Room Data Sheets Management SOP Quiz

Study Notes

Objective

Describes the procedure for creating and managing Room Data Sheets (RDS) in a standardized format.

References & Associated Documents

Standard Operating Procedures (SOP) for various aspects including creation, quality management, incident handling, document control, and change control.

Scope

Applicable to RDS standardization and management at Incepta Pharmaceuticals Ltd., Vaccine Division.

Responsibility

Engineering Department:
- Prepares and reviews RDS for new and existing facilities.
- Sends RDS to user departments for review and archives the approved master copy with the QA department.
User Department:
- Reviews area RDS for further approval.
Validation:
- Verifies RDS data during qualification processes (IQ/OQ/PQ/Requalification).
Quality Assurance:
- Approves area RDS and archives the approved copy.
- Shares information copies of approved RDS with relevant departments.

Safety Instruction and System Description

No specific safety instructions provided.

Procedure for RDS Preparation

Collects essential information during RDS preparation:
- Sequential serial number for the facility.
- Room number and name.
- AHU number covering the rooms.
- Calculated room area (in m²), height (in m), and volume (in m³).
- Required maintained class and environmental controls:
  - Room temperature (°C)
  - Relative humidity (RH%)
  - Differential pressure (Pa)
  - Room pressure (Pa) relative to ambient
  - Minimum air changes per hour (ACPH).
RDS becomes effective from the date of QA approval.

Definition & Elaboration of Abbreviation

Room Data Sheet (RDS):
- Provides design and HVAC system requirements based on area activity and equipment load.
Abbreviations Explained:
- ACPH: Air Change Per Hour
- CCF: Change Control Form
- DCCF: Document Change Control Form
- DPG: Differential Pressure Gauge
- HVAC: Heating Ventilation & Air Conditioning
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
- RDS: Room Data Sheet

Engineering Drawings Procedure Overview

Applicable to all Engineering drawings at Incepta Pharmaceuticals Ltd., Vaccine Division.
Essential for the generation, distribution, and archival of drawings.

Reference Documents

Standard Operating Procedures (SOPs) guide the process including:
- Creation and Control SOP (Ref.Doc.No.QAD/SOP/GEN-001).
- Preventive and Breakdown Maintenance SOPs (Doc.No.: ENG/SOP/GEN-001/002).
- Quality Manual (Ref.Doc.No.IPV/QAM/001).
- Incident & Deviation Management SOP (Ref.Doc.No: QAD/SOP/GEN-003).
- Document Control SOP (Ref.Doc.No.QAD/SOP/GEN-043).
- Change Control SOP (Ref.Doc.No.QAD/SOP/GEN-007).

Responsibilities

Engineering Department:
- Prepare, modify, and update drawings as required.
- Submit final drawings (hardcopy and softcopy) to QA for archival.
- Provide previous versions to QA before issuing new drawings.
- Maintain an updated list of drawings.
- Head of Engineering ensures SOP implementation.
Quality Assurance Department:
- Approve drawings and ensure SOP compliance.
- Archive both hardcopy and softcopy drawings.
- Issue new drawings and manage destruction of obsolete copies.

Drawing Preparation

Use compatible versions of AUTOCAD for drawing preparation.
Generate PDF versions and maintain soft and hard copies.
Assign drawing numbers following a specified format.
Include necessary details in the drawing title box.
Electrical and special equipment drawings should reference supplier copies.
Print drawings in A3/A2/A1 size based on readability and visibility.
Validate drawings until officially revised or modified.

Drawing Size and Display

Display facility layouts and utility schematics near relevant areas for easy access.

Drawing Number Generation

Format: XXX/YYY/ZZZ–CCC–DD where:
- XXX = IPV (Incepta Pharmaceuticals Ltd., Vaccine Division)
- YYY = Department/Section Code
- ZZZ = Type or name of the drawing (3 letters)
- CCC = Sequential drawing number (001-999)
- DD = Version number (01-99)
Example: IPV/PRD/FCL–001–01 signifies a specific production department layout.

Distribution and Archiving Workflow

Archive approved Active Copies in QA.
Share Information Copies with relevant departments or authorities.
Replace previous Active Copies with Obsolete Copy seals before distributing updates.
Distribution of drawings requires submission of the original soft copy to QA.

Summary of Procedure Steps

Follow detailed steps for drawing preparation, numbering, printing, distribution, and archiving to maintain compliance and ensure effective documentation practices.

Description

Test your knowledge on the procedures for creating and managing Room Data Sheets (RDS) at Incepta Pharmaceuticals Ltd. This quiz covers standard operating procedures, responsibilities of departments, and the role of quality assurance in the RDS process. Enhance your understanding of RDS standardization and management within the vaccine division.