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? | 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? | What should I look for on the ISO 21501-4 calibration certificate?
Where can I learn more about Analyte Specific Reagents (ASRs)? | Where can I learn more about Analyte Specific Reagents (ASRs)?
What aspects have to be considered while manufacturing under cGMP? | What aspects have to be considered while manufacturing under cGMP?
Why is Beckman Coulter offering ASRs outside the U.S.? | Why is Beckman Coulter offering ASRs outside the U.S.?
What aspects of the ASR regulation ensure consistency of the product? | What aspects of the ASR regulation ensure consistency of the product?
What does Beckman Coulter do to ensure the ASR product quality? | What does Beckman Coulter do to ensure the ASR product quality?
What are the benefits of cGMP Manufacturing? | What are the benefits of cGMP Manufacturing?
What are the requirements for calibration certificates of test equipment? | 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? {D068CAA5-DDCE-4673-8182-8BB027E5847B}|{6B81A591-2B23-47F4-8F1E-7DF0B29AFD77}|{48B794E8-25AB-4428-8C2F-FE4BE0B4399F}|{DACE6BFD-8FB8-49FA-9877-631632899795}|{2EBC6B45-CFBA-4FCC-917D-5B2D5CD218C4}|{3144F8D9-C5C2-421B-85E0-88AC31044BCE} | {39A28571-75B3-4DD1-AA68-E30E426FFFC4}|{5140ED78-C4D4-4C98-8CC5-84D01AC9C44C}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? | What are the cGMP requirements for the organization and the personnel?
What are the cGMP requirements for equipment? | What are the cGMP requirements for equipment?
What are the cGMP requirements for production process and control? | What are the cGMP requirements for production process and control?
What are the cGMP requirements for raw material control? | What are the cGMP requirements for raw material control?
What are the cGMP requirements for the laboratory? | What are the cGMP requirements for the laboratory?
What are the cGMP requirements for warehousing? | What are the cGMP requirements for warehousing?
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? | 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? | What aspects of the regulation ensure consistency of the product?
What does the FDA mean by ‘contemporaneously’? | What does the FDA mean by ‘contemporaneously’?
What is an audit trail and how to do I create one? | What is an audit trail and how to do I create one?
What is the difference between cGMP and GPM? | What is the difference between cGMP and GPM?
Are scanned or electronically generated regulatory documents be considered electronic documents subject to Part 11? | 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? | 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? | {B24812CA-1B6E-4ACD-8E71-A9D5229A0669}What is flow rate and why is it important for instrument calibration and measurement?
What file format is preferred for electronic records maintenance? | What file format is preferred for electronic records maintenance?
Are open systems ever permitted for GXP cleanroom monitoring? | Are open systems ever permitted for GXP cleanroom monitoring?
Are there impacts to periodic 14644-1 classification and re-classification? | Are there impacts to periodic 14644-1 classification and re-classification?
What elements are tested as part of an ISO 21501 calibration? {D068CAA5-DDCE-4673-8182-8BB027E5847B}|{0940F4AC-7B9B-48D6-984D-F9E2C42532AE}|{6CC809AF-8EB6-405F-A5C3-CEC8BB4855F6}|{1A085B75-5D0B-4B73-B017-6A63554C648D} | {39A28571-75B3-4DD1-AA68-E30E426FFFC4}What elements are tested as part of an ISO 21501 calibration?
How does the ISO 21501-4 calibration standard improve compliance? | How does the ISO 21501-4 calibration standard improve compliance?
Почему силиконовое масло может быть проблемой? | Почему силиконовое масло может быть проблемой?
What are the key changes to sampling, classification and reclassification? | 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? | {B24812CA-1B6E-4ACD-8E71-A9D5229A0669}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>)? | Какие основные разделы содержит глава <1787> Фарм. США (USP <787>)?
What do the ISO 14644-1 changes mean for pharmaceutical cleanroom classification? | What do the ISO 14644-1 changes mean for pharmaceutical cleanroom classification?
How does 14644-1 address nanoscale particles? | How does 14644-1 address nanoscale particles?
What is the National Institute of Standards and Technology (NIST)? | {B24812CA-1B6E-4ACD-8E71-A9D5229A0669}What is the National Institute of Standards and Technology (NIST)?
What are NIST (National Institute of Standards and Technology) traceable standards? | {B24812CA-1B6E-4ACD-8E71-A9D5229A0669}What are NIST (National Institute of Standards and Technology) traceable standards?
Are offsite databases preferred over onsite databases? | Are offsite databases preferred over onsite databases?
Что представляют собой парентеральные лекарственные препараты? | Что представляют собой парентеральные лекарственные препараты?
How are particle count measurements taken? | {B24812CA-1B6E-4ACD-8E71-A9D5229A0669}How are particle count measurements taken?
Where can I find guidance for proper calibration of my air and/or liquid particle counter? {D068CAA5-DDCE-4673-8182-8BB027E5847B}|{6B81A591-2B23-47F4-8F1E-7DF0B29AFD77}|{F1039B12-BCA0-4185-BDAD-4EFC9DDD03D3}|{FC2C5B0A-747D-4519-9B40-7705EC608849}|{FDBDB341-EFD0-499F-BE36-332BF93F72F8}|{DA12B452-2119-46EE-951F-1F88F8912E59}|{960B5C2C-B852-4C5F-874A-A26B59652BC7}|{90B48452-7722-4B97-9610-74626F7BD3B1}|{6CC809AF-8EB6-405F-A5C3-CEC8BB4855F6} | {39A28571-75B3-4DD1-AA68-E30E426FFFC4}|{AE58FB2D-EB96-4B5D-8149-2D5A3743F7C3}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? {D068CAA5-DDCE-4673-8182-8BB027E5847B}|{0940F4AC-7B9B-48D6-984D-F9E2C42532AE}|{6CC809AF-8EB6-405F-A5C3-CEC8BB4855F6} | {39A28571-75B3-4DD1-AA68-E30E426FFFC4}Why is counting efficiency checked at each calibration interval?
How are ‘particles of interest’ measured in cleanroom and controlled processing environments? {16D8196D-AB69-4272-8E11-A03E1605B1B8}|{E38F1B19-18AF-4E5E-AE66-1C34EEC14E82}|{70BF5ED9-25AB-4502-93F5-5414AAADC771}|{D068CAA5-DDCE-4673-8182-8BB027E5847B}|{0940F4AC-7B9B-48D6-984D-F9E2C42532AE} | {EA311E80-3B38-495C-BB5E-87AD6D05DA2F}|{AE58FB2D-EB96-4B5D-8149-2D5A3743F7C3}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? | What does the recent ISO 14644-2:2015 update mean for pharmaceutical cleanroom monitoring?
Какие трудности связны с белковыми лекарственными формами? | Какие трудности связны с белковыми лекарственными формами?
Чем обусловлен диапазон размеров невидимых невооруженным глазом частиц? | Чем обусловлен диапазон размеров невидимых невооруженным глазом частиц?
What is a “risk-based approach” to 21 CFR 11 compliance? | 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? | {B24812CA-1B6E-4ACD-8E71-A9D5229A0669}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? | {B24812CA-1B6E-4ACD-8E71-A9D5229A0669}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>)? | 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? | What aspects of the cleanroom environmental monitoring workflow must be validated?
Why can silicone oil be a problem? | Why can silicone oil be a problem?
Что представляют собой продукты вымывания? | Что представляют собой продукты вымывания?
What is coincidence error and how is it determined? | {B24812CA-1B6E-4ACD-8E71-A9D5229A0669}What is coincidence error and how is it determined?
What is an Analyte Specific Reagent (ASR)? | What is an Analyte Specific Reagent (ASR)?
What is cGMP? | What is cGMP?
What is a consensus standard? | {B24812CA-1B6E-4ACD-8E71-A9D5229A0669}What is a consensus standard?
What is ISO 11171? | {B24812CA-1B6E-4ACD-8E71-A9D5229A0669}What is ISO 11171?
What is SRM 2806? | {B24812CA-1B6E-4ACD-8E71-A9D5229A0669}What is SRM 2806?
When can we expect an update to Part 11? | When can we expect an update to Part 11?
What are the cGMP requirements for buildings and facilities? | What are the cGMP requirements for buildings and facilities?
What are the cGMP requirements for documentation? | What are the cGMP requirements for documentation?