OBJECTIVE:
To lay down the procedure for the manual loading of material into the equipment.
SCOPE:
This SOP is applicable to the procedure for the manual loading of material into the equipment.
RESPONSIBILITY:
Initiator Executive/Designee: Production shall ensure the compliance of the SOP.
Initiator Officer/Designee: Production shall perform the operation activity as per SOP.
ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
About Manual Loading:
Manual material loading in pharmaceutical manufacturing can be beneficial. It helps maintain the integrity of delicate materials, allows for precise handling and inspection, and supports smaller batch sizes or specialized products. Manual processes can also be cost-effective for lower production volumes and offer flexibility for adapting to changing needs. Additionally, manual loading can be advantageous for processes requiring specific operator skills or judgment, ensuring quality control and consistency.
PROCEDURE:
Ensure clean scoops and aids are used for handling materials.
Ensure the equipment and materials are appropriately labelled before starting activity.
Loading of Material:
Equipment shall be verified for cleanliness.
Material to be loaded manually shall be kept near the machine in which it is to be loaded.
Cable tie shall be removed and discarded properly into designated bins.
Clean scoops shall be taken and material shall be scooped out into the equipment.
Personnel shall ensure that if the material loading is taking longer times, the materials shall be properly closed and stored.
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https://pharmaguidehub.com/product/manual-loading-of-material-into-the-equipment/
Unloading of materials:
Material shall always be unloaded into clean double polybag lined containers.
Ensure that collection containers are near to the equipment.
Unload the materials into these containers and tie the open ends of the Polybags with cable ties.
Ensure unloaded materials containers are properly labelled and stored.
REFERENCES:
Not Applicable
ANNEXURES:
Not Applicable
ENCLOSURES: SOP Training Record.
DISTRIBUTION:
Controlled Copy No. 01 : Head Quality Assurance
Controlled Copy No. 02 : Head Production
Master Copy : Quality Assurance Department
ABBREVIATIONS:
| PD | : | Production |
| No. | : | Number |
| SOP | : | Standard Operating Procedure |
| BMR | : | Batch manufacturing record |
| HDPE | : | High density polyethylene |
| IPQA | : | In process Quality Assurance |
REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Written Manual |
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/manual-loading-of-material-into-the-equipment/
