OBJECTIVE:
To lay down the procedure for coding of screens, meshes and FBP bags, and bellows.
SCOPE:
This SOP is applicable to the procedure for coding of screens, meshes and FBP bags, and bellows at {Company Name} {Company Location}.
RESPONSIBILITY:
PD Executive/Designee – is responsible to follow the procedure as per SOP.
Head Production – is responsible for compliance of the SOP.
ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
PROCEDURE:
Purpose of codification:
In Pharmaceutical industry codification procedure provide the unique identfication to screen, mesh & FBP bags. So content wise tracking can be possible and history of each content can be possible.
By tracking the history their use, inspection, any damage and destruction cen be track so any kind of data integrity and product contamination can be avoided.
Procedure of codification:
Check integrity of screen / mesh & FBP bags before coding.
Incase any discrepancy observed inform QA by raising NCR as per SOP and shall be investigated.
Coding shall be done to the Screen, Mesh, FBP bag & Bellows which has passed the Integrity Test.
CODING OF MULTI MILL/CONE MILL SCREENS: The coding for the screen will be given as PD/XX/YY/NN.
Where,
- PD :- Production department
- XX: – Mill Type. For Cone Mill the code shall be CO, for multi mill the code shall be MM
- YY: – Screen Size.
- NN: – Serial number starting from 01, 02.. and so on.
For example, for the first 1.0 MM screen of Multi mill, the coding will be as PD/MM/1.0 /01.
For example, for the first 1.0 MM screen of cone mill, the coding will be as PD/CO/1.0 /01.
CODING OF MESHES:
The coding for the mesh will be given as per PD/SFT/XX/YY/NN.
Where,
- PD: – Production department
- SFT: – Sifter
- XX: – Size of sifter
- YYY: – Sieve size
- NN: – Serial number starting from 01,02.. and so on.
For example, First sieve of 20 mesh of 12 inch diameter Sifter the coding shall be done as PD/SFT/12/20/01.
The first mesh of 20 mesh of 30 inch diameter coding will be PD/SFT/30/20/01.
CODING OF FBP BAGS:
The FBP bags name shall be coded as Product name with embroyding
CODING OF BELLOWS:
The Bellows name shall be coded as Product name with embroyding.
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 |
| FBP | : | Fluid Bed Processor |
| NCR | : | Non Conformance Report |
| No. | : | Number |
| SOP | : | Standard Operating Procedure |
REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To be written manual |