Escolar Documentos
Profissional Documentos
Cultura Documentos
Title
BATCHES
SOP No.
ARDXXX-00
Effective Date
1.0
Function
Research and
Development
Page No.
1 of 4
`OBJECTIVE
To lay down a procedure for establishing % yield for intermediate and Active
Pharmaceutical Ingredients (API) stages.
2.0
SCOPE
This procedure is applicable to all APIs and intermediates developed in IPD
(Integrated Product Development) of Dr.Reddys laboratories limited.
3.0
RESPONSIBILITY
3.1
R&D and PE are responsible for establishing the yield range for trial batches from
development batches & CPP batches data.
3.2
NPM and R&D and PE are responsible for establishing the yield ranges for Process
Validation (PV) and commercial batches.
4.0
DEFINITION(s)
Not applicable.
5.0
TO BE REVISED BEFORE
6.0
PROCEDURE
6.1
6.2
Output Weight
Molecular weight of input
------------------- X ------------------------------------ X 100
Input Weight
Molecular weight of output
R&D and PE shall finalise the % yield from lab and pilot plant batches after
completion of Optimization, what-if and spiking study experiments.
PREPARED BY
User Function
Name:
REVIEWED BY
Head - Function
Name:
APPROVED BY
Development Quality Assurance
Name:
Sign:
Sign:
Sign:
Date:
CDQ-F-001-00
Date:
Date:
Title
BATCHES
SOP No.
ARDXXX-00
Effective Date
6.3
Function
Research and
Development
Page No.
2 of 4
Minimum three batches as per final process, purging experimental data with specified
impurities and scale dependent what-ifs shall be considered for fixing the yield
range. Why purging & what-if are required?
6.3
S.No.
1.
2.
3.
4.
Experiment /
Batch No.
#001
#002
#003
#004
Input
(g/ Kg)
100.0 g
100.0 g
100.0 g
100.0 g
(%) Yield
Remarks
75.0
74.0
76.0
68.0
%Yield range for trial batch shall be fixed based on the T&V batch size also
considering the handling losses (high contribution of handling loss in lower batch
sizes) as per below table.
S.No.
% Yield Range
PREPARED BY
User Function
Name:
REVIEWED BY
Head - Function
Name:
APPROVED BY
Development Quality Assurance
Name:
Sign:
Sign:
Sign:
Date:
CDQ-F-001-00
Date:
Date:
Title
BATCHES
SOP No.
ARDXXX-00
Effective Date
1.
1-2 Kg
2.
2-5 Kg
3.
5-10 Kg
4.
>10 Kg
Note: Higher % Yield should be maximum 100.
Function
Research and
Development
Page No.
3 of 4
yield
25 %
70 25 %
20 %
70 20 %
15 %
70 15 %
10 %
70 10 %
What is the rationale for allowed variation & yield
range?
6.5
Actual yield obtained in trial batches shall be considered for establishing the yield
range for process validation batches.
6.6
Acceptable limit for % Yield for unit operations (Sieving, milling, micronisation,
blending etc.,) shall be established by NPM team based on previous products
historical data.
6.7
Based on actual yield obtained in process validation batches and 10-15 commercial
batches control limits, action and alert limits for % yield shall be established.
6.8
% Yield variations in validation and commercial batches which are beyond the
acceptance criteria shall be investigated in the below areas (but not limited to)
6.8.1
6.8.2
6.8.3
6.8.4
Hold up losses
6.8.5
Product loss in to the Filtered MLs during the filtration due to the solubility of
material in solvent/ Leakage of filtration bed.
PREPARED BY
User Function
Name:
REVIEWED BY
Head - Function
Name:
APPROVED BY
Development Quality Assurance
Name:
Sign:
Sign:
Sign:
Date:
CDQ-F-001-00
Date:
Date:
Title
BATCHES
SOP No.
ARDXXX-00
Effective Date
6.8.6
Function
Research and
Development
Page No.
4 of 4
Validation
Allowed % yield
Batch size
variation from lab
1-2 Kg
25%
2-5 Kg
20%
5-10 Kg
15%
>10 Kg
10%
7.0
REFERENCE(s) :
SOP No(*)
% Yield
Range
70 25 %
70 20 %
70 15 %
70 10 %
Title
ARD007
*Current Version
8.0
9.0
ABBREVIATION(s)
Abbreviation
AR&D
DQA
R&D
API
PE
ANNEXURE(s)
Full Description
Analytical Research and Development
Development Quality Assurance
Research and Development
Active pharmaceutical ingredient
Process Engineering
Not applicable.
10.0
FORMAT(s)
Details/Title of Format
Format No.*
PREPARED BY
User Function
Name:
REVIEWED BY
Head - Function
Name:
APPROVED BY
Development Quality Assurance
Name:
Sign:
Sign:
Sign:
Date:
CDQ-F-001-00
Date:
Date:
Title
BATCHES
SOP No.
ARDXXX-00
Effective Date
Function
Research and
Development
Page No.
5 of 4
NA
*Current Version
PREPARED BY
User Function
Name:
REVIEWED BY
Head - Function
Name:
APPROVED BY
Development Quality Assurance
Name:
Sign:
Sign:
Sign:
Date:
CDQ-F-001-00
Date:
Date: