Standard operating procedure for storage and receiving of inprocess batches.
1.0 Purpose
The purpose of this standard operating procedure is to develop a standard procedure for storage and receiving of inprocess batches.
2.0 Scope
This SOP is applicable for the procedure used for storage and receiving of inprocess batches from the inprocess storage area.
3.0 Responsibility
3.1 The production supervisor is responsible for batch storage and receiving.
3.2 The production officer is responsible for implementing this SOP.
3.3 The Production Manager is responsible for ensuring the implementation of this SOP.
3.4 QA Officer monitors the compliance of this SOP.
4.0 Procedure
4.1 The inprocess batches (granulated,compressed,coated,filled capsules) shall be stored after completion of one stage into work inprocess storage area.
4.2 The production supervisor shall store the batch in storage area at designated location.
4.3 The production supervisor shall record the storage activity in the log book.
4.4 The production supervisor shall store the batch in the presence of production officer.
4.5 The production supervisor shall receive the stored batch from storage area on production demand.(For compression,coating, filling, blistering)
4.6 The batch shall be received in the presence of production officer.
4.7 Record in logbook & signed the batch receiving activity.
4.8 The production supervisor shall deliver the batch to the required work station in production.
5.0 Abbreviations
5.1 SOP: Standard Operating Procedure
5.2 QA: Quality Assurance
Note
Inprocess storage area is established in the production department for storage of all the inprocess batches.When a batch is required for further processing then this batch is received from the storage area & delivered to the required work station.