SOP For Naming Procedure for Chromatographic Analysis

1. OBJECTIVE:

           The purpose of this Standard Operating Procedure (SOP) is to describe the  procedure for naming of method, program and sequences in chromatographic analysis. 

2. SCOPE:

            This SOP is applicable to chromatographic analysis performed on HPLC and GC.  

3. RESPONSIBILITY: 

1. Analyst or his designee shall be responsible for follow the SOP.
2. The Head of Quality Control Department or his designee shall be responsible and implementation of the SOP. 

4. PROCEDURE:

1. Naming of program file

1. Name the program file as follows :

F_XXX_T_ P

Where,

F         :      Prefix for program file for Finished product (Similarly “A” for API product   

               and “R” for Raw material)

XXX  : Abbreviated Item / Product Name (e.g. PARA for Paracetamol Tablets)

T : Abbreviated Test Name (e.g. RS for Related substance)

            P        : Suffix for program file.   e.g. F_PARA_RS_P

4. If multiple program files are required to be prepared for the same sequence, name the program file with the same name as above with the suffix changed to next i.e. P1, P2, P3 etc.

4. Name the program title as “Test name” (e.g: Assay).

4.2   Naming of Quantification (Method) file

4.2.1 Name the Quantificationfile as follows :

  F_XXX_T_Q 

Where,

F     :     Prefix for Quantification file for Finished product (Similarly

                “A” for API and “R” for Raw material)

   XXX  : Abbreviated Item / Product Name (e.g. PARA for PARACETAMOL)

   T   :  Abbreviated Test Name (e.g. RS for Related substance)

   Q      :  Suffix for Quantification file  

               e.g. F_PARA_RS_Q  

4. If multiple method files are required to be prepared for the same sequence, name   the method file with the same name as above with the suffix changed to next i.e. Q1, Q2, Q3 etc.

4. Name the Method file title as “Product name_Test name” 

           (e.g: Paracetamol_Tab_Assay)

4.3 Naming of pre-evaluation sequence:

4.3.1 Name  pre-evaluation sequence as follows :

XXX_T_D_A 

           Where,

                   XXX          :  Abbreviated Item / Product Name (e.g. PARA for PARACETAMOL)

                   T                :  Abbreviated Test Name (e.g. RS for Related substance, ASS for Assay)

                  Note : For method validation study it should be Abbreviated Test Name with Parameter (e.g. RS_SP for related substance test and specificity parameter).

                  D      : Date of analysis (e.g. 23 for 23.06.2016)

                  A     :      Suffix for Pre evaluation sequence.

           e.g PARA_RS_23_A

4.3.2 If any injections are to be repeated on the same day, append the existing sequence to perform the pre-evaluation.

              4.3.3    If the pre-evaluation is to be continued the next day for the same analysis append the sequence already created on the previous day.

4.4     Naming of sample sequence

4.4.1 Name the sample sequence as follows ;

          XXX_T_D_B 

Where,

XXX : Abbreviated Item / Product Name (e.g. PARA for PARACETAMOL)

T : Abbreviated Test Name (e.g. RS for Related substance)

Note : For method validation study it should be Abbreviated Test Name with parameter (e.g. RS_SP for related substance test and specificity parameter).

D  : Date of analysis (e.g. 24 for 24.05.2022)                        

B  : Suffix for sample sequence.

              e.g. PARA_RS_24_B

4.4.2        If the sequence is required to be repeated on the same day, create a new sequence  with the same name as above with the suffix changed to next i.e. B1,B2, B3 etc.

4.     For multiple sequence of the same product having a common PE and System  suitability sequence, name the sequence as above with the suffix changed to C,D, E, F etc.

Note : 

1. If the same product is to be analyzed, on the same day, on the same system, with entire new preparations, change the abbreviated product / item name in the PE sequence, System suitability sequence and sample sequence. Rest of the name of the sequences will be as per the above procedure.

1. Naming of Calibration sequence :

4.5.1    Name the calibration sequence as follows :

T_D_Ca

Where,

T   : Abbreviated Test Name (e.g. GRADIENT_TEST for gradient composition)

D  : Date of analysis (e.g. 29 for 29.05.2022)

                      Ca  :   Suffix for calibration sequence.

              e.g. GRADIENT_TEST_29_Ca

1. If the same sequence is to be repeated on the same day, create a new sequence with the same name as above with the suffix changed to next i.e. Ca1, Ca2, Ca3 etc  

4.6      Naming of maintenance sequences

4.6.1 For System flushing

           System flushing sequences to be named as Flushing Date

 e.g. Flushing_30. If any injections are to be repeated, append in the same sequence.

4.7       Naming the sequence title in the sequence file

            The sequence title to be named as Product name (e.g.: Paracetamol Capsules 500 mg)

5. TRAINING: 

Trainer : Head – Quality Control 

Trainees : Sectional Heads / Analyst / Officers

6. DISTRIBUTION: 

            Controlled Copy No.1 :  Head of Department – Quality Assurance

            Controlled Copy No.2 :  Head of Department – Quality Control

            Original Copy :  Head – Quality Assurance 

7. ANNEXURE:

Nil

8. REFERENCES: 

            In-house

9. REVISION HISTORY: 

Sr. No.	Revision No.	Change Control Number	Details of Revision	Reasons(s) for Revision
1	00	———–	New SOP	New SOP