1.0
PURPOSE:
To describe a standard operating procedure (SOP) for identification and tracing.
2.0
SCOPE:
The SOP describes in detail the method of identification and tracing of raw materials,
intermediates, recovered and purified materials, reagents and finished products
3.0
RESPONSIBILITY:
The responsibility of following the SOP and labeling as per the SOP lies with the
staff of the rank not lower than operator of the production department.
The responsibility of preparing, reviewing and approving the SOP lies with the Officer
(Production), Head of Production and Head of QAD respectively.
4.0
METHOD:
4.1
All the raw materials are identified by both product labels and status labels. The
product labels contain information such as product name, I.H.B. No. etc. while
status labels (quarantine/hold, passed/approved, rejected) contain informa tion such
as product name, batch No. etc. as applicable.
4.2
The raw materials used can be traced back as they are drawn against batch
numbers of intermediates or finished products.
4.3
The intermediates & finished products, which are isolated are also identified by
product labels and status labels just like raw materials.
4.4
The intermediates and finished products are given batch numbers according to
the following system.
INTERMEDIATES
PRODUCT
a)
b)
c)
d)
e)
BATCH No.
Salbutamol Sulphate/ Albuterol sulfate.
Terbutaline Sulphate
Labetalol Hydrochloride
Ciprofloxacin Hydrochloride
Sotalol Hydrochloride
SS X/YYY
TS X/YYY
LH X/YYY
CP X/YYY
SH X/YYY
Where 'X' stands for Stage number and YYY stands for batch number.
are integers and have values 1 .......9 and 0 ..... 9 respectively.
X and Y
FINISHED PRODUCTS
PRODUCT
a)
b)
c)
d)
e)
f)
g)
h)
i)
j)
k)
l)
m)
n)
o)
BATCH No.
Benzyl salbutamol
Benzyl albuterol
Salbutamol
Salbutamol sulphate
Albuterol
Albuterol sulfate
N-benzyl t-butyl amine
Terbutaline sulphate
Labetalol HCl
Ciprofloxacin HCl
Sotalol HCl
5-Acetyl salicylamide
Q-acid (Ciprofloxacin)
Ciprofloxacin base
4-Chloro acetyl methane sulfonanilide
BSIXXYYZZZ
BEIXXYYZZZ
SBIXXYYZZZ
SSIXXYYZZZ
ABIXXYYZZZ
ASIXXYYZZZ
BBIXXYYZZZ
TSIXXYYZZZ
LHIXXYYZZZ
CPIXXYYZZZ
SHIXXYYZZZ
AAIXXYYZZZ
CQIXXYYZZZ
CBIXXYYZZZ
SCIXXYYZZZ
For finished products 'I' stands for Unit-I, 'XX' stands for month, 'YY' for the year
and 'ZZZ' for the batch number and X, Y and Z are digits and have values 0 ......... 9.
4.5
The recovered solvents are given batch Nos. as detailed below:
a)
b)
c)
d)
e)
Salbutamol Sulphate
Terbutaline Sulphate
Labetalol Hydrochloride
Ciprofloxacin Hydrochloride
Sotalol Hydrochloride
:
:
:
:
:
SS X/RS/SOLVENT/abc
TSX/RS/SOLVENT/abc
LHX/RS/SOLVENT/abc
CPX/RS/SOLVENT/abc
SHX/RS/SOLVENT/abc
Where 'X' stands for the stage of the product and has values 1 .... 9. RS for
Recovered solvent. Solvent name will be given in place of solvent. a,b and c are
digits and have values 0 .....9 and stands for Batch number.
For purified solvents, the batch numbering system is same
solvents except that 'RS' is replaced 'PS'.
as that for recovered
For distilled mother liquors, the batch numbering system is same
recovered solvents except that 'RS' is replaced 'DM'.
4.6
as that for
The reagents prepared wherever necessary are given batch numbers as detailed
below.
Abbreviated form of the reagent/abc, where a,b and c are digits and have values 0
..... 9 and abc stands for batch number.
Different auxillary materials are given batch numbers as detailed below.
1.
2.
3.
4.
5.
6.
10 N sulfuric acid
Reagent Q solution
N-benzyl t-butyl amine
IMS-HCl.
Methanolic HCl.
Ammonia solution
... SL/abc
... RQ/abc
... BB/abc
... IH/abc
... MH/abc
... AH/abc
4.7
Unreacted reactants/reagents recovered by distillation and solids recovered by
further treatment are given the batch numbers as detailed below.
Rec-(reactant/reagent)/abc where Rec- stands for recovered, abc stands for batch
No. and have values 0 ....... 9.
The batch numbers for different recovered reagents are as shown below.
1. Tertiary butylamine
2. p-hydroxyacetophenone
3. Triethylamine
..... Rec-t-BA/abc.
..... Rec-p-HA/abc.
..... Rec-t-EA/abc.