Sop for allocating Analytical Reference Number

This Document describes (Standard Operating procedure) Sop for allocating Analytical Reference Number (A.R. No.)

Sop for allocating Analytical Reference Number (A.R. No.)

I. Purpose & Scope:

• The purpose of this SOP is to lay down a procedure for giving Analytical Reference Number (A.R. No.) for Raw Material, Packaging Material, In-process samples, Finished Product, Validation Samples, Hold time study samples, Rinse water samples, Purified water, Potable water, Water for injection, Stability samples and Analytical Method Validation, Analytical Method Verification samples received for analysis in QC Laboratory

II. Responsibilities:

• All Quality Control personnel’s shall be responsible to follow and implement this SOP.

III : Introduction and Procedural Part :

1) ANALYTICAL REFERENCE NUMBERING SYSTEM FOR RAW MATERIALS/  PACKAGING MATERIALS/ FINISHED & INPROCESS PRODUCTS/STABILITY SAMPLES/ VALIDATION SAMPLES/HOLD TIME STDUTY:

• Analytical reference  numbers are unique, alphanumeric, having eleven   characters
• The first & second & Third character is an alphabet – CDR for Raw material, CDP for Packaging material, CDI for In process, CDF for Finished products. CDS for Stability samples / CDV for Validation, CDH for Hold time study samples, CDFT – For Finished product trial or registration sample, CDIT – In process trial sample.
• The fourth character is always a slash (/).
• The fifth and sixth character will be numeric indicating year in use 15 e.g. for 2015.
• The seventh character is always a slash (/).
• The eighth, ninth, tenth and eleventh characters shall  be  numeric  with  sequential number for RM, PM, IP ,PV,HT &  FP, starting  from  0001  to 9999.  In every calendar year the numbering shall start from 0001. The financial year consider 2015- from January.
• A typical example for Raw material shall be as follows

CDR/15/0001

Where,

CDR      –    For Raw Material sample receipt

15          –      Year (2015)

0001       –       First reference number of the year 2015

• A typical example for packing material shall be as follows.

CDP/15/0001

Where,

CDP      –     For packing material sample receipt

15          –      Year (2015)

0001       –       First reference number of the year 2015

• A typical example for in-process Sample shall be as follows.

CDI/15/001

Where,

CDI    –    For in-process sample receipt

15        –    Year (2015)

0001    –    First reference number of the year 2015

• A typical example for finished product shall be as follows.

CDF/15/0001

Where,

CDF    –    For finished product sample receipt

15        –    Year (2015)

0001   –    First reference number of the year 2015.

• A typical example for stability sample shall be as follows.

CDS/15/0001

Where,

CDS    –    For stability sample receipt

15        –    Year (2015)

0001   –    First reference number of the year 2015.

2) ANALYTICAL REFERENCE NUMBERING SYSTEM FOR RINSE WATER :

• Analytical reference numbers are unique, alphanumeric, having twelve characters.
• The first, second, Third and fourth character is an alphabet-CDRI for Rinse water sample.
• The Fifth character is always a slash (/).
• The sixth and seven character will be numeric indicating year in use 15 e.g. for 2015
• The eight characters is always a slash (/).
• The ninth, tenth eleventh and twelfths character shall be numeric with sequential number starting from 0001 to 9999.In every calendar year the numbering shall start from 0001.The financial year consider 2015-from January.
• A typical example for Rinse water sample shall be as follows

CDRI/15/0001

CDRI    –    Rinse water analysis

15        –    Year (2015)

0001   –    First reference number of the year 2015

3) ANALYTICAL REFERENCE NUMBERING SYSTEM FOR RETESTING OF RAW MATERIALS AND  PACKAGING MATERIALS:

• Analytical reference numbers are unique, alphanumeric, having thirteenth characters.
• The first & second & Third character is an alphabet – CDR for Raw material, CDP for Packaging material.
• The fourth character is always a slash (/).
• The fifth and sixth character will be numeric indicating year in use 15 e.g. for 2015.
• The seventh character is always a slash (/).
• The eighth, ninth, tenth and eleventh characters shall be numeric  with  sequential number for RM, PM, IP & FP, starting  from  0001  to 9999.  In every calendar year the numbering shall start from 0001. The financial year consider 2015- from January.
• Twelfth character is R for Retest.
• Thirteenth character is N (Like 1,2,3,4…. and so on)
• A typical example for Raw Materials ‘in case of first retesting shall be as follows.

CDR/15/0001R1, 2,3.

CDR – Raw Materials analysis

15 – Year (2015)

0001 – First reference number of the year 2015

R – Retesting

1  –  First Retesting

2 – Second retesting

3 – Third retesting.

IV) ANALYTICAL REFERENCE NUMBERING SYSTEM FOR POTABLE WATER AND PURIFIED WATER:

• Analytical reference number shall have ten characters.
• The first and second characters shall always be RW for Potable water and PW for Purified Water.
• The third character shall be slash (/).
• The fourth & fifth character is an  indicating year in use e.g. 15  for 2015
• The sixth character shall be slash (/).
• The seventh, eighth, ninth & tenth characters shall be sequential number starting from 0001 to 9999 in every calendar year, form Jan to Dec. the numbering shall be start from 0001
• A typical example for Potable water of Block I and block II shall be as follows :

RW/15/0001

RW    –    Potable Water

15        –    Year (2015)

0001 –    First reference number of the year 2015

• A typical example for Purified water of General block shall be as follows :

PW/15/0001

PW    –    Purified Water

15        –    Year (2015)

0001 –    First reference number of the year 2015

V) ANALYTICAL REFERENCE NUMBERING SYSTEM FOR MISCELLANEOUS SAMPLES :

• Analytical reference number shall have tenth characters.
• The first two characters shall be either PS for Pre-shipment Samples (for Vendor Qualification) or PL for Contract Manufacturing.
• The third & fourth character is an indicating year in use e.g. 15  for 2015
• The fifth & sixth characters is as indicating month of Analysis
• The seventh character shall be slash (/).
• The eighth, ninth & tenth. Characters shall   be   sequential number starting from 001 to 999 in every calendar year, form Jan to Dec. the numbering shall start at every year from Jan 01 as 001.
• A typical example for Pre shipment Sample shall be as follows :

PS/1501/001

PS       –    Pre shipment Sample

15        –    Year (2015)

01        –    Month

001      –    First reference number of the year 2015

VI) ANALYTICAL REFERENCE NUMBERING SYSTEM FOR ANALYTICAL METHOD VALIDATION/VERIFICATION:

• • Analytical reference number shall have tenth/eleven characters.
  • The first two characters shall be MVE for (Analytical Method Verification) And MV For (Analytical Method Validation)
  • The third/Forth character shall be slash (/).
  • Fifth,sixth,seventh,eighth  character is an  indicating year in use e.g. 2015
  • The ninth characters shall be slash (/).
  • The tenth Characters shall be   sequential number starting from 01 to 99 in every calendar year, form Jan to Dec. the numbering shall start at every year from Jan 01 as 01.
  • A typical example for Analytical Method Validation as follows :

MV/2015/01

MV     – Method Validation

2015    –    Year (2015)

01      –    First reference number of the year 2015

• A typical example for Analytical Method Verification as follows :

MVE/2015/01

MVE     – Method Verification

2015    –    Year (2015)

01      –    First reference number of the year 2015

• ANNEXURE:

Annexure I : Hold Time Study sample inward register

 

ANNEXURE -I

HOLD TIME STUDY SAMPLE INWARD REGISTER 

 

Sr.No.	TRF No.	TRF. Received Date	A.R.No.	Name of  Product	Batch No.	Mfg. Date	Exp. Date	Stage	Reviewed By