1.0 OBJECTIVE:To lay down the procedure for media stock maintenance and suitability testing of media.
2.0 SCOPE:This SOP is applicable to Microbiology Section of Quality Control Dept.
4.0 ACCOUNTABILITY:Head Quality Control Department
5.1 Media Stock Maintenance:5.1.1 On Receipt of media from the supplier, check the bottles of media for manufacturing date and expiry date.
5.1.2 In case the expiry date of media is within one year (except for the solutions where the expiry date labeled itself is one year or less), reject the same and send back to the supplier.
5.1.3 Paste the label for the media bottle / box.
5.1.4 Store dehydrated media in tightly closed packs in the dark or as directed by the manufacturer.
5.1.5 Enter the details of the received media in the media stock register..
5.1.6 Enter the details in such a way that in case there are 2 boxes/ bottles of media of the same batch, 2 lines are allotted for the further record of the same.
5.1.7 The next 2-bottles/ boxes with a different batch number will be entered after that, and 2 lines will be allotted for that batch.
5.1.8 Ensure that the expiry dates of the bottles are in chronological order if more than one batch is received.
5.1.9 In case there are smaller packets in a box each individual pack shall be labeled.
5.1.10 Ensure that the media stock is used on a First In First Out or First Expiry First Out basis and that only one pack of medium is in use at any given time.
5.1.11 On opening a new pack, enter the date of opening on the label of the bottle/ box and in the media stock register.
5.1.12 Follow the media preparation instruction on the label for rehydration.
5.1.13 For each new batch of dehydrated media received carry out the fertility test of the media before using for microbiological analysis.
5.1.14 Enter the date of release in the label on the pack and in the media stock record on successful completion of the fertility test.
5.1.15 Maintain Media Consumption Record.
5.2 Suitability of Media:5.2.1 Check if the media is having any lumps formation, if any, discard the media.
5.2.2 The media are suitable if a clearly visible growth of the microorganisms occurs.
NOTE: Media, which fail for suitability shall not be used for testing.
5.3 Retesting of Media Bottles:Dehydrated media, if stored in tight container, can be used for one year but it should be tested for fertility test after completion of one year, if it complies for suitability test.
Note: If a new consignment of Media has got the same batch number as that of previous batch number of media used, perform the fertility test of the respective media.
6.0 ABBREVIATIONS:6.1 USP : United States Pharmacopoeia
6.2 QC : Quality Control
6.3 SOP : Standard Operating Procedure
6.4 Dept. : Department
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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