1.0 Purpose : To provide instructions for Stability study of Finished product.
2.0 Objective : To provide a documented procedure for Stability study of Finished product.
3.0 Scope : This procedure is applicable for Stability study of Finished product in QC department.
4.0 Responsibility :
· Primary : QC Chemist / QC Officer
· Secondary : Manager QC / Manager QA
5.0 Procedure :
· Selection of batches for stability study :
Ø For any new product at site the first 3 batches shall be under taken for stability study (long term and accelerated stability conditions).
Ø For routine ongoing stability study, yearly one batch shall be kept for long-term stability study.
Ø In case of any changes in the Manufacturing process, Raw Material or Packing Material in existing product the first 3 batches shall be undertaken for stability study.
Ø Stability samples shall be retained in the form of original sales pack or equivalent economical convenient pack as API products are packed in bulk quantity.
Ø In case of any deviation observed in the result of stability study, deviation shall be noted and takes corrective measures shall be taken.
· Sample Size :
Ø Require number of samples should be packed individually and each individual sample pack to be removed and analyzed as per the required condition.
Ø Total 30 g sample are required for long-term stability study and 15 g samples for accelerated stability study.
Ø Sample quantity and packaging for individual product is as described as under:
| Packaging type | Sample quantity |
| Double Poly bags in HDPE container | 3 g |
· Frequency of testing:
Ø Accelerated stability study :
| 1st testing 0 month |
| 2nd testing after 1 months |
| 3rd testing after 2 months |
| 4th testing after 3 months |
| 5th testing after 6 months |
Ø Acceptance Criteria for duration of testing : ± 07 days
Ø Long term stability study :
| 1st testing 0 month |
| 2nd testing after 3 months |
| 3rd testing after 6 months |
| 4th testing after 12 months |
| 5th testing after 24 months |
| 6th testing after 48 months |
| 7th testing after 60 months |
Ø Acceptance Criteria for duration of testing:
ü ±7 days up to 9 months.
ü ±15 days from 12 months onwards.
· Conditions to be maintain for storing the stability samples:
Ø Long term stability study
ü 30-35 °C ± 2 °C temperature and 60 % ± 5 % relative humidity.
Ø Accelerated stability study
ü 40-45°C ± 2 °C temperature and 70 % ± 5 % relative humidity
· Test to be carried out :
Ø Following tests shall be carried out in samples of each product if it is included in the specification:
ü pH if applicable.
ü Related substances or chromatographic impurities.
ü Loss on drying / Water Content
ü Assay.
ü Melting point if applicable.
ü Any other critical test as described in the individual monograph.
· Procedure for Stability Study Test :
Ø Select the batches for stability study as per above guideline.
Ø Label the samples as per following format:
STABILITY STUDY
ACCELERATED
(40-45°C ± 2 °C temp. and 70 % ± 5 % RH)
SAMPLE NO.: ________ Study Month: ________
PRODUCT:
BATCH NO.:
BATCH SIZE:
DATE OF MFG.:
DATE OF EXP.:
STABILITY STUDY
LONG TERM
(30-35°C ± 2 °C temp. and 60 % ± 5 % RH)
SAMPLE NO.: ________ Study Month: ______
PRODUCT:
BATCH NO.:
BATCH SIZE:
DATE OF MFG.:
DATE OF EXP.:--->Carry out above the mentioned tests as per respective product specifications
Ø Record the result in the Stability study form and stability study logbook / protocol.
------>In case of any deviation, inform the QA
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