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swapnil.kuche ★ 2011-01-20 07:47 (5223 d 07:30 ago) (edited on 2011-01-20 11:20) Posting: # 6452 Views: 26,242 |
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Dear All, Most of Quality Assurance departments used to claim that 20% raw data (Inprocess & Retrospective) and final bioequivalence report will be audited during course of conduct of the study. My question is
Swapnil |
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Helmut ★★★   Vienna, Austria, 2011-01-20 13:05 (5223 d 02:12 ago) @ swapnil.kuche Posting: # 6453 Views: 24,825 |
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Dear Swapnil! ❝ Most of Quality Assurance departments used to claim that 20% raw data […] will be audited during course of conduct of the study. ❝ 1. Do you feel it's ideal procedure to be followed? No. I don’t think that it makes sense to leave 80% unaudited. IMHO not less than 100% should be audited. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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ElMaestro ★★★ Denmark, 2011-01-20 14:02 (5223 d 01:15 ago) @ swapnil.kuche Posting: # 6454 Views: 24,706 |
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Dear Swapnil, ❝ Most of Quality Assurance departments used to claim that 20% raw data (Inprocess & Retrospective) and final bioequivalence report will be audited during course of conduct of the study. ❝ My question is ❝ 1. Do you feel it's ideal procedure to be followed? Your 20% is not uncommon. Whether or not it is ideal depends on a lot of factors, incl. previous history of noncompliance. Let's say you start out with a much higher percentage than 20 in a young organisation but your qualified auditors don't ever find anything = a mature QMS and you can probably argue the percetange to go down. If on the other hand your auditors ID areas with noncompliance then these can with good argumentation be subject to more intensive audit than others. Along the same lines, if for example nobody left the bioanalytical dept. for six years but 30% of the study nurses in the clin. dept. quit last year then you have a reason for paying closer attention to that. It sounds a little dumb but I think you should audit to the extent necessary, whether it be 1% or 99%. How to find out which percentage is right for you is a science in itself (risk analyses are popular at the moment; greedy course organisers will be happy to skin you alive). Best regards, EM. — Pass or fail! ElMaestro |
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Helmut ★★★ Vienna, Austria, 2011-01-20 15:13 (5223 d 00:04 ago) @ ElMaestro Posting: # 6455 Views: 25,086 |
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Dear ElMaestro & Swapnil! ❝ It sounds a little dumb but I think you should audit to the extent necessary, whether it be 1% or 99%. OK. ❝ How to find out which percentage is right for you is a science in itself (risk analyses are popular at the moment; greedy course organisers will be happy to skin you alive).  Well, Swapnil has asked for raw data audits. I think even more important is checking critical points, which cannot be corrected afterwards:
When it comes to data-transfer again it depends… When we switched from manual data-entry (CDSs ⇒ calibration ⇒ analytical results ⇒ biostatistical database) to electronic data flow within a LIMS we evaluated two studies in parallel during validation. We expected less than 1% of transfer errors (mainly transposed digits like 3657.45 instead of 3567.45) but were surprised to find ≈2%. Didn’t affect the studies’ outcome (maybe in the 6th decimal), but still interesting. Once the data-flow is validated, I think it's sufficient to check whether it was followed according to the SOPs (audit trail, hardcopies,  ).However, if data come from external sources I don’t get the point why the data-import (analytics, lab values ⇒ statistics) should not be checked 100%. Takes about one hour for an average study. I have seen strange things (mostly caused by the nightmare Excel). Data in some (!) cells were formatted as text instead of numbers. The import seemed to work, but set text values to missing (the nice ‘.’ in SAS). Bad luck if you checked only 20%. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Ohlbe ★★★ France, 2011-01-20 21:26 (5222 d 17:51 ago) @ Helmut Posting: # 6463 Views: 24,883 |
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Dear all, Several comments:
Regards Ohlbe — Regards Ohlbe |
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Helmut ★★★ Vienna, Austria, 2011-01-21 05:23 (5222 d 09:54 ago) @ Ohlbe Posting: # 6465 Views: 24,595 |
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Dear Ohlbe! 100% agree. I must confess that I probably never in depth comprehended the subtile difference between QC and QA. Thanks for the clarification! — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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swapnil.kuche ★ 2011-01-21 06:32 (5222 d 08:45 ago) @ Helmut Posting: # 6466 Views: 24,639 |
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Dear Helmut, Ohlbe & ElMaestro, Thanks for most comprehensive disscussion on my post. Through this disccusion i think you all elaborate ideal QA practices to be implemented. (As there is no such guidance is available for extend of QA audit). At the end I think it is important for any QA system to assure error free data with proper implementation of QMS system. Similarly this disscussion will clear difference between QA & QC responsibilities. Regards, Swapnil |
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ElMaestro ★★★ Denmark, 2011-01-21 14:39 (5222 d 00:37 ago) @ Helmut Posting: # 6472 Views: 24,914 |
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Dear all, ❝ 100% agree. I must confess that I probably never in depth comprehended the subtile difference between QC and QA. ...and why oh friggin why are the GLP docs so completely unclear regarding QC... EM. — Pass or fail! ElMaestro |
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Ohlbe ★★★ France, 2011-01-23 16:18 (5219 d 22:59 ago) @ ElMaestro Posting: # 6482 Views: 24,614 |
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Ahoy Captain ! ❝ ...and why oh friggin why are the GLP docs so completely unclear regarding QC... True ! GCP make a clear difference between QC (monitoring) and QA (auditing), but there is nothing about QC in GLP. Regards Ohlbe — Regards Ohlbe |
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ElMaestro ★★★ Denmark, 2011-01-25 14:15 (5218 d 01:02 ago) @ Ohlbe Posting: # 6488 Views: 24,519 |
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Ahoy Ohlbe, ❝ True ! GCP make a clear difference between QC (monitoring) and QA (auditing), but there is nothing about QC in GLP. <rant> And while we are at it: — Pass or fail! ElMaestro |
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joy_fm ☆ Indonesia, 2014-01-15 08:55 (4132 d 06:21 ago) @ Ohlbe Posting: # 12171 Views: 22,194 |
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Dear all, so what is the conclusion ? What's the difference between QA and QC in daily activities ? Because both of department (QC and QA) check the same raw data to ensure that report reflect the raw data. best regards Joy_fm |
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riteshsrmc ☆ India, 2014-01-16 13:55 (4131 d 01:22 ago) @ joy_fm Posting: # 12178 Views: 22,119 |
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Hi Joy. QC: Dependent (May be biased) QA: Independent: Unbiased (should not be biased) |
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Mahesh M ★ India, 2014-01-16 14:30 (4131 d 00:47 ago) @ riteshsrmc Posting: # 12179 Views: 22,127 |
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Dear Joy. QA is for ensuring quality in the processes. QA aims to prevent mistake/ error with a focus on the process/ Regulatory requirements/SOP. It is a proactive quality process. QC is for ensuring quality in raw data (study specific). Activities focus on identifying mistake/ error in the raw data. Regards mahesh M |
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ElMaestro ★★★ Denmark, 2014-01-16 14:35 (4131 d 00:42 ago) @ joy_fm Posting: # 12180 Views: 22,099 |
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Tricky, tricky with these definitions. My proposal: QA: Any activity related to assurance of quality: Training, SOP updates, QC, QMS maintenance and so on. QC: The specific act of ensuring four eyes and/or check on source documentation. Audit: The act of being an outright paranoid and unfair pain in the neck to someone who is in all likelihood completely innocent and doing a good job. EM. |
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joy_fm ☆ Indonesia, 2014-01-16 15:55 (4130 d 23:22 ago) @ ElMaestro Posting: # 12182 Views: 22,177 |
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Dear riteshsrmc, Mahesh M, ElMaestro thank you for the explanation. Very helpful  But, I'm still confused by this statement in a previous post from Ohlbe ❝ and of course checking the report against raw data, or consistency of the raw data… If QC has checked 100% raw data, why QA should check again? and how to ensure consistency of the raw data, if QA do random check only as an external auditor do? Because in OECD, only describes QA program and not about the QC Program Best regards Joy_fm Edit: Standard quotes restored, post linked. [Helmut] |
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Mahesh M ★ India, 2014-01-17 13:01 (4130 d 02:15 ago) @ joy_fm Posting: # 12185 Views: 22,114 |
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Hi Joy, "If QC has checked 100% raw data, why QA should check again?" Yes you are right because QA work as independent body means QA not repored to laboratory manager or analysist but QC reported to laboratory manager/ Scientest. In practical "QC department is healping hand of analyst or lab manager to detact error or mistake" Regards Mahesh M |
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joy_fm ☆ Indonesia, 2014-01-17 14:42 (4130 d 00:35 ago) @ Mahesh M Posting: # 12187 Views: 22,122 |
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Dear Mahesh M, Thank u, I absolutely agree with your opinion. Dear Helmutz, Can u explain about this statement ❝ However, if data come from external sources I don’t get the point why the data-import (analytics, lab values ⇒ statistics) should not be checked 100%. Takes about one hour for an average study. In my opinion, it will take at least two days to check 100% raw data. How to check 100% raw data in one hour ? What's your checking point ? Best regards Joy_fm Edit: Standard quotes restored, post linked. [Helmut] |
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Helmut ★★★ Vienna, Austria, 2014-01-17 15:16 (4130 d 00:01 ago) @ joy_fm Posting: # 12188 Views: 22,140 |
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Hi Joy, ❝ Dear Helmutz, Who? ❝ ❝ However, if data come from external sources I don’t get the point why the data-import (analytics, lab values ⇒ statistics) should not be checked 100%. Takes about one hour for an average study. ❝ ❝ In my opinion, it will take at least two days to check 100% raw data. How to check 100% raw data in one hour ? What's your checking point ? Let’s say you have 900 data values in two tables (from the analytical and biostatistical reports). Assuming an eight-hours working day (including a 30 minutes lunch-break) it would take you one minute to compare each data pair‽ I would say my four seconds are already rather slow. And if it really would take you two days, so what? PS: Please see this post. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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joy_fm ☆ Indonesia, 2014-01-20 08:38 (4127 d 06:39 ago) @ Helmut Posting: # 12198 Views: 22,044 |
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Dear Helmut, Thank u for the explanation. I'm sorry, because I wrote your name with "Z". Best regards Joy_fm |
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Ohlbe ★★★ France, 2014-01-17 16:27 (4129 d 22:50 ago) @ Mahesh M Posting: # 12189 Views: 22,248 |
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Dear Manesh, ❝ Yes you are right because QA work as independent body means QA not repored to laboratory manager or analysist but QC reported to laboratory manager/ Scientest. Sorry but I totally disagree with this statement. Actually I would put it the other way round:
("Inspection" in this case should be understood as QA audit, not regulatory inspection), as shown by § 2.2.c). — Regards Ohlbe |
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mittyri ★★ Russia, 2014-01-20 15:29 (4126 d 23:48 ago) @ Helmut Posting: # 12205 Views: 22,135 |
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Dear Helmut & All, According to the ICH E3 Guideline there could be an Appendix 16.1.10. "Documentation of inter-laboratory standardisation methods and quality assurance procedures if used" in the Clinical Study Report. In our BEQ reports we include in this chapter only the information about method preparation and validation & QA (if any). The information about QC series is usually included to the chapter PK evaluation of the main report. Could you explain your practice: have you used to include in this chapter QC data? — Kind regards, Mittyri |
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Helmut ★★★ Vienna, Austria, 2014-01-20 16:20 (4126 d 22:57 ago) @ mittyri Posting: # 12206 Views: 22,137 |
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Hi Miityri, ❝ Could you explain your practice: have you used to include in this chapter QC data? In my reports I use to give in this section certificates of the clinical laboratory (e.g., attendance in national interlaboratory comparison programmes, ISO 900x, accredited methods) covering parameters measured in pre-/post study exams. I never referred to the bioanalytical method used for PK there. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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mittyri ★★ Russia, 2014-01-22 19:44 (4124 d 19:33 ago) @ Helmut Posting: # 12229 Views: 22,104 |
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Dear Helmut, ❝ I never referred to the bioanalytical method used for PK there. Could you specify, where do you include method preparation and validation? In accordance with your consent I would broaden the question: BE studies are very specific, and typical Report structure (from E3) should be deeply modified. Sometimes keen discussions are conducted in our department about it. Many men, many minds... I cannot find any recommendations to the structure of BE Report. Please advise — Kind regards, Mittyri |
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Helmut ★★★ Vienna, Austria, 2014-01-22 21:53 (4124 d 17:23 ago) @ mittyri Posting: # 12231 Views: 22,155 |
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Hi Miityri, ❝ ❝ I never referred to the bioanalytical method used for PK there. ❝ Could you specify, where do you include method preparation and validation? I give both the analytical and statistical reports as parts of the appendix. These reports contain their respective protocols as appendices within. Haven’t seen any information about method development in the E3 report so far. ❝ In accordance with your consent I would broaden the question: ❝ BE studies are very specific, and typical Report structure (from E3) should be deeply modified. Absolutely. I hate to read reports, where you have headings on top of empty pages – or worse – “this page contains no text” printed across. Also brilliant: All of E3’s headings and some followed by “(not applicable)”… E3 is almost twenty years old and it was not written having BE in mind.❝ Sometimes keen discussions are conducted in our department about it. Many men, many minds... Don’t you have NLYW in the department? ❝ I cannot find any recommendations to the structure of BE Report. There are a few basic recommendations in national guidelines. They are all completely different but may inspire you. However, as a starter I recommend ICH’s Q&A on E3. Some quotes: For example, pharmacokinetic […] results could be placed in appropriately identified subsections of the efficacy and safety results sections, or they could be placed in new, appropriately identified results sections.
Be creative rather than formalistic. BTW, I don’t write anything about statistics under 16.1.9.  — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz