Microbiology Sop's

SAIKA PHARMACEUTICALS
Title : SOP FOR ENVIRONMENT MONITORING I''(e Date .an" /%&%
FOR RESTRICTED CIRCULATION

Department : MICROBIOLOG E))e*ti+e Date Fe0" /%&% 7"C" Mana1er Ne,t Re+ie- Date .an" /%&/ Appr!+e3 04 : 7"A" Mana1er
SOP N!" # CP$MBS$%%& Pa1e N!" : & t! 2 Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04
C5e*6e3 04
1. 2.
Objective: Scope:
To lay down a procedure for Environment Monitoring. The procedure of this SOP shall be applicable for Microbiology Department of Saika Pharmaceuticals !ohtak
3. 4. 5.
Responsibility: Accountability: Abbreviations:
Microbiologist ".#. Manager
S.O.P. $ "# "% 6. Procedure: $ $
Standard Operating Procedure "uality #ontrol "uality %ssurance
&.' &.)
!ecord the temperature ( humidity in the environmental monitoring chart. !egulate the %*# or Dehumidifier if the temperature of a particular area is out of the prescribed limit.
&.+
The limit is specified below$
Title : SOP FOR ENVIRONMENT MONITORING I''(e Date .an" /%&%

SOP N!" # CP$MBS$%%& Pa1e N!" : / t! 2 Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04
C5e*6e3 04
Area #orridors !aw material Stores 34on 5eta ( 5eta6 7nstrument !oom ( Micro-biology !oom #hemical 8aboratory "uarantine ( #ontrol Sample !oom Ointments ( 8otions ).
e!perature ),-)./# )+-)./# ),-)./# )9-+0/# ),-)./# ),-)./#
"u!idity .01 ma2. ,01 ma2. ,01ma2 .01ma2 ,01ma2 ,0-,,1
!ecord the result in the following format $
%rea 4ame$ #ate i!e e!perature $i!it "u!idity $i!it %&ec'ed by
Title : SOP FOR ENVIRONMENT MONIORING I''(e Date .an" /%&%

SOP N!" # CP$MBS$%%& Pa1e N!" : 8 t! 2 Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04
C5e*6e3 04
A.
R(%()*)+,: Pre (ntry %leanin'. ). +. <. %ll containers and package must be effectively cleaned before entering to manufacturing areas. #leaning is carried out as per suitable SOP. :acuum #leaner is used to prevent displacement of dust. ;ooden cases and crates must be opened outside the stored area and empty aces ( crates must be discarded. 7nterior surfaces of the areas where raw and packaging materials are received must not shed particles.
..
SA/P$)+,: '. ). +. <. ,. Elaborate SOP must be followed to ensure prevention of contamination of material. Sample only one material at one time and in a segregated cubicle or booth fitted with suitable air control systems will minimi=e the risk of contamination. >se dedicated tools for sampling. Prescribe and follow SOP for cleaning of tools used in sampling and periodically validated. Do not return residues of samples to original containers. Sampling of potent materials like steroids hormones beta-lacto and cyto-to2ic substances must be done under specific conditions or in separate areas to protect sampling personnel as well as other products. &. Sterile products must be sampled under aseptic conditions.

SOP N!" # CP$MBS$%%& Pa1e N!" : 9 t! 2 Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04
C5e*6e3 04
%.
#.
#)SP(+S)+, '. Dispensing stations or benches must be e?uipped with suitable dust e2traction systems. ). Dispense only one material at a time use cleaned scoops or measures for dispensing each materials even if the different materials are components of the same product. +. Effectively clean weighing e?uipment and dispensing bench after dispensing each material. <. %s far possible encourage the use of disposable gloves etc ,. To prevent displacement of dust do not use ceiling or tabletop fans during dispensing. &. Materials used for construction of inner surfaces of such areas must permit easy and effective cleaning and disinfections. PRO#0% )O+: '. Efficiency segregates each production activity. ). Provide ade?uate dust e2traction e?uipment. +. Evolve and follow suitable e?uipment cleaning procedures. Periodically validate them to confirm effectiveness. <. !egularly check and confirm integrity of oil seals. ,. To the e2tent possible use dedicated accessories such as filter finger bags dust covers sleeves etc. &. !ecord the temperature ( humidity in the environmental monitoring chart. .. !egulate the %*# or Dehumidifier if the temperature of a particular area is out of the prescribed limit. The limits for different sections are specified below. 9. !ecord of Temp. ( @umidity is maintained in the following format. A. Bor aseptic areas validation of air supply systems is very critical and special care must be taken to ensure that contaminants are not introduced through air handing system.

SOP N!" # CP$MBS$%%& Pa1e N!" : : t! 2 Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04
C5e*6e3 04
'0.
%ir supply for the production and dispensing areas must be designed to avoid contamination in to the airflows or to the manufacturing areas. The air supply system must be validated monitored and controlled to deliver air of appropriate ?uality. Documentation of the same must be maintained.
''. '). '+. '<.
The recommended limits for airborne particles and microbial contamination are as follows$ Cases supplied to manufacturing areas must be of the appropriate ?uality and care must be taken to see that they are not sources of contamination. %ir compressors used for supply of compressed air for product contact purposes and cleaning product contact surfaces must be of the oil free type. ;ater and steam generation and distribution systems must be designed to protect contamination of products and manufacturing areas. Monitoring and controlling of ?uality of water and steam are of great importance especially in aseptic manufacture.
',.
Potent and sensiti=ing products causing anaphylactic reactions like beta-lacto geota2is and se2 hormones must not be manufacturing in a general purpose facility. %de?uate segregation and*or separation must be ensured for handling these products.
'&.
Microbiological contamination is done by plate count method pathogens and fungal count should be nil in all sections.

SOP N!" # CP$MBS$%%& Pa1e N!" : ; t! 2 Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04
C5e*6e3 04
Crade
At rest Ma2imum permitted number of particles per cubic meter e?ual to or greater than 0.,Dm +,)0 +,)00 +,)000 ,Dm )A )A+ )A+0
At actual or si!ulated 1or'inMa2imum permitted number of Ma2imum permitted particles per cubic meter e?ual to number of viable or greater than micro-organisms per by settle plates method 0.,Dm +,00 +,)000 +,)0000 ,Dm )A )A+0 )A+00 E' , ,0
% 5 # D
+,)0000 )A+00 4ote defined 4ote defined '00 Crade Types of operations for aseptic preparations. % %septic preparation and filling. 5 5ackground room conditions for activities re?uiring Crade % # Preparation of solution to be filtered D @andling of components after washing 2or +on3sterile products Product 8ocation Particles Particles :iable 4 ,.0 D * m+ F 0.,D * m+ micro-organisms #fu * m+ Topical and Oral li?uids Point of 4MT )0 000 4MT + ,00 000 4MT '00 supply to mfg room where product is e2posed
%ll other nonsterile products
Point of supply to mfg room where product is e2posed
4MT )0 000
4ot applicable
4MT ,00

SOP N!" # CP$MBS$%%& Pa1e N!" : < t! 2 Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04
C5e*6e3 04
(. ,(+(RA$ '. Primary packaging components such as bottles caps etc. that are used in packaging should be handled only for one product at a time. 7f e2igencies demand handling of more than one product then segregate each primary packaging activity. ). Effectively clean every packaging e?uipment used in primary packaging before using the same for packaging another product. +. %ll personnel must be made aware of the ha=ards of contamination. <. %ll operating personnel must be attired in clean and suitable garments. ,. !egularly train operating in their respective functions to perform their tasks in a manner that prevents contamination. &. Ensure air supply is suitable filtered to minimi=e airborne contamination. .. ;ater being the most widely used material regularly monitors the ?uality particularly to control microbial contamination. 9. %ll personnel involved in the manufacture of non-sterile formulations must wear appropriate head covers dedicated footwear and clean overalls appropriate to the need for protection of materials and product. A. Personnel working with processes where materials and products are e2posed must wear gloves and e2cessive facial hair must be covered. '0. Personnel working in aseptic areas must use a fresh set of aseptic garments during each entry to aseptic areas. Cloves used in aseptic areas must be powder free. ''. Employees working in contact with material and products must be medically fit and free from contagious diseases.
'). Pipe works light fittings and other service lines must be designed and laid in such a way that recess which are difficult to clean are avoided.
Title: SOP FUMIGATION OF MICROBIOLOG LAB" SOP N!" # CP$MBS$%%/ Pa1e N!" : & t! & Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%&%

1. 2.
Objective: Scope:
To lay down a procedure for Bumigation of Microbiology 8ab. The procedure of this SOP shall be applicable for Microbiology
3. 4. 5.
6.
&.' &.) &.+ &.< &., &.&
Department of Saika Pharmaceuticals !ohtak. Responsibility: Microbiologist Accountability: ".#. Manager Abbreviations: S.O.P. $ Standard Operating Procedure "# $ "uality #ontrol "% $ "uality %ssurance %@> $ %ir @andling >nit 8%B $ 8aminar %ir Blow Procedure:
%t the last day of working 3week end6 and after completion of all the cleaning activities. Prior to fumigation ensure no trace of water present on any place. Bumigation container is placed near the door of each room i.e. sterility testing room change room. Shut down individual 8%B ( %@>. %dd )0 g of potassium permanganate to the fumigation container. 4ow add '00 ml formaldehyde in very slowly and gently to each container. #lose the doors.
Title : SOP BACTERIAL ENDO TO=IN TEST I''(e Date .an" /%&%

SOP N!" # CP$MBS$%%8 Pa1e N!" : & t! & Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04
C5e*6e3 04
1. 2.
Objective: Scope:
To lay down a procedure for 5acterial Endo to2in Test. The procedure of this SOP shall be applicable for Microbiology
3. 4. 5.
6.
&.' &.) &.+ &.< &., &.& &.. &.9
Department of Saika Pharmaceuticals !ohtak. Responsibility: Microbiologist Accountability: ".#. Manager Abbreviations: S.O.P. $ Standard Operating Procedure "# $ "uality #ontrol "% $ "uality %ssurance Procedure:
;ash the all glassware with purified water twice then with distilled water once. #over all the glassware with aluminium foil. @eat all the glassware to be used for the 5acterial End to2in test at )<0 # for ) G hrs. so as to make it dehydrogenated. ;eigh the samples. Prepare the dilution of the sample and control standard end to2in. Dilute the 8%8 reagent with '.) ml 8%8 reagent water. Place the tubes over the heating blocks. Birst put water for 4P# and #SE for PP#.
&.A &.'0 &.'' &.')
4ow dispense the samples followed by 8%8 reagent. Place two tubes as blank. 7ncubate at +. '#. Observe the tube after e2actly one hour the PP# should have the gel formation 3firm gel6 and 4P# along with blank should not have.
Title : SOP FOR CLEANING AND SANITATION OF MICROBIOLOG LAB$ STERILIT ROOM SOP N!" # CP$MBS$%%9 Pa1e N!" : & t! / Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%&%

1. 2.
Objective: Scope:
To lay down a procedure for #leaning ( Sanitation of Microbiology 8ab * Sterility !oom. The procedure of this SOP shall be applicable for Microbiology
3. 4. 5.
6.
&.' &.) &.+ &.<
%fter completing work in the Microbiology 8aboratory remove all used and unused material immediately. #lean the 8%B bench and floor with a dry nylon brush to remove the materialsH like vials bungs aluminum foils papers waste media traces and seals etc. #ollect all the wastes in a plastic tray and transfer it to the dust bean. Birst mop the floors and the walls of laboratory with the sanitation solution 3#ombatant DS6 with the help of sterili=ed nylon cloth.
&., &.& &.. &.9
Mope the working table with a dry nylon cloth than clean the table with the suitable detergent 38anoline 0.,1 solution6 with the help of nylon cloth. Binally clean the table with nylon cloth soaked in sterile water in order to remove the traces of detergents. Swab the working table with suitable disinfectant 3#ombatant DS6 and then by .01 7P%. %ll cleaning and sanitation activities shall be followed by the spraying disinfectant. This is applied for disinfections of the air of area as well as surface.
Title : SOP FOR CLEANING AND SANITATION OF MICROBIOLOG LAB$ STERILIT ROOM SOP N!" # CP$MBS$%%9 Pa1e N!" : / t! / Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%&%

%leanin- Sc&edule o5 /icrobiolo-y $ab.

/on. Pre-4oon Savlon )1 Mopping %fter 4oon Mopping Dettol )1 ue. Dettol )1 Savlon )1 6ed. Bairgenol )1 5.I.#. )1 &u. 5.I.#. )1 Bairgenol )1 2ri. Savlon )1 Dettol )1 Sat. Dettol )1 Savlon )1
Re!ar's: Spray the area with .01 7P% before +0 mts. of starting the work.
Spray with )1 8ysol daily after completion of work. Bumigate the on every Saturday as per SOP 4o. #P*M5S*00,
Title : SOP FOR STERILIT TESTING SOP N!" # CP$MBS$%%: Pa1e N!" : & t! & Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%&%

1. 2. 3. 4. 5.
Objective: Scope:
To lay down a procedure for Sterility Testing. The procedure of this SOP shall be applicable for Microbiology
6.
&.'
Prepare the media Bluid Thioglycolate and Soybean casein Digest 5roth according to specified dilution and transfer the same into glass test tubes. %utoclave it at ')'# temp and at ', lbs pressure. 7ncubate the media at +) )., # for <9 hrs. %s preoccupation. So as to check the proper sterili=ation of the same. Prepare ' liter 30.'16 Peptone ;ater and filter it through 0.<,m filter paper and autoclave it at ')'# temp and ', lbs. Pressure for )0 minute. Switch on the 8%B and >: light )hrs before the sterility test.
&.) &.+ &.<
&., &.& &.. &.9 &.A
Dissolve the sample in '00 ml sterili=ed peptone water and pass the solution through 0.<,m filter paper. ;ash the filter paper with 'liter peptone water. #ut the membrane filter paper into two pieces with a sterili=ed blade. 7noculate Bluid Thioglycolate media with one piece and Soybean casein Digest 5roth with another one. 7ncubate the Soybean casein Digest 5roth at ))., ).,# and Bluid Thioglycolate Media at +) )., #. 7.P. products are incubating for . days and 5.P ( >.S.P products for '< days.
Observation: Bluid Thioglycolate Media is observed for aerobic and anaerobic 5acterial growth and Soybean #asein Digest 5roth is observed for fungal growth.
Title : SOP FOR S>AB TESTING SOP N!" # CP$MBS$%%; Pa1e N!" : & t! / Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%&%

1. 2.
Objective: Scope:
To lay down a procedure for Swab Testing. The procedure of this SOP shall be applicable for Microbiology
3. 4. 5.
Department of Saika Pharmaceuticals !ohtak. Responsibility: Microbiologist Accountability: ".#. Manager Abbreviations: S.O.P. $ Standard Operating Procedure "# $ "uality #ontrol "% $ "uality %ssurance
6.
&.' &.) &.+ &.< &.,
Procedure:
Prepare swabs by rapping cotton on glass rods. Ieep the swabs in test tube filled with distilled water. Sterili=ed the tubes in %utoclave. Prepare soybean casein digest medium as per microbiological media preparation SOP. Take the swab from the critical * specified places.
&.& &.. &.9
7ncubate the swab rods into the sterili=ed tubes of Soybean #asein Digest medium. 7ncubate the tubes on +) )., # to check the bacterial growth and on ))., ).,# to check the fungal growth. Observe the growth in the tubes. Crade % 5 # D %rea #lass '00 #lass '000 #lass '0000 #lass '00000 #ontact plates 3dia. ,, mm6 cfu per plate. E' , ), ,0 FOR RESTRICTED CIRCULATION
Department : MICROBIOLOG E))e*ti+e Date Fe0" /%%; 7"C" Mana1er Ne,t Re+ie- Date .an" /%%2 Appr!+e3 04 : Prepare3 04 C5e*6e3 04 7"A" Mana1er
Title : SOP FOR MONITORING OF ASEPTIC AREA B SETTLE PLATE METHOD SOP N!" # CP$MBS$%%< Pa1e N!" : & t! / Re+i'i!n N!" : %& Si1nat(re Date I''(e Date .an" /%%;
1. 2.
Objective: Scope:
To lay down a procedure for Monitoring of %septic %rea by Settle Plate Method. The procedure of this SOP shall be applicable for Microbiology
3. 4. 5.
6.
&.' &.) &.+
Sterili=ed the petrel plates in D@S Prepare the media as per microbiological media preparation SOP Pour )0-), ml media in Petri plate under 8%B.
&.< &., &.& &.. &.9 &.A &.'0 &.''
%llow the plates to solidify Pre incubate the plates for <9 hrs. at the temperature +00 to +,0c. Transfer the pre-incubated plates in aseptic processing area. Put the plates on the specified location. Open the lids of Petri plates and e2pose for ) hrs. #lose the plates 7ncubate the plates at re?uired temperature in 5OD incubator * 5acteriological incubator for re?uired time for fungus ( bacteria. %fter completing incubation period count the colony forming units in individual plates.
Title : SOP FOR MONITORING OF ASEPTIC AREA B SETTLE PLATE METHOD SOP N!" # CP$MBS$%%< Pa1e N!" : / t! / Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%&%

Reco!!ended $i!its 5or /icrobiolo-ical /onitorin- o5 Aseptic Areas 7)n Operation8 by S( $( P$A (.
Crade %rea Settle plates dia. A0 mm #fu * ) hrs. % 5 # D #lass '00 #lass '000 #lass '0000 #lass '00000 E' , ,0 '00
Title : SOP FOR OPERATION ? CALIBRATION OF LAMINAR AIR FLO> BENCH SOP N!" # CP$MBS$%%2 Pa1e N!" : & t! / Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%&%

1. 2.
Objective: Scope:
To lay down a procedure for Operation ( #alibration of 8aminar %ir Blow 5ench The procedure of this SOP shall be applicable for Microbiology
3. 4. 5.
6.
&.' Ensure that the instrument is clean and free from dust and placed in such a position that any air while opening the airlock door does not affect the positive pressure of the instrument.
&.) #heck the level of the instrument base. The base should posses uniform level with no upJs and downJs. &.+ Switch on the mains. &.< There are three switches and a pressure barometer on the instrument These switches represent$ '6 %ir flow )6 Ordinary light +6 >: light &., Switch on the 4o.' switch to start airflow. &.& Press switch + to start the >: light. &.. The airflow and >: light should be kept on for about ) hours before carrying out any work under laminar airflow. &.9 Switch off the >: light and put on switch )nd for ordinary light. &.A #heck the pressure barometer the level of red oil indicator should be at ', marks when airflow is on.
Title : SOP FOR OPERATION ? CALIBRATION OF LAMINAR AIR FLO> BENCH SOP N!" # CP$MBS$%%2 Pa1e N!" : / t! / Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%&%

. 9 A
The function of instrument in to maintain the aseptic condition while carrying out any microbiological tests. Blame the burner and put it inside 8%B. Done every work in front of the flame of the lamp.
%alibration '. ). +. <. The calibration is done by the plate e2posure method i.e. Settle plate method. Prepare the plates of 4utrient agar media and savored de2trose agar media. Switch on the 8%B and e2pose the plates at different position in 8%B for ) hour. 7ncubate the plates of 4utrient agar on +) ).,# savraud de2trose agar at ))., )., #.
,.
Observe the plates for no growth 4utrient agar is used for 5acterial count and savraud de2trose agar is used for fungal count.
Title : SOP FOR OPERATION ? CALIBRATION OF BACTERIOLOGICAL INCUBATOR SOP N!" # CP$MBS$%%@ Pa1e N!" : & t! & Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%%;

Department : MICROBIOLOG E))e*ti+e Date Fe0" /%%; 7"C" Mana1er Ne,t Re+ie- Date .an" /%%2 Appr!+e3 04 : 7"A" Mana1er
1. 2.
Objective: Scope:
To lay down a procedure for Operation ( #alibration of 5acteriological 7ncubator. The procedure of this SOP shall be applicable for Microbiology
3. 4. 5.
6.
Department of Saika Pharmaceuticals !ohtak. Responsibility: Microbiologist Accountability: ".#. Manager Abbreviations: S.O.P. $ Standard Operating Procedure "# $ "uality #ontrol "% $ "uality %ssurance Procedure: Operation
Place the unit away from draft ventilating outlets radiators or any other device that may cause sever changes in the temperature conditions surrounding the indicator cabinet. &.) Place the shelves in their positions provided inside the chamber before loading the material. 8oad the selves evenly. &.+ Switch on the main switch 3main indicator of lamp !ed should glow6 &.< Set the controller knob to indicate re?uired temperature on its dial. &., %llow the temperature to rise to re?uired temperature and let it remain constant. 9.: %alibration: ..' Dip the calibrated thermometer in Clycerin and keep it in the shelf 4o. ' allow stabili=ing the temperature for ', minute. 4ote down the temperature displayed by the 7nstrument and the thermometer. !epeat the procedure 4o. & for all the shelves. ..) #orrect the temperature re?uired with the help of temperature setting knob first by the coarse and then by the fine knob. ..+ Such calibration is done on monthly basis.
&.'
Title : SOP FOR OPERATION ? CALIBRATION OF BOD INCUBATOR SOP N!" # CP$MBS$%&% Pa1e N!" : & t! & Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%&%

1. 2.
Objective: Scope:
To lay down a procedure for Operation ( #alibration of 5od 7ncubator. The procedure of this SOP shall be applicable for Microbiology
3. 4. 5.
6.
Department of Saika Pharmaceuticals !ohtak. Responsibility: Microbiologist Accountability: ".#. Manager Abbreviations: S.O.P. $ Standard Operating Procedure "# $ "uality #ontrol "% $ "uality %ssurance Procedure: Operation
&.' &.) &.+ &.<
Ieep the instrument in a room having constant temperature and away form any heating device. Switch on main button 3red light will glow6. %dKust re?uired temperature with help of coarse and finally with help of fine adKustment. Digital display will show the desired temperature.
9.: %alibration:
..'. %dKust the temperature of the 5OD incubator by the above procedure. ..). Put a calibrated =eal thermometer on the selvesJ of the incubator. ..+. #ompare the temperatures displayed by the instruments and by the calibrated thermometer. ..<. !epeat the same procedure with the other selves. .., #alibrated the incubator on monthly basis.
Title : SOP FOR OPERATION OF MICROBIOLOG SECTION SOP N!" # CP$MBS$%&& Pa1e N!" : & t! / Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%&%

1. 2.
Objective: Scope:
To lay down a procedure for Operation of Microbiology Section. The procedure of this SOP shall be applicable for Microbiology
3. 4. 5.
6.
Operation of Microbiology Section is divided in the following activities$ a6 Double Door Entry to Microbiology Section. b6 Preparation of the E?uipmentJs. c6 Microbiological Testing. d6 #leaning of the Microbiology Section. (ntry to /icrobiolo-y Section: a6 The Person puts on the sterile garment and covers his*her shoe with shoe guard in the air lock. b6 @e * She washes his * her hand with disinfectant solution and put in sterile hand gloves. c6 Opens the door by using his elbows and enter the Microbiology 8aboratory. Preparation o5 t&e (;uip!ent<s : a6 The table top of laminar airflow workstation is cleaned with .01 7P% Solution. b6 The culture tubes inoculums plates inoculation spatula membrane filtration assembly etc. are kept on the side table. c6 The 5unsen burner is lit on and inoculation process is started. d6 Once done each tube is closed by using the same Lcotton plugsM.
Title : SOP FOR OPERATION OF MICROBIOLOG SECTION SOP N!" # CP$MBS$%&& Pa1e N!" : / t! / Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%&%

/icrobiolo-ical estin-: a6 b6 c6 d6 e6 f6 The testing includes Microbiological %ssay for %ntibiotics ( :itamins. Total bacterial count. Total fungal count. Morphological testing after staining. 7dentification of individual or group of microbes etc. 5io burden analysis in bulk solution.
g6
Pathogenic analysis in DM water ( water for inKection. %ll these tests are done following official monographs like 7P*5P*>SP*7@S*SOP.
Cleaning of the area:

i6 ii6 iii6 %fter the dayJs operation the entire floor furniture tops etc are cleaned by disinfectant solution as per cleaning schedule. %ll the dirt and usages are taken out of the area. The area is sprayed with '1 Cluteraldehyde in propylene glycol by using air guns.
iv6 v6
Spray the area with .01 7P% before +0 mts. of starting the work. Spray with )1 8ysol daily after completion of work.
Title : SOP FOR PREPARATION OF MICROBIOLOG MEDIA SOP N!" # CP$MBS$%&/ Pa1e N!" : & t! & Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%&%

1. 2.
Objective: Scope:
To lay down a procedure for Preparation of Microbiology Media. The procedure of this SOP shall be applicable for Microbiology
3. 4. 5.
6.
&.' &.) &.+ &.< &., &.& &..
#heck the date of e2piry of the media to be used. #lean and dry the re?uired glassware ( accessories. #heck the suitability of glasswareJs and re?uirement of preparation of media. ;eight the ?uantity of media according to the re?uirement. Place the container on the magnetic stirrer with magnet bead and add the sufficient ?uantity of distilled water and add the weighed media in it. 5oil to mi2 the medium properly and make up the volume. #heck the p@ with calibrated p@ meter adKust if re?uired either by 0.' M 4ao@ for soyabean casein digest medium or by '.0 M 4ao@ incase of fluid thioglycollate and pour it according to the re?uirement in the tubes. Put the cotton plug in the tubes. Ieep the media in autoclave for sterili=ation and run autoclave for recommended time. #ool down the media up to room temperature after sterili=ation and pre incubate the media for recommended temperature for <9 hours.
&.9 &.A &.'0
Title : SOP FOR CULTURE HANDLING I''(e Date .an" /%&%

SOP N!" # CP$MBS$%&8 Pa1e N!" : & t! / Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04
C5e*6e3 04
1. 2.
Objective: Scope:
To lay down a procedure for #ulture @andling. The procedure of this SOP shall be applicable for Microbiology Department of Saika Pharmaceuticals !ohtak.
3. 4. 5.
S.O.P. $
Standard Operating Procedure
"# "% 6. Re;uire!ent:
$ $
"uality #ontrol "uality %ssurance
&.' &.) &.+ &.<
Pre Sterilised garments Sterile Cloves Sterile 8oops Sterilise Media
Title : SOP FOR CULTURE HANDLING I''(e Date .an" /%&%

SOP N!" # CP$MBS$%&8 Pa1e N!" : / t! / Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04
C5e*6e3 04
..' ..) ..+ ..< .., ..&
Prepare the slants of agar medium ( sterilise at ')'0# for )00 minutes. 7ncubate the slants at +00# to +,0#. %rrange the mother culture from authentic source. Transfer the mother culture in sterilise agar plate. Prepare the daughter cultures from mother culture. %gain incubate the daughter cultures at +,0# for five days.
...
8abel the daughter culture slants with name ( %T## 4o. Store the culture in the !efrigerator.
..9 ..A ..'0
!epeat the same process to prepare the making culture. Ma2imum five passages one allowed from mother culture to working culture. Maintain the record by sub culturing at the register.
Title : SOP FOR SAMPLING PLAN OF STERILE RA> MATERIAL SOP N!" # CP$MBS$%&9 Pa1e N!" : & t! / Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%&%

1. 2.
Objective: Scope:
To lay down a procedure for Sampling Plan of Sterile !aw Material. The procedure of this SOP shall be applicable for Microbiology Department of Saika Pharmaceuticals !ohtak.
3. 4. 5.
S.O.P. $ "# "% 6.

&.'
$ $
Re;uire!ent:
%fter getting the sample re?uisition slip from the !aw Material store the microbiologist will prepare the sampling plan for taking of sample. &.) &.+ Sampling has to be done from each container. Sample 4o. of containers for sterility test as per following table.
Title : SOP FOR SAMPLING PLAN OF STERILE RA> MATERIAL SOP N!" # CP$MBS$%&9 Pa1e N!" : / t! / Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%&%

$ess t&an 4 containers < containers but 4ot more than ,0 containers More than ,0 containers
(ac& container )01 or < containers whichever is greater )1 or '0 containers whichever is greater
%nd for other analysis sampling has to be done from all containers. '. #heck the sampling re?uisition with labels of the containers and P.O. * 5ill * #hallan.
). +. <. ,.
&. .. 9. A. '0.
#heck the outer conditions of each drum * bo2. Sampling has to be done in aseptic area. Disinfect the outside of containers with .01 7P% with transfer it to aseptic area. 5efore starting sampling check the following points in aseptic area $ a. %@> ( 8%B should be O4. b. Temperature N 4MT ),0#. c. @umidity N as per product re?uirement. d. Proper cleaning of area. Draw sample aseptically from each container under 8%B in sterili=ed and depyrogenated glass vials. Paste labels having no. of container and information regarding the material on sample vial * poly bags. Seal raw material containers * poly bags properly from which sample has been drawn. %fter drawing samples ".#. person will paste a sampled sticker on the right hand side of under test sticker. %naly=ed samples as per applicable protocol.
Title : SOP FOR INVESTIGATION OF THE OOS RESULTS IN ENVIRONMENT MONITORING SOP N!" # CP$MBS$%&: Pa1e N!" : & t! ; Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%&%

1.
Objective:
To lay down a procedure for 7nvestigation of the OOS results in environment monitoring.
2.
Scope:
The procedure of this SOP shall be applicable for Microbiology Department of Saika Pharmaceuticals !ohtak.
3.
Responsibility:
Microbiologist
4. 5.
Accountability: Abbreviations:
".#. Manager
S.O.P. $ "# "% 6.

&.'
$ $
Action Steps:
7f the #P> count e2ceeds the %lert * %ction levels at any location any day in the samples taken from the Environment or Personnel the Production @ead ( "% @ead will immediately be informed by "# Department with a dully filled L%ction Taken !eport BormatM. %ction Taken !eport Bormat will contain the following details. a. 4ame of the %rea. b. Date of monitoring c. Sampling method used d. Sampling location e. Microbial count e2ceeds %lert * %ction limit
&.)
Title : SOP FOR INVESTIGATION OF THE OOS RESULTS IN ENVIRONMENT MONITORING SOP N!" # CP$MBS$%&: Pa1e N!" : / t! ; Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%&%

&.+ &.<
f. #B> observed g. %ction limits 7nvestigation will be carried out in "uality control ( Production department. "uality #ontrol Department a. !esults will be discussed with the Microbiologist for any unusual observations made in the area and for any difficulty faced during sampling.
b. Media Preparation ( Sterili=ation !ecords and 4egative controls of the Media will be checked for any abnormity. c. 7dentify the organism up to possible level from the plate showing O.O.S. result. d. 7dentify the organism isolated from other places which are having same colony characteristics to establish the possible source of contamination. e. Document the historical review of environmental monitoring results for the site in ?uestion. &., 7f above observations do not confirm as a cause of analytical error then check at the production department. &.& Production Department. &.. The investigation will be carried out as per the checklist given in the %nne2ure the SOP. &.9 The "% @ead will investigate the cause of the O.O.S. results in co-ordination with Microbiology section 3".#.6 and Production @ead. &.A %fter investigations are over the Plain manager will send dully filled action taken report along with the investigation report to ".#. 6.1: O.O.S. )nvesti-ation 5or Alert level. &.'' The alert level can consider as an Learly warningM of potential drift from normal operating conditions and it allows the corrective actions to be taken before product ?uality is adversely affected. &.') Document the previous results for the affected site to determine the possibility of unfavorable and developed.
Title : SOP FOR INVESTIGATION OF THE OOS RESULTS IN ENVIRONMENT MONITORING SOP N!" # CP$MBS$%&: Pa1e N!" : 8 t! ; Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%&%

&.'+
>pon review of above determined results further investigation and * or additional sampling can be warranted. 7nstruct the in-charge 3Operation in clean area6 to take e2tra measures for disinfection of the site in ?uestion.
6.14 &.',
O.O.S. investi-ation 5or Action $evel. 7f there have been multiple e2cursions in e2cess of alert level or it the action level has been e2ceeded investigate the parameters shown.
&.'& &.'. &.'9
On the basis of investigation made as per establish the corrective action re?uired and implement it. %fter the corrective actions are taken check the effectiveness of these actions by suitable monitoring. 7f count e2ceed alert * action level for Operator glove or gown check the following parameters $ a. Operator activity b. Environment monitoring history of operator. c. Other environmental monitoring data in the working area. d. Periodic saniti=ation for groves. e. Types of organisms identified. f. OperatorJs validation data during media fill.
&.'A
Take the actions as mentioned in Step 4o. <.)' to <.)+ for product release action. %lso instruct the in charge for the re ?ualification of the operator and give and ade?uate training to the operator.
Title : SOP FOR INVESTIGATION OF THE OOS RESULTS IN ENVIRONMENT MONITORING SOP N!" # CP$MBS$%&: Pa1e N!" : 9 t! ; Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%&%

=0A$) > %O+ RO$ #(PAR /(+

SOP +O. =A 299 )+*(S ),A )O+ R(POR 2OR O.O.S. R(S0$ S )+ (+*)RO+/(+ /O+) OR)+, #A ( O2 O.O.S R(S0$ S :
2A%)$) > SA/P$( #( A)$S S. +o. '. ). +. <. ,. &. .. 9. Para!eters %&ec'ed Temperature !elative @umidity Differential pressure of area Manometer reading of 8.%.B. @EP% integrity checked last time on an result #leaning ( Disinfection of the area Disinfectant preparation date #leaning ( Disinfection of the area
: : Accep. $i!it Observations Re!ar's
Title : SOP FOR INVESTIGATION OF THE OOS RESULTS IN ENVIRONMENT MONITORING SOP N!" # CP$MBS$%&: Pa1e N!" : : t! ; Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%&%

A. '0. ''. '). '+.
%ny Deviation observed during batch manufacturing 8ast fumigation recorded on :isual observations of the %rea for any %bnormalities %ny Power failure on that day )5 yes? !ention duration Maintenance record for any
recent activity in area '<. @istorical review of environmental monitoring for the site in ?uestion 7dentification of organisms and comparison with organisms isolated from other site to determine source P(RSO++($ '&. '.. '9. 'A. 4o. of persons working in area Personnel monitoring results if not satisfactory give details Possible source of contamination with Kustification !eason for O.O.S.
',.
Title : SOP FOR INVESTIGATION OF THE OOS RESULTS IN ENVIRONMENT MONITORING SOP N!" # CP$MBS$%&: Pa1e N!" : ; t! ; Re+i'i!n N!" : %& Si1nat(re Date Prepare3 04 C5e*6e3 04 I''(e Date .an" /%&%

A% )O+ A@(+ R(POR 2OR/A Brom "# N Microbiology 8ab. To The 7n-charge Production * 7n-charge ".%. OOOOOOOOO.. 2ind &ere t&e details o5 t&e environ!ental !onitorin- results? s&o1in- %20 eAceedin- t&e Alert B Action levels:
Date of Monitoring $ Sampling method used $ 8ocation showing high counts $ %lert limits $ %ction limits $ Please investigate the matter and return the dully filled %.T.!. format to ".#.
C/icrobiolo-istD B!OM P!OD>#T7O4
C)n3%&ar-e /icrobiolo-yD D%TE$
C=.%. )n3%&ar-eD
On the basis of investigations made as per following actions were taken$ C%&e!ist E ProductionD C)n3%&ar-e ProductionD

Microbiology Sop&#39;s

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SAIKA PHARMACEUTICALS

Title : SOP FOR ENVIRONMENT MONITORING I''(e Date .an" /%&%

FOR RESTRICTED CIRCULATION

Responsibility: Accountability: Abbreviations:

Microbiologist ".#. Manager

S.O.P. $ "# "% 6. Procedure: $ $

Standard Operating Procedure "uality #ontrol "uality %ssurance

The limit is specified below$

FOR RESTRICTED CIRCULATION

e!perature ),-)./# )+-)./# ),-)./# )9-+0/# ),-)./# ),-)./#

"u!idity .01 ma2. ,01 ma2. ,01ma2 .01ma2 ,01ma2 ,0-,,1

!ecord the result in the following format $

%rea 4ame$ #ate i!e e!perature $i!it "u!idity $i!it %&ec'ed by

FOR RESTRICTED CIRCULATION

FOR RESTRICTED CIRCULATION

FOR RESTRICTED CIRCULATION

''. '). '+. '<.

FOR RESTRICTED CIRCULATION

%ll other nonsterile products

Point of supply to mfg room where product is e2posed

FOR RESTRICTED CIRCULATION

FOR RESTRICTED CIRCULATION

FOR RESTRICTED CIRCULATION

&.A &.'0 &.'' &.')

FOR RESTRICTED CIRCULATION

&., &.& &.. &.9

FOR RESTRICTED CIRCULATION

%leanin- Sc&edule o5 /icrobiolo-y $ab.

FOR RESTRICTED CIRCULATION

&.) &.+ &.<

&., &.& &.. &.9 &.A

FOR RESTRICTED CIRCULATION

&.& &.. &.9

&.< &., &.& &.. &.9 &.A &.'0 &.''

FOR RESTRICTED CIRCULATION

FOR RESTRICTED CIRCULATION

FOR RESTRICTED CIRCULATION

FOR RESTRICTED CIRCULATION

FOR RESTRICTED CIRCULATION

&.' &.) &.+ &.<

FOR RESTRICTED CIRCULATION

FOR RESTRICTED CIRCULATION

Cleaning of the area:

FOR RESTRICTED CIRCULATION

&.' &.) &.+ &.< &., &.& &..

&.9 &.A &.'0

FOR RESTRICTED CIRCULATION

Responsibility: Accountability: Abbreviations:

Microbiologist ".#. Manager

Standard Operating Procedure

"# "% 6. Re;uire!ent:

"uality #ontrol "uality %ssurance

&.' &.) &.+ &.<

Pre Sterilised garments Sterile Cloves Sterile 8oops Sterilise Media

FOR RESTRICTED CIRCULATION

..' ..) ..+ ..< .., ..&

..9 ..A ..'0

FOR RESTRICTED CIRCULATION

Responsibility: Accountability: Abbreviations:

Microbiologist ".#. Manager

S.O.P. $ "# "% 6.

Standard Operating Procedure "uality #ontrol "uality %ssurance

FOR RESTRICTED CIRCULATION

FOR RESTRICTED CIRCULATION

Microbiology Sop's

Microbiology Sop's