1.0 PURPOSE
1.1 To lay down the procedure for handling of retention samples.
2.0 SCOPE
2.1 This procedure is applicable in Quality Control.
3.0 RESPONSIBILITY
3.1 Quality control personnel
4.0 ACCOUNTABILITY
4.1 Manager - Quality Control
5.0 PROCEDURE
5.1 Gases, corrosive, flammables, acids, catalyst, hygroscopic and volatile materials shall not be kept as retention sample.
5.2 All Retention samples shall be kept immediately after sampling that is before analysis started.
5.3 Key starting material, Intermediate for sale and Penultimate intermediate of API
5.3.1 Retention Sample shall be kept for key starting material, intermediate for sale and Penultimate intermediate for API.
5.3.2 Quantity of sample necessary for two complete analyses shall be drawn as Retention sample.
5.3.3 Retention sample shall be drawn as per the respective sampling SOP in Simulated Pack.
5.3.4 Retention sample shall be labeled as per the specimen given in Annexure I.
5.3.5 Sample details shall be entered in the retention sample inward record as per the specimen given in Annexure II.
5.3.6 These samples shall be kept chronologically in the designated area.
5.3.7 Samples shall be retained for a period of one year after the release of the product if their stability allows. This period may be shortened if their stability, as mentioned in the relevant specification.
5.4 Active Pharmaceutical ingredient/Component of Blend API
5.4.1 Retention Sample shall be kept for all the batches of API’s.
5.4.2 Quantity of sample necessary for two complete analyses shall be drawn as Retention sample.
5.4.3 Retention sample shall be drawn as per the respective sampling SOP in Simulated Pack.
5.4.4 Retention sample shall be labeled as per the specimen given in Annexure I.
5.4.5 Sample details shall be entered in the retention sample inward record as per the specimen given in Annexure II.
5.4.6 These samples shall be kept chronologically in the designated area.
5.4.7 Samples shall be retained for a period of one year after Expiry/ Retest date of API or three years after batch is completely distributed into the market which ever is longer.
5.5 All the retention samples shall be stored below 25°C or as specified.
5.6 Temperature of the retention sample room shall be monitored and recorded.
5.7 If any Sample is withdrawn for any purpose, the sample request shall be given by Manager-QC to the concern section in-charge as per the Annexure- III
5.8 Details of the withdrawn sample shall be entered in the Retention sample record as per format given in Annexure IV.
5.9 Retention sample shall be examined visually at least once a year for evidence of deterioration unless visual examination would affect the integrity of retention sample.
5.10 After the completion of the retention period the sample shall be dissolved in a suitable solvent and discarded. Destruction shall be recorded in the format as given in Annexure-V.
Retention samples, hygroscopic, penultimate, annexure , manager qc
