Follow
OBJECTIVE: This Standard Operating Procedure is to describe that room can not randomly selected and directly used without verification. It is essential to ensure the suitability of room for a specific activity against requirement. Hence it is to be qualified before use.
SCOPE: This procedure is applicable for all the rooms related with GMP activities at (Company Name).
RESPONSIBILITY
3.1 A team of experts from different disciplines such a Production, Quality Control, Quality Assurance, Validation; Engineering shall be responsible to carry out this procedure as defined.
3.2 Concerned department Head, Manager Validation & Head of Engineering shall be responsible for effective implementation of procedure.
3.3 Head of QA shall be responsible for approval.
ACCOUNTABILITY: Head of Quality.
PRECAUTIONS:
5.1 Ensure that the Room Data Sheet is completed during facility validation.
PROCEDURE:
6.1 The Room data sheet shall contain the following information and shall be recorded as per ANNEXURE-I.
6.1.1 Document No. and Date of preparation; Document no. shall be assigned as per the following illustration:
Document no.: RDQA01
Where, RD = Room Data Sheet
QA = Dept. code
01 = Consequent serial no.
6.1.2 A list of Document numbers for Room Data Sheet shall be prepared as per ANNEXURE-II.
6.1.3 Room Name and Room No.
6.1.4 Spatial Information regarding Area, Height and Volume of the room.
6.1.5 Surface Finishes of Floor, Wall, Ceiling/False ceiling, Coving, Skirting, Windows, Doors, Drain and Pass box.
6.1.6 Description of Electrical Services regarding power outlets.
6.1.7 Description of other utility services such as Potable water, Purified Water, Compressed Air, Steam and Vacuum.
6.1.8 AHU Details containing AHU No., Pressure differential, Room temperature, Relative humidity, No. of supply air grilles, No. of Return air grilles and No. of Return air risers.
6.1.9 Description of Equipments inside the room regarding Name and code and capacity of equipment.
6.1.10 Description of Communication and Security containing PABX Extn. No. of the room, Availability of computer connection, Security alarm, Fire Alarm, Door Alarm, Thermal Detector, PA System, Emergency light and Fire extinguishers (Type and number).
