natgillin/translations-raw huggingface dataset:
The need for such inspections should be established according to a risk-based approach but third country manufacturers should be inspected at least if there is a suspicion that the investigational medicinal products are not manufactured by applying quality standards at least equivalent to those applicable in the Union.
Potrebo po takšnem pregledu bi bilo treba opredeliti na podlagi pristopa, ki temelji na tveganju, vendar pa bi bilo treba proizvajalce iz tretjih držav pregledati, takoj ko se pojavi sum, da se pri proizvodnji zdravil v preskušanju ne uporabljajo standardi kakovosti, ki bi bili vsaj enakovredni standardom v Uniji.
Inspectors should consider the Commission guidelines on good manufacturing practice for investigational medicinal products for human use.
Inšpektorji bi morali upoštevati smernice Komisije o dobri proizvodni praksi za zdravila za uporabo v humani medicini v preskušanju.
To achieve and maintain mutual recognition of inspection findings in the Union and facilitate the cooperation of the Member States, commonly recognised standards on the conduct of inspections on good manufacturing practice for investigational medicinal products in the form of procedures should be developed.
Da bi dosegli in ohranili medsebojno priznavanje izsledkov pregledov v Uniji ter olajšali sodelovanje držav članic, bi bilo treba razviti splošno priznane standarde za izvedbo pregledov dobre proizvodne prakse za zdravila v preskušanju, in sicer v obliki postopkov.
The Commission guidelines and these procedures should be maintained and regularly updated, according to technical and scientific developments.
Smernice Komisije in te postopke bi bilo treba vzdrževati in redno posodabljati v skladu s tehničnim in znanstvenim razvojem.
During inspections of a site the inspectors should check whether a site respects good manufacturing practice as regards both investigational medicinal products and medicinal products authorised to be placed on the market.
Inšpektorji bi morali med pregledom obrata preveriti, če se v obratu upošteva dobra proizvodna praksa tako pri proizvodnji zdravil v preskušanju kot pri proizvodnji zdravil, za katera je bilo izdano dovoljenje za promet z zdravilom.
For that reason, and in order to ensure the effective supervision, procedures and powers to carry out inspections to verify that good manufacturing practice for investigational medicinal products for human use is followed should be aligned as much as possible to those for medicinal products for human use.
Zaradi zgoraj navedenega in za učinkovit nadzor bi morali biti postopki in pooblastila za izvedbo pregledov, s katerimi se preveri, ali se za zdravila za uporabo v humani medicini v preskušanju uporablja dobra proizvodna praksa, v največji možni meri usklajeni s postopki in pooblastili, ki se uporabljajo za zdravila za uporabo v humani medicini.
To ensure that inspections are effective, inspectors should be appropriately empowered.
Da bi bili pregledi učinkoviti, bi morali imeti inšpektorji ustrezna pooblastila.
Member States should be able to take action in case of non-compliance with good manufacturing practice for investigational medicinal products for human use.
Države članice bi morale imeti možnost, da ukrepajo v primeru neskladnosti z dobro proizvodno prakso za zdravila za uporabo v humani medicini v preskušanju.
The competent authorities should be required to set up quality systems to ensure that the inspection procedures are observed and consistently monitored.
Pristojni organi bi morali biti obvezani vzpostaviti sisteme kakovosti, s katerimi bi zagotovili upoštevanje in dosledno spremljanje postopkov pregledov.
A well-functioning quality system should comprise an organisational structure, clear processes and procedures, including standard operating procedures to be followed by inspectors when performing their tasks, clearly defined details of the inspectors' duties and responsibilities and ongoing training requirements, as well as adequate resources and mechanisms which aim to eliminate non-compliance.
Dobro delujoč sistem kakovosti bi moral vsebovati organizacijsko strukturo, jasne procese in postopke, vključno s standardnimi operativnimi postopki, ki jih morajo inšpektorji upoštevati pri opravljanju nalog, jasno opredeljene podrobnosti o njihovih dolžnostih, odgovornostih in zahtevah glede stalnega usposabljanja ter ustrezne vire in mehanizme za odpravljanje neskladnosti.
This Regulation should apply from the same date as Commission Directive (EU) 2017/1572 [3],
To uredbo bi bilo treba uporabljati od istega datuma kot Direktivo Komisije (EU) 2017/1572 [3] –
This Regulation specifies the principles and guidelines of good manufacturing practice for investigational medicinal products for human use the manufacture or import of which requires an authorisation as referred to in Article 61(1) of Regulation (EU) No 536/2014 and lays down arrangements for inspections of manufacturers in relation to compliance with good manufacturing practice in accordance with Article 63(4) of that Regulation.
Ta uredba določa načela in smernice dobre proizvodne prakse za zdravila za uporabo v humani medicini v preskušanju, za katerih proizvodnjo ali uvoz je potrebno dovoljenje iz člena 61(1) Uredbe (EU) št. 536/2014, ter ureja potek pregledov proizvajalcev, s katerimi se preveri, če proizvajalci izpolnjujejo zahteve v zvezi z dobro proizvodno prakso v skladu s členom 63(4) navedene uredbe.
‘manufacturer’ means any person engaged in activities for which an authorisation is required in accordance with Article 61(1) of Regulation (EU) No 536/2014;
„proizvajalec“ pomeni vsako osebo, ki se ukvarja z dejavnostmi, za katere je potrebno dovoljenje iz člena 61(1) Uredbe (EU) št. 536/2014;
‘third country manufacturer’ means any person established in a third country and engaged in manufacturing operations in that third country;
„proizvajalec iz tretje države“ pomeni vsako osebo s sedežem v tretji državi, ki izvaja proizvodne postopke v navedeni tretji državi;
‘product specification file’ means a reference file containing, or referring to files containing, all the information necessary to draft detailed written instructions on processing, packaging, quality control, testing and batch release of an investigational medicinal product and to perform batch certification;
„dokument s specifikacijami zdravila“ pomeni referenčni dokument, ki vsebuje ali se nanaša na dokumente, ki vsebujejo vse informacije, potrebne za pripravo podrobnih pisnih navodil o obdelavi, pakiranju, kontroli kakovosti, preskušanju in sprostitvi serij zdravila v preskušanju ter za certificiranje serij;
‘validation’ means action of proving, in accordance with the principles of good manufacturing practice, that any procedure, process, equipment, material, activity or system actually leads to the expected results.
„validacija“ pomeni dejanje, s katerim se v skladu z načeli dobre proizvodne prakse dokaže, da vsak postopek, oprema, material, dejavnost ali sistem dejansko prinaša pričakovane rezultate.
GOOD MANUFACTURING PRACTICE
DOBRA PROIZVODNA PRAKSA
The manufacturer shall ensure that manufacturing operations are carried out in accordance with good manufacturing practice for investigational medicinal products specified in this Regulation and subject to an authorisation as referred to in Article 61(1) of Regulation (EU) No 536/2014.
Proizvajalec zagotovi, da se proizvodni postopki izvajajo v skladu z dobro proizvodno prakso za zdravila v preskušanju iz te uredbe, za katera je potrebno dovoljenje iz člena 61(1) Uredbe (EU) št. 536/2014.
When importing an investigational medicinal products, the holder of the authorisation referred to in Article 61(1) of Regulation (EU) No 536/2014 shall ensure that the products have been manufactured by applying quality standards at least equivalent to those laid down by this Regulation and in Regulation (EU) No 536/2014, and that the third country manufacturer is authorised or entitled to in accordance with the laws of that country to manufacture that investigational medicinal products in that third country.
Imetnik dovoljenja iz člena 61(1) Uredbe (EU) št. 536/2014 pri uvozu zdravil v preskušanju zagotovi, da so bila zdravila proizvedena ob upoštevanju standardov kakovosti, ki so vsaj enakovredna standardom iz te uredbe in Uredbe (EU) št. 536/2014, ter da ima proizvajalec iz tretje države v skladu z zakonodajo navedene države dovoljenje ali pravico, da proizvaja navedeno zdravilo v preskušanju v navedeni tretji državi.
Compliance with clinical trial authorisation
Skladnost z dovoljenjem za klinično preskušanje
The manufacturer shall ensure that all manufacturing operations for investigational medicinal products are carried out in accordance with the documentation and information provided by the sponsor pursuant to Article 25 of Regulation (EU) No 536/2014 and as authorised in accordance with the procedure laid down in Chapter II, or if documentation and information was subsequently amended, in Chapter III of abovementioned Regulation (EU) No 536/2014.
Proizvajalec zagotovi, da se vsi proizvodni postopki za zdravila v preskušanju izvedejo v skladu z dokumentacijo in informacijami, ki jih zagotovi sponzor v skladu s členom 25 Uredbe (EU) št. 536/2014 in kakor je dovoljeno v skladu s postopkom iz poglavja II, oziroma, če so bile dokumentacija in informacije naknadno spremenjene, iz poglavja III zgoraj navedene Uredbe (EU) št. 536/2014.
The manufacturer shall regularly review his manufacturing methods in the light of scientific and technical progress and experience gained by the sponsor during the development of the investigational medicinal product.
Proizvajalec redno preverja svoje proizvodne metode ob upoštevanju znanstvenega in tehničnega napredka ter izkušenj, ki jih sponzor pridobi med razvojem zdravila v preskušanju.
The manufacturer shall inform the sponsor of his reviews of the manufacturing methods.
Proizvajalec o svojih preverjanjih proizvodnih metod obvešča sponzorja.
Where, following a review, an amendment to the clinical trial authorisation is necessary, the application for the amendment shall be submitted in accordance with Article 16 of Regulation (EU) No 536/2014 where the change to the clinical trial is a substantial modification or the amendment shall be carried out in accordance with Article 81(9) of that Regulation where the change to the clinical trial is not a substantial modification.
Če je ob zaključku preverjanja potrebna sprememba dovoljenja za klinično preskušanje, se vloga za spremembo predloži v skladu s členom 16 Uredbe (EU) št. 536/2014, če je sprememba kliničnega preskušanja bistvena sprememba, oziroma v skladu s členom 81(9) navedene uredbe, če sprememba kliničnega preskušanja ni bistvena sprememba.
The manufacturer shall establish, implement and maintain effective organised arrangements to ensure that the investigational medicinal products are of the quality required for their intended use.
Proizvajalec pripravi, izvaja in vzdržuje učinkovite organizacijske ukrepe ter tako zagotovi, da zdravila v preskušanju ustrezajo kakovosti, ki se zahteva za njihovo predvideno uporabo.
Those arrangements shall include the establishment of a good manufacturing practice and a quality control.
Med te ukrepe spada uvedba dobre proizvodne prakse in kontrole kakovosti.
Senior management and personnel from different departments shall participate in the establishment of the pharmaceutical quality system.
Višje vodstvo in osebje različnih oddelkov sodelujejo pri uvedbi sistema farmacevtske kakovosti.
At each manufacturing site, the manufacturer shall have a sufficient number of competent and appropriately qualified personnel at his disposal to ensure that the investigational medicinal products are of the quality required for their intended use.
Proizvajalec ima v vsakem proizvodnem obratu na voljo zadostno število odgovornega in ustrezno usposobljenega osebja, da zagotovi, da zdravila v preskušanju ustrezajo kakovosti, ki se zahteva za njihovo predvideno uporabo.
The duties of managerial and supervisory staff, including the qualified persons, responsible for implementing and operating good manufacturing practice shall be set out in their job descriptions.
Naloge vodstva in nadzornega osebja, vključno z usposobljenimi osebami, pristojnimi za izvajanje dobre proizvodne prakse, so opredeljene v opisu njihovih del in nalog.
Their hierarchical relationships shall be set out in an organisation chart.
Njihovi hierarhični odnosi se določijo v organigramu.
The organisation chart and the job descriptions shall be approved in accordance with the manufacturer's internal procedures.
Organigram in opisi del in nalog se potrdijo v skladu z notranjimi postopki proizvajalca.
The personnel shall receive initial and ongoing training covering in particular the following areas:
Osebje se udeleži začetnega in nadaljnjega izobraževanja, ki zajema zlasti naslednja področja:
the theory and application of the concept of pharmaceutical quality;
teorijo in uporabo koncepta farmacevtske kakovosti;
good manufacturing practice.
dobro proizvodno prakso.
The manufacturer shall verify the effectiveness of the training.
Proizvajalec preveri učinkovitost usposabljanja.
The manufacturer shall establish hygiene programmes, including procedures relating to health, hygiene practice and clothing of personnel.
Proizvajalec pripravi higienske programe, vključno s postopki, ki se nanašajo na zdravje, higiensko prakso in oblačila za osebje.
The programmes shall be adapted to the manufacturing operations to be carried out.
Programi so prilagojeni proizvodnim postopkom, ki se bodo izvajali.
The manufacturer shall ensure that the programmes are observed.
Proizvajalec zagotovi, da se programi upoštevajo.
The manufacturer shall ensure that premises and manufacturing equipment are located, designed, constructed, adapted and maintained to suit the intended operations.
Proizvajalec zagotovi, da se prostori in proizvodna oprema namestijo, načrtujejo, izdelajo, prilagodijo in vzdržujejo tako, da ustrezajo predvidenim postopkom.
The manufacturer shall ensure that the premises and manufacturing equipment are laid out, designed and operated in such a way as to minimise risk of error and permit effective cleaning and maintenance in order to avoid contamination, cross contamination and any other adverse effect on the quality of the investigational medicinal product.
Proizvajalec zagotovi, da se prostori in proizvodna oprema razporedijo, načrtujejo in se z njimi upravlja tako, da se zmanjša tveganje napak na najmanjšo možno mero in omogoči učinkovito čiščenje in vzdrževanje z namenom izogibanja kontaminaciji, navzkrižni kontaminaciji in na splošno vsemu, kar bi lahko neugodno vplivalo na kakovost zdravila v preskušanju.
The manufacturer shall ensure that those premises and equipment to be used for manufacturing operations which are critical to the quality of the investigational medicinal products are subjected to appropriate qualification and validation.
Proizvajalec zagotovi, da so navedeni prostori in oprema za uporabo v proizvodnih postopkih, ki odločilno vplivajo na kakovost zdravil v preskušanju, ustrezno preverjeni in validirani.
The manufacturer shall establish and maintain a documentation system recording the following, where appropriate having regard to the activities undertaken:
Proizvajalec vzpostavi in vzdržuje sistem dokumentiranja ter beleži naslednje (po potrebi ob upoštevanju dejavnosti, ki se izvajajo):
processing and packaging instructions;
navodila za obdelavo in pakiranje;
procedures and protocols, including procedures for general manufacturing operations and conditions;
postopke in protokole, vključno s postopki za splošne proizvodne postopke in pogoje;
records, in particular covering the various manufacturing operations performed and batch records;
evidence, ki vsebujejo zlasti vse izvedene proizvodne postopke, in evidence v zvezi s serijami;
technical agreements;
tehnične sporazume;
certificates of analysis;
certifikate o analizi.
The documents specific to any investigational medicinal product shall be consistent with the product specification file as relevant.
Dokumenti, ki zadevajo posamezno zdravilo v preskušanju, so skladni z ustreznim dokumentom s specifikacijami zdravila.
The documentation system shall ensure the data quality and integrity.
Sistem dokumentacije zagotavlja kakovost in celovitost podatkov.
The manufacturer shall retain the product specification file and batch documentation for at least five years after the completion or discontinuation of the last clinical trial in which the batch was used.
Proizvajalec hrani dokument s specifikacijami zdravila in dokumentacijo o vsaki seriji najmanj pet let po zaključku ali uradni prekinitvi zadnjega kliničnega preskušanja, v katerem je bila serija uporabljena.
When documentation is stored using electronic, photographic or other data processing systems, the manufacturer shall first validate the systems to ensure that the data will be appropriately stored during the period of storage laid down in paragraph 3.
Kadar se za hrambo dokumentacije uporabijo elektronski, fotografski ali drugi sistemi obdelave podatkov, proizvajalec najprej validira te sisteme in tako zagotovi, da bodo podatki v obdobju shranjevanja iz odstavka 3 ustrezno shranjeni.
Data stored by those systems shall be made readily available in readable form.
Podatki, ki se shranjujejo s takimi sistemi, so na razpolago v čitljivi obliki.
The electronically stored data shall be protected against unlawful access, loss or damage of data by techniques such as duplication, back-up and transfer onto another storage system.
Elektronsko shranjeni podatki so zaščiteni pred neupravičenimi dostopi, izgubo ali poškodbami na različne načine, kot so priprava dvojnika, priprava varnostne kopije ali prenos na drug sistem shranjevanja.
Audit trails, meaning records of all relevant changes and deletions in those data, shall be maintained.
Ohranjajo se revizijske sledi, se pravi evidence vseh sprememb in izbrisov navedenih podatkov.
The documentation shall be provided to competent authority upon request.
Dokumentacija se pristojnemu organu predloži na zahtevo.
The manufacturer shall carry out production operations in accordance with pre-established instructions and procedures.
Proizvajalec izvaja proizvodne postopke v skladu s predhodno določenimi navodili in postopki.
The manufacturer shall ensure that adequate and sufficient resources are made available for the in-process controls and that all process deviations and product defects are documented and thoroughly investigated.
Proizvajalec zagotovi, da so na voljo ustrezna in zadostna sredstva za kontrole faz postopka ter da se vsi odmiki v postopku in vse neustreznosti zdravila dokumentirajo in temeljito raziščejo.
The manufacturer shall take appropriate technical or organisational measures to avoid cross contamination and unintentional mixing of substances.
Proizvajalec sprejme ustrezne tehnične ali organizacijske ukrepe, da se preprečita navzkrižna kontaminacija in nenamerno mešanje snovi.
Particular attention shall be paid to the handling of investigational medicinal products during and after any blinding operation.
Posebna pozornost se nameni ravnanju z zdravili v preskušanju med in po vsakem postopku zakrivanja.
The manufacturing process shall be validated in its entirety, as far as is appropriate, taking into account the stage of product development.
Proizvodni postopek se validira v celoti, kolikor je to primerno, ob upoštevanju stopnje razvoja zdravila.
The manufacturer shall identify the process steps that ensure the safety of the subject, such as sterilisation, and the reliability and robustness of the clinical trial data generated in the clinical trial.
Proizvajalec opredeli faze postopka, kot je sterilizacija, s katerimi zagotovi varnost udeležencev ter zanesljivost in trdnost podatkov, pridobljenih med kliničnim preskušanjem.
Those critical process steps shall be validated and regularly re-validated.
Te kritične faze postopka se validirajo in nato redno ponovno validirajo.
All steps in the design and development of the manufacturing process shall be fully documented.
Vse faze oblikovanja in razvoja proizvodnega postopka se v celoti dokumentirajo.
The manufacturer shall establish and maintain a quality control system under the authority of a person who has the requisite qualifications and is independent of production.
Proizvajalec vzpostavi in vzdržuje sistem kontrole kakovosti, ki ga vodi oseba z ustreznimi kvalifikacijami in ki deluje neodvisno od proizvodnje.
That person shall have access to one or more quality control laboratories appropriately staffed and equipped to carry out the examination and testing of starting materials and packaging materials and the testing of intermediate and finished investigational medicinal products.
Ta oseba ima dostop do enega ali več laboratorijev za kontrolo kakovosti z ustreznim osebjem in opremo za izvajanje pregledov in preskušanj vhodnih snovi in snovi ovojnine ter preskušanj vmesnih in končnih zdravil v preskušanju.
The manufacturer shall ensure that the quality control laboratories comply with information provided in the application dossier, referred to in Article 25(1) of Regulation (EU) No 536/2014, as authorised by Member States.
Proizvajalec zagotovi, da laboratoriji za kontrolo kakovosti upoštevajo informacije iz dosjeja vloge iz člena 25(1) Uredbe (EU) št. 536/2014, kakor so ga odobrile države članice.
When investigational medicinal products are imported from third countries, analytical control in the Union shall not be mandatory.
Kadar so zdravila v preskušanju uvožena iz tretjih držav, analizna kontrola v Uniji ni obvezna.
During the final control of the finished investigational medicinal product, and before its release by the manufacturer, the manufacturer shall take into account:
Proizvajalec med končno kontrolo končnega zdravila v preskušanju in preden to zdravilo sprosti v promet, upošteva:
production conditions;
proizvodne pogoje;
the results of in-process controls;
rezultate kontrol faz postopka;
the examination of the manufacturing documents;
pregled proizvodne dokumentacije;
the conformity of the product with its specifications;
skladnost zdravila z njegovimi specifikacijami;
conformity of the product with the clinical trial authorisation;
skladnost zdravila z dovoljenjem za klinično preskušanje;
examination of the final finished packaging.
pregled končne zunanje ovojnine.
Retention of samples used for quality control
Hramba vzorcev za kontrolo kakovosti
The manufacturer shall retain sufficient samples of each batch of bulk formulated product, of key packaging components used for each finished investigational medicinal product batch and of each batch of finished investigational medicinal product for at least two years after the completion or discontinuation of the last clinical trial in which the batch was used.
Proizvajalec hrani zadostno število vzorcev vsake serije zdravil v nepakirani obliki, vzorcev glavnih sestavnih delov ovojnine, uporabljenih pri vsaki seriji končnega zdravila v preskušanju, ter vzorcev vsake serije končnega zdravila v preskušanju najmanj dve leti po zaključku ali uradni prekinitvi zadnjega kliničnega preskušanja, v katerem je bila serija uporabljena.
Samples of starting materials, other than solvents, gases or water, used in the manufacturing process shall be retained by the manufacturer for at least two years after the release of the investigational medicinal product.
Vzorce vhodnih snovi, razen topil, plinov ali vode, uporabljenih v proizvodnem postopku, proizvajalec hrani najmanj dve leti po sprostitvi zdravila v preskušanju v promet.
However, this period may be shortened where the period of stability of the starting material, as indicated in the relevant specification, is shorter.
To obdobje je mogoče skrajšati, če je obdobje stabilnosti vhodne snovi, kot je navedeno v ustrezni specifikaciji, krajše.
In all cases samples shall be maintained by the manufacturer at the disposal of the competent authority.
V vsakem primeru proizvajalec hrani vzorce in jih da na voljo pristojnim organom.