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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 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. Oxidisable 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


  • NOTE: Before using water for manufacturing of any product, the water sample should be tested and passed by Q.C department.
  • Sampling Locations:
  1. Chemical Testing: Raw water, De-mineralized water
  2. Biological Testing: Raw water, De-mineralized water

REFERENCE(s)
Nil.

ABBREVIATION(s)
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(s)
Annexure No. – 1 - Purified water report

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