ORAL DOSAGE FORM SOPs

1.0 PURPOSE

To provide a procedure for entry and exit in Microbiology Area.

2.0 SCOPE: 

This procedure is applicable to entry and exit in Microbiology Area

5.0 PROCEDURE:

5.1       Entry procedure for Microbiology

5.1.1    Nobody should enter into the microbiological lab unnecessarily except the microbiologist or authorized person.

5.1.2    Enter the “ENTRY RESTRICTED ZONE”.

5.1.3    Follow pictorial Representation to enter into Aseptic area.

5.1.4    Enter into 1^st air lock Room.

5.1.5    Remove the lab footwear and keep in designated place.

5.1.6    Sit on the cross over bench provided and cross over the bench to other side.

5.1.7    Wear Disposable Booties provided in Microbiology testing area.

5.1.8     Sanitize the hands with 70% IPA

1.0 PURPOSE

To provide a procedure for Microbiological Good laboratory practices. 

2.0 SCOPE: 

This SOP is applicable for microbiology laboratory 

5.0 PROCEDURE:

5.1 PERSONNEL

5.1.1 Each person engaged in all phases of microbiological testing should have the education, training, and experience to do his or her job.

5.1.2 Microbiologists should not independently conduct a microbial test until they are qualified to run the test.

5.1.3 Training records should be current, documenting the microbiologist's training in the proper revision to the particular SOP.

5.1.4 Microbiologists with supervisory or managerial responsibilities should have appropriate education and in-house training in supervisory skills, laboratory safety, scheduling, laboratory investigations, technical report writing, relevant SOPs, and other critical aspects of the company's processes as suggested in their role of directing a laboratory function.

5.2 ENVIRONMENT - LABORATORY LAYOUT AND OPERATIONS

5.2.1 Laboratory layout and design should carefully consider the requirements of good microbiological practices and laboratory safety considering the suitability of construction materials to enable appropriate cleaning, disinfection and minimize the risks of contamination.

5.2.2 There should be separate air supply to laboratories and production areas. Separate air-handling units and other provisions, including temperature and humidity controls where required, should be in place for microbiological laboratories. The air supplied to the laboratory should be of appropriate quality and should not be a source of contamination.

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1.0 PURPOSE

To provide a procedure for receipt, storage and handling of biological indicators for sterilization.

2.0 SCOPE: 

This SOP is applicable for all microbiology laboratory

5.0 PROCEDURE:

5.1 RECEIPT AND STORAGE

5.1 Procure BI from approved vendors. 

5.1.1 Receive the invoice, sent by stores department.

5.1.2 Check details mentioned in the invoice against the received consignment.

5.1.3 Check physical condition of the box & packing, code and name of BI.

5.1.4 Verify the CoA for Lot No., manufacturing date, expiry date, D Value, Survival and Kill times as per the acceptable limits 

5.1.5 Calculate the survival time and kill time using the following equation.

5.1.6 The acceptance criteria for Survival time (in minutes) = not less than (labeled D value) × (log labeled spore count per carrier 2); and Kill time (in minutes) = not more than (labeled D value) × (log labeled spore count per carrier + 4). Record the details in the annexure-2.

5.1.7 In case of any discrepancy inform microbiology head. Sign the invoice and transfer the consignment to microbiology if it is satisfactory as per the table-I.

5.1.8 Physically check the quantity of BI’s received & Negative controls, update the stock register and annexure-2 and preserve in the original package under the conditions recommended on the label, and protect from light, toxic substances, excessive heat, and moisture.

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1.0 PURPOSE

To provide a procedure for receipt, storage, handling, sequential subculturing, inoculum preparation of microbiological cultures and readily available culture suspension kits. 

2.0 SCOPE: 

This SOP is applicable for all microbiology laboratory

5.0 PROCEDURE:

5.1 ORDERING INFORMATION, RECEIPT AND STORAGE

5.1.1 Identify the microbial cultures required, strain number, form (slant/ lyophilized) along with the source.

5.1.2 Raise an indent requesting for the identified cultures and specify the required passage (Zero passage is desired).

5.1.3 Receive the invoice, sent by stores department. Check details mentioned in the invoice against the received consignment.

5.1.4 Check physical condition of the box & packing, code and name of culture, availability of COA etc. Incase of any discrepancy inform microbiology head.

5.1.5 Check the details mentioned on culture carrier against the certificate of analysis and ATCC/ CIP/ NCTC/ NCIMB number. Stamp verified by seal and sign along with date.

5.1.6 Sign the invoice and transfer the consignment to microbiology if 5.1.3 to 5.1.5 is satisfactory and approve the GRN prepared by stores.

5.1.7 Label as Master Cultures and store between 2 deg. C - 8 deg. C in a refrigerator and file the certificate of analysis.

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1.0 PURPOSE

To provide a procedure for sampling, testing, data handling and failure investigation of samples for Microbial enumeration tests and tests for specified microorganisms. Samples include but not limited to Non sterile Active Pharmaceutical Ingredients, Excipients, Non sterile Bulk solution, rinse samples, swab samples, Non sterile blend and finished formulations, Miscellaneous samples including but not limited to disinfectants, process validation etc.

SCOPE: 

This SOP is applicable to Management of Microbial Culture in Microbiology Laboratory

5.0 ​PROCEDURE:

5.1  SAMPLING

5.1.1    Sample the test material in suitable carriers

5.1.2      Transfer the samples to microbiology laboratory.

5.1.3     Refer AR No allotted by Quality control chemical section. If the sample is exclusively for        microbiological test, allot a miscellaneous AR No

5.2       TESTING :

5.2.1     Subject the sample for Microbial enumeration test and / or for test for specified microorganisms as per   the respective specifications/ procedures/ protocols.

5.2.2     For media preparation and controls.

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PURPOSE

To provide a procedure for performing microbiological assay for Antibiotic drug substances/drug products and vitamin supplements.

SCOPE: 

This SOP is applicable for performing Microbiological assay by using cup plate method.

5.0 PROCEDURE:

5.1 SAMPLING:

5.1.1 Sample the material as per the respective procedures or receive the sampled material from QC chemical section.

5.1.2 Refer the AR No allotted by Quality control chemical section.

5.1.3 Issue the respective work sheet as per the testing procedure in case the sample is only for microbiological analysis or issue the work sheet and assign the sample to the qualified analyst.

5.2 PLANNING AND PREPARATION: 

5.2.1 Refer the product specific specification and standard testing procedure for the assay design to be used for test.

5.2.2 Check for the availability of required culture suspension or micro organism, Media and respective working standard/Reference standard.

5.2.3 Prepare the required quantity of Antibiotic Assay agar media by referring standard testing procedure and current version SOP titled “Control of Microbiological Media” and record the details in media preparation record.

5.2.4 Prepare the culture suspension as per the procedure given in respective standard testing procedure and record the details in format.

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1.0 PURPOSE

To provide a procedure for identification of Microbial isolates obtained during but not limited to Environmental monitoring, Personnel monitoring, Water analysis, Compressed gases monitoring, Microbial limit test analysis/Sterility test (Material, Product), Simulation trial positive units.

2.0 SCOPE: 

This SOP is applicable to identification of Microbial isolates in Microbiology Laboratory

4.0 DEFINITIONS:

4.1 Gram’ stain - a staining technique used to classify bacteria; bacteria are stained with gentian violet and then treated with gram’s Iodine solution, after being decolorized with alcohol and treated with safranine and  washed with water, those that retain gentian violet are Gram-positive and those that do not retain it are Gram’s- negative.

4.2 Spore – A small, usually single-celled reproductive body that is highly resistant to desiccation and heat and is capable of growing into a new organism, produced especially by certain bacteria, fungi, algae, and non-flowering plants. A dormant non-reproductive body formed by certain bacteria is response to adverse environmental conditions.

4.3 Species- A group of organisms having many characteristics in common and ranking below a genus. Organisms that reproduce sexually and belong to the same species interbreed and produce fertile offspring. Species names are usually written lower case in italics, as epidermidis in staphylococci epidermidis.

4.4 Genus – A taxonomic category ranking below a family and above a species and generally consisting of a group of species exhibiting similar characteristics. In taxonomic nomenclature the genus name is used, either alone or flowed by a Latin adjective or epithet, to form the name of a species.

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1.0 PURPOSE

This SOP describes the Job Responsibilities of Microbiologist.

2.0 SCOPE: 

This SOP is to be applied at the time of Job Responsibility of microbiologist

5.0 PROCEDURE:

5.1       Maintenance of mother cultures, periodic sub culturing and destruction of obsolete cultures and maintain records of the same.

5.2       Procuring and storage of dehydrated media.

5.3       Preparation, maintenance and decontamination of used media.

5.4       Water sampling and analysis. 

5.5       Environmental monitoring by settle plate, air sampling, surface sampling.

5.6       Personnel monitoring by contact plate method and finger dab test method.

5.7       To perform the Microbiological Assay’s as per the requirement.

5.8       Microbial limit test for raw materials, Inprocess and finished products

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1.0 PURPOSE

To provide the guidelines for Preparation of Media

2.0 SCOPE: 

This SOP is to be applied for the media Preparation in the microbiology laboratory.

5.0  PROCEDURE:

5.1  REQUIREMENTS

De-hydrated media

Cleaned SS spatula

Purified water

Non-absorbent cotton

Clean paper for media weighing

Aluminium foil

Cleaned Glassware

Calibrated balance

Autoclave

Clean –dry glass bottle: 100ml/ 250ml /500ml

5.2  Preparation of media

5.2.1     Keep all the media containers properly as per the instructions of the manufacturer.

5.2.2     Keep record of all the purchased Media.

5.2.3     Perform the Growth Promotion Test.

5.2.4     Record the results of Growth Promotion Test in a format. Use the GPT passed media for routine testing.

5.2.5     Always use fresh purified water for preparation of Media.          

5.2.6     Always prepare adequate quantity of the Media as per instructions given by manufacturer on container.

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1.0 PURPOSE

This SOP provides the Procedure for Pre Incubation of Microbiological culture media.

2.0 SCOPE: 

This SOP is to be applied at the time of Pre incubation of Microbiological Culture media.

5.0 PROCEDURE:

5.1 The agar plates/Broth bottles used for environmental monitoring, Raw material, finished product, water analysis and other selective agar media plates have to be pre-incubated.

5.2  The agar plates/Broth media used for bacterial testing should be pre-incubated for 48 hours at 30 to 35 ⁰C.

5.3  The agar plates used for fungi should be incubate at 20 to 25 ⁰C for 3 to 5 days

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