Anonymous
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I and a colleague have a disagreement regarding who the GLP's. Where do they apply?
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Anonymous
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In response to Anonymous
Good Laboratoty Practices - as the name implies refers to laboratories. This is the regulating guideline for the laboratory as GMP is for manufacturing. In fact ISO Gude 17025 which specifically applies to laboratory accredition requires that a laboratory adhere to established GLP.
nellie
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Anonymous
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In response to Anonymous
The GLPs (Good Laboratory Practice) regulations in the US can be either the FDA or EPA regulations that apply to non-human safety studies intended for submission to EPA or FDA and which support safety claims for products seeking approval for marketing or human testing.
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Anonymous
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In response to Anonymous
The GLPs are actually world wide. Japan has a set of GLP regulations, as does the EU (OECD) and Britian, France etc.
The regulations are almost identical, with some minor differences exisiting.
The Office of Regulatory Affairs of the FDA put out a document comparing US FDA GLPs vs EPA GLPS vs OECD GLPS last year. It is a pretty good document.
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Anonymous
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In response to Anonymous
GLP stands for Good Laboratory Practices and they are regulations that govern non-clinical laboratory studies conducted early in the development of medicinal products.GLP's are meant to ensure that new medicinal products will be safe to test in humnas
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Anonymous
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In response to Anonymous
Which means that theyapply to Laboratories that conduct Animal studies.
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Anonymous
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In response to Anonymous
No! This means any thing under development product or procedure that will be used for human beings falls under the catagory of GLP. Initial it was always associated with animals because all reseaech work was mostly done on aniamls.
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Anonymous
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In response to Anonymous
Lets get specific GLP is a generic acronym, the EU the USA's FDA and OECD countries all have codes of GLP.
Do you mean 21 CFR Part 58 code of GLP for the USA's FDA?
I also would like to know if this applies to a QC testing lab for a generic drug manufacuruer outside the US who is suppling the US market or do they just need to comply with 21 CFR Part 210 & 211 code of GMP for finished Pharmaceuticals?
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Anonymous
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In response to Anonymous
I would be interested in seeing the USA's FDA regulatory affairs departments comparison of the various international codes of GLP, do you have the link to the report?
Regards
PaulS
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ljmcdonald
stranger
Posts: 13
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In response to Anonymous
The problem is with the name Good Laboratory Practices. They apply to non-clinical studies intended to demonstrate safety of a product. They do not apply to R&D or QC laboratory work for characterization of a product, or to in process or final testing during cGMP manufacturing. That being said, any laboratory work at any stage of product development or manufacturing can be performed according to GLP standards, if desired. The GLP regulations would require the study to be run under a protocol, with approval and active monitoring of the study by an independent QA Unit, along with auditing of the final report and data by the QAU. There are several other requirement, also.
| Lee J. McDonald, Ph.D.
Manager, Manufacturing QA
Memorial Sloan-Kettering Cancer Center |
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Anonymous
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In response to Anonymous
There was a request for this link by Paul S.
Here is the link to the the Comparison Chart of FDA and EPA
Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP http://www.fda.gov/ora/compliance_ref/bimo/comparison_chart/
Celeste Rose
RoseTECH Consulting
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12-03-04 06:01 AM -