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SAIKA PHARMACEUTICALS

FOR RESTRICTED CIRCULATION

Title : SOP FOR ENVIRONMENT MONITORING

SOP No. – CP/MBS/001

Department : MICROBIOLOGY

Issue Date

Effective Date

Next Review Date

Jan. 2010

Feb. 2010

Jan. 2012

Page No. : 1 to 8 Revision No. : 01

Approved by : Prepared by

Checked by

Q.C. Manager

Q.A. Manager

Signature Date

1.

Objective:

To lay down a procedure for Environment Monitoring.

2.

Scope:

The procedure of this SOP shall be applicable for Microbiology Department of Saika Pharmaceuticals, Rohtak

3.

Responsibility:

Microbiologist

4.

Accountability:

Q.C. Manager

5.

Abbreviations:

6.

S.O.P. :

Standard Operating Procedure

QC

:

Quality Control

QA

:

Quality Assurance

Procedure:

6.1

Record the temperature & humidity in the environmental monitoring chart.

6.2

Regulate the A/C or Dehumidifier if the temperature of a particular area is out of the prescribed limit.

6.3

The limit is specified below:

SAIKA PHARMACEUTICALS

FOR RESTRICTED CIRCULATION

Title : SOP FOR ENVIRONMENT MONITORING

SOP No. – CP/MBS/001

Department : MICROBIOLOGY

Issue Date

Effective Date

Next Review Date

Jan. 2010

Feb. 2010

Jan. 2012

Page No. : 2 to 8

Approved by :

Revision No. : 01

Prepared by

Checked by

Q.C. Manager

Q.A. Manager

Signature Date

Area Corridors Raw material Stores (Non Beta & Beta) Instrument Room & Micro-biology Room Chemical Laboratory Quarantine & Control Sample Room Ointments & Lotions 2.

Temperature 25-27°C 23-27°C 25-27°C 28-30°C 25-27°C 25-27°C

Humidity 70% max. 50% max. 50%max 70%max 50%max 50-55%

Record the result in the following format :

Area Name: Date

Time

Temperature

Limit

Humidity

Limit

Checked by

SAIKA PHARMACEUTICALS

FOR RESTRICTED CIRCULATION

Title : SOP FOR ENVIRONMENT MONIORING

SOP No. – CP/MBS/001

Department : MICROBIOLOGY

Issue Date

Effective Date

Next Review Date

Jan. 2010

Feb. 2010

Jan. 2012

Page No. : 3 to 8

Approved by :

Revision No. : 01

Prepared by

Checked by

Q.C. Manager

Q.A. Manager

Signature Date

A.

RECEIVING: Pre Entry Cleaning 1.

All containers and package must be effectively cleaned before entering to manufacturing areas. Cleaning is carried out as per suitable SOP.

2.

Vacuum Cleaner is used to prevent displacement of dust.

3.

Wooden cases and crates must be opened outside the stored area and empty aces & crates must be discarded.

4.

Interior surfaces of the areas where raw and packaging materials are received must not shed particles.

B.

SAMPLING: 1.

Elaborate SOP must be followed to ensure prevention of contamination of material.

2.

Sample only one material at one time and in a segregated cubicle or booth fitted with suitable air control systems will minimize the risk of contamination.

3.

Use dedicated tools for sampling. Prescribe and follow SOP for cleaning of tools used in sampling and periodically validated.

4.

Do not return residues of samples to original containers.

5.

Sampling of potent materials like steroids, hormones, beta-lacto, and cyto-toxic substances must be done under specific conditions or in separate areas to protect sampling personnel as well as other products.

6.

Sterile products must be sampled under aseptic conditions.

SAIKA PHARMACEUTICALS

FOR RESTRICTED CIRCULATION

Title : SOP FOR ENVIRONMENT MONIORING

SOP No. – CP/MBS/001

Department : MICROBIOLOGY

Issue Date

Effective Date

Next Review Date

Jan. 2010

Feb. 2010

Jan. 2012

Page No. : 4 to 8 Revision No. : 01

Approved by : Prepared by

Checked by

Q.C. Manager

Q.A. Manager

Signature Date

C.

D.

DISPENSING 1. Dispensing stations or benches must be equipped with suitable dust extraction systems. 2. 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. 3. Effectively clean weighing equipment and dispensing bench after dispensing each material. 4. As far possible encourage the use of disposable gloves etc 5. To prevent displacement of dust do not use ceiling or tabletop fans during dispensing. 6. Materials used for construction of inner surfaces of such areas must permit easy and effective cleaning and disinfections. PRODUCTION: 1. Efficiency segregates each production activity. 2. Provide adequate dust extraction equipment. 3. Evolve and follow suitable equipment cleaning procedures. Periodically validate them to confirm effectiveness. 4. Regularly check and confirm integrity of oil seals. 5. To the extent possible use dedicated accessories such as filter finger bags, dust covers, sleeves, etc. 6. Record the temperature & humidity in the environmental monitoring chart. 7. Regulate the A/C or Dehumidifier if the temperature of a particular area is out of the prescribed limit. The limits for different sections are specified below. 8. Record of Temp. & Humidity is maintained in the following format. 9. For 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.

SAIKA PHARMACEUTICALS

FOR RESTRICTED CIRCULATION

Title : SOP FOR ENVIRONMENT MONIORING

SOP No. – CP/MBS/001

Department : MICROBIOLOGY

Issue Date

Effective Date

Next Review Date

Jan. 2010

Feb. 2010

Jan. 2012

Page No. : 5 to 8 Revision No. : 01

Approved by : Prepared by

Checked by

Q.C. Manager

Q.A. Manager

Signature Date

10.

Air 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 quality. Documentation of the same must be maintained.

11.

The recommended limits for airborne particles and microbial contamination are as follows:

12.

Gases supplied to manufacturing areas must be of the appropriate quality and care must be taken to see that they are not sources of contamination.

13.

Air compressors used for supply of compressed air for product contact purposes and cleaning product contact surfaces must be of the oil free type.

14.

Water and steam generation and distribution systems must be designed to protect contamination of products and manufacturing areas. Monitoring and controlling of quality of water and steam are of great importance especially in aseptic manufacture.

15.

Potent and sensitizing products causing anaphylactic reactions, like beta-lacto, geotaxis and sex hormones must not be manufacturing in a general purpose facility. Adequate segregation and/or separation must be ensured for handling these products.

16.

Microbiological contamination is done by plate count method, pathogens and fungal count should be nil in all sections.

SAIKA PHARMACEUTICALS

FOR RESTRICTED CIRCULATION

Title : SOP FOR ENVIRONMENT MONIORING

SOP No. – CP/MBS/001

Department : MICROBIOLOGY

Issue Date

Effective Date

Next Review Date

Jan. 2010

Feb. 2010

Jan. 2012

Page No. : 6 to 8 Revision No. : 01

Approved by : Prepared by

Checked by

Q.C. Manager

Q.A. Manager

Signature Date

At rest Maximum permitted number of particles per cubic meter equal to or greater than

At actual or simulated working Maximum permitted number of Maximum permitted particles per cubic meter equal to number of viable or greater than micro-organisms per by settle plates method

A

0.5µm 3520

5µm 29

0.5µm 3500

5µm 29

5.0 µ / m3 > 0.5µ / m3 micro-organisms Cfu / m3 Topical and Oral liquids Point of NMT 20,000 NMT 3,500,000 NMT 100 supply to mfg room where product is exposed

All other nonsterile products

Point of supply to mfg room where product is exposed

NMT 20,000

Not applicable

SAIKA PHARMACEUTICALS

FOR RESTRICTED CIRCULATION

Title : SOP FOR ENVIRONMENT MONIORING

SOP No. – CP/MBS/001

Department : MICROBIOLOGY

Issue Date

Effective Date

Next Review Date

Jan. 2010

Feb. 2010

Jan. 2012

Page No. : 7 to 8 Revision No. : 01

NMT 500

Approved by : Prepared by

Checked by

Q.C. Manager

Q.A. Manager

Signature Date

E. GENERAL 1. Primary packaging components such as bottles, caps etc. that are used in packaging should be handled only for one product at a time. If exigencies demand handling of more than one product then segregate each primary packaging activity. 2. Effectively clean every packaging equipment used in primary packaging before using the same for packaging another product. 3. All personnel must be made aware of the hazards of contamination. 4. All operating personnel must be attired in clean and suitable garments. 5. Regularly train operating in their respective functions to perform their tasks in a manner that prevents contamination. 6. Ensure air supply is suitable filtered to minimize airborne contamination. 7. Water being the most widely used material, regularly monitors the quality particularly, to control microbial contamination. 8. All 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. 9. Personnel working with processes where materials and products are exposed must wear gloves and excessive facial hair must be covered. 10. Personnel working in aseptic areas must use a fresh set of aseptic garments during each entry to aseptic areas. Gloves used in aseptic areas must be powder free. 11. Employees working in contact with material and products must be medically fit and free from contagious diseases.

12. 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.

SAIKA PHARMACEUTICALS

FOR RESTRICTED CIRCULATION

Title: SOP FUMIGATION OF MICROBIOLOGY LAB. SOP No. – CP/MBS/002

Department : MICROBIOLOGY

Issue Date

Effective Date

Next Review Date

Jan. 2010

Feb. 2010

Jan. 2012

Page No. : 1 to 1 Revision No. : 01

Approved by : Prepared by

Checked by

Q.C. Manager

Q.A. Manager

Signature Date

1. 2.

3. 4. 5.

6.

Objective: Scope:

To lay down a procedure for Fumigation of Microbiology Lab. The procedure of this SOP shall be applicable for Microbiology

Department of Saika Pharmaceuticals, Rohtak. Responsibility: Microbiologist Accountability: Q.C. Manager Abbreviations: S.O.P. : Standard Operating Procedure QC : Quality Control QA : Quality Assurance AHU : Air Handling Unit LAF : Laminar Air Flow Procedure:

6.1

At the last day of working (week end) and after completion of all the cleaning activities.

6.2

Prior to fumigation ensure no trace of water present on any place.

6.3

Fumigation container is placed near the door of each room i.e. sterility testing room, change room.

6.4

Shut down individual LAF & AHU.

6.5

Add 20 g of potassium permanganate to the fumigation container. Now add 100 ml formaldehyde in very slowly and gently to each container.

6.6

Close the doors.

SAIKA PHARMACEUTICALS

FOR RESTRICTED CIRCULATION

Title : SOP BACTERIAL ENDO TOXIN TEST

SOP No. – CP/MBS/003

Department : MICROBIOLOGY

Issue Date

Effective Date

Next Review Date

Jan. 2010

Feb. 2010

Jan. 2012

Page No. : 1 to 1 Revision No. : 01

Approved by : Prepared by

Checked by

Q.C. Manager

Q.A. Manager

Signature Date

1. 2.

3. 4. 5.

6.

Objective: Scope:

To lay down a procedure for Bacterial Endo toxin Test. The procedure of this SOP shall be applicable for Microbiology

Department of Saika Pharmaceuticals, Rohtak. Responsibility: Microbiologist Accountability: Q.C. Manager Abbreviations: S.O.P. : Standard Operating Procedure QC : Quality Control QA : Quality Assurance Procedure:

6.1 6.2

Wash the all glassware with purified water twice then with distilled water once. Cover all the glassware with aluminium foil.

6.3

Heat all the glassware to be used for the Bacterial End toxin test at 240°C for 2 ½ hrs.

6.4 6.5 6.6 6.7 6.8

so as to make it dehydrogenated. Weigh the samples. Prepare the dilution of the sample and control standard end toxin. Dilute the LAL reagent with 1.2 ml LAL reagent water. Place the tubes over the heating blocks. First put water for NPC and CSE for PPC.

6.9 6.10

Now dispense the samples followed by LAL reagent. Place two tubes as blank.

6.11

Incubate at 37 ± 1°C.

6.12

Observe the tube after exactly one hour the PPC should have the gel formation (firm gel) and NPC along with blank should not have.

SAIKA PHARMACEUTICALS

FOR RESTRICTED CIRCULATION

Title : SOP FOR CLEANING AND SANITATION OF MICROBIOLOGY LAB/ STERILITY ROOM SOP No. – CP/MBS/004

Department : MICROBIOLOGY

Issue Date

Effective Date

Next Review Date

Jan. 2010

Feb. 2010

Jan. 2012

Page No. : 1 to 2 Revision No. : 01

Approved by : Prepared by

Checked by

Q.C. Manager

Q.A. Manager

Signature Date

1.

Objective:

2.

Scope:

3. 4. 5.

6. 6.1 6.2 6.3 6.4

To lay down a procedure for Cleaning & Sanitation of Microbiology Lab / Sterility Room. The procedure of this SOP shall be applicable for Microbiology

Department of Saika Pharmaceuticals, Rohtak. Responsibility: Microbiologist Accountability: Q.C. Manager Abbreviations: S.O.P. : Standard Operating Procedure QC : Quality Control QA : Quality Assurance Procedure: After completing work in the Microbiology Laboratory, remove all used and unused material immediately. Clean the LAF bench and floor with a dry nylon brush to remove the materials; like vials, bungs, aluminum foils, papers, waste media traces and seals etc. Collect all the wastes in a plastic tray and transfer it to the dust bean. First mop the floors and the walls of laboratory with the sanitation solution (Combatant DS) with the help of sterilized nylon cloth.

6.5 6.6 6.7 6.8

Mope the working table with a dry nylon cloth, than clean the table with the suitable detergent (Lanoline 0.5% solution) with the help of nylon cloth. Finally 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 (Combatant DS) and then by 70% IPA. All 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.

SAIKA PHARMACEUTICALS

FOR RESTRICTED CIRCULATION

Title : SOP FOR CLEANING AND SANITATION OF MICROBIOLOGY LAB/ STERILITY ROOM SOP No. – CP/MBS/004

Department : MICROBIOLOGY

Issue Date

Effective Date

Next Review Date

Jan. 2010

Feb. 2010

Jan. 2012

Page No. : 2 to 2 Revision No. : 01

Approved by : Prepared by

Checked by

Q.C. Manager

Q.A. Manager

Signature Date

Cleaning Schedule of Microbiology Lab. Mon.

Tue.

Wed.

Thu.

Fri.

Sat.

Pre-Noon Savlon 2% Mopping

Dettol 2%

Fairgenol 2%

B.K.C. 2%

Savlon 2%

Dettol 2%

After Noon Mopping

Savlon 2%

B.K.C. 2%

Fairgenol 2%

Dettol 2%

Savlon 2%

Dettol 2%

Remarks: • Spray the area with 70% IPA before 30 mts. of starting the work.

• Spray with 2% Lysol daily after completion of work. • Fumigate the on every Saturday as per SOP No. CP/MBS/005

SAIKA PHARMACEUTICALS

FOR RESTRICTED CIRCULATION

Title : SOP FOR STERILITY TESTING SOP No. – CP/MBS/005

Department : MICROBIOLOGY

Issue Date

Effective Date

Next Review Date

Jan. 2010

Feb. 2010

Jan. 2012

Page No. : 1 to 1 Revision No. : 01

Approved by : Prepared by

Checked by

Q.C. Manager

Q.A. Manager

Signature Date

1. 2. 3. 4. 5.

6. 6.1

6.2 6.3 6.4

Objective: Scope:

To lay down a procedure for Sterility Testing. The procedure of this SOP shall be applicable for Microbiology

Department of Saika Pharmaceuticals, Rohtak. Responsibility: Microbiologist Accountability: Q.C. Manager Abbreviations: S.O.P. : Standard Operating Procedure QC : Quality Control QA : Quality Assurance Procedure: Prepare the media Fluid Thioglycolate and Soybean casein Digest Broth according to specified dilution and transfer the same into glass test tubes. Autoclave it at 121°C temp and at 15 lbs pressure. Incubate the media at 32 ± 2.5° C for 48 hrs. As preoccupation. So as to check the proper sterilization of the same. Prepare 1 liter (0.1%) Peptone Water and filter it through 0.45µm filter paper and autoclave it at 121°C temp and 15 lbs. Pressure for 20 minute. Switch on the LAF and UV light 2hrs, before the sterility test.

6.5 6.6 6.7 6.8 6.9

Dissolve the sample in 100 ml sterilized peptone water and pass the solution through 0.45µm filter paper. Wash the filter paper with 1liter peptone water. Cut the membrane filter paper into two pieces with a sterilized blade. Inoculate Fluid Thioglycolate media with one piece and Soybean casein Digest Broth with another one. Incubate the Soybean casein Digest Broth at 22.5 ± 2.5°C and Fluid Thioglycolate Media at 32 ± 2.5° C. I.P. products are incubating for 7 days and B.P & U.S.P products for 14 days.

Observation: Fluid Thioglycolate Media is observed for aerobic and anaerobic Bacterial growth and Soybean Casein Digest Broth is observed for fungal growth.

SAIKA PHARMACEUTICALS

FOR RESTRICTED CIRCULATION

Title : SOP FOR SWAB TESTING SOP No. – CP/MBS/006

Department : MICROBIOLOGY Issue Date

Effective Date

Next Review Date

Jan. 2010

Feb. 2010

Jan. 2012

Page No. : 1 to 2 Revision No. : 01

Approved by : Prepared by

Checked by

Q.C. Manager

Q.A. Manager

Signature Date

1. 2.

3. 4. 5.

6.

Objective: Scope:

To lay down a procedure for Swab Testing. The procedure of this SOP shall be applicable for Microbiology

Department of Saika Pharmaceuticals, Rohtak. Responsibility: Microbiologist Accountability: Q.C. Manager Abbreviations: S.O.P. : Standard Operating Procedure QC : Quality Control QA : Quality Assurance

Procedure:

6.1

Prepare swabs by rapping cotton on glass rods.

6.2

Keep the swabs in test tube filled with distilled water.

6.3

Sterilized the tubes in Autoclave.

6.4

Prepare soybean casein digest medium as per microbiological media preparation SOP.

6.5

Take the swab from the critical / specified places.

6.6

Incubate the swab rods into the sterilized tubes of Soybean Casein Digest medium.

6.7

Incubate the tubes on 32 ± 2.5 °C to check the bacterial growth and on 22.5 ± 2.5°C to check the fungal growth.

6.8

Observe the growth in the tubes. Grade

Area

Contact plates (dia. 55 mm) cfu per plate.

A

Class 100