| Visual inspection in sterile bulk & formulation |
1.0 OBJECTIVE To lay down the procedure for visual inspection of particulate matter in sterile bulk & formulation. 2.0 SCOPE This procedure is applicable for visual inspection of particulate matter in sterile bulk and formulation. 3.0 RESPONSIBILITY • Officer or above Production/IPQA shall be responsible for checking of particulate matter in filled vials. • Officer or above Microbiologist shall be responsible for checking of particulate matter in sterile bulk powder. 4.0 ACCOUNTABILITY Head Quality / QA 5.0 PROCEDURE 5.1 Bulk Sample: 5.1.1 Particulate matter shall be checked by microbiologists of sterile bulk powder. 5.1.2 Take 5 numbers of clean test tubes with glass stopper. 5.1.3 Wash the tubes and stopper with plenty of particle free water (Water for injection). 5.1.4 Add approximately 20 ml of particle free water (WFI) to 5 test tubes under LAF. 5.1.5 Switch on the hood and clean the area with a lint free mopping cloth. 5.1.6 Bring all the test tubes and place it in the visual checking hood. Wipe the outer surface of tube with lint free cloth. 5.1.7 Take one test tube, hold it in between the thumb and forefinger, and swirl it in such a way that water in the test tube shall have a swirling action. 5.1.8 Check the tube first in the white background for any black particles or any fiber. 5.1.9 Swirl the test tube again in the similar way and check the tube in the black background for any suspended white particles or fiber. Check all the test tubes in the similar way. 5.1.10 If any of the test tube is having any type of particulate matter discard all the test tubes and wash it again with fresh particle free water (WFI). 5.1.11 If the test tubes are found to have no particulate matter, then bring it back and place it under LAF. 5.1.12 Add approximately 2g of the product sample into each of the 5 test tubes, reconstitute the powder with the help of a vortex mixer, and observe in visual hood. 5.1.13 Wipe the outer surface of the test tube with a lint free cloth for any water droplet or material. 5.1.14 Take one test tube and swirl it. 5.1.15 Check the test tube in the white background and then in the black background for black and white particulate matter respectively. 5.1.16 Check all the test tubes in the similar way and record the observations in the report. 5.1.17 If any black particles, fibers observed in the test tube then immediately inform to department Head for further action. 5.1.18 Immediately Head QC shall inform to Head QA and Head Production respectively and investigation shall be performed as per procedure for out of specification. 5.2 Formulation Samples: 5.2.1 Particulate matter shall be checked by IPQA of filled vials. 5.2.2 Initially take 24 vials (1 vial per head) for checking of particulate matter and during operation take 10 vials every two hours for checking of particulate matter. 5.2.3 Clean the outer surface of the vials with particle free purified water to remove any particulate matter from the outer surface of the vial. 5.2.4 With the help of a syringe, reconstitute each vial with water for injection. 5.2.5 Dissolve the contents of the vial by swirling it. 5.2.6 Take all the vials and place it in the visual checking hood. 5.2.7 Switch on the visual hood and clean the internal surface of the hood. 5.2.8 Take one vial and swirl it by placing it between the thumb and the forefinger. 5.2.9 Check the vial in the white background and then in the black background for any particulate matter and reconstitution time. 5.2.10 Perform this exercise for all other vials and record the observations in the BMR. 5.2.11 If any black particles, fibers observed in the test tube then immediately inform to department Head for further action. 5.2.12 Investigation shall be performed as per procedure for CAPA. |
