SOPs

Physical and chemical quality control test of purified water

ABHA

 Physical and chemical quality control test of purified water

OBJECTIVE 

  • To provide the procedure of purified water quality control.

SCOPE

  • This procedure is applicable to the quality control of purified water in the sampling point.

RESPONSIBILITY 

  • Quality Control Analyst shall be responsible to follow the procedure mentioned in this SOP.

ACCOUNTABILITY 

  • Quality Control and Head QA Head shall be accountable for compliance of this SOP.

ATTACHMENTS 

  • Raw water analysis report  –  Attachment-I

PROCEDURE

  • Use 500 ml sample bottle with a stopper for sampling.
  • On the sample bottle write the name of sample, place and date of sampling.
  • Allow water to run for 2-3 min. before sampling.
  • Fill the sample bottle to the brim level to avoid any gaseous contamination.
  •  Analyze water as per BP specification.
  • Carry out the following tests every Monday from the point No.5: Description, Nitrates, Heavy Metals, Acidity or Alkalinity, Oxidisable Substances, Chlorides, Sulphates, Ammonium, Calcium and Magnesium, Residue on Evaporation, pH, Conductivity.
  • Purified water is sampled daily and analyzed only for the following parameters: Description, pH, Conductivity.
  • From other points sampling is carried out as per the approved plan.
  • Perform the analysis in duplicate if results are erroneous.
  • Report any unusual observations to Lab. In-Charge.

REFERENCES

  • In-house

ABBREVIATIONS 

  • None

DISTRIBUTUON LIST 

  • Quality Assurance Department
  • Quality Control Department
  • Engineering Department

HISTORY OF REVISION

 Attachment-I

Raw water analysis report 

Name of productPurified waterSpec-n No. (Code)
Grade:Manufacturer

Supplier:

Batch No.:
Quantity:Date of samplingQuantity sampledPoint:
Mfg. date:
S. No.Test parameterSpecificationObservation

Remarks: the product complies with the specification

Prepared By:Approved By:
Date:Date:

 

ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube