.
1.0 OBJECTIVE:
To lay
down the procedure for collection, storage and analysis of stability samples of
finished products.
2.0 SCOPE:
This SOP
shall be applicable to Quality Control Dept.
3.0 RESPONSIBILITY:
Supervisor
Quality Control
4.0 ACCOUNTABILITY:
Sr.
Manager Quality Assurance
5.0 PROCEDURE:
5.1 The
responsibility for collection, storage and analysis of stability samples and
recommendations (if any) shall be followed as per flow chart.
5.2 Collection of Sample:
5.2.1 For each
new product collection of sample shall be done for first three consecutive batches for Stability study under Accelerated temperature and humidity
conditions.
5.2.2 For all
products at least one batch per year shall be kept under Long-term stability
study.
5.2.3 Quality
Assurance Supervisor shall collect the sample as per instructions from Manager
Quality Assurance as per stability study schedule
5.3 Sample Size:
5.3.1 Samples
shall be collected as intact-marketed pack. The quantity of sample collected
shall be in sufficient number depending upon the product and its stability
indicating tests.
5.4 Storage of Sample:
5.4.1 Samples shall be kept at Controlled temperature (25 + 2 0C) and Relative humidity (60 ± 5%) conditions for Long-term stability study.
5.4.2 Samples
shall be kept at temperature (40 + 20C) and Relative humidity
(75 + 5%) for Accelerated stability study.
Related: Mean Kinetic Temperature (MKT) in Stability Studies
Related: Mean Kinetic Temperature (MKT) in Stability Studies
5.5 Testing Parameter and Periodicity of Analysis:
5.5.1 Testing
parameters for different products shall be as per the Stability program.
5.5.2 The
initial analysis data shall be taken from Certificate of analysis of the
respective product and batch, provided the Date-in (To) of stability
study sample is within the period of one month from the date of release of the
batch. In case the period is more than one month the initial analysis shall be
carried out once again at the time of “Date-in”.
5.5.3 If the
stability assay method is different from the product release assay method, then
initial analysis shall be performed as To as per stability assay method.
5.5.4 Additional
stability indicating tests (other than product release specification) if
any, as per stability program, shall be performed at the time of “Date-in” (To).
5.5.5 Periodicity
of analysis for stability samples shall be as follow:
a) Accelerated
stability conditions (450C ±20C/75%±5%) = 0,1,2,3 and 6 months.
b) Long term
Stability Conditions (250C±20C/60%±5%) = 0,3,6,9,12,18,24
36,48,60 months.
c) Long term stability study shall be carried out upto
the expiry period of the product.
5.5.6 Long-term
stability analysis shall be performed within ±7 working days of the due date.
Accelerated stability samples shall be analyzed within ± 5 working days of the
due date.
5.5.7 The
sample for stability studies shall be taken within one month from the date of
approval of the batch. An annual schedule of the batches to be studied for
stability and the date of analysis shall be made every December for the
following year.
5.5.8 Entry in
stability register shall be made accordingly.
Related: Guidelines for Pharmaceutical Stability Study
Related: Guidelines for Pharmaceutical Stability Study
5.6 Evaluation of Stability Data:
5.6.1 Evaluation
of stability data shall be made once in a year. Based on evaluation of data,
recommendations if any shall be made by Sr. Manager Quality Assurance.
5.6.2 During
stability study any adverse change in physical parameters, pH, failure in
assay, content uniformity, dissolution rate shall be brought to the attention
of Sr. Manager Quality Assurance, GM-Technical Operation, GM-Technical Services
and GM-R&D. Investigation shall be done on the affected batch along with
all the batches produced at the same time. Investigation shall be extended to
all ingredients used, manufacturing process, process parameters followed and
analysis at different stages.
5.6.3 Decision
on recalling the affected batches and /or along with other batches produced
during the same time shall be taken by GM-Technical Services in consultation
with Chairman & Managing Director & Vice Chairman.
6.0 ABBREVIATIONS:
6.1 SOP : Standard operating procedure
6.2 QA : Quality assurance
6.3 QC : Quality control
6.4 Dept. : Department
stability study different opinions on analysis of samples like ranging +/- 5 to 14 days. could u please suggest any guideline support for analysis of stability samples a/f due date
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