OBJECTIVE:
To lay down a Procedure for Codification of Room in pharmaceutical.
SCOPE:
This SOP is applicable for Codification of in pharmaceutical at {Company Name} {Location}.
RESPONSIBILITY:
- Technician- Follow the instruction as per procedure.
- Engineering Officer/Executive- Execution as per laid down procedure.
- Engineering Head- Technical correction, review, training & monitoring of SOP.
ACCOUNTABILITY:
Engineering Head
Quality Assurance Head
PROCEDURE:
Codification of rooms in the pharmaceutical industry is essential for maintaining strict regulatory compliance and efficient facility management. Each room is assigned a unique identification code based on its function, location, and cleanliness classification. This systematic coding facilitates traceability, streamlines operations, and ensures proper segregation of activities like production, quality control, and storage. Codification supports Good Manufacturing Practices (GMP) by reducing the risk of cross-contamination and ensuring all areas are easily identifiable during audits and inspections. It also aids in documentation, maintenance scheduling, and workflow optimization. Effective codification enhances operational integrity and ensures a safe, controlled environment for pharmaceutical manufacturing.
Codification of Room:
- Engineering officer/executive shall prepare the master list of room.
- Each and every room has defined room name and number.
- After discussion with the user departments the engineering officer/Executive shall allots the room name and the room number.
- The same room name and the room number shall display in front of the room.
- The room name and room number shall be displayed in the Area layout of {Company Name} Plant.
- Following procedure has to be followed for to allot codification for room wise.
- G-BBB.
- Where the following are stands for:
- G- Indicate the Ground floor.
- BBB- Indicate the Room number like 001, 002, and 003………
- Example: In the case of ground floor entry in plant, the room number shall be assigned as G-001.
- The Master list shall update as per Plant.
- The room I.D allotted shall not be repeated for any other room.
- The room name and room number shall be listed in the master list as per Annexure-I.
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REFERENCES:
Not Applicable
ANNEXURES:
| ANNEXURE No. | TITLE OF ANNEXURE |
| Annexure-I | Master List of Room Id |
ENCLOSURES: SOP Training Record
DISTRIBUTION:
Master Copy Quality Assurance Department
Controlled Copy No. 1 Quality Assurance Head
Controlled Copy No. 2 Engineering Head
ABBREVIATIONS:
SOP : Standard Operating Procedure
QA : Quality Assurance
I.D : Identification
REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Written Manual |
ANNEXURE-I
MASTER LIST OF ROOM ID
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/codification-of-room-in-pharmaceutical/