Industry Standards FAQs

Here you'll find answers to important questions about quality standards and regulations that apply to the industries we serve. These include certified Good Manufacturing Practices (cGMP), ISO compliance standards, FDA regulations such as 21 CFR 11, and more.

 

 
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?
How does the ISO 21501-4 calibration standard improve compliance? | How does the ISO 21501-4 calibration standard improve compliance?
Why might silicone oil present an issue? | Why might silicone oil present an issue?
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?
What are the main sections of USP <1787>? | What are the main sections of USP <1787>?
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?
What are parenteral drug products? | What are parenteral drug products?
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?
What are some of the challenges associated with protein-based formulations? | What are some of the challenges associated with protein-based formulations?
What is the rational for the subvisible measurement range? | What is the rational for the subvisible measurement range?
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?
What does USP <1787> cover and how is it different from USP <787>? | What does USP <1787> cover and how is it different from USP <787>?
What aspects of the cleanroom environmental monitoring workflow must be validated? | What aspects of the cleanroom environmental monitoring workflow must be validated?
What are extractables? | What are extractables?
What are leachables? | What are leachables?
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?