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.
3.3 HOD shall be responsible for the authorization 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 the 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., The date & time of collection and collection 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; the rest can be studied at normal /slow rate conditions.
5.12 Storage condition:
|
Study |
Storage condition |
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
Sr. : Senior
QCD : Quality Control Department
No. : Number
N.A : Not Applicable
Lab. : Laboratory
END OF THE DOCUMENT
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