| Collection And Handling Of Control Sample |
1.0 OBJECTIVE: 1.1 To lay down the procedure for collection, preservation and inspection of the control sample of finished goods. 2.0 SCOPE: 2.1 This Procedure is applicable for Collection And Handling Of Control Sample at formulation plant. 3.0 RESPONSIBILITY: 3.1 Experienced and qualified QA Officer /Executive are responsible for handling verification of control sample per the procedure mentioned in this SOP. 3.2 Sr. QA Executive is responsible for implementation of the procedure as per this SOP. 3.3 QA Head is responsible for compliance of procedure as per this SOP. 4.0 ABBREVIATIONS 4.1 QA : Quality Assurance 4.2 SOP : Standard Operating Procedure 4.3 ºC : Degree Celsius 4.4 Mfg Date : Manufacturing Date 4.5 Exp. Date : Expiry Date 4.6 MRP : Maximum Retail Price 4.7 IPQA : In-Process Quality Assurance 4.8 BPR : Batch Packing Record To Read this SOP Click Here SOP for Handling Of Left Over Samples. 5.0 PROCEDURE: 5.1 Collection of the control sample 5.1.1 IPQA-Chemist/Officer shall collect the control sample at different time interval during packing of the finished goods. 5.1.2 Control sample shall be preserve in the same packing as product goes to the market for distribution. 5.1.3 QA-Officer/Executive shall receive sample and past a red colour printed label with sign & date. As per label specimen. COMPANY NAME Control Sample: Sign/Date: 5.1.4 Label shall be affix on the opening flaps of the samples & maintain the record as per annexure-XXX). 5.2 Sample quantity 5.2.1 Sample quantity for control sample shall be withdrawn as per attached Annexure-XXX). 5.2.2 If a batch decided in to sub lots as “Physician sample” their representive sample also collect from sub lots and make the entry in respective BPR. 5.3 Storage condition 5.3.1 Storage conditioned shall be same as require to product manufacturing. 5.3.2 Temperature of the control sample room should not be more than 25ºC. 5.3.3 The record of temperature be maintained one a day as per as per annexure-XXX. 5.4 Periodic inspection of control sample Periodical observation for retained samples to be carried out as follows; 5.4.1 At least four times inspection shall perform at time interval of shelf life (in months). 5.4.2 Inspection shall perform of few packing units for physical appearance and the record shall be maintained for the same as per as per annexure-XXX). 5.4.3 If any abnormal observation found, the same shall be informed to Head-QA for necessary action as per as per annexure-XXX). 5.4.4 If any control sample required for testing or reference purpose concern person will fill the control sample request form. 5.5 Selection of batches for periodic inspection 5.5.1 Every 10th batch or at least one batch per annum, whichever will be more shall undergo periodic inspection. 5.6 Period of preservation 5.6.1 Control sample shall be preserved for 3 month after completion of the expiry period of concern product. 5.7 Destruction of control sample 5.7.1 After preservation period sample shall be destroyed by QA-Officer and record shall be maintained as per as per annexure-XXX after approval of QA-Head. |
