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vish14184 ★ India, 2008-11-15 10:35 (6025 d 04:49 ago) Posting: # 2673 Views: 21,684 |
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Dear All, I would like to know that in BA/BE studies, 1. Shall we train QA auditor only for QA SOP is enough? or Shall we train all SOPs (Other Department SOPs) before audit? 2. Is there need to document protocol training of QA Auditor? IF yes, where we document protocol training? Regards Vishal Nakrani |
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Ohlbe ★★★ France, 2008-11-15 14:16 (6025 d 01:08 ago) @ vish14184 Posting: # 2676 Views: 20,075 |
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Dear Vishal, For the clinical part of the trial and for the PK and stats analyses, according to the ICH GCP guideline, §5.19.1: The purpose of a sponsor's audit, which is independent of and separate from routine monitoring or quality control functions, should be to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements. For the bioanalytical part of the trial, according to the OECD principles of GLP, §2.2.1.c, responsibilities of QA personnel: conduct inspections to determine if all studies are conducted in accordance with these Principles of Good Laboratory Practice. Inspections should also determine that study plans and Standard Operating Procedures have been made available to study personnel and are being followed. QA personnel may not need the same level of "SOP training" that the personnel who will use them, but obviously they have to know what's inside. Same for the protocol, at least if there are specific requirements compared to the standard protocol you use. Regards Ohlbe |
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chidambarajoshi ★ Hyderabad-INDIA, 2008-11-17 12:08 (6023 d 03:16 ago) @ Ohlbe Posting: # 2684 Views: 20,034 |
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❝ QA personnel may not need the same level of "SOP training" that the ❝ personnel who will use them, but obviously they have to know what's ❝ inside. Same for the protocol, at least if there are specific requirements ❝ compared to the standard protocol you use. I do admit to Ohlbe. But it will be QA's responsibility to answer to for either sponsor or regulatory query. For this at least the QA person should have knowledge of all SOPs (Clinical/Bioanalytical/Stat). As for as protocol is concerned if QA a part of protocol reviewing team training can be skipped. Regards Joshi -- Edit: Follow-up post removed (you may edit your own post within 24 hours). [Helmut] — Best Regards Joshi |
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vish14184 ★ India, 2008-11-18 10:12 (6022 d 05:12 ago) @ chidambarajoshi Posting: # 2703 Views: 19,963 |
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Dear Joshi sir, QA is a part of protocol review process but person audit the study has not review the protocol in that case we need to document protocol training of QA Auditor. Regards Vishal nakrani |
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mbshankar ☆ 2008-11-18 12:31 (6022 d 02:53 ago) @ vish14184 Posting: # 2712 Views: 20,019 |
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Dear Vishal Nakrani, This is shankar sir of ARCP. Now working as Manager QA for a CRO that is involved in BE. The protocol training must be given and documented so that the auditor knows what to look for and as u said, all of those who audit are do not review protocol. However during the study if you depute QA personnel for overall monitoring (critical areas) of the conduct of study the protocol specific activities can been monitored for right conduct. I too was under impression that there may be need for training in all SOPs, but the coplience to SOPs can be verified by refering the SOPs present at the site of operation. When designated auditor visits the facility for internal audit he/she can go through the SOPs before conducting the audit. -- Edit: Full quote removed. Please see this post! [Jaime] |
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chidambarajoshi ★ Hyderabad-INDIA, 2008-11-18 13:00 (6022 d 02:24 ago) @ mbshankar Posting: # 2714 Views: 19,917 |
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Dear Vishal and Shankar, This also requires the QA person should have minimum knowledge of SOPs or procedures adopted and practiced at the CRO. This may not only be in conduct of study if the same QA person is reviewing Bioanalytical data..? Then he/she should have sufficient sound knowledge of SOPs at Bionalytical. That's why QA should sound in all SOPs Regards Joshi — Best Regards Joshi |
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mbshankar ☆ 2008-11-18 13:43 (6022 d 01:41 ago) @ chidambarajoshi Posting: # 2715 Views: 19,956 |
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Dear Chidambarjoshi, I thought of Bioanalytical aspect after i posted my earlier message. The QA can have special trainning for reviewing bioanalytical work for its staff. Where the only necessary SOPs can be included and this is different to general SOP training which is needed for the user. Thanks for your message Regards Shankar -- Edit: Full quote removed. Please see this post! [Helmut] |
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chiragkhatri ★ India, 2008-11-19 06:56 (6021 d 08:28 ago) @ mbshankar Posting: # 2725 Views: 19,973 |
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Dear all, This seems to be an interesting discussion. However at our end we do ensure that all QA auditors undergo training of all SOPs of their respective areas of audit.Also it becomes difficult to remember the requirements of all SOPs so at the time of audit it can be again referred. During the training session itself QA can raise the objection on certain procedures included or revised or clarify the doubts. This will avoid QA raising objection only when he goes for audit and finds things not proper or not acceptable. In my opinion QA auditors should undergo training of all SOPs which also should be well documented. Regards Chirag Khatri -- Edit: Full quote removed. Please see this post! [Helmut] |
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chidambarajoshi ★ Hyderabad-INDIA, 2008-11-19 08:28 (6021 d 06:56 ago) @ chiragkhatri Posting: # 2727 Views: 19,905 |
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Dear Chirag, ❝ During the training session itself QA can raise the objection on certain procedures included or revised or clarify the doubts. This type situation won't occur when QA has a procedue called Document Control where we can have document change request and QA will review the prposed change in procedure / introduction of new procedure and may give it's inputs Regards Joshi — Best Regards Joshi |
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mbshankar ☆ 2008-11-19 11:43 (6021 d 03:41 ago) @ chidambarajoshi Posting: # 2731 Views: 19,923 |
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Dear Chirag, Yes the discussion is interesting and important too... since its not technical or instrument related. I wish to have discussion on individual activity of QA in a BE work. Training QA staff on all SOPs appears logical and its practical if the firm has a large team and auditing activity is well defined for individual personnel in advance delegated. But i wish to say one thing regarding change control that MR. Chidambarajoshi mentioned, not all staff review SOPs. I think if the senior staff in QA can train the new auditors in activities and ensure that they know what to look for. That should take care of it. I repeat....auditor is not same as user but then auditor should know the activity and audit it with lot of receptivity. Regards -- Edit: Full quote removed. Please see this post! [Helmut] |
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chidambarajoshi ★ Hyderabad-INDIA, 2008-11-19 12:45 (6021 d 02:39 ago) @ mbshankar Posting: # 2734 Views: 19,790 |
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Dear All ❝ I think if the senior staff in QA can train the new auditors in activities and ensure that they know what to look for. That should take care of it. Yes I do agree with this  Joshi — Best Regards Joshi |
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chidambarajoshi ★ Hyderabad-INDIA, 2008-11-19 12:47 (6021 d 02:37 ago) @ mbshankar Posting: # 2735 Views: 19,801 |
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Dear Shankar, ❝ I wish to have discussion on individual activity of QA in a BE work. I appreciate this and we shall continue to discuss activity/ies of QA in this forum Regards  Joshi — Best Regards Joshi |
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mbshankar ☆ 2008-11-20 07:46 (6020 d 07:38 ago) @ chidambarajoshi Posting: # 2743 Views: 19,881 |
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Dear Joshi, I too was looking forward for such forum where we can discuss all activities. I thank you for your promting on this issue. I wish to discuss two issues. 1. Trainig of staff at a facility (clinical and bioanalytical) 2. The activity of QA in the bioanalytical area (this is tricky bec we are cannot claim to be GLP copliant. Daily i wish to put one aspect on each Issue so let me start today...(later we will take up auditing various activites follwoed by Validation issues in IT) 1. Training: Given the situation that the field is not too old its difficult to get trained staff and also the management cant approve the training expenditures. And the sponsors insist on trained staff and the confidentiality issues make it dificult for you to go and have a look at other established CROs for systems. SO i think we have to evolve day by day into a good system. 2. QA- in Bio analytical (BA) work.: My question is What are the crucial areas of BA activites that can be audited online to ensure quality of data produced? Regards and thanks again for initiating the discussion. -- Edit: Full quote removed (like in all your previous posts)! Please see this post! [Helmut] |
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vish14184 ★ India, 2008-11-20 10:37 (6020 d 04:47 ago) @ mbshankar Posting: # 2746 Views: 19,897 |
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Dear Sankar sir, Nice to meet u again.I am ur student from ARCP (from Nadiyad). I am also working in QA department (BA/BE study). QA role in Bio Analytical
Regards Vishal Nakrani |
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chidambarajoshi ★ Hyderabad-INDIA, 2008-11-21 06:43 (6019 d 08:41 ago) @ mbshankar Posting: # 2757 Views: 19,836 |
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Dear Shankar, ❝ we have to evolve day by day into a good system. Yes..! Training of not only QA but also clinical and Bioanaytical is QA's resposibility. This requires ofcourse management's support. Or else also we can pick the technically sound guys and arrange for in-house training According ISO a person working in the organization should undergo atlease 3 days/72 hrs of training in an year ❝ What are the crucial areas of BA activites that can be audited online to ensure quality of data produced? It starts with
Regards Joshi — Best Regards Joshi |
)and QA can have it's own user ID and passwords to look into audit trail of the data|
mbshankar ☆ 2008-11-22 06:09 (6018 d 09:15 ago) @ chidambarajoshi Posting: # 2771 Views: 19,848 |
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Dear Joshi, Thanks for the elaborated response. Repeat analysis is of course a hot topic and attracts curiosity and we will take it up soon. Some labs want their MV protocols and method SOPs to be reviewed by QA to the extent that they wanted QA to sign it on the signature page and that does not appear to be right to me. They also want it to be done before they start using them. The GLP required QA to be very independent and QA should always be. Since they are drafted based on SOPs which are in line with GLP principles and FDA guidance to industry on MV and the operational staff of course should not be deviating, this looks to be as too much involment in the work. QA statement should suffice bec as per GLP we will give the details of what is audited and when. Regarding training of all staff: QA i think shall ensure that the staff are trained in their areas where as the department head is responsible to abide by this dictum. And verify the training records or personnel while doing the documentation review for both clinical and bioanalytical work. -- Edit: Full quote removed - like in all your previous posts! Please see this post! [Helmut] |
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chidambarajoshi ★ Hyderabad-INDIA, 2008-11-24 12:22 (6016 d 03:01 ago) @ mbshankar Posting: # 2781 Views: 19,656 |
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Dear Shankar ❝ The GLP required QA to be very independent and QA should always be. IMHO irrestive of GLP / Non GLP QA is independent. ❝ Regarding training of all staff: QA i think shall ensure that the staff are trained in their areas where as the department head is responsible to abide by this dictum. And verify the training records or personnel while doing the documentation review for both clinical and bioanalytical work. Yes! One more thing QA needs to look in to the Incurred sample analysis. Regards, joshi — Best Regards Joshi |
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mbshankar ☆ 2008-11-24 13:22 (6016 d 02:02 ago) @ chidambarajoshi Posting: # 2782 Views: 19,860 |
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Dear Joshi, I could not find in guidelines the criterial for selecting LLOQ. Some articles mention it to by 1/100 to 1/32 of the Cmax and some authors used that too. And industry practice seems to be 5%-10 % or Cmax. And regarding QA I found that persons from GMP back grownd (staff or sponsors) tend to involve QA more into the activites. One can feel it while facing sponsor and third party audits. Your comments please Regards -- Edit: Full quote removed. Please see this post! [Ohlbe] |
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Ohlbe ★★★ France, 2008-11-24 13:41 (6016 d 01:43 ago) @ mbshankar Posting: # 2784 Views: 19,906 |
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Dear mbshankar, Please read this post! The three moderators on this forum (Helmut, Jaime and myself) had to edit each and every of your responses. Also read the Forum policy and instructions. Quoting part of the message you are answering can be helpful to understand your response, particularly if you want to refer to a specific question, or if you are answering several questions successively. But letting the full message reduces the readability of your response and increases the weight of the messages on Helmut's server. Regards Ohlbe |
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chidambarajoshi ★ Hyderabad-INDIA, 2008-11-24 13:49 (6016 d 01:35 ago) @ mbshankar Posting: # 2786 Views: 19,694 |
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Dear shankar ❝ I could not find in guidelines the criterial for selecting LLOQ. Yes..! 1/20 of Cmax is usually followed ❝ I found that persons from GMP back grownd (staff or sponsors) tend to involve QA more into the activites. One can feel it while facing sponsor and third party audits. Your comments please Yes..! This is what I mean in my previous answer. At the time of audit Sponsor/third party though respective departmental Group leaders respond for queries it's ultimately responsibility of QA whole. So though we are QA we shall not limit ourselves to QA only. Involve in every activity (Can be off Training SOP) then QA will be the master and dependable. For ex: If QA is reviewing the calibration document of LC-MS/MS it's not possible to understand without the basic knowledge of LC-MS/MS. So train the QA guys to the core to handle all the situations Regards, Joshi  — Best Regards Joshi |
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Helmut ★★★   Vienna, Austria, 2008-11-24 13:54 (6016 d 01:30 ago) @ mbshankar Posting: # 2787 Views: 20,178 |
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Dear Shankar, please read Ohlbe's post first! Since you have agreed to comply with the Forum's policy during registration, I will block your account if you fail to do so. ❝ I could not find in guidelines the criterial for selecting LLOQ. Did you search the Guideline collection? In many guidelines it's mentioned that AUCT/AUCinf >80% AUCinf. With knowledge of the pharmacokinetics of the drug and it's variability it's up to you to come up with a suitable working range for the method (both ULOQ and LLOQ). ❝ Some articles mention it to by 1/100 to 1/32 of the Cmax and some authors used that too. Stupid enough. ❝ And industry practice seems to be 5%-10 % or Cmax. ACK, but stupid as well. — 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 |
Ing. Helmut Schütz