compliance with good manufacturing practices and quality measures.
Kadar proizvajalec zdravilne učinkovine kateri koli del proizvodnje zaupa drugi osebi, je treba v pisni obliki jasno določiti odgovornosti te druge osebe, kar zadeva skladnost z dobro proizvodno prakso in ukrepi za kakovost.
The application of good manufacturing practices to the process of repackaging and relabelling is necessary to avoid that active substances are wrongly labelled or become contaminated in the process,
Upoštevanje dobrih proizvodnih praks v postopku prepakiranja in ponovnega etiketiranja je potrebno, da se prepreči napačno označevanje ali onesnaženje zdravilnih učinkovin v postopku –
This Regulation lays down the principles and guidelines of good manufacturing practice for active substances for medicinal products for human use, including active substances intended for export.
Ta uredba določa načela in smernice dobre proizvodne prakse za zdravilne učinkovine za zdravila za uporabo v humani medicini, vključno z zdravilnimi učinkovinami, namenjenimi za izvoz.
‘manufacturing’ means any total or partial operation of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control or release of active substances, and the related controls;
„proizvodnja“ pomeni popolno ali delno dejavnost prejema materialov, izdelave, pakiranja, prepakiranja, označevanja, ponovnega označevanja, nadzora kakovosti ali dajanja zdravilnih učinkovin v promet, in s tem povezane kontrole;
‘active substance starting material’ means any substance from which an active substance is manufactured or extracted;
„vhodni material zdravilne učinkovine“ pomeni katero koli snov, iz katere se proizvaja ali ekstrahira zdravilna učinkovina;
‘active substance intermediate’ means a substance which is obtained during the production of an active substance and which is intended for further processing;
„intermediat zdravilne učinkovine“ pomeni snov, ki se pridobiva pri proizvodnji zdravilne učinkovine in je namenjena za nadaljnjo predelavo;
‘raw material’ means any substance, reagent or solvent which is intended for use in the production of an active substance and from which the active substance is not directly manufactured or extracted.
„surovina“ pomeni katero koli snov, reagent ali topilo, ki je namenjeno uporabi v proizvodnji zdravilne učinkovine in iz katerega zdravilna učinkovina ni neposredno proizvedena ali ekstrahirana.
Manufacturers of active substances (‘the manufacturer’) shall establish, document and implement an effective system for managing the quality of those substances during the manufacturing operations performed by them (the ‘manufacturing process’).
Proizvajalci zdravilnih učinkovin (v nadaljnjem besedilu: proizvajalec) vzpostavijo, dokumentirajo in izvajajo učinkovit sistem za upravljanje kakovosti teh snovi v proizvodnih dejavnostih, ki jih izvajajo (v nadaljnjem besedilu: proizvodni postopek).
The system shall provide for the active participation of the management and manufacturing personnel.
Sistem zagotavlja aktivno udeležbo vodstvenega osebja in osebja, ki dela v proizvodnji.
The system shall ensure that the active substances meet the specifications for their quality and purity established in accordance with Article 12(1).
Sistem zagotavlja, da zdravilne učinkovine izpolnjujejo specifikacije za njihovo kakovost in čistost, določene v skladu s členom 12(1).
The system shall incorporate quality risk management.
Sistem vključuje ukrepe za obvladovanje tveganja na področju kakovosti.
The manufacturer shall appoint a quality unit that is independent of the production unit to be responsible for quality assurance and quality control.
Proizvajalec imenuje enoto za kakovost, ki je neodvisna od proizvodne enote in je odgovorna za zagotavljanje in nadzor kakovosti.
The manufacturer shall conduct regular internal audits and follow-up on the findings.
Proizvajalec izvaja redne notranje revizije in sprejema nadaljnje ukrepe v zvezi z ugotovitvami.
The manufacturer shall ensure an adequate number of personnel having the necessary qualifications acquired through education, training or experience to carry out and supervise the manufacturing of active substances.
Proizvajalec zagotovi ustrezno število osebja, ki ima potrebne kvalifikacije, pridobljene preko izobraževanja, usposabljanja ali izkušenj na področju izvajanja in nadzora proizvodnje zdravilnih učinkovin.
Personnel shall practice good sanitation and hygiene in the manufacturing area.
Osebje skrbi za dobre sanitarne in higienske razmere na območju proizvodnje.
Personnel shall not access the manufacturing area if they:
Člani osebja ne dostopajo do proizvodnega območja, če:
suffer from an infectious disease or have open lesions or other dermatological conditions on the exposed surface of the body that could negatively affect the quality and purity of the active substance;
trpijo zaradi nalezljivih bolezni ali imajo odprte rane ali druge dermatološke težave na izpostavljeni površini telesa, ki bi lahko negativno vplivale na kakovost in čistost zdravilne učinkovine;
wear clothing which is visibly dirty, or does not protect the active substance from potential contamination coming from personnel, or does not protect personnel from exposure to active substances potentially harmful to human health;
nosijo oblačila, ki so vidno umazana ali ne ščitijo zdravilne učinkovine pred možnim onesnaženjem s strani osebja ali ne varujejo osebja pred izpostavljenostjo zdravilni učinkovini, ki bi lahko bila škodljiva za zdravje ljudi;
at the moment of entering the manufacturing area, are performing activities that could contaminate or otherwise compromise the quality of the active substance.
v trenutku vstopa na območje proizvodnje opravljajo dejavnosti, ki bi lahko onesnažile ali kako drugače ogrozile kakovost zdravilne učinkovine.
Buildings and facilities
Zgradbe in objekti
Buildings and facilities used in the manufacturing of active substances shall be located, designed and constructed to suit the intended operations and to facilitate cleaning and maintenance having regard to the type and stage of manufacturing which the buildings and facilities are used for.
Zgradbe in objekti, ki se uporabljajo za proizvodnjo zdravilnih učinkovin, so locirani, zasnovani in zgrajeni tako, da ustrezajo predvidenim postopkom in olajšajo čiščenje in vzdrževanje, ob upoštevanju vrste in stopnje proizvodnje, za katero se te zgradbe in objekti uporabljajo.
Facilities and the flow of material and personnel through the facilities shall be designed to ensure that different substances and materials are kept separate and do not contaminate each other.
Objekti in pretok materiala ter osebja v objektih so zasnovani tako, da se različne snovi in materiali hranijo ločeno in ne onesnažujejo drug drugega.
Buildings shall be properly maintained and repaired and kept in a clean condition.
Zgradbe se ustrezno vzdržujejo, popravljajo in ohranjajo v čistem stanju.
Highly sensitising active substances shall be produced in separate production areas.
Zdravilne učinkovine, ki povzročajo preobčutljivost, se proizvajajo v ločenih proizvodnih območjih.
When carrying out production operations, the manufacturer shall assess the need for separate production areas for other active substances with the potential to be harmful to human health because of their potency or their infective or toxic nature.
Pri izvajanju proizvodnih dejavnosti proizvajalec oceni potrebo po ločenih proizvodnih območjih za druge zdravilne učinkovine, ki so lahko škodljive za zdravje ljudi zaradi njihove potentnosti, toksičnosti ali infektivnosti.
The assessment shall evaluate the risk to human health posed by those active substances by taking account of the active substance potency, toxicity, infectivity and the risk minimisation procedures in place.
Pri oceni se ovrednoti tveganje za zdravje ljudi, ki ga predstavljajo navedene zdravilne učinkovine, ob upoštevanju potentnosti, toksičnosti in infektivnosti zdravilne učinkovine ter obstoječih postopkov za zmanjševanje tveganja.
The assessment shall be documented in writing.
Ocena se dokumentira v pisni obliki.
Where the assessment shows a risk of harm to human health, the active substance shall be produced in separate production areas.
Kadar ocena pokaže tveganje za zdravje ljudi, se zdravilna učinkovina proizvaja v ločenih proizvodnih območjih.
Equipment used in the manufacturing of active substances shall be appropriately designed, sized and located for its intended use, cleaning, maintenance and, where appropriate, sanitisation.
Oprema, ki se uporablja pri proizvodnji zdravilnih učinkovin, je ustrezno oblikovana, velika in locirana za predvideno uporabo, čiščenje, vzdrževanje in, kjer je primerno, higienizacijo.
Equipment shall be constructed and operated so that surfaces that come into contact with raw materials, active substance starting materials, active substance intermediates or active substances do not alter the quality of the raw materials, the active substance starting materials, the active substance intermediates or the active substances to the extent that they no longer comply with the specifications established in accordance with Article 12(1).
Oprema je sestavljena in upravljana tako, da površine, ki pridejo v stik s surovinami, vhodnimi materiali zdravilne učinkovine, intermediati zdravilne učinkovine ali zdravilnimi učinkovinami, ne spremenijo kakovosti surovin, vhodnih materialov zdravilne učinkovine, intermediatov zdravilne učinkovine ali zdravilnih učinkovin do te mere, da ne bi bili več v skladu s specifikacijami, določenimi v skladu s členom 12(1).
The manufacturer shall establish written procedures for the cleaning of equipment and the subsequent verification of its suitability for use in the manufacturing process.
Proizvajalec vzpostavi pisne postopke za čiščenje opreme in naknadno preverjanje njene primernosti za uporabo v proizvodnem postopku.
Control, weighing, measuring, monitoring and test equipment that is critical for assuring the quality of the active substance shall be calibrated in accordance with written procedures and an established schedule.
Nadzor, tehtanje, merjenje, spremljanje in preskusna oprema, ki je bistvenega pomena za zagotavljanje kakovosti zdravilne učinkovine, se prilagodijo v skladu s pisnimi postopki in vzpostavljenim razporedom.
Documentation and records
Dokumentacija in evidence
The manufacturer shall establish and maintain a documentation system and written procedures covering the manufacturing process.
Proizvajalec vzpostavi in vzdržuje sistem dokumentiranja in pisne postopke, ki zajemajo proizvodni postopek.
All documents in relation to the manufacturing process shall be prepared, reviewed, approved and distributed in accordance with written procedures.
Vsi dokumenti v zvezi s proizvodnim postopkom se pripravijo, pregledajo, odobrijo in razširjajo skladno s pisnimi postopki.
The manufacturer shall maintain records of at least the following elements in relation to the manufacturing process:
Proizvajalec hrani evidence za vsaj naslednje elemente v zvezi s proizvodnim postopkom:
equipment cleaning and use;
čiščenje in uporaba opreme;
origins of raw materials, active substance starting materials and active substance intermediates;
poreklo surovin, vhodnih snovi zdravilnih učinkovin in intermediatov zdravilnih učinkovin;
controls in relation to raw materials, active substance starting materials and active substance intermediates;
kontrole v zvezi s surovinami, vhodnimi snovmi zdravilnih učinkovin in intermediati zdravilnih učinkovin;
use of raw materials, active substance starting materials and active substance intermediates;
uporaba surovin, vhodnih snovi zdravilnih učinkovin in intermediatov zdravilnih učinkovin;
labelling of the active substances and of the packaging materials;
označevanje zdravilnih učinkovin in embalažnega materiala;
master production instructions;
glavna navodila za proizvodnjo;
batch production and control;
proizvodne serije in kontrola serij;
laboratory controls.
laboratorijski nadzor.
The issuance, revision, replacement and withdrawal of documents related to the manufacturing process shall be controlled, and records of their revision, replacement and withdrawal shall be kept.
Izdajanje, pregledovanje, zamenjevanje in odstranjevanje dokumentov, ki se nanašajo na proizvodni postopek, se kontrolirajo, podatki o njihovem pregledu, zamenjavi in odstranitvi pa se hranijo.
All quality related activities carried out during the manufacturing process shall be recorded at the time they are performed.
Vse s kakovostjo povezane dejavnosti, ki se izvajajo med proizvodnim postopkom, se evidentirajo takrat, ko se izvedejo.
Any deviation from the written procedures referred to in Article 7(1) shall be documented and explained.
Kakršno koli odstopanje od pisnih postopkov iz člena 7(1) se dokumentira in pojasni.
Deviations affecting the quality of the active substance or preventing the active substance from meeting the specifications referred to in Article 12(1) shall be investigated, and the investigation and its conclusions shall be documented.
Odstopanja, ki vplivajo na kakovost zdravilne učinkovine ali zaradi katerih zdravilna učinkovina ne izpolnjuje zahtev iz člena 12(1), se preučijo, preiskava in njeni zaključki pa se dokumentirajo.
After carrying out production and control operations, the manufacturer shall retain all production and control records for at least one year after the expiry date of the batch.
Po opravljenih dejavnostih proizvodnje in nadzora proizvajalec hrani vse evidence o proizvodnji in nadzoru vsaj eno leto od datuma izteka roka uporabnosti serije.
For an active substance with retest dates, the manufacturer shall retain records for at least three years after the complete batch has been placed on the market.
Za zdravilne učinkovine z datumi ponovnega preskušanja proizvajalec hrani evidenco vsaj tri leta potem, ko je bila popolna serija dana v promet.
Material management
Upravljanje z materiali
The manufacturer shall have written procedures in place for ensuring the quality of incoming material covering the following elements:
Proizvajalec ima vzpostavljene pisne postopke za zagotavljanje kakovosti vhodnih snovi, ki zajemajo naslednje elemente:
receipt;
prejem;
identification;
identificiranje;
quarantine;
karanteno;
handling;
ravnanje;
sampling;
vzorčenje;
testing;
preskušanje;
approving;
odobritev;
rejection.
zavrnitev.
The manufacturer shall have a system in place for evaluating suppliers of critical materials.
Proizvajalec ima vzpostavljen sistem za ocenjevanje dobaviteljev kritičnih surovin.
Production and in-process control
Nadzor proizvodnje in postopka
Production operations shall be subject to controls in order to monitor and adjust the production process or verify that the active substance conforms to the specifications of quality and purity pursuant to Article 12(1).
Proizvodne dejavnosti se kontrolirajo, da se spremlja in prilagaja proizvodni postopek ali da se preveri, ali zdravilna učinkovina ustreza specifikacijam o kakovosti in čistosti v skladu s členom 12(1).
Production operations which are critical to ensure that the active substance meets the quality specifications referred to in Article 12(1) shall be carried out under the visual supervision of qualified personnel or subjected to an equivalent control.
Proizvodne dejavnosti, ki so ključnega pomena za zagotovitev, da zdravilna učinkovina izpolnjuje specifikacije o kakovosti iz člena 12(1), se izvajajo pod vizualnim nadzorom kvalificiranega osebja ali podobnim ustreznim nadzorom.
Weighing and measuring of raw materials and active substance starting materials shall be accurate and shall be conducted in a manner which does not affect their suitability for use.
Tehtanje in merjenje surovin in vhodnih snovi zdravilnih učinkovin sta natančna in se izvajata na način, ki ne vpliva na njihovo primernost za uporabo.
Production operations, including any operation after purification of the active substance intermediates or the active substance, shall be conducted in a manner that prevents raw materials, active substance starting materials, active substance intermediates and active substances from being contaminated by other materials.
Proizvodne dejavnosti, vključno s kakršno koli dejavnostjo, ki sledi čiščenju intermediatov zdravilne učinkovine ali zdravilne učinkovine, se izvajajo tako, da se prepreči onesnaženje surovin, vhodnih snovi zdravilne učinkovine, intermediatov zdravilne učinkovine in zdravilne učinkovine z drugimi materiali.
Packaging and labelling
Pakiranje in označevanje
Containers shall provide adequate protection against deterioration or contamination of the active substance from the moment the active substance is packaged to the moment it is used in the manufacturing of medicinal products.
Zabojniki zagotavljajo ustrezno zaščito pred kvarjenjem ali onesnaženjem zdravilne učinkovine od trenutka, ko se zdravilna učinkovina zapakira, do trenutka, ko se uporabi pri proizvodnji zdravil.