Standard Operating Procedure for Fitz Mill
1.0 Purpose
The purpose of the current SOP is to develop a standard procedure for operating the Fitzpatrick mill.
2.0 Scope
This SOP is applicable for the Fitz mill in the granulation area of the production section.
3.0 Responsibility
3.1 Machine Operator is responsible for operating the Fitz Mill.
3.2 Production Pharmacist is responsible for the implementation of this SOP.
3.3 The HOP is responsible for ensuring the implementation of the current SOP.
3.4 Q.A Officer monitors the compliance of this SOP.
4.0 Procedure
4.1 Pharmacist will ensure that the Fitzpatrick Mill & the area is properly cleaned.
4.2 Pharmacist will ensure that the Fitz mill & Area is labeled with Cleaned label status.
4.3 Before starting the working of a Fitz mill, affix product-related labels to the Fitzpatrick mill & Area and take line clearance from the QA officer.
4.4 The mesh or sieve to be used for Fitz mill is verified by the pharmacist.
4.5 Attach a polythene or place a container to the lower side of the Fitz mill to collect the sieved granules or sieved material.
4.6 Add dried granules or material to be sieved in the hopper of the Fitz mill and start its working by pressing the ON button.
4.7 When the sieving process is completed, press the Off button and remove the polythene bag to check the weight of the granules to calculate the product yield.
4.8 Affix Fitz mill to be cleaned, label and record the activity in the logbook of the Fitz mill and sign it.
5.0 Abbreviations
5.1 SOP: Standard Operating Procedure
5.2 BMR: Batch Manufacturing Record
5.3 QA: Quality Assurance
5.4 HOP:Head Of Production
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