In-process Checks of FBD

 In this post Standard Operating Procedure of In-process Checks of FBD in pharmaceuticals is describe.

1.0 OBJECTIVE:

1.1 To lay down a procedure for In process checks of FBD.

2.0 SCOPE:

2.1 This SOP is applicable for the In process checks of FBD in the production area.

3.0 RESPONSIBILITY:

3.1 Technical Associate : Operation as per SOP

3.2 Production Officer/ Executive : Checking Operation & In process as per SOP

3.3 IPQA Person : On line Process Confirmation as per SOP

3.4 Head Production : SOP Compliance

4.0 DEFINITION (S):

4.1 NA

5.0 PROCEDURE:

5.1 Check the FBD bag integrity before and after drying and record it in the respective BMR.

5.2 Operates the FBD as per their respective SOP.

5.3 Place the FBD bowl containing wet milled granules under the retarding chamber and fit it to the retarding chamber by operating the control panel.

5.4 Reshuffle the granules after every drying cycle completed and record it in the respective BMR.

5.5 At the time of drying monitor the inlet, bed and out let temperature and record it at every 30 minutes interval in the respective BMR.

5.6 LOD shall be periodically monitored as protocol base during validation and after achieving outlet temperature. So in non validation, LOD checks during routine manufacturing, the LOD shall be recorded once outlet achieved.

6.0 ABBREVIATION (S):

6.1 IPA : Iso Propyl Alcohol

6.2 SOP : Standard Operating Procedure

6.3 BMR : Batch Manufacturing Record

6.4 HMI : Human Machine Interface

7.0 REFERENCES (S):

7.1 NA

8.0 ANNEXURE (S)

9.0 DISTRIBUTION:

9.1 Master Copy : Quality Assurance

9.2 Controlled copy (s) : Production department (02) and Quality Assurance (01)

9.3 Reference copy (s) : Production department (05)

10.0 REVISION HISTORY: