OBJECTIVE:
The purpose of this SOP to lay down the procedure for Analytical Report (AR) numbering.
SCOPE:
This SOP is applicable for the procedure for Analytical Report (AR) numbering in Quality Control Department at manufacturing facility.
RESPONSIBILITY:
Analyst / Section Head or his designee shall be responsible for follow the SOP.
The Head of Quality Department or his designee shall be responsible and implementation of the SOP.
PROCEDURE:
In-process materials:
For all in-process and intermediate products of bulk are entered date wise and serial number wise in the finished product register.
Raw materials:
AR numbering is COMPANY NAME/RM/YY/ABCD
Where,
COMPANY NAME :
RM : Raw material
YY : Year
ABCD : Serial number
Packing materials:
AR numbering is COMPANY NAME/PM /YY/ABCD
Where,
COMPANY NAME :
PM : Packing material
YY : Year
ABCD : Serial number
Finished product:
Tablets:
AR numbering is COMPANY NAME/TA/YYABCD
Where,
COMPANY NAME :
TA : Tablets
YYABCD : Year & Serial Number
Pellets :
AR numbering is COMPANY NAME/PE/YYABCD
Where,
COMPANY NAME :
PE : Pellets
YYABCD : Year & Serial Number
Hard Gelatin Capsules :
AR numbering is COMPANY NAME/HC/YYABCD
Where,
COMPANY NAME :
HC : Hard Gelatin Capsules
YYABCD : Year & Serial Number
Water analysis:
AR numbering is COMPANY NAME/PW/BW/RW-DD/MM/YYABCD
Where,
COMPANY NAME :
PW/BW/RW : Purified water and Potable water / Bore water / Raw water
DD : Date
MM : Month
YY : Year
ABCD : Serial No.
Rinse-Swab Cleaning Sample:
AR numbering is COMPANY NAME/SW/YY/ABCD
Where,
COMPANY NAME :
SW : Rinse/Swab Cleaning sample
YY : Year
ABCD : Serial number
Miscellaneous:
AR numbering is COMPANY NAME/MS /YY/ABCD
Where,
COMPANY NAME :
MS : Miscellaneous item
YY : Year
ABCD : Serial number
TRAINING:
As per Training SOP
DISTRIBUTION:
As per SOP Documentation Control
ANNEXURE:
Annexure – I : A.R Number register of Pellets
Annexure – II : A.R. Number register of Rinse/Swab Cleaning sample
Annexure – III : A.R. Number register of Miscellaneous items