Вопросы об отраслевых стандартах

В этом разделе представлены ответы на часто задаваемые вопросы (FAQs) о стандартах качества и нормативах, применимых в отраслях, которые мы обслуживаем. К ним относятся Надлежащая производственная практика (cGMP), стандарты ISO, нормативы FDA, например, 21 CFR Part 11, и др.

 
Does 21 CFR 11 make any statements regarding the level of training required for personnel conducting environmental monitoring? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Does 21 CFR 11 make any statements regarding the level of training required for personnel conducting environmental monitoring?
What should I look for on the ISO 21501-4 calibration certificate? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What should I look for on the ISO 21501-4 calibration certificate?
Where can I learn more about Analyte Specific Reagents (ASRs)? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Where can I learn more about Analyte Specific Reagents (ASRs)?
What aspects have to be considered while manufacturing under cGMP? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What aspects have to be considered while manufacturing under cGMP?
Why is Beckman Coulter offering ASRs outside the U.S.? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Why is Beckman Coulter offering ASRs outside the U.S.?
What aspects of the ASR regulation ensure consistency of the product? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What aspects of the ASR regulation ensure consistency of the product?
What does Beckman Coulter do to ensure the ASR product quality? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What does Beckman Coulter do to ensure the ASR product quality?
What are the benefits of cGMP Manufacturing? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the benefits of cGMP Manufacturing?
What are the requirements for calibration certificates of test equipment? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the requirements for calibration certificates of test equipment?
Do EU GMP or cGMP guidelines require the use of a specific particle counter for air particle cleanliness classification and monitoring? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Do EU GMP or cGMP guidelines require the use of a specific particle counter for air particle cleanliness classification and monitoring?
What are the cGMP requirements for the organization and the personnel? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the cGMP requirements for the organization and the personnel?
What are the cGMP requirements for equipment? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the cGMP requirements for equipment?
What are the cGMP requirements for production process and control? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the cGMP requirements for production process and control?
What are the cGMP requirements for raw material control? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the cGMP requirements for raw material control?
What are the cGMP requirements for the laboratory? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the cGMP requirements for the laboratory?
What are the cGMP requirements for warehousing? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the cGMP requirements for warehousing?
Should I anticipate changes on my product specifications and performance post-IVDR? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Should I anticipate changes on my product specifications and performance post-IVDR?
A CRO relies solely on paper-based record keeping citing fears of a data breach by a competitor. Is cleanroom data from this CRO submissible to the FDA? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]A CRO relies solely on paper-based record keeping citing fears of a data breach by a competitor. Is cleanroom data from this CRO submissible to the FDA?
What aspects of the regulation ensure consistency of the product? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What aspects of the regulation ensure consistency of the product?
What does the FDA mean by ‘contemporaneously’? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What does the FDA mean by ‘contemporaneously’?
What is an audit trail and how to do I create one? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is an audit trail and how to do I create one?
What is the difference between cGMP and GPM? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is the difference between cGMP and GPM?
Are scanned or electronically generated regulatory documents be considered electronic documents subject to Part 11? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Are scanned or electronically generated regulatory documents be considered electronic documents subject to Part 11?
Are all cleanroom records required to be maintained in electronic format? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Are all cleanroom records required to be maintained in electronic format?
What is flow rate and why is it important for instrument calibration and measurement? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is flow rate and why is it important for instrument calibration and measurement?
What file format is preferred for electronic records maintenance? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What file format is preferred for electronic records maintenance?
Are open systems ever permitted for GXP cleanroom monitoring? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Are open systems ever permitted for GXP cleanroom monitoring?
Are there impacts to periodic 14644-1 classification and re-classification? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Are there impacts to periodic 14644-1 classification and re-classification?
What elements are tested as part of an ISO 21501 calibration? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What elements are tested as part of an ISO 21501 calibration?
How does the ISO 21501-4 calibration standard improve compliance? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]How does the ISO 21501-4 calibration standard improve compliance?
Почему силиконовое масло может быть проблемой? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Почему силиконовое масло может быть проблемой?
Does the IVDR have implications for individual clinical laboratories? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Does the IVDR have implications for individual clinical laboratories?
Will additional IVDR requirements limit the release of new CE-marked products in the future? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Will additional IVDR requirements limit the release of new CE-marked products in the future?
What are the key changes to sampling, classification and reclassification? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the key changes to sampling, classification and reclassification?
What are my options for determining a change in my liquid particle counter’s operating characteristics? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are my options for determining a change in my liquid particle counter’s operating characteristics?
Какие основные разделы содержит глава <1787> Фарм. США (USP <787>)? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Какие основные разделы содержит глава <1787> Фарм. США (USP <787>)?
What do the ISO 14644-1 changes mean for pharmaceutical cleanroom classification? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What do the ISO 14644-1 changes mean for pharmaceutical cleanroom classification?
How does 14644-1 address nanoscale particles? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]How does 14644-1 address nanoscale particles?
What is the National Institute of Standards and Technology (NIST)? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is the National Institute of Standards and Technology (NIST)?
What are NIST (National Institute of Standards and Technology) traceable standards? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are NIST (National Institute of Standards and Technology) traceable standards?
Do you anticipate the obsolescence of selected CE-marked products? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Do you anticipate the obsolescence of selected CE-marked products?
Are offsite databases preferred over onsite databases? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Are offsite databases preferred over onsite databases?
Что представляют собой парентеральные лекарственные препараты? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Что представляют собой парентеральные лекарственные препараты?
How are particle count measurements taken? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]How are particle count measurements taken?
Where can I find guidance for proper calibration of my air and/or liquid particle counter? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Where can I find guidance for proper calibration of my air and/or liquid particle counter?
Why is counting efficiency checked at each calibration interval? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Why is counting efficiency checked at each calibration interval?
How are ‘particles of interest’ measured in cleanroom and controlled processing environments? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]How are ‘particles of interest’ measured in cleanroom and controlled processing environments?
What does the recent ISO 14644-2:2015 update mean for pharmaceutical cleanroom monitoring? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What does the recent ISO 14644-2:2015 update mean for pharmaceutical cleanroom monitoring?
Какие трудности связны с белковыми лекарственными формами? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Какие трудности связны с белковыми лекарственными формами?
Чем обусловлен диапазон размеров невидимых невооруженным глазом частиц? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Чем обусловлен диапазон размеров невидимых невооруженным глазом частиц?
What is a “risk-based approach” to 21 CFR 11 compliance? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is a “risk-based approach” to 21 CFR 11 compliance?
Is it possible to check on the status of hydraulic fluids in an active system? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Is it possible to check on the status of hydraulic fluids in an active system?
What is a threshold noise level and how is it determined? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is a threshold noise level and how is it determined?
Какие аспекты охватывает глава <1787> Фарм. США (USP <1787>)и чем она отличается от главы <787> Фарм. США (USP <787>)? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Какие аспекты охватывает глава <1787> Фарм. США (USP <1787>)и чем она отличается от главы <787> Фарм. США (USP <787>)?
What aspects of the cleanroom environmental monitoring workflow must be validated? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What aspects of the cleanroom environmental monitoring workflow must be validated?
Why can silicone oil be a problem? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Why can silicone oil be a problem?
Что представляют собой продукты вымывания? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]Что представляют собой продукты вымывания?
What is coincidence error and how is it determined? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is coincidence error and how is it determined?
What is an Analyte Specific Reagent (ASR)? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is an Analyte Specific Reagent (ASR)?
What is cGMP? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is cGMP?
What is a consensus standard? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is a consensus standard?
What is ISO 11171? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is ISO 11171?
What is SRM 2806? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What is SRM 2806?
When can we expect an update to Part 11? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]When can we expect an update to Part 11?
What are the cGMP requirements for buildings and facilities? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the cGMP requirements for buildings and facilities?
What are the cGMP requirements for documentation? System.Collections.Generic.List`1[System.Guid] | System.Collections.Generic.List`1[System.Guid]What are the cGMP requirements for documentation?