SOP for Logic for Giving Number to the Method for Analysis of Finished Product and Raw Material : Pharmaceutical Guidelines

SOP for Logic for Giving Number to the Method for Analysis of Finished Product and Raw Material

Standard operating procedure to give the numbering to the Method of Analysis of Finished Products and Raw Materials.

1.0 OBJECTIVE

To clearly lay down the logic for giving the number to the method for analysis of finished product and raw material.

2.0 SCOPE

This procedure is applicable for of all method of analysis of raw material and finished products.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant
3.2 Checking: Executive/Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Logic for coding of MOA for the finished product

5.1.1 Follow seven digit coding system for MOA of the finished product.
5.1.2 First three digits represent initial letters of the product name.
5.1.3 Forth digit represents the pharmacopeia status of the product.
Pharmacopeia        Code
I.P.                               I
U.S.P.                       U
B.P.                           B
E.P.                           E
In-house                    H
5.1.4 Fifth digit of the code represent as Finished product .i.e F.
5.1.5 Sixth digit of the code represents a 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 the specification is not revised and method needs revision due to change in GTP or method of analysis, and then allot the method no with an alphabetical suffix from A after the method No. as mentioned in specification e.g 1225161/4A
5.2.4 For the identical test, refer to GTP.

5.2.5 First digit code is raw material.
5.2.6 Second and third place is for the therapeutic category.
5.2.7 Fourth place is for serial no. of raw material with respect to the category.
5.2.8 Fifth place is for the physical status of raw material e.g for solid –1 and for liquid -2
5.2.9 Sixth place indicate the pharmacopeia status of the raw material.
5.2.10 Seventh place indicates the type of material. 1-for active material and 2-for inactive material.

6.0 ABBREVIATIONS

6.1 U.S.P = United States Pharmacopoeia
6.2 I.P. = Indian pharmacopeia
6.3 B.P. = British pharmacopeia
6.4 E.P. = European Pharmacopeia
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.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


Click Here

No comments: Read Comment Policy ▼

Post a Comment


Follow Pharmaguideline



ADVERTISE HERE


GET APP FOR NEWS UPDATES

Scan to Download

Android App
Android App

Recent Posts