Hi,
We have a USP method for a finished product in a facility which we would like to transfer to another facility, what tests would need to be foramlly transferred, is it just the Quantifiable tests or all tests, and what level of work would be required.
regards
Rob
[quote=RobPotts]Hi,
We have a USP method for a finished product in a facility which we would like to transfer to another facility, what tests would need to be foramlly transferred, is it just the Quantifiable tests or all tests, and what level of work would be required.
regards
Rob[/quote]
Dear Rob
For USP method or any pharmacopea method it is taken for granted that the method is validated, but in Finished product case Formulation may vary so instead of full validation some parameters like specificity and Precision repeatability should be done in method validation before implementation of method. Some organization do 3 lot results varification additionally. For APIs a USP method or any Pharmacopea method need not to be validated it can be transfered or recommended as a pharmacopea method.
hi,
for a method transfer to another facility you needs to cover all the test that you do for this method in your facility.
I have completed alot of method transfers at the site I work in, this is the receiving lab for transfers.
2 analysts on 2 different days from the receiving lab v’s 2 analysts on 2 different days in the sending lab, all the results from the test would have to pass the specs set from the sending lab and be in a ratio with eack other between 0.90-1.0.
Precision and accuracy needs to be complete.
you should transfer all testing from the sending lab that you aim to execute in the receiving lab.
ruth
Dear Ruth
All u described is about inhouse method. but here we are discussing about Phamacopeal method. What is your openion abou that???
[quote=Shahid Ali]Dear Ruth
All u described is about inhouse method. but here we are discussing about Phamacopeal method. What is your openion abou that???[/quote]
Dear Shahid
Any method ither Pharmacopeal or inhouse should be transfer
Dharmver
[quote=Dharmveer]Dear Shahid
Any method ither Pharmacopeal or inhouse should be transfer
Dharmver[/quote]
Dear Dharamveer
When i said not to transfer the method, Please read my post above. I have described how to transfer a Pharmacopeal method.
[quote=Shahid Ali]Dear Ruth
All u described is about inhouse method. but here we are discussing about Phamacopeal method. What is your openion abou that???[/quote]
Compendial and other standard methods should be verified to ensure suitability for their intended use. For example FDA’s 21 CFR Part 211 states: The suitability of all testing methods used shall be verified under actual conditions of use.
There are two guideline documents important to any method validation process : USP Chapter 1225: Validation of Compendial Methods; and the International Conference on Harmonization (ICH) Guideline: Validation of Analytical Procedures: Text and Methodology Q2 (R1). While the USP is the sole legal document in the eyes of the FDA, this article draws from both guidelines as appropriate for definitions and methodology.
Ruggedness is defined in the current USP guideline as the degree of reproducibility of test results obtained by the analysis of the same samples under a variety of conditions, such as different
* laboratories;
* analysts;
* instruments;
* reagent lots;
* elapsed assay times;
* assay temperatures; and
* days.
That is, it is a measure of the reproducibility of test results under the variation in conditions normally expected from laboratory to laboratory and from analyst to analyst. The use of the term ruggedness, however, is not used by the ICH, but is certainly addressed in guideline Q2 (R1) under intermediate precision (within-laboratory variations; different days, analysts, equipment, and so forth) and reproducibility (between-laboratory variations from collaborative studies applied to the standardization of the method). It is also falling out of favor with the USP, as evident in recently proposed revisions to chapter 1225, where references to ruggedness have been deleted to harmonize more closely with ICH, using the term “intermediate precision”
Dear Shahnawaz
Yes USP emphasize to MERELY verify the compendial method on actual condition of use, now does it mean by MERELY. Determining the appropriate parameters to establish the efficacy of compendial test methods can be confusing especially when performed using a particular lab’s analysts, instrumentation, and supplies. Moreover, the requirements for method verification are not well defined. The Current Good Manufacturing Practice (cGMP) regulations include a requirement to verify the suitability of testing methods under actual conditions of use, as listed in 21 CFR 211.194(a)(2). Although this is a long-standing part of the regulations, the meaning of this section is difficult to interpret. Like so many of the cGMP requirements, the expectations of the industry with regard to method verification have evolved over time. So simply it can be decide to have Ruggedness for method transferation then what is the use or benifit of the Compendial method.
USP recently proposed a new general information chapter, <1225> Verification of Compendial Procedures, to clarify guidelines for ensuring that a compendial method will give acceptable results. Although transfer protocols and method validation for finished products and active pharmaceutical ingredients are common in the contract laboratory setting, it is much less common to apply these same detailed principles to compendial methods on inactive ingredients or excipients. The proposed chapter recommends verification of tests that use liquid chromatography, gas chromatography, spectrophotometric, titrimetric, and thin-layer chromatography techniques. Verification is not required for USP general chapter tests, such as residue on ignition <281>, pH<791>, and heavy metals <231>. Microbiological procedures are also excluded from the proposal because they are covered in other USP chapters.
Method verification typically includes a subset of the parameters evaluated when a complete validation is performed. Precision, specificity, and detection limit are among the characteristics checked when verifying a compendial method. No matter what parameters are to be verified, the study should proceed according to an approved protocol that defines the characteristics to be evaluated and sets acceptance criteria to be used in judging the results of the study. Data from a method verification study should be summarized in a final report that will serve as documentation of the lab’s ability to achieve reliable results for a given test.
Hey guyz very nice discussion. But I want to know that how do we carry out the verification of USP method? What does verification actually means and what are the essential parameters that should be considered.
Moreover, do you have idea about system suitability test for UV photospectrophotometer?
For UV method how do I carry out the verification of the USP method in my lab?
Prawan Dahal
The biggest issue is around the formulation, and the degree of variance that your formulation dispalys to that of the pharmacopoeial formulation and the capability of the paharmacopoeial method to remain unaffected by the difference in formulations. If your formulation differs significantly from the pharmacopoeial one, you would need to prove that the method is not affected in any way by the difference, and that the API is able to be effectively extracted and analysed. Usually, this would mean that a fairly extensive method validation protocol would have to be executed, despite the fact that pharmacopoeial methods are already validated. I think this has been pretty well established from discussions above.
Back to the original post, if the product to be transferred to another facility within your group does not undergo a formulation change and is transferred using matching technology and analysed using the same method and test equipment you have already successfully validated you would not need the rigorous method validation exercise as usually required. You would merely have to prove equivalence. So basically you would do specificity, system suitability and intermediate precision (this takes care of repeatability and accuracy in any case).