Wednesday, December 1, 2010

Stability Study of Finished Product

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      Description.
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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