Procedure For Sampling and Testing of Purified, Raw and R.O. Water
1.0 Objective
Objective of this Standard Operating Procedure is to provide guidelines for
Sampling and Testing of Purified, Raw & R.O Water.
2.0 Scope
Standard Operating Procedure is to provide guidelines for Sampling and Testing of Purified, Raw and
R.O Water in quality control department at abc company.
3.0 Responsibility
3.1 Executive – Quality Control.
3.2 In charge/Head-Quality Control.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QC : Quality Control
CC NO : Change Control Number
cGMP : Current Good Manufacturing Practice
G : General
5.0 Procedure
5.1 General procedure:
5.1.1 Clean the bottles with tap water and rinse with Teepol solution. Rinse with tap water 2 to 3 times.
Final rinse with DM water for the complete removal of residue of tap water.
5.1.2 Label all the bottles with sticker as per sampling point.
5.2 Sampling procedure:
5.2.1 Disinfect the sampling point with IPA solution & open the valve of specified sampling point
and allows the water to flow for at least 1-2 minutes.
5.2.2 Rinse the bottle 3 times with the specified water sample and then collect the water sample.
5.2.3 Follow the same sampling procedure for all sampling points for procuring water samples.
5.3 Precautions:
5.3.1 Sampling points should be properly mentioned on the labels.
5.3.2 Do not drain too much of sampled water.
5.3.3 Do not fill the water samples in bottles up to the brim. Leave at least 6-8 mm
headspace between water level and bottle cap.
5.3.4 Analyses the water samples immediately after collection.
6.0 Forms and Records
6.1 None.
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Assurance, Quality Control
8.0 History
| Revision Number | Details For Change |
Reason for Revision |
| 00 | New SOP | NA |
Online Rejection in parenteral
Receipt of Batch from Production to Packing Department
sop for for Spillage Handling in parenteral area
sop for calibration of vessels with dipstick
sop for Cleaning of Bins and Containers
cip of mixing vessel and holding vessel
sop for Cleaning of Ampoule Filling and Sealing Machine
sop for Fogging in Sterile and Non Sterile Area
sop for for Filtration of Bulk Solution
sop for fumigation in production area
sop for post cleaning after media fill
sop for cip of mixing vessel mixing mobile vessel and holding vessel
sop for De-Bagging of Three Piece Vial Dropper Caps
sop for calibration and verification of check weigher
sop for Batch number and Manufacturing and Expiry Date Coding System
standard operating procedure machine history file
sop for operation and cleaning of Hand coder
sop for Cleaning and Handling and Silicone Tubes
sop on operation and cleaning of coating pan
sop for Operation of cleaning of pipe lines
sop for operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
sop for monitoring of reprocessing of products
sop for in-process control on liquids orals
sop for in process controls on tablets capsules packaging line
sop for Issuance retrieval and destruction of BMR and analytical records
sop for in process controls during granulation compression coating inspection
sop for Cleaning of Blister packing machine
sop for for charge hand over between the shifts
Performance requalification report of visual inspectors
sop for Cleaning and operation of ROPP caps inspection table
sop for usage and destruction of filter pad and cartridge filter
sop for cleaning and storage of transfer pipe
sop for Cleaning and operation of labeling machine
Cleaning and operation of the mono block filling and sealing machine
sop for Cleaning and operation of empty bottle inspection table
sop for Cleaning and operation of filter press
sop for cleaning and operation of liquid transfer pump and line
sop for cleaning and operation of storage vessels
sop for cleaning and operation of sugar syrup manufacturing vessel
sop for cleaning issuance and retrieval of accessories and change parts
sop for Cleaning and operation of visual inspection conveyor belt
sop for Cleaning and operation of spray gun and assemble
sop for Fogging in Aseptic and Non Aseptic Area
Cleaning And Assembly Of Tube Filling Machine
Proper Handling of Non Recoverable Residues
sop for Handling Of Off Line Packing
Air Washing Of Collapsible Tube
Handling Of Dispensed Material
Procedure for House Keeping in quality Control Department
Procedure For Rounding off procedure for analytical numeric values
Procedure For Stability product handling and testing
Procedure For Sampling and Testing of Purified Raw and R O Water