SOP on Analytical Report (AR) Numbering

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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

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