Finished Product Sampling (Sterile)

1.0  OBJECTIVE

1.1 To describe the procedure for sampling of filled containers during filling for Quality Control analysis, in such a manner that it truly represents the entire filling operation.

1.2 To describe the procedure for sampling of filled containers after Terminal sterilization.      

   

2.0 SCOPE

2.1 This procedure is applicable for sampling of all the filled units during filling and also products which are terminally sterilized after terminal sterilization for Sterility testing and other analysis manufactured at company.

3.0 RESPONSIBILITY

3.1 IPQA Chemist

4.0 ACCOUNTABILITY

4.1 In Charge QA

5.0 PROCEDURE

5.1 A box/polybag is kept at the sample collection site with label as finished product samples for QAD with details of the Product, batch no., date of mfg., date of exp., lot no., date of sampling, Q.A.chemist signature.

5.2 As the initial vials / ampoules / PFS are filled collect the samples as given in the tables below before the volume adjustment, and put them in the first section of the box/ poly bag labelled as 0 min. These samples shall be sent only for sterility testing

5.3 As the filling starts after volume adjustment, collect samples as specified in the table for the product that is applicable, and at the interval of 30 min and place them in each section of the box or poly bag labelled accordingly for the time of collection.

5.4 The sequence of operations as specified in step no: 5.3 continues until filling is completed.

5.5 Pool the samples from each 30 min section including '0' min for sterility and excluding 0 min for other analysis as given in the appropriate table below and send them to Quality control duly labelled for sterility and other analysis separately. The balance containers shall be returned to production

5.6 If filling continues beyond 8 hours or there is a change in crew, samples are collected separately for the subsequent fills for lot segregation. 

6.0 ANNEXURES

6.1    Annexure I --- Finished product sampling record