1.0 OBJECTIVE
To lay
down the procedure for Controlled Stability.
2.0
SCOPE
This
SOP shall be applicable for controlled stability in
Chemistry Lab.
3.0
RESPONSIBILITY
3.1
Sr. Chemist and above shall be responsible for
the preparation and execution of this SOP
3.2
Manager QC & Manager QA shall be responsible for the checking and approval of this
SOP.
4.0
ACCOUNTABILITY
Manager QC
5.0
PROCEDURE
5.1
There are two types of Stability test
program:
5.2
Stability test carried out on Commercial
products within the framework of a routine program.
5.3 Further stability test or additional
stability test whenever there is a change in the manufacturing process,
composition source of input material or packing material which may affect the
stability forecast of the products.
5.4 Purpose of Stability: To verify the
assigned shelf- life (comparison of the shelf on currently produced batches
with the one laid down).
5.5 To generate the data for updating the
stability reports (i.e., extension or
reduction of shelf-life) shall collect stability samples from first (or
three) batch(s) of every academic year; these samples shall be drawn in small LDPE
polybags (sampling cover) with seaming draw 6 samples; 50gr. per pouch.
5.6 Entry of B.No’s of the sample is done in
the register; note-down the number of samples drawn., Date & time of
collection and collected by, all the particulars must be clear for the
stability studies.
5.7 Enter the stability readings of the
concerned batch after every completion of the analytical process.
5.8 Produce the entire data of the concerned
batch once annually.
5.9 Relative humidity & temperature of
the room shall be monitored and recorded by QC- chemist.
5.10 The Analytical data shall be frequently
generated by a QC-chemist and submitted to QC- in charge.
5.11 Some extremist samples shall be studied
at accelerated conditions; rest all can be studied at normal /slow rate
conditions.
5.12 Storage condition:
|
Study |
Storage condition |
The minimum time period covered by data at submission |
|
Long term (0, 3, 6, 9, 12 months
& follow test frequency) |
25
oC +/- 2 oC / 60 % RH +/- 5% RH. Or 30
oC +/- 2 oC / 65% RH +/- 5% RH. |
12 months
|
|
Accelerated (0, 3 & 6 months) |
40
oC +/- 2 oC / 75% RH +/- 5% RH |
06 months |
5.13 Test frequency: For long-term stability
studies, Products with a proposed shelf life of more than 12 months, the
frequency of testing at the long term storage condition should normally be
every 3 months over the first year. every 6 months over the second year (if more than
2 years’ shelf life).
5.14 At the accelerated storage condition, a minimum
of three time points, e.g., 0, 3, and 6 months’ study should be covered.
5.15 Stress
testing: Stress testing of the herbal products can help in identifying the
likely degradation products, Stress testing of herbal products should include the
effect of elevated temperature and humidity
5.16 Report:
Every year a review certified report on the results of the follow-up program
has to comply with the product in tabular form.
6.0
REFERENCES
Not Applicable
7.0
ANNEXURE
Not Applicable
8.0
ABBREVIATIONS:
SOP : Standard Operating
Procedure
QCD : Quality Control Department
EQP : Equipment
Dept. : Department
QC : Quality Control
QA : Quality Assurance
QCD : Quality Control Department
No. : Number
N.A : Not Applicable
Lab. : Laboratory
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