NUMBERING SYSTEM FOR NON CONFORMANCES AND PROCESS DEVIATIONS

1.0 OBJECTIVE: To laid down a procedure for numbering system for Non conformance’s and process deviations forms.
2.0 SCOPE: This SOP is applicable to Formulations Units
3.0 RESPONSIBILITY: Executive-Production
4.0 ACCOUNTABILITY: Manager-Production
5.0 PROCEDURE :
5.1. Non-Conformance’s and Deviations will be initiated by concerned Production Executive / Officer as per SOP No.xxxxx.
5.1.2. A separate numbering system should be followed for Non-conformance’s and Process deviations.
5.2 PROCEDURE FOR ALLOTTING NUMBER FOR PROCESS DEVIATION
5.2.1. Deviation number consists of 8 characters.The 8 characters can be split up as follows Separate numbering system has to be given for Non-conformance’s and process deviation.
Eg: 34DTYXXX
34DCYXXX
34DPYXXX
5.2.2 The first two characters will always be 34

5.2.3 The third and fourth character will be allotted as per the following characterization
DT­­­------- Stands for deviation in tablets
DC------- Stands for deviation in capsules.
DP------- Stands for deviation in pellets
5.2.4 The fifth character’Y’ denotes the year of deviation as per the following representation
A------Year 2001
B------ Year 2002
C------ Year 2003
5.2.5 The sixth, seventh, eighth character denotes the sequential number allotted in series of deviations received under each category
5.2.6 A typical deviation number for tablets will be given as follows
Eg: 34DTA005
34 Stands for Formulations unit/Facility
DT Stands for deviation in tablets
A Stands for Year
005 Stands for sequential number
5.3 PROCEDURE FOR ALLOTTING NUMBER FOR NON CONFORMANCE’S
5.3.1 Deviation number consists of 8 characters. The 8 characters can be split up as follows.
Separate numbering system has to be given for Non-conformances and process deviation.
Eg: 34NTYXXX
34NCYXXX
34NPYXXX
5.3.2 The first two characters will always be 34
5.3.3 The third and fourth character will be allotted as per the following characterisation
NT­­­------- Stands for Non conformance in tablets
NC------- Stands for Non conformance in capsules.
NP------- Stands for Non conformance in pellets
5.3.4 The fifth character’Y’ denotes the year of deviation as per the following representation
A------Year 2001
B------ Year 2002
C------ Year 2003
5.3.5 The sixth,seventh,eighth character denotes the sequential number allotted in series of deviations received under each category
5.3.6 A typical deviation number for tablets will be given as follows
Eg: 34NTA005
34 Stands for Formulations unit/Facility
NT Stands for Non conformance in tablets
A Stands for Year
005 Stands for sequential number