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FDA / GMP guidelines
In the guidelines, it is not clear when you need cleanroom facilities destined in FDA / GMP guidelines.
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Compliance with ISO 13485 or GMP for Class III device
Hello, There is a requirement for planning the plant for medical device class 3 production(dermal filler) another than ISO 13845? The plant will be under demand of ISO 13845 or under GMP demand? In Europe. -
Temperature mapping of storage areas ISO13485
... apping exercise is not available in the Company therefore it is not possible to evaluate the hottest and coldest points representative of the worst conditions for placing the Data Logger. Temperature is controlled and monitored in all our areas, however, there was no temperature mapping qualification performed. Temperature mapping is required for e.g. storage of pharmaceutical products (GLP/GMP/GDP), however, I cannot find evidence this is a requirement for storage of medical devices. I would like to know if this is mandatory. Thanks in advance!
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ISO 17025 and 22716
... ... at has undergone FDA inspections. We are considering using in-house stability data to set the expiration date of products. Currently, we are referring to outsourced stability data from an external lab(ISO 17025) for checking product stability and active potency. To ensure the acceptability of our in-house data, is it necessary to have an ISO 17025 certificate?
We are complying with CGMP. -
Good Manufacturing Practice in pharmaceutical
We are looking for guidance with regards to Good Manufacturing Practice. Is this a certification that pharmaceutical companies need to apply for? How do they apply? If the company has ISO13485, can they use the GMP mark? or do they need to be registered for GMP?
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Method validation/verification
Yes, we are in the process of implementing ISO17025 and have almost completed creating our quality management system. I am struggling with method validation/verification for my analyses. One is semi-quantitative while primarily identification (NIOSH 9002) and I am unsure how to verify the method since I can’t order standards and I have previous PT samples I can use but they don’t cover the entire scope and since the method is partially identification I can’t re-use them as blinds. The other method is random by nature so again I can’t order standards. I just want to ensure that the verification that I perform is robust enough.
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LEEA and ISO 17025
If a company has gained LEEA. is this covered by ISO17025?
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Equipment Handling
The ISO17025 states in Section 6.4.3: The laboratory shall have a procedure for handling, transport, storage, use and planned maintenance of equipment in order to ensure proper functioning and to prevent contamination and deterioration. The 17025 Academy toolkit, PR.08, 3.3 Equipment Handling, refers to this requirement. Will this section meet the requirement of having the needed procedure? -
17025 vs 13485
First of all, thanks for having this platform, very helpful! My question is around how 17025 interacts with 13485. We have an ISO13485 QMS and we want to get accredited to ISO17025 for one of our labs, multiple in the future. Our core business is medical devices and 13485 is the heart of that, with a relative small part for calibration activities (internal use) where we want 17025 accreditation for. Would it be best practice to integrate the ISO17025 requirements in the ISO13485 QMS or make a separate ISO17025 QMS for the labs? Many thanks in advance.