SOP for Next Earliest Batch : Procedure for Ensuring Addition In Next Earliest Batch 1

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