SOP for Testing Procedure of Water for Manufacturing Use

OBJECTIVE

To lay down a procedure for Testing Procedure of Water for Manufacturing Use.

SCOPE

This procedure applies to the pharmaceutical manufacturing facilities of XYZ Limited.

RESPONSIBILITY

The Quality Control Chemist is responsible for the implementation of the process.

The Quality Control Manager is responsible for the execution of the procedure.

PROCEDURE

• Purified water BP should be used for all manufacturing purpose.
• To ensure the quality of the water it should be subjected to all the tests as per BP daily and the report for water analysis should be filed. Tests to be carried out every day include the following:

1. pH
2. Conductivity
3. Oxidizable substances
4. Chlorides
5. Nitrates
6. Sulphates
7. Residue on evaporation

• To ensure the full analysis of water as per WHO guidelines it should be sent to Government Chemist Laboratory every two months.
• The following action limits are specified for the full analysis.

1. Microbiological Purity: Max. 100/ml (Absence of Pseudomonas species and E.Coli)
2. Conductivity: NMT 10 µS
3. Chemical Purity

ALSO READ: SOP for Sampling and Analysis of Wash Water from Production Equipment

• NOTE: Before using water for manufacturing of any product, the water sample should be tested and passed by the Q.C department.
• Sampling Locations:

1. Chemical Testing: Raw water, De-mineralized water
2. Biological Testing: Raw water, De-mineralized water

REFERENCE

Nil.

ABBREVIATION

SOP: Standard Operating Procedure

Q.A: Quality Assurance

No. : Number

Q.C: Quality control

µS: Micro siemens

TDS: Total dissolved solids

WHO: World Health Organization

ml: Milliliter

ANNEXURE

Annexure No. – 1 - Purified water report

REVISION HISTORY

Nil

ALSO READ: SOP for Statistical Analysis of Purified Water Trend