OBJECTIVE:
To lay down the procedure for movement of materials in production area.
SCOPE:
This SOP is applicable to the procedure for movement of materials in production area.
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 the control of dispensed material
In pharmaceutical manufacturing, the dispensed material cage plays a critical role in ensuring the integrity and safety of raw materials. Secure closure of this cage is paramount. It prevents unauthorized access, contamination, and potential diversion of materials. Numbered tag systems are essential to prevent unauthorized access. Regular inspections and audits are crucial to verify the cage’s integrity and ensure adherence to Good Manufacturing Practices (GMP). Proper documentation of all access and material movements within the cage is vital for traceability and compliance with regulatory requirements.
PROCEDURE:
After dispensing a batch, the store person shall put all the materials in a cage trolley by putting tamper proof sealed tag.
Write the details of the product and batch number on the outside of the cage trolley and transfer the securely closed trolley to the dispensing hold area. Record the seal number on the outer label of cage trolley.
Carry out weighing of the materials as per the SOP.
During the verification of the materials, the concerned production and IPQA executive has to verify the number on the tag and on outer label of the cage trolley.
After verification of the sealed tag number, broke open the seal in common weighing area and verify the materials.
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/handling-of-securely-closed-cage-trolleys-and-tags/
After verification of all the materials, again put into the same cage trolley, put afresh tamper proof sealed tag. Record the number of sealed on outer label cage trolley.
Transfer the verified material into the material entry of the respective area as per the SOP and verify the number on the tag and BMR.
Then once again cross check the labels of all the materials with BMR and taken for further processing
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 |
| 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/handling-of-securely-closed-cage-trolleys-and-tags/