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 Control4.0 ACCOUNTABILITY
Sr. Manager Quality Assurance5.0 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 the 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 testing.
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 an 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°C) and Relative humidity (60 ±5%) conditions for Long term stability testing.5.4.2 Samples shall be kept at temperature (40 ±2°C) and Relative humidity (75 ±5%) for Accelerated stability testing.
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 the 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 Testing Conditions (45°C ±2°C/75%±5%) = 0,1,2,3 and 6 months.
b) Long Term Stability Testing Conditions (25°C±2°C/60%±5%) = 0,3,6,9,12,18,24 36,48,60 months.
c) Long-term stability study shall be carried out up to 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 Studies
5.6 Evaluation of Stability Data
5.6.1 Evaluation of stability data shall be made once in a year. Based on the evaluation of data, recommendations if any shall be made by Sr. Manager Quality Assurance.5.6.2 During stability testing 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. The investigation shall be done on the affected batch along with all the batches produced at the same time. The 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 procedure6.2 QA: Quality assurance
6.3 QC: Quality control
6.4 Dept.: Department
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