To describe a standard operating procedure (SOP) for identification and tracing.
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
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PRODUCT |
BATCH No. |
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a) |
Salbutamol Sulphate/ Albuterol sulfate. |
SS X/YYY |
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b) |
Terbutaline Sulphate |
TS X/YYY |
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c) |
Labetalol Hydrochloride |
LH X/YYY |
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d) |
Ciprofloxacin Hydrochloride |
CP X/YYY |
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e) |
Sotalol Hydrochloride |
SH X/YYY |
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Where 'X' stands for Stage number and YYY stands for batch number. X and Y are integers and have values 1 .......9 and 0 ..... 9 respectively. |
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FINISHED PRODUCTS
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PRODUCT |
BATCH No. |
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a) |
Benzyl salbutamol |
BSIXXYYZZZ |
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b) |
Benzyl albuterol |
BEIXXYYZZZ |
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c) |
Salbutamol |
SBIXXYYZZZ |
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d) |
Salbutamol sulphate |
SSIXXYYZZZ |
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e) |
Albuterol |
ABIXXYYZZZ |
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f) |
Albuterol sulfate |
ASIXXYYZZZ |
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g) |
N-benzyl t-butyl amine |
BBIXXYYZZZ |
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h) |
Terbutaline sulphate |
TSIXXYYZZZ |
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i) |
Labetalol HCl |
LHIXXYYZZZ |
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j) |
Ciprofloxacin HCl |
CPIXXYYZZZ |
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k) |
Sotalol HCl |
SHIXXYYZZZ |
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l) |
5-Acetyl salicylamide |
AAIXXYYZZZ |
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m) |
Q-acid (Ciprofloxacin) |
CQIXXYYZZZ |
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n) |
Ciprofloxacin base |
CBIXXYYZZZ |
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o) |
4-Chloro acetyl methane sulfonanilide |
SCIXXYYZZZ |
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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. |
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4.5 |
The recovered solvents are given batch Nos. as detailed below: |
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a) |
Salbutamol Sulphate |
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SS X/RS/SOLVENT/abc |
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b) |
Terbutaline Sulphate |
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TSX/RS/SOLVENT/abc |
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c) |
Labetalol Hydrochloride |
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LHX/RS/SOLVENT/abc |
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d) |
Ciprofloxacin Hydrochloride |
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CPX/RS/SOLVENT/abc |
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e) |
Sotalol Hydrochloride |
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SHX/RS/SOLVENT/abc |
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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. |
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For purified solvents, the batch numbering system is same as that for recovered solvents except that 'RS' is replaced 'PS'. |
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For distilled mother liquors, the batch numbering system is same as that for recovered solvents except that 'RS' is replaced 'DM'. |
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4.6 |
The reagents prepared wherever necessary are given batch numbers as detailed below. |
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Abbreviated form of the reagent/abc, where a,b and c are digits and have values 0 ..... 9 and abc stands for batch number. |
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Different auxillary materials are given batch numbers as detailed below. |
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1. 10 N sulfuric acid ... SL/abc 2. Reagent Q solution ... RQ/abc 3. N-benzyl t-butyl amine ... BB/abc 4. IMS-HCl. ... IH/abc 5. Methanolic HCl. ... MH/abc 6. Ammonia solution ... AH/abc
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4.7 |
Unreacted reactants/reagents recovered by distillation and solids recovered by further treatment are given the batch numbers as detailed below. |
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Rec-(reactant/reagent)/abc where Rec- stands for recovered, abc stands for batch No. and have values 0 ....... 9. |
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The batch numbers for different recovered reagents are as shown below. |
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1. Tertiary butylamine ..... Rec-t-BA/abc. 2. p-hydroxyacetophenone ..... Rec-p-HA/abc. 3. Triethylamine ..... Rec-t-EA/abc. |
Production, identification, tracing
