1.0 OBJECTIVE:To lay down the procedure for collection and storage of control samples (Raw material and finished goods).
2.0 SCOPE:This SOP shall be applicable to Quality Control Dept.
3.0 RESPONSIBILITY:Officer Quality Assurance
4.0 ACCOUNTABILITY:Sr. Manager Quality Assurance
5.1 Collection:5.1.1 The control samples shall be collected from each batch of finished goods manufactured and from each batch of raw material ingredients received.
5.1.2 The In Process Quality Assurance (IPQA) supervisor shall collect the control sample from packing line in case of finished goods. For raw material the same shall be taken from the remaining portion after completion of initial analysis in Quality Control Dept., or may be collected from Stores.
5.1.3 The quantity of retention sample for finished product and Raw material should be twice the quantity required for carrying out the complete analysis as per prescribed method of analysis.
5.1.4 Entry of the control sample collected shall be made in the Batch Manufacturing Record.
5.1.5 The sample shall be stamped as “CONTROL SAMPLE”, entry shall be taken in the record Performa, and shall be properly stored in the control sample room under storage condition according to the nature of the product.
5.1.6 The record shall state the date of collection, Product name, Batch number, Batch size, manufacturing date, expiry date, Opening balance, Quantity retained, Quantity withdrawn, Closing balance, Due date of destruction, Actual date of destruction, Quantity destroyed and destroyed by.
Related: SOP for Destruction of Control Samples (Raw Material and Finished Product)
5.2 Storage:5.2.1 According to alphabetical manner store control sample in the racks.
5.2.2 Control sample shall be segregated product wise.
5.2.3 Store the control sample in the control sample room under lock and key arrangements for a period of one year beyond the expiry of the batch in case of finished product.
5.2.4 Samples of active and inactive raw material shall be stored for a period of one year beyond the expiry date of the last batch of respective finished product in which the material is used.
Related: SOP for Preservation of Control Samples of Active Ingredients
6.0 ABBREVIATION:6.1 SOP : Standard Operating Procedure
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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