Water System in Pharma

2. High-containment Drugs Manufacturing Plant
Uses of Water in Pharma Manufacturing
Water is one of the most widely used substances,
and raw material, or an ingredient in the
production, processing, and formulation of
pharmaceuticals.

3. High-containment Drugs Manufacturing Plant
CONTROLS
 Organic impurities
 Inorganic impurities
 Microbiological
Quality of water is
important because
proliferation of micro-
organisms in water may
occur during the purification,
storage, and distribution of
this substance.

4. High-containment Drugs Manufacturing Plant
GRADE OF WATER
Grades of water are closely related to the manufacturing
methods and distribution systems of water.
Major differences among these grades of water consist of the
following quality attributes:
 Microbial Counts
 Endotoxin, which is due to the presence of microbes
 Organic and Inorganic impurities

5. High-containment Drugs Manufacturing Plant
GRADE OF WATER IN ONCOGEN
1. Chlorinated
City Water
3. Purified
Water
2. Treated
Water
4. WFI

6. High-containment Drugs Manufacturing Plant
QUALIFICATION STAGES

7. High-containment Drugs Manufacturing Plant
Updated P&IDs
Purified line Piping’s MOC, boroscopy report and slope test report.
Sanitization of Storage tanks and Loop
System Operation and Maintenance SOP with availability of inter related
utilities or system’s SOP i.e. steam generator, Reverse osmosis plant,
preparation and utilization of sodium hypochlorite solution and sodium
metabisulphite, washing of main tank
Operator training record
Instrument calibration
PQ PRE – REQUISITES

8. High-containment Drugs Manufacturing Plant
Performance Qualification Phases
 Pre-Qualification Phase
 Phase I
 Phase II
 Phase III
Conformance of Quality Attributes of
commissioned items.
Investigation Phase
Short Term Control
Long Term Control

9. SAMPLING & TESTING
 Pre-Qualification Phase  Performed in last Qualification
 Phase I  Daily (Monday to Friday) – 15days
 Phase II  Daily (Monday to Friday) – 15days
 Hold Time Study  Performed in last Qualification
 Phase III  Weekly – 1year