1.0 OBJECTIVETo clearly lay down the logic for giving number to the method for analysis of finished product and raw material.
2.0 SCOPEThis procedure is applicable for of all method of analysis of raw material and finished products.
3.1 Doing : Technical Assistant
3.2 Checking : Executive/Manager
Head of the Department
5.1 Logic for coding of MOA for finished product
5.1.1 Follow seven digit coding system for MOA of finished product.
5.1.2 First three digits represent initial letters of product name.
5.1.3 Forth digit represents the pharmacopeia status of the product.
5.1.4 Fifth digit of the code represent as Finished product .i.e F .
5.1.5 Sixth digit of the code represent different strength of particular product in alphabetical order i.e A,B,C.
5.1.6 Assign addition no. of method .i.e M1 in sequential as required.
5.1.7 Seventh digit of the code is different types of the test.
5.1.8 e.g. Final code for Assay method of XYZ 150 Tab.(USP) will be XYZUFA01.
5.1.9 Assign version no. and effective date for each method.
5.2 Logic for coding of MOA for Raw material
5.2.1 Follow the seven digit code system for MOA of Raw material.
5.2.2 Mention the current specification no. of raw material along with edition no. for giving code No of MOA i.e if current specification no. of ABC is 1225161/4 its method of analysis no. will be 1225161/4
5.2.3 In case of specification is not revised and method needs revision due to change in GTP or method of analysis, and then allot the method no with alphabetical suffix from A after the method No. as mentioned in specification e.g 1225161/4A
5.2.4 For identical test, refer GTP.
5.2.5 First digit code is raw material.
5.2.6 Second and third place is for therapeutic category.
5.2.7 Fourth place is for serial no. of raw material with respect to category.
5.2.8 Fifth place is for physical status of raw material e.g for solid –1 and for liquid -2
5.2.9 Sixth place indicate the pharmacopeia status of raw material.
5.2.10 Seventh place indicates type of material. 1-for active material and 2-for inactive material.
6.1 U.S.P =
6.2 I.P. = Indian pharmacopoeia
6.3 B.P. = British pharmacopoeia
6.4 E.P. = European pharmacopoeia
6.5 GTP = General test procedure
6.6 SOP = Standard operating procedure
6.7 No. = Number
6.8 MOA = Method of Analysis
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question
Spread the Knowledge ⇩⇩⇩