Glossary entry (derived from question below)
Spanish term or phrase:
compromiso de registro
English translation:
reporting requirement/s
Added to glossary by
liz askew
Jan 5, 2011 07:41
13 yrs ago
8 viewers *
Spanish term
Spain
compromiso de registro
Spanish to English
Tech/Engineering
Medical: Pharmaceuticals
THIS IS PART OF A STANDARD OPERATING PROCEDURE, IN THIS CASE FOR REPROCESSING AND REWORK FOR PHARMACEUTICAL MANUFACTURING. REPROCESSING IS BEING DEFINED.
Un reproceso, al ser repetición de un proceso rutinario establecido y que por tanto cumple **compromiso de registro**, no hace falta notificarlo a las autoridades Sanitarias, aunque deberá ser notificado al Departamento de Registros
ANOTHER EXAMPLE - THIS IS PART OF A VALIDATION PROCEDURE DESCRIPTION
El protocolo se ajusta a los **compromisos de registro** y al plan de validación aprobado.
HERE IS A MORE COMPLETE TEXT OF THE FIRST EXAMPLE
Según las GMP´s europeas y el GQS 401 (Production Practices), las operaciones de reproceso se definen como una reincorporación o reintroducción de un producto, incluyendo aquel que no esté en conformidad con normas o especificaciones, en el proceso y repetición de una etapa que forme parte del proceso establecido.
En la planta de xxxxxxxx, un ejemplo de reproceso sería la repetición de la fase de molienda de un producto que haya sido tamizado con una malla de tamaño de luz superior a la validada.
No se considera un reproceso, por lo tanto es considerado un proceso normal, la continuación de una fase cuando un control en proceso da un resultado indicativo de que dicha fase no ha llegado a su término. Ejemplos de una continuación serían secado o granulado hasta un punto final.
Un reproceso, al ser repetición de un proceso rutinario establecido y que por tanto cumple **compromiso de registro**, no hace falta notificarlo a las autoridades Sanitarias, aunque deberá ser notificado al Departamento de Registros.
Un reproceso, al ser repetición de un proceso rutinario establecido y que por tanto cumple **compromiso de registro**, no hace falta notificarlo a las autoridades Sanitarias, aunque deberá ser notificado al Departamento de Registros
ANOTHER EXAMPLE - THIS IS PART OF A VALIDATION PROCEDURE DESCRIPTION
El protocolo se ajusta a los **compromisos de registro** y al plan de validación aprobado.
HERE IS A MORE COMPLETE TEXT OF THE FIRST EXAMPLE
Según las GMP´s europeas y el GQS 401 (Production Practices), las operaciones de reproceso se definen como una reincorporación o reintroducción de un producto, incluyendo aquel que no esté en conformidad con normas o especificaciones, en el proceso y repetición de una etapa que forme parte del proceso establecido.
En la planta de xxxxxxxx, un ejemplo de reproceso sería la repetición de la fase de molienda de un producto que haya sido tamizado con una malla de tamaño de luz superior a la validada.
No se considera un reproceso, por lo tanto es considerado un proceso normal, la continuación de una fase cuando un control en proceso da un resultado indicativo de que dicha fase no ha llegado a su término. Ejemplos de una continuación serían secado o granulado hasta un punto final.
Un reproceso, al ser repetición de un proceso rutinario establecido y que por tanto cumple **compromiso de registro**, no hace falta notificarlo a las autoridades Sanitarias, aunque deberá ser notificado al Departamento de Registros.
Proposed translations
(English)
| 3 +2 | reporting requirement/s |
liz askew
|
| 4 +1 | records requirement |
Dr. Jason Faulkner
|
| 4 +1 | registration/filing requirements |
Jorge Arteaga M.D.
|
| 4 | Commitment Register |
Constantinos Faridis (X)
|
Change log
Jan 16, 2011 14:17: liz askew Created KOG entry
Proposed translations
+2
4 hrs
Selected
reporting requirement/s
http://www.google.co.uk/search?q=reporting requirements phar...
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Note added at 4 hrs (2011-01-05 12:34:03 GMT)
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EM Strategic Health Authority - Incident Near Miss Reporting Policy
East Midlands Strategic Health Authority. Search our Site .... NHS East Midlands will comply with the reporting requirements of the following external agencies: ... Notify the HSE and statutory agency within legal timescales ...
www.eastmidlands.nhs.uk/.../incident-near-miss-reporting-po... - Cached - Similar
--------------------------------------------------
Note added at 4 hrs (2011-01-05 12:34:50 GMT)
--------------------------------------------------
Pharmacovigilance and Drug Safety for European markets
EU Regulation for Pharmaceutical Product Registration and .... staff to comply with these strict reporting requirements and increased workload but are ..... The European Commission is the responsible authority for the products which ... Expedited Reporting Notification (submission) of an ICSR in a designated format ...
www.pharmacovigilance.org.uk/ - Cached - Similar
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Note added at 5 hrs (2011-01-05 12:41:11 GMT)
--------------------------------------------------
in fact it could be even stronger
reporting obligations/record keeping obligations
--------------------------------------------------
Note added at 5 hrs (2011-01-05 12:41:52 GMT)
--------------------------------------------------
#
When and how to inform respondents of AE reporting obligations
31 Dec 2010 ... Adverse Event Reporting in Market Research. ... Respondents must be made aware of AE reporting obligations before they agree to take part in ...
www.bhbia.org.uk/Default.aspx?TabId=572&page=203...48 - Cached
#
Adverse Event Reporting System (AERS)
20 Aug 2009 ... The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety ...
www.fda.gov › ... › Surveillance - Cached
#
Adverse Event Reporting Policy
The adverse event reporting requirements outlined in this policy apply to both internal .... REQUIREMENTS FOR PROMPT REPORTING OF ADVERSE EVENTS TO THE PHRC ...
healthcare.partners.org/phsirb/adverse_events.htm - Cached - Similar
--------------------------------------------------
Note added at 4 hrs (2011-01-05 12:34:03 GMT)
--------------------------------------------------
EM Strategic Health Authority - Incident Near Miss Reporting Policy
East Midlands Strategic Health Authority. Search our Site .... NHS East Midlands will comply with the reporting requirements of the following external agencies: ... Notify the HSE and statutory agency within legal timescales ...
www.eastmidlands.nhs.uk/.../incident-near-miss-reporting-po... - Cached - Similar
--------------------------------------------------
Note added at 4 hrs (2011-01-05 12:34:50 GMT)
--------------------------------------------------
Pharmacovigilance and Drug Safety for European markets
EU Regulation for Pharmaceutical Product Registration and .... staff to comply with these strict reporting requirements and increased workload but are ..... The European Commission is the responsible authority for the products which ... Expedited Reporting Notification (submission) of an ICSR in a designated format ...
www.pharmacovigilance.org.uk/ - Cached - Similar
--------------------------------------------------
Note added at 5 hrs (2011-01-05 12:41:11 GMT)
--------------------------------------------------
in fact it could be even stronger
reporting obligations/record keeping obligations
--------------------------------------------------
Note added at 5 hrs (2011-01-05 12:41:52 GMT)
--------------------------------------------------
#
When and how to inform respondents of AE reporting obligations
31 Dec 2010 ... Adverse Event Reporting in Market Research. ... Respondents must be made aware of AE reporting obligations before they agree to take part in ...
www.bhbia.org.uk/Default.aspx?TabId=572&page=203...48 - Cached
#
Adverse Event Reporting System (AERS)
20 Aug 2009 ... The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety ...
www.fda.gov › ... › Surveillance - Cached
#
Adverse Event Reporting Policy
The adverse event reporting requirements outlined in this policy apply to both internal .... REQUIREMENTS FOR PROMPT REPORTING OF ADVERSE EVENTS TO THE PHRC ...
healthcare.partners.org/phsirb/adverse_events.htm - Cached - Similar
4 KudoZ points awarded for this answer.
+1
8 mins
records requirement
Sounds like they are referring to the routine requirement to document all incidents, procedures, etc.
Peer comment(s):
| agree |
Muriel Vasconcellos
: I saw some good references on the Internet - you could have included them.
1 hr
|
12 mins
Commitment Register
(Pharmaceuticals industry). January 1997 — January 1999 (2 years 1 month). Front End Process Training manager for Commitment Register tool to Product ...
www.linkedin.com/.../hillarymintzsteele
www.linkedin.com/.../hillarymintzsteele
Peer comment(s):
| neutral |
AllegroTrans
: committing who or what? how does your ref demonstrate this to be a good translation?
2 days 15 hrs
|
+1
5 hrs
Jorge Arteaga M.D.
United States
United States
Native in Spanish
Specializes in field
United States
MD specialized in medical translations
Native in: Spanish (Variant: Latin American) 
Works in: English to Spanish, Spanish
Related KudoZ points
:
41
registration/filing requirements
As I understand it this refers to the requirements regulatory institutions demand pharmaceutical companies fulfill in order to approve a drug/procedure.
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