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Procedure for analysis of Water

1.0

PURPOSE
To lay down the procedure for the analysis of water.

2.0

SCOPE
Applicable to all sampling points of water system as per the Annexure-II.

3.0

RESPONSIBILITY
Microbiologist

4.0

PROCEDURE
Collect the sample as per Standard operating Procedure for water sampling and
analysis for chemical and microbiological parameters as per their specifications.

4.1

Chemical Analysis
Prepare the solutions/ reagents as per Annexure-I for chemical analysis.

4.1.1

Description
Examine the water physically such as Colour, Odour.

4.1.2

Hardness
Take 100 ml sample add 2 ml of ammonia buffer pH 10.0, 50 mg of mordant
black 11 mixture and add of 0.01 M disodium edetate until, a pure blue colour is
produced. Measures the volume of disodium edetate used and calculate the
hardness by the following formula.
Hardness as mg/L = ml of EDTA used x 1000 mg/L
Sample volume

4.1.3

Total Suspended Solids (TSS)

Take the gouch crucible clean and dry in oven for one hour at 105C, Cool the
gouch crucible in desiccator and take the empty weight ofgouch crucible and
then filter the 30 ml water sample from the gouch crucible with the help of
vacuum pump and calculate the TSS with the help of the formula.
TSS =

W2-W1
1000 (mg/L).
ml of solution taken

W1 : Weight of Gouch crucible before filtration

W2 : Weight of Gouch crucible After filtration
4.1.4

Total dissolved solids (TDS)

Measure the conductivity at 25 C with a calibrated conductivity meter and
convert the value in TDS by the following formula.
TDS in mg/L= conductivity in S X 0.667 (Geographical factor of area)

4.1.5

Acidity

Take 10 ml sample freshly boiled and cooled sample, add 0.05 ml of methyl red
solution and mix, the resulting solution is not red.
Interpretation of result: If the solution is in red colour the sample is Acidic
4.1.6

Alkalinity
Take 10 ml sample freshly boiled and cooled sample, add 0.1 ml of
bromothymol blue solution and mix.
Interpretation of result: If the solution is in blue colour the sample is Alkaline.

4.1.7

Ammonium
Take 20 ml sample add 1 ml of alkaline potassium mercuri-iodide solution and
allow standing for 5 minutes. When vertically viewed the solution is not more
intensely coloured than a solution prepared at the same time by adding 1 ml of
alkaline potassium mercuri-iodide solution to a solution containing 2.5 ml of
dilute ammonium chloride solution and 7.5 ml of the liquid being examined.

4.1.8

Calcium & Magnesium

Take 100 ml sample add 2 ml of ammonia buffer pH 10.0, 50 mg of mordant
black 11 mixture and 0.5 ml of 0.01 M disodium edetate, a pure blue colour is
produced.

4.1.9

Heavy Metals
In a glass-evaporating dish evaporate 150 ml of sample to 15 ml on a water
bath.
Standard solution
Into a small Nessler Cylinder, pipette 10.0 ml of lead standard solution (1ppm
Pb).
Test Solution
Pipette 12 ml into a small nessler cylinder.

Procedure
To the cylinder containing the standard solution add 2.0 ml of the test solution
and mix. To each cylinder add 2 ml of acetate buffer pH 3.5, mix, add 1.2 ml
of thioacetamide reagent, allow to stand for 2 minutes and view downwards
over a white surface, the colour produced with the test solution is not more
intense than that produced with the standard solution.
4.1.10

Chloride
Take 10 ml sample add 1 ml of 2 M nitric acid and 0.2 ml of 0.1 M silver
nitrate, the appearance of the solution does not change for at least 15 minutes.

4.1.11

Nitrate
Take 5 ml sample in a test tube immersed in ice add 0.4 ml of a 10% w/v
solution of Potassium chloride, 0.1 ml of diphenylamine solution and drop wise
with shaking 5 ml of sulphuric acid. Transfer the tube to a water bath at 50C to
allow standing for 15 minutes. Any blue colour in the solution is not more
intense than that in a solution prepared at the same time and in the same manner
using a mixture of 4.5 ml of nitrate free water and 0.5 ml of nitrate standard
solution (2 ppm NO3).

4.1.12

Sulphate
Take 10 ml sample add 0.1 ml of 2 M Hydrochloric acid and 0.1 ml of barium
chloride solution. The appearance of the solution does not change for at least 1
hour.

4.1.13

Oxidisable substances
Take 100 ml sample add 10 ml of 1 M sulphuric acid and 0.1 ml of 0.02 M
potassium permanganate and boil for 5 minutes, the solution should remain
faintly pink.

4.1.14

Residue on evaporation
Evaporate 100 ml sample to dryness into hot plate and dry to a constant weight
at 105C. The residue weighs not more than 1 mg (0.001%).
Residue on evaporation:

W2-W1

100 (mg/L)

ml of solution taken
W1 : Weight of Evaporating dish
W2 : Weight of Evaporating dish + Residue
4.1.15

Total Organic Carbon

4.1.15.1

Analyse the sample for TOC in a calibrated TOC Analyser as per SOP.
Alert and Action limit for Total Organic Carbon of water system

S.No.

Type of Water

Alert Limit (ppb) Action Limit (ppb)

Purified water

290.0

500

Water for injection

240.0

500

Pure Steam

240.0

500

4.1.15.2

If the TOC results are above alert and action limit, follow the SOP.

4.1.16

Conductivity
Take the 100 ml sample in a suitable container, and stir the test sample by
maintaining the temperature 25C 1C, measure the conductivity with the
help of calibrated conductivity meter.

Temperature and the respective Conductivity.

Temperature (C)
0
5
10
15
20
25
30
35
40
45

Conductivity S cm 1
0.6
0.8
0.9
1.0
1.1
1.3
1.4
1.5
1.7
1.8

50
55
60
65
70
75
80
85
90
95
100
4.1.17

1.9
2.1
2.2
2.4
2.5
2.7
2.7
2.7
2.7
2.9
3.1

pH
Take 100 ml of sample and add 0.3 ml of saturated KCL solution. Mix the
solution well and then measure the pH with the help of Calibrated pH meter.
NOTE : If results are observed out of limit in chemical analysis of water,
follow the SOP.

4.2

Microbiological Analysis
Analyse the water samples for Microbiological analysis as per specifications.

4.2.1

Pour Plate Method

Dispense one ml of sample into two petridishes. Approximately add 15-20 ml of
R2A / Plate count Agar into each petridishes. Cool the media approximately
45C (feel on the dorsal side of the hand, it should be bearable). Cover the
petridish, mix the sample with the agar by tilting or rotating the dishes and
allow the contents to solidify at room temperature. Invert the petridishes and
incubate at 30-35C for 5 days. After incubation, examine the plates for growth,
count the number of colonies and express the average for the two plates in terms
of the number of colony forming units per ml.

4.2.2

Membrane Filtration Technique

The procedure gives the use of a single disposable/ autoclaveable filtration
funnels and filter holder, using MILLIFLEX system.

Preparation of the Filtration apparatus

Operate the Milliflex as per its SOP. Use sample size as specified in the
specification for filtration through the 0.45 filter.
After completion of filtration of sample, rinse the filter with 100 ml sterile
water remove the filter using sterilised forceps and transfer it immediately to the
previously prepared petri-dish with appropriate medium (R2A agar/Plate count
agar).
Place the membrane carefully so that the air should not be trapped inside the
filter, as this will prevent nutrient medium from reaching the entire membrane
surface. Replace the lid. Incubate the plates in upright position (in case of filter)
at 30-35C for 5 days. Count the number of colonies on the membrane and
express the results as per specification.
4.2.3

Bacterial Endotoxin Test Refer the SOP.

4.2.4

Pathogens
The sample shall be tested for the following four specific pathogens.
Salmonella species
Escherichia coli
Pseudomonas aeruginosa
(D)
Staphylococcus aureus
Filter 100 ml of water sample through the 0.45 membrane filter fixed on
Milliflex system. After filtration remove the filter aseptically and put it in 100
ml Soyabean Casein Digest Medium and incubate at 30-35C for 24-48 hours.
From Soybean Casein Digest Medium, inoculate sterile 10 ml volumes of the
following enrichment broths using 1 ml of inoculated broth

1.
2.
3.
4.
5.

Selenite Cystine Broth for Salmonella species.

Tetrathinate Broth for Salmonella species.
MacConkeys Broth for Escherichia coli
Cetrimide Broth for Pseudomonas aeruginosa
Giolitti Cantoni Broth for Staphylococcus aureus (use sterile liquid paraffin for
anaerobic conditions).

Incubate the tubes for 24-48 hours at 30-35C.

(A)

Test for Salmonella species:

If growth is present in Selenite Cystine Broth and Tetrathionate Broth, inoculate
the following selective media plates and incubate at 30-35 C for 24-48 hours
for presumptive identification of the pathogen.

Medium
Xylose-Lysine
Deoxycholate
medium
Bismuth Sulphite agar medium

Description of Colony
agar

Brilliant Green agar

Red with or without Black Centre

Black or Green colonies
Small, transparent, colourless or pink
to
white
Opaque
(frequently
surrounded by pink to red zone)

Confirmatory Test
From the selective media plates pick the suspected colonies and go for
confirmatory tests with the following biochemical/media and by gram reaction.
Individually transfer the suspected colony by first streaking the slope of slant,
of Triple Sugar-Iron Agar with inoculating loop and then stabbing with
inoculating straight wire well in the butt.
Incubate at 30-35 C for 24-48 hours
After incubation, examine the tube of Triple Sugar Iron Agar Medium for the
presence
of
microbial
growth and for the following Physical
characteristics.
(a) Slant Surface

: Alkaline reaction (red colour)

(b) Butt
: Acid reaction (yellow colour) and/or gas bubble (with or
without concomitant blackening).
If the butt, slant of Triple Sugar Iron Agar shows growth and physical
characteristics confirming to the above descriptions the presence of Salmonella
species is indicated.

(B)

Test for Escherichia coli

If the inoculated MacConkeys broth tube shows acid and gas formation,
inoculate the following selective media plates and incubate at 30-35C for 2448 hours for presumptive identification of the pathogen.
Medium
Description of Colony
Brick red may have surrounding zone
MacConkeys Agar
of precipitated bile.
Eosin Methylene Blue Agar
Metallic sheen with dark grey colonies
Confirmatory Test
From the selective media plates pick the suspected colonies and go for
confirmatory tests into the following bio-chemicals/media and by gram
reaction.
Add 0.1 ml of the contents of the tube showing acid and gas to tubes containing
10 ml of peptone water
From peptone water tube perform Indole test as follow
Add 0.5 ml of Kovacs reagent to peptone water tube, allow to stand for one
minute, if a red colour is produced in the reagent layer indole is present
The presence of acid and gas in MacConkey's broth, in peptone water and
indole, indicates the presence of Escherichia coli.
Presence of Escherichia coli shall be confirmed by Gram staining (Gram-ve
rods) and by streaking a loopful of the MacConkeys broth, with acid and gas
production on plates of MacConkey Agar, and Levine Eosin Methylene Blue
Agar.
Incubate the plates at 30-35C for 24-48 hours.
If after incubation, plates shows colonies of following characteristics presence
of Escherichia coli is confirmed.
MacConkeys Agar: Brick red colonies with or without surrounding zone of
precipitates.

Levine Eosin Methylene blue Agar: Colonies with characteristic of metallic

sheen under reflected light and blue-black appearance under transmitted light.
(C)

Test for Pseudomonas aeruginosa

If the inoculated Cetrimide broth tube shows growth with greenish/bluish
pigmentation, inoculate the following selective media plates and incubate at 3035C for 24-28 hours for presumptive identification of the pathogens.

Medium
Cetrimide Agar

Pseudomonas Agar (For Pyocyanin)

Pseudomonas Agar (For Fluorescein)

Description of Colony
Greenish colonies, which exhibit a
greenish fluorescence under ultra violet
light.
Colourless to yellowish, yellowish
under ultra violet light.
Colourless to yellowish, yellowish
under ultra violet light.

Confirmatory Test
From the selective media plates pick the suspected colonies and go for
confirmatory tests
Streak suspected colony on Pseudomonas Agar for Fluorescenin (PAF)
Detection and Psedomonas Agar for Pyocyanin (PAP) Detection using
inoculating loop. Incubate the plates in inverted condition at 30-35C for 24-28
hours. Simultaneously inoculate the suspected colony in 100 ml of Soyabean
casein digest medium and incubate at 41 to 43C for 18 to 24 hours.
After incubation, examine the plates and tube of Soyabean casein digest
medium for the presence of microbial colonies of Gram-Negative rods
exhibiting following characteristics. Pseudomonas Agar for fluorescenin
detection: Colourless to yellowish fluorescence under ultra violet light.
Pseudomonas Agar for Pyocyanin Detection: Greenish colonies, which exhibit a
blue fluorescence under ultra violet light. Soyabean casein digest medium:
Growth occurs.
If colonies are found confirming to above descriptions, Oxidase test shall be

performed to confirm identification as follow:

With the aid of an inoculating loop, transfer suspected colonies to strip or discs
of
filter
paper
impregnated
with N,
N-dimethyl-pphenylenediamine dihydrochloride.
If a Pink-Purple colour is produced within five to ten seconds, the presence
of Pseudomonas aeruginosa is confirmed.
(D)

Test for Staphylococcus aureus

If growth is present in Giolitti Cantoni (G.C) broth, usually characterized by
black settled growth at the bottom of the broth under anaerobic conditions,
inoculate the following selective media plates and incubate at 30-35C for 2428 hours for presumptive identification of pathogen.
Medium
Mannitol Salt Agar Medium
Vogel Johnson Agar Medium
Baird Parker Agar Medium

Description of Colony
Yellow colonies with yellow zones
Black surrounded by yellow zone
Black, shiny, surrounded by clear
zones of 2-5 mm

Confirmatory Test
From the selective media plates pick the suspected colonies and go for
confirmatory tests
If colonies are found confirming to the above descriptions identification shall be
performed by a coagulase test as follow.
With the aid of an inoculating loop, individually transfer suspected colonies to
separate tubes containing 0.5 ml of mammalian plasma (preferably rabbit or
horse).
Incubate in a water-bath / incubator at 370C for 3 to 24 hours, in parallel with
positive control using known strain of Staphylococcus aureus and negative
control using Plasma alone.
Examine after 3 hours and at suitable intervals thereafter for the presence of
coagulation.
If coagulation in any degree is observed, the presence of Staphylococcus
aureus is indicated. And perform the gram staining for the presence of gram

Positive cocci.
4.2.5

Coli forms
Filter 100 ml of test sample and transfer the filter to M-Endo agar and incubate
at 35C for 22-24 hrs count colonies that are pink to dark red with a green
metallic surface sheen, the sheen may vary from pinpoint to complete coverage
of colony. Report the as number of Coliforms colonies per 100 ml.

4.2.6

After completion of testing prepare a test report according to Annexure-II.

4.2.7

If the counts obtained are above the limits specified below investigate the
results and take necessary actions as per SOP.

4.3

Alert and Action limit for TAMC of water system

S.No
1
2
3
4
5
6
7

Type of water
Raw water
Soft water
Potable water
Drinking water
Purified water
Water for injection
Pure steam

Alert limit
143
134
167
108
50
3
3

Action limit
500
500
500
500
100
10
10

If the Microbial results are above alert and action limit, follow the SOP
No. SOP/QCM/028
5.0

ABBREVIATIONS AND DEFINITIONS

SOP
QCM
QAD
Rev.
No.
M

Standard Operating Procedure

Quality Control Microbiology
Quality assurance Department
Revision
Number
Molarity

mg
TSS
TDS
ppm
TOC
%
C
PAF
PAP
G.C
TAMC
mL

Milli gram
Total Suspended Solids
Total Dissolved Solids
Parts per million
Total Organic Carbon
Percent
Degree Centigrade
Pseudomonas agar for Fluorescenin
Pseudomonas agar for Pyocyanin
Giolitti Cantoni broth
Total Aerobic Microbial Count
Milli litre

Action limit: Established criteria, requiring immediate follow-up and corrective action if
exceeded
Established criteria giving early warning of potential drift from normal
condition which are not necessarily grounds for definitive corrective action but
which require follow-up investigation.
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Topic List

Microbial Limit Test of Raw material and Finished product

Operation and Calibration of Conductivity meter

Operation and Cleaning of Microscope

Operation of Milliflex Water filtration Unit

Pharmaceutical sample SOP, example SOP, SOP format, SOP templates

Procedure for Operation, Calibration, and System Suitability of Total Organic

Carbon (TOC) Analyser

SOP For Operation And Calibratioin of Polarimeter

SOP For Backup/Restore And Archival of Analytical Data,In Electronic Form

SOP For Calibration Of Glasswares

SOP For Calibration Procedure of BOD / Bacteriological Incubator

SOP For Cleaning And Operation of Horizontal Autoclave

SOP For Cleaning Of Quality Control Laboratory

SOP For Cleaning Of Sampling Equipment

SOP For Cleaning of microbiology lab

SOP For Entry/Exit Procedure For Quality Control Laboratory

SOP For HPLC Analysis And Documentation

SOP For Identification Of Micorganisms

SOP For Maintenance Of Desiccator

SOP For Monitoring Of Raw And Potable Water Quality

SOP For Operation And Calibration Of FT-IR Spectrometer

SOP For Operation And Calibration Of Leak Test Apparatus

SOP For Operation And Calibration Of Tap Density Apparatus

SOP For Operation And Calibration Of Water Bath

SOP For Operation And Calibration of Auto Titrator (Metrohm)

SOP For Operation And Calibration of Sieve Shaker

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SOP For Operation Of UV Cabinet

SOP For Operation of Bacteriological Incubator

SOP For Operation of HPLC System Using Chemistation Software

SOP For Preparation And Standardisation Of Volumetric Solution

SOP For Preparation of Culture Of Microorganism

SOP For Procedure For Glasswares Washing

SOP For Qualification of Facility/Equipments/Systems

SOP For Safety Measurs of QC Laboratory

SOP For Storage Of Sampling Tool

SOP For Validation Of Autoclave With Biological Indicator For Sterilization

Efficiency

SOP For handling of market complaints

SOP for Antimicrobial effectiveness testing

SOP for Cleaning and Operation of Anaerobic Culture Jar

SOP for Cleaning of Glassware

SOP for Deaeration of Dissolution media

SOP for Disposable of mediafill vials after incubation

SOP for Entry and Exit procedure for microbiology testing area and Sterility
testing area

SOP for Identification of microbial cultures using biomeriux identification system

SOP for L.O.D. oven

SOP for Microbial staining procedures

SOP for Monitoring of Compressed Air/Gases for Microbiological, Non-Viable

Particulate, Oil and Moisture Content

SOP for Operation and Calibration of Conductivity meter

SOP for Operation and Calibration of Top Pan Balance

SOP for Operation and Cleaning of Colony Counter

SOP for Operation and Cleaning of Garment Cubicle

SOP for Operation and Cleaning of Pass box

SOP for Operation and Cleaning of Vertical Portable Autoclave

SOP for Operation and Maintenance of Sterilization Reel Sealer

SOP for Operation and Performance qualification of Biomerieux Kit (mini API,
Densimat and Electronic pipette)

SOP for Operation of Rady Count Down Timer

SOP for Personnel Qualification of personnel entering into Aseptic area and
Sterility Testing area

SOP for Post Sterility Growth Promotion Test

SOP for Preparation of Trends

SOP for Procedure For Bioburden, BET, And LPC Of Primary Packaging Materials

SOP for Procedure for Bacterial Endotoxin (LAL) test

SOP for Procedure for Die Blocking

SOP for Procedure for Handling of Out Of Limit Results in Environmental

Monitoring and Water Analysis.

SOP for Procedure for Operation of Deduster Cum Metal Detector

SOP for Procedure for Receipt of Raw and Packing Material

SOP for Procedure for Storage and Preparation of Microbiological Culture Media

SOP for Procedure for preparation of dresses for sterilization.

SOP for Sampling and Testing of Pure Steam

SOP for Sterility Testing Using Manifold For Dilution Study and Stability

SOP for Swab sampling for validation of test surface to evaluate cleaning efficacy.

SOP for Testing of Particulate Matter in Injections and Operation and Maintenance
of Liquid Particle Counter

SOP for a procedure for preparation of the volumetric solutions

SOP for allocating identification number to instrument/ equipment

SOP for bacteriological incubator

SOP for calibration Total Organic Carbon (TOC) Analyser

SOP for calibration of HPLC column oven

SOP for calibration of pH meter temperature sensor

SOP for calibration of Autotitrator

SOP for calibration of Gas chromatograph

SOP for calibration of Head Space Gas Chromatograph

SOP for calibration of Polarimeter

SOP for calibration of autotitrator

SOP for calibration of balance

SOP for calibration of conductivity TDS meter

SOP for calibration of disintegration test apparatus

SOP for calibration of hardness tester

SOP for calibration of infrared moisture balance

SOP for calibration of karl fischer apparatus

SOP for calibration of plunger operated pipette

SOP for calibration of refractometer

SOP for calibration of the refractometer

SOP for calibration of walk-in- incubators 20-25c and 30-35c

SOP for calibration procedure of u.v.cabinet

SOP for careful handling of poisonous chemicals

SOP for check suitability of dissolution test apparatus

SOP for cleaning and disinfection

SOP for cleaning and operation of RLAF unit in Sampling Room

SOP for cleaning and operation of incubator

SOP for cleaning for DHS

SOP for cleaning of Dispensing & Sampling Room

SOP for cleaning of Metrohm Karl fisher

SOP for cleaning of Vertical Autoclave

SOP for cleaning of automatic distillation apparatus

SOP for cleaning of colony counter

SOP for cleaning of disintegration test apparatus

SOP for cleaning of dissolution tester

SOP for cleaning of friability test apparatus

SOP for cleaning of melting point apparatus

SOP for cleaning of oven for incubator at 55c

SOP for cleaning of slit to agar air sampler

SOP for cleaning of tablet hardness tester

SOP for cleaning procedure for Alu-Alu Packing Machine

SOP for cleaning procedure for Automatic Coating System

SOP for cleaning procedure for Blister Packing Machine

SOP for cleaning procedure for Colloidal Mill

SOP for cleaning procedure for Deblistering machine

SOP for cleaning procedure for Dehumidifier

SOP for cleaning procedure for EPD Collator machine with strip packing machine
line

SOP for cleaning procedure for FBD Bag

SOP for cleaning procedure for Hose Pipe Of Dust Extraction System

SOP for cleaning procedure for Mini roll compactor

SOP for cleaning procedure for Paste Kettle

SOP for cleaning procedure for Rapid Mixer Granulator (R.M.G.)

SOP for cleaning procedure for Semi-Automatic Cartoning Machine

SOP for cleaning procedure for Strip Packing Machine

SOP for cleaning procedure for Vacuum Cleaner

SOP for cleaning procedure for brooke field viscometer

SOP for cleaning procedure for capsule filling cubicle

SOP for cleaning procedure for centrifuge

SOP for cleaning procedure for dissolution test apparatus

SOP for cleaning procedure for heating block

SOP for cleaning procedure for microbiological laboratory other than clean area.

SOP for cleaning procedure for multi mill

SOP for cleaning procedure for polarimeter

SOP for cleaning procedure for semi auto induction cap sealing machine

SOP for cleaning procedure for u.v. /visible spectrophotometer

SOP for cleaning procedure for ultrasonic bath

SOP for cleaning procedure for water bath

SOP for cleaning procedure for zone reader

SOP for cleaning procedure of balances

SOP for cleaning procedure of deep freezer

SOP for cleaning procedure of puncture resistance tester

SOP for cleaning procedure of sterile dress cabinate

SOP for collection and storage of retained samples of packaging material

SOP for control of master data generation by computer system

SOP for destruction of control samples (Raw material and Finished product)

SOP for dispensing and issuing of Packing Material as per the requirement from
Production Department

SOP for disposal of expired chemicals, reagents, solvents and micro-biological

medium.

SOP for disposal procedure for media containing growth

SOP for environmental monitoring of dispensing and sampling area in raw

materials

SOP for environmental monitoring of solid dosage form area by non viable air
particle count

SOP for evaluation of environmental monitoring results (trend analysis)

SOP for for measurement of particle size of raw materials using microscopic
method

SOP for general test procedure

SOP for gowning procedure for the visitors

SOP for guideline for storage condition of raw material

SOP for hand wash procedure

SOP for handling and control for the prohibited items

SOP for handling and testing of various samples

SOP for handling of glassware

SOP for handling of spillage of solid/liquid media containing growth

SOP for heat distribution study in chamber of depyrogemation oven using

different probe with data logger

SOP for heat distribution study in oven using multi probe data logger

SOP for hplc column receipt checking and regeneration

SOP for identification of organisms

SOP for inventory and issuances of media in quality control lab

SOP for investigation of sterility test failure

SOP for laboratory safety

SOP for laminar air flow workstation

SOP for logic for giving number to the method for analysis of finished product and
raw material

SOP for maintenance & cleaning procedure for sampling equipment

SOP for maintenance of desiccator

SOP for media disposal

SOP for method for programme file checks of software of instruments

SOP for microbial limit test for raw materials and finished products

SOP for microbial testing of drain water

SOP for microbiological monitoring of clean equipment in to solid dosage area.

swab method

SOP for muffel furnace

SOP for operating procedure of Dehumidifier

SOP for operating procedure of culture cabinet

SOP for operating procedure of double door autoclave

SOP for operating procedure of laminar air flow

SOP for operation and calbration of dry bath

SOP for operation and calibration of bursting strength tester

SOP for operation and calibration of pH meter (GMPH)

SOP for operation and calibration of tablet disintegration apparatus

SOP for operation and cleaning of LAF unit in Sampling Room

SOP for operation and monitoring of performance of garment cabinet

SOP for operation of magnetic stirrer with hot plate

SOP for operation of particle counter

SOP for operation of sonicator

SOP for operational check of friability test apparatus

SOP for oven for depyrogenetion

SOP for palm swabbing

SOP for performance check of UV - visible spectrophotometer (Jasco)

SOP for performance check of autodiluter

SOP for performance checks of karl fischer apparatus

SOP for physical monitoring of microbiology section

SOP for preparation and handling of primary standard

SOP for preparation of bench reagents

SOP for preparation of sterile petridishes, agar slants and agar butts

SOP for procedure environmental monitoring of parenteral processing area : by

settling plate count method.

SOP for procedure for DOP testing (Integrity Testing) of HEPA filter

SOP for procedure for Operation and cleaning of Automatic Batch Printing Machine

SOP for procedure for Operation of Automatic Capsule Filling Line

SOP for procedure for Operation of Batch Printing Machine (Semi Automatic)

SOP for procedure for Operation of Compression Machine 20 station (Single

Rotary Type)

SOP for procedure for Operation of Deblistering Machine

SOP for procedure for Operation of Drum mixer

SOP for procedure for Operation of Multimill

SOP for procedure for Operation of Paste Kettle

SOP for procedure for Operation of Stirrer

SOP for procedure for Operation of Tablet Inspection machine

SOP for procedure for Operation of Vibro Sifter

SOP for procedure for Ordering, Receiving, Storage, Issue, & Destruction of Dies &
Punches

SOP for procedure for Pre Filter cleaning of RLAF

SOP for procedure for Receipt, Issuance, Storage and Handling of solvent

SOP for procedure for Tablet granulation, compression and coating

SOP for procedure for action to be taken during spillage/breakage of materials

SOP for procedure for analyst validation

SOP for procedure for calibration of instruments

SOP for procedure for carrying out air borne particle count in static condition

SOP for procedure for cleaning and maintenance of boilers

SOP for procedure for cleaning installation, operational and performance

qualification of equipment / instruments.

SOP for procedure for cleaning of barrel pump & pipe

SOP for procedure for cleaning of clean area

SOP for procedure for cleaning of equipment and accessories in Production Area

SOP for procedure for cleaning of microbiological glassware

SOP for procedure for collection and storage of control sample

SOP for procedure for cooling towers

SOP for procedure for destruction of rejected materials

SOP for procedure for electrical safety

SOP for procedure for entering in sterility testing room

SOP for procedure for environmental monitoring of aspetic area: finger prints and
gown sampling

SOP for procedure for environmental monitoring of parenteral processing area :

surface testing by means of rodac plate and swab

SOP for procedure for fumigation in microbiology lab

SOP for procedure for handling of Rejected Raw Material

SOP for procedure for handling of sieves and screen

SOP for procedure for inspection of pressure vessels, lifts and chain pulley blocks

SOP for procedure for issuance of additional packaging materials

SOP for procedure for maintaining and up-keeping the facility

SOP for procedure for making production related entries in SAP system

SOP for procedure for measurement of air velocity and calculation of air changes
per hour for classified areas

SOP for procedure for operating and cleaning of Vacuum Cleaner

SOP for procedure for operation after M.S.E.B. power failure

SOP for procedure for operation and calibration of precision oven

SOP for procedure for operation and maintenance of low tension (L. T.) panels

SOP for procedure for operation of EPD Collator coupled with strip packing
machine

SOP for procedure for operation of axial flow fan units (supply and return)

SOP for procedure for operation of conveyor belt in packing

SOP for procedure for operation of high tension (H.T.) panel

SOP for procedure for operation of semi auto induction cap sealing machine

SOP for procedure for operation of the domestic hot water system

SOP for procedure for overprinting of batch details on cartons and catch covers

SOP for procedure for performance of automatic distillation apparatus

SOP for procedure for preparation of reagent solution

SOP for procedure for preparation of working standards

SOP for procedure for proper disposal of expired finished goods

SOP for procedure for reanalysis of raw material

SOP for procedure for recleaning

SOP for procedure for recording of Temperature & Humidity in Stores Department

SOP for procedure for recording of Temperature in Production Department

SOP for procedure for return of Raw & Packing materials from production
department

SOP for procedure for safe unloading of chemicals, furnace oil and high-speed
diesel from vehicle inside the factory premises

SOP for procedure for sampling and testing schedule of water for injection and
clean steam

SOP for procedure for sanitization of purified water generation system using hot
water

SOP for procedure for stability studies of finished goods

SOP for procedure for stenciling of shippers used for packing

SOP for procedure for storage & transference of dispensed raw material in day
store

SOP for procedure for temperature mapping

SOP for procedure for testing and release/rejection of packing materials

SOP for procedure for the Blister Pack Machine

SOP for procedure for the intimation of break down of utilities services &
equipments in manufacturing & packing department during working

SOP for procedure for the operation of Semi-Automatic Cartoning Machine (VP120)

SOP for procedure for the passivation of purified water storage tank and
distribution piping

SOP for procedure for transfer of the finished goods to bonded store room

SOP for procedure for validation of microbiologist

SOP for procedure for vessels operated greater than atmospheric pressure

SOP for procedure of fumigation in production area by using 5 % Gramicid and

Fogger

SOP for procedure to specify the responsibilities of production department

SOP for quantification of culture

SOP for receipt and maintenance of working standards of API

SOP for release of finished product

SOP for retesting schedule of packaging material

SOP for retesting schedule of raw material (for API)

SOP for routine cleaning verifictaion by TOC-SSM method

SOP for sampling and release of Inprocess samples

SOP for sampling and testing schedule of purified water

SOP for sampling of packing material

SOP for selection criteria and its procedure before dissolution profile study

SOP for statistical study for trend analysis of purified water and water for
injection

SOP for sterile dress cabinet

SOP for storage and use of reagents & chemicals

SOP for testing for bioburden of fractional solutions

SOP for testing of miscellaneous sample

SOP for training procedure for qc persons

SOP for ultrasonic cleaner

SOP for validation of DHS with biological indicator

SOP for validation of autoclave with biological-indicator

SOP for validation of oven for depyrogeneation.

SOP for verification of system suitability test measured by chrom card software
for GC

SOP for writing method of analysis for P.M

SOP procedure for preparation and Bioburden monitoring of IPA 70% V/V

WHO SOP list for Pharma Microbiology

WHO SOP list for Pharma Quality Assurance

WHO SOP list for Pharma Quality Control Cleaning

Water sampling procedure