Dear Rishabh,
Test procedures for assessment of the quality levels of pharmaceutical articles are subject to various requirements. According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the United States Pharmacopeia and the National Formulary constitute legal standards. The Current Good Manufacturing Practice regulations [21 CFR 211.194(a)] require that test methods, which are used for assessing compliance of pharmaceutical articles with established specifications, must meet proper standards of accuracy and reliability. Also, according to these regulations [21 CFR 211.194(a)(2)], users of analytical methods described in USP–NF are not required to validate the accuracy and reliability of these methods, but merely verify their suitability under actual conditions of use. Recognizing the legal status of USP and NF standards, it is essential, therefore, that proposals for adoption of new or .revised compendial analytical procedures be supported by sufficient laboratory data to document their validity
https://hmc.usp.org/sites/default/files/documents/HMC/GCs-Pdfs/c1225.pdf
Hoping this will be helpful,
Rafik
In my opinion, It is necessary to validate the analytical methods as per described in pharmacopoeias like USP, BP, EP, IP etc. Moreover, for equipment validation you also can run the standard on the instrument to validate (called as Equipment Validation).
If you using exactly the analytical method described in Pharmacopea, you do not have validate at all, because there this method has been validated from Pharmacopea itself.
So the answer is: no .
The method should be verified and not validated, because it is valid, the importance of verification comes from, the formula of the product you have may different from the point of view of formulation, manufacturing technology used to produce this medicine, rather than the standard product where the initial method designated for.
It's not necessary if you have the EXACT standards, equipment and procedures and if your country have that pharmacopoeia as legal (if you are making something commercial).
Partial validation is needed in case of pharmacopoeial methods. Not full validation.
Please refer to USP for more details on the criteria that need to be validated.
In my opinion it is not necessary to validate an analytical methodology that there is in pharmacopoeia, unless that adaptations to be made of the method.
You can refer to United States Pharmacopeia 32, : Verification of Compendial Methods.
As per 21CFR , Pharmacopoeial methods are verified under actual conditions of use.
In details,
Partial validation should be enough. out of 8 parameters of validation, 2 to 3 parameters are assessed on the method.
since our reagents and instruments and settings are nothing but actual conditions of use.
Regards,
Bujji Reddy Kanchi.
Dear Medhat Emad,
In case if you are following the method as writtern in the pharmacopoeia, Then you need not the validate the method. Only verification will suffice the need.
Verification will include
1. Method Precision (Including system precision)
2. Specificity
3. Recovery
4. Solution Stability.
Atleast you need to perform above parameters need to be performed. More you can do.
Regards,
Hitesh Inamdar
Verification, not full validation is required. For details, refer to USP verification of compendial methods.
Pharmacopeia methods used to test and release medicinal products should be verified prior to use. There is a EDQM guideline - Validation of Analytical Procedures PA/PH/OMCL (13) 82 2R, Feb 2.
For example, for Active substance - The analytical procedures described in a monograph of a pharmacopoiea are considered to be validated. In this case it should be made sure that all reference materials needed are available and the required system suitability tests are performed. Nevertheless, it should also be considered that a pharmacopoeial monograph is only considered validated (related substances test) when it is applicable to the control of the listed impurities (specific source material, see Ph Eur).
Identification: no formal validation required; Testing for Impurities: no formal validation required; Assay: no formal validation required.
Medicinal product - The pharmacopoeial monograph for a specific dosage form is a good basis for the analysis; however as in many cases there is no indication about the exact composition of the product (qualitative and quantitative composition of the excipients), it must at least be made sure that these do not interfere in the analysis of the active substance, unless addressed in the monograph. - Identification: no formal validation required; - Testing for Impurities: specificity: no interference from excipients; reporting threshold (at least the quant.limit) - Assay: specificity, accuracy: mainly recovery, minimum 1 determination., precision (repeatability): around the target test concentration (minimum 2 independent determinations) linearity at three measuring points in the range around the target value.