Table of Contents
1.0 OBJECTIVE: –
1.1 To ensure addition in next earliest batch.
2.0 SCOPE: –
2.1 To provide appropriate storage condition and avoid deterioration. This procedure is applicable for handling of recoverable rejection.
3.0 RESPONSIBILITY:-
3.1 Production officer
3.2 Production Executive
4.0 ACCOUNTABILITY:
4.1 Production Head
5.0 Procedure: Next Earliest Batch
To Read this SOP click here Procedure for Breakdown Maintenance, Preventive Maintenance 1.
5.1 Collection:
5.1.1 Collect compressed tablets during batch parameter setting.
5.1.2 Collect the tablets after inspection of compressed/coated tablets
5.1.3 Collect de-foiled tablets which are not good enough physically to repack.
5.2 Storage:
5.2.1 Keep the collected tablets product wise and B. No. wise separately in a plastic container at the specified area in “Granules” Quarantine room.
5.2.2 Record the weight/No. of tablets in B.P. Rat respective stage and record it in yield Register.
5.3 Usage: Next Earliest Batch
5.3.1 Add (NMT 10 %) RR of Previous batch in the next batch to be manufactured at granulation stage.
5.3.2 Crush uncoated tablets directly in Mill/Multi Mill with dry granules screening of the fresh batch.
5.3.3 If the tablet is film coated/enteric coated then crush it separately and remove the film add the appropriate sized final granule in to the same size of fresh batch by sifting it.
Note: Any product having vitamin content or is sustained release type formulation, then Tablets collected at any stage be treated as non- recoverable rejection and destroy it. Any RR older than 3 months must be analyses before addition and Quality control report of the same should be attached with Batch Production Record.
6.0 ABBREVIATIONS:
6.1 EFF. : Effective
6.2 SOP : Standard Operating Procedure
6.3 Mfg. : Manufacturing