HPLC Column Management; Purpose

The tenacity of this SOP is to define proper controlling of all HPLC columns during receive, use and storage period to confirm that the HPLC column performs satisfactorily and gives reproducible results.

HPLC Column Management; Scope

This process is applicable for stock usage of HPLC columns required for Materials and Products analysis in quality control laboratory of general block of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[] QC: Quality Control.

[] HPLC: High performance liquid chromatography.

[] CoA: Certificate of analysis.

Responsibilities:

The roles and responsibility is as follows

Officer/Executive/Senior Executive, Quality Control

• To confirm that this procedure is followed.
• To maintain the records properly as per SOP.

Assistant Manager, Quality Control

• To confirm that this procedure is kept up to date.
• To ensure that the SOP is technically sound & reflects the required working practices.
• Organize training on the SOP to all relevant personnel.
• To confirm implementation of the SOP after training.
• Schedule calibration of the instrument at the defined intervals.

Head of Quality Assurance

• Initiative to take approval of the SOP.
• To confirm overall implementation of this SOP.

Procedure:

• Preserve column with appropriate end fitting during storage.
• Prevent the column from any type of mechanical shocks.
• Always use the column in the indicated direction.
• Clean solvent reservoir filter in the mobile phase by sonication in the Methanol for 30 minutes, when required.
• Test sample should be free from any type of particulate matter.
• Stock review and raise requisition

Executive, QC will raise a purchase requisition considering the following elements:

• Product & Method wise dedicated column.
• New method related to Product Development which is in product launch pipeline for commercialization.
• New Pharmacopoeia (BP, USP & EP) requirements.
• Underprivileged system suitability performance of a column that has been triggered from HPLC column usage register and included in retired HPLC column register.
• Executive, QC will make a list for purchasing of new columns on the basis of purchase requisitions to ensure uninterrupted HPLC analysis.
• In-Charge, QC will finally review the list for purchasing of new columns by checking the HPLC column stock and issue and retired HPLC column register status or considering column requirement for new product.

Column receiving

• Executive, QC will receive new column with CoA.
• After receiving a new HPLC column, QC Executive will check the column CoA, specification & physical condition and compare with Purchase Order and Invoice description.
• If complies with ordered description, then assign an individual column serial number (e.g. GQC-H001, where H represents HPLC column and 001 is the serial number) and record necessary information [Column receiving date, Column description (Name, brand, particle size and dimension etc.), Part number/ Catalogue, Manufacturer name, Supplier name, Column Sl. No., Column dedicated for (Product /Material), Column issue date etc.] in the HPLC column stock and issue register.

Column performance check for new column: HPLC Column Management

• Check availability of reference reagents /standards required for performance test. If unavailable, then promptly raise requisition.
• Carry out the column performance test for new HPLC column, as per manufacturer’s instructions. (If particular chemicals as per Manufacturer’s CoA are available.)
• Check column with respect to Manufacturer’s CoA for retention time, theoretical plates using the material provided with the column & method specified by manufacturer.
• In case of emergency carry out performance check only with the available reference standards/reagents.
• Connect the column to HPLC system.
• Flush (condition) specific column with shipping solvent (the details available with manufacturer’s CoA) or methanol for at least 30 minutes with a flow rate of 0.5 ml/min.
• Flush column with mobile phase as mentioned in the technique for respective columns.
• Prepare test solution in mobile phase as recommended in the procedure.
• After column is conditioned, inject 20 µl or as per manufacturer’s CoA & record chromatograph of test solution.
• Calculate tangent (theoretical plates) as per the USP method. The result should meet system suitability parameters.

Theoretical plate: (N) = 16 (t/W)2

Asymmetry (10%) = w/2f

Where, t = Retention time

W = Width of peak measured by extrapolating the relatively straight sides to the baseline

W = Width of peak at 10% of peak height

f = Distance between perpendicular dropped from apex of the peak and leading edge of peak at 10% of peak height

• Keep records of the performance check on the HPLC Column Performance Check Record (as per Annexure-IV).
• Accept column for use if observed values are within limit specified in manufacturer’s CoA.
• Inform manufacturer through Purchase Department, if test result doesn’t comply with the accepted limit mentioned in the manufacturer’s CoA.
• If problem is not resolved, reject same & information Purchase Department regarding rejection.

Material/Product Dedicated Column

• In-Charge, QC will ensure method and/or product wise dedicated columns are available for HPLC analysis.
• Same column can be used for analysis of two or more products in different dosage form where product formulation & active ingredients are same. But prior to use, method shall be validated using same column.
• If dedicated column is not available, instantly discuss with In-Charge, Quality Control.
• Column other than material and/or product dedicated column can be used in case of emergency with the concern of In-Charge, Quality Control.

Column Issue

• Prior to issue a new column, review previous column history & record all information [Initial theoretical plates (Before issue), Column issue date, Issued by, Remarks] in the HPLC column stock and issue register.
• If dedicated column is not available for a new material/product analysis, discuss the matter with In-Charge, QC for alternate decision.
• All decisions shall be recorded in HPLC column stock and issue register (Annexure-I).
• After issue, record the column information in a new page in HPLC Column usage register. (Annexure-II).

Column Care

• Confirm that the integrity of the column packing is not be disturbed by needless opening of the column ends.
• Handle HPLC columns as per manufacturers’ instructions, e.g. avoidance of physical shock, vibration and storage at high temperature.
• For silica-based columns, avoid eluents outside the pH range of 3-8 where possible, except when column manufacturer specifications acclaim otherwise.
• Wash column as per HPLC column washing procedure.
• After use, wash the column to make it free from buffer salts with a suitable solvent (typically 1:1 aqueous/organic solvent for reversed phase columns) about 45 to 60 minutes maintaining a flow rate of 1.5 to 2.0 ml per minute.
• After washing cap or seal column for storage in designated place.
• In case of poor system suitability performance or column blockage caused by precipitation of buffer salts, always incorporate a flush with a solvent/water mixture before switching to pure solvent as per HPLC analysis and system suitability check procedure SOP No.: (SOP/QC/009).
• Record the HPLC column flushing time in HPLC log book. Maintain HPLC column cleaning and storage as per manufacturer’s instructions.

Regeneration of a column

• If the system suitability fails only then do the column regeneration.
• For columns C6, C4, C18, C8, Phenyl, Amino, Polymeric follow the sequence given below with a 1.0 ml flow per minute flow rate.
• Flush with filtered and de-gassed water for 30 minutes. Inject 20 µL of 1.0% of Acetic acid in purified water.
• Flush with Methanol for 30 minutes, inject 20 µL of 1.0% Dimethyl Sulphonic Oxide (spectroscopic grade) in Methanol.
• Flush with

1. Acetonitrile for 15 minutes;
2. Chloroform for 10 minutes;
3. Methanol for 30 minutes sequentially;
4. Isopropanol for 15 minutes;
5. Purified water for 15 minutes

• Check pH of water at inlet and outlet, which should be identical.
• Mobile phase for the compound to be analyzed.

 

Retired HPLC Column

• After washing, if the HPLC column performance is not improved then In-Charge, QC will review column washing process and column history prior to discarding/retiring a column.
• The column retiring information must be recorded in the respective page of HPLC column usage log sheet (Annexure-II) and retired column register (Annexure-III).
• Keep all retired columns under lock & key in a separate locker in the lab area. Before keeping analyst must ensure that the retired column has been separated from usage stock and de-shaped.
• Periodically the HPLC column usage log sheet and retired column register shall be reviewed and retired column shall be destroyed as per column destruction process and manufacturers’ instructions.
• Retired column storage period should not be less than last test product shelf-life plus one year.

Download All Annexure: HPLC Column Management

Annexure I HPLC Column Stock and Issue Register

Annexure II HPLC Column Usage Register

Annexure III Retired HPLC Column Register

Annexure IV HPLC Column Performance Check Record

Waste Management; Purpose

The purpose of this SOP is to describe the laboratory waste management procedure for disposal of test samples (raw materials, in-process, bulk/ finished product left over samples); expired retention samples (raw materials, finished product); broken glassware and glass container; packaging materials; all Laboratory chemicals & reagents used within the quality control laboratory.

Waste Management; Scope

This procedure is applicable to all laboratory operations associated with the disposal activity in the quality control and microbiology laboratory for general block at XX Pharmaceuticals Limited.

Definitions / Abbreviation

• SOP: Standard Operating Procedure
• QC: Quality Control
• ETP: Effluent Treatment Plant
• MSDS: Material Safety Data Sheet

Responsibilities

The roles and responsibilities are as follows

Senior Executive/Executive, QC & Microbiology

• To ensure that this procedure is followed.
• To identify correct sample for disposal.

 Asst. Manager, Quality Control

• To ensure that this procedure is kept up to date.
• To confirm that the SOP reflects the required working practices.
• Arrange training on the SOP to all concerned personnel.
• To ensure implementation of the SOP into routine use after training.
• To ensure availability of adequate facilities, systems and resources to carry out this process and approve the SOP.

Head of Quality Assurance

• Take initiative to Approval of this SOP
• To ensure the overall implementation of the SOP

Procedure

• Wear rubber gloves, mask, safety glass and footwear during disposal work.
• Carry out the disposal work at the designated place.
• Wash hands thoroughly with soap and water, at the end of the operation.
• Always keep the waste bin covered with lids.
• Destroy any label/carton/ foil before dumping into the bin for disposal.
• Cross mark all label on the container with marker pen or destroy the label of container before disposal.
• Use separate container for collecting the broken glass and transfer to the salvage yard-marking container as “BROKEN GLASSWARE”.
• Do not return left over samples of raw materials, in-process material, bulk/ filled products to the container or work points from which it has been taken.
• Keep all the waste in designated bin.
• Carefully identify the name and check the status label of the sample to be disposed off.
• Check the MSDS of raw materials for the hazardous identification and proper method of disposal.
• Check the container properly for any left out material before disposition of the containers.
• Use the sink of fume cupboard to drain out flammable, toxic, corrosive water-soluble solvent and all mobile phase.
• Never light any type of flames & always place sign “No Flames” to warn others about the presence of Ether. Accumulate water immiscible solvents [like Chloroform, Dichloromethane, Carbon Tetrachloride, etc.) into one bottle & ether (Diethyl Ether waste) in another bottle & evaporate them separately using beaker by placing in fume cupboard.
• Place hazardous solid waste (e.g. tissue paper, filter paper, cotton, contaminated gloves etc.) in dedicated bin/container.
• Dispose liquid samples in sink by using large amount of tap water.
• After completion of test, retain left over samples of raw materials, in-process material, bulk/ finished products with proper identification labeled as “UNDER TEST SAMPLE” in specified place the batch is approved.
• After approval of the batch, transfer the excess samples (tablets, raw materials, capsules) of approved batch to a place labeled as “SAMPLE FOR DISPOSAL” record the disposal details in the Sample Disposal Register (Annexure-I).
• Once in a month or when required, collect and destroy all samples for disposal following the above steps.
• In case of raw materials, in-process material, and bulk/ finished products, empty out the sample from the poly bag into a container containing water, destroy the sample label of poly bag by shredding into “WASTE BIN FOR PAPER” & destroy the ploy bag in to the bin, labeled as “HAZARDOUS SOLID WASTE “.
• Shake dispersion of sample in container with the help of a glass & allow disintegrating. After the complete disintegration, drain out slowly into designated place & clean the drain with adequate water flushing.
• For stability sample after approval of report, analyst shall destroy the samples by dispersing them into a container having sufficient water and destroy the film, foil, de-blistered strips/blisters into a designated bin, labeled as “FILM/ FOILS FOR DISPOSAL”;
• The secondary packaging materials (carton, leaflets, labels, shipper carton, master carton) into “WASTE BIN FOR PAPER” and other packaging materials (i.e. polyethylene bag, cap, plastic stopper, dropper etc.) into another bin, labeled as “PACKAGING MATERIAL FOR DISPOSAL”.
• Shake the dispersion of sample in container with the help of a glass rod and allow to disintegrate. After complete disintegration, drain out slowly into designated place and clean the drain with adequate water flushing.
• In case of ampoules, vials and bottles; break open the glass ampoule, open the vials and bottles, empty the contents in water and discard the broken ampoule and vial into a bin, labeled as “BROKEN GLASSWARE”. Shake the dispersion of sample in container with the help of a glass rod and allow to disintegrate. After the complete disintegration, drain out slowly into designated place and clean the drain with adequate water flushing.
• Collect all types of waste from the respective bins into the different polythene bag by attaching “TO BE DISPOSED” label, weigh the waste content, and send waste to the salvage yard with a waste transfer note.

Download Annexure Here: Waste Management

Annexure I Sample Disposal Register

Test solution and volumetric solution; Purpose

The tenacity of this procedure is to describe procedure for preparation & handling of test solution and volumetric solution.

Test solution and volumetric solution; Scope

This SOP is valid for preparation of chemical reagent in Quality Control Laboratory at XX Pharmaceuticals Ltd.

Definitions

N/A

Responsibilities

The roles and responsibility is as follows

Officer/Executive/ Sr. Executive, Quality Control

• To confirm tests are performed with correct reagent as specified in method.
• To confirm record of reagent preparation in the work sheet.
• To confirm correct storage of reagent.
• To confirm use of reagent within the shelf life.
• To confirm reagents are retained until test results are approved.
• To confirm use of log book.

Assistant Manager, Quality Control

• To ensure reagents are in place and controlled.
• To assess & disposition of expired reagent.
• To maintain record.
• To incorporate sound technical knowledge.

Head of Quality Assurance

• To ensure the overall implementation of the SOP.
• Take initiative to approval of the SOP.

Procedure

Precaution(s):

• Wear protective clothing, gloves and goggles. Avoid contact with skin, eyes & clothing & inhalation of vapor.
• Use a fume hood while preparing solutions.
• Read label instructions of reagent container for any special precaution.

General

• For solution preparation use purified water & analytical grade reagents & chemicals.
• Prepare solution as per respective approved worksheet.
• Calculate expiry date of solutions from date of preparation.
• Check the following things before preparation of any solution.

1. Glassware being used is clean & dried.
2. Required reagents are available.
3. Required instruments are calibrated.

• Wear suitable safety appliances while making concentrated solutions of acid & alkali/any hazardous chemicals/substances.

 General guideline for the preparation of Test Solution

• Enter details in test solution preparation register (as per Annexure-I)
• Assign sequential reference number as below:

1. g.TS-001/09/XX
2. Where, TS is the abbreviation of Test Solution
3. 001 is the sequential number
4. / is separator
5. 09 is the month of preparation (September)
6. XX is last two digits of year 20XX

• Affix respective label on container as per Annexure-III.
• Expiry date of test solutions will be 06 months or as per mentioned in respective worksheet. During usage, any change in physical properties of the solution identified then discard it.
• If a solution is directed to prepare “fresh” then it must be prepared on the same day of use
• Discard the excess solution after expiry/ usage by diluting the solution with doubled quantity of water & then drain it into the drainage, and & entry on the respective worksheet & register.

General guideline for the preparation of volumetric solution

• Analyst shall prepare all type of volumetric solutions as per respective worksheet.
• Enter details in volumetric solution preparation register (as per Annexure-II)
• Assign sequential reference number as below:

1. g.VS001-001/08/XX
2. Where, VS001 is the code no. of 0.1 M Ammonium thiocyanate VS
3. 001 is the sequential number
4. / is separator
5. 09 is the month of preparation (August)
6. XX is last two digits of year 20XX

• Affix respective label on the container as per Annexure-IV.
• Volumetric solutions and standard solution for limit test must not be store for more than three months. If during usage any change in physical properties of the solution identified then discard the solution.
• Where stabilization time is not mentioned, stabilize solution for one hour before standardization.
• Carry out standardization & calculate factor of the solution twice & RSD of two results must be within 0.2%
• Find out the mean factor, which will be within ±5.0% of the labeled factor.
• If factor of prepared solution identified more than ±5.0% variation, do the necessary dilutions/weight adjustments and carry out re-standardization. Report the factor upto four digits after decimal.
• Solution should be re-standardized in 1 month +7 days interval. In case, where extraneous matters, layer separation or hazy solution observed then discard the solution.

Assign re-standardization reference number as below

e.g. Reference No./R1

Where, Reference No. of the volumetric solution subjected to re-standardization

/ is separator

R1 is re-standardization for first time (e.g. R1, R2…..)

Store all the solutions in cleaned dry containers & use amber color containers for light sensitive solutions.

Reject excess solution after expiry/ usage by diluting the solution with doubled quantity of water and then drain it into the drainage, and make entry on the respective worksheet & specific register.

Download all Annexure Here

Annexure I Test Solution Preparation Register

Annexure II Volumetric Solution Preparation and Standardization Register

Annexure III & IV Label for Test Solution & Label for Volumetric Solutions

Chemicals and Reagents Management; Purpose

The tenacity of this SOP is to define the process for order, receipt, labeling, daily issue, stock control, handling, storage, labeling and expiry dating of all laboratory chemicals and reagents, solvents & solutions used within the quality control laboratory at XX Pharmaceuticals Ltd.

Chemicals and Reagents Management; Scope

This procedure is applicable to all laboratory chemicals & reagents, solvents & solutions used in the quality control laboratory at XX Pharmaceuticals Limited.

Chemicals and Reagents Management; Definitions / Abbreviation

[] ACS: American Chemical Society.

[] AR: Analytical Reagent.

[] GR: Guaranteed reagent.

[] MSDS: Material safety data sheet.

[] SOP: Standard Operating Procedure.

[] QC: Quality Control.

 

Reagent

Reagent is a substance which is added to a system in order to cause a specific chemical reaction, or added to notice if a reaction occurs or not.

Flash point

It is describe as minimum temperature of liquid at which it provides sufficient vapor to form ignitable mixture with the air.

Flammable liquid

Any liquid having Flash Point below 37.8⁰C[100 F]. Less-flammable liquids having flashpoint between 100 F & 200 F are well-defined as the combustible liquids.

HLF:

Highly flammable liquid having Flash Point of less than 32⁰C

Corrosive substance

A corrosive substance can be defined as which destroy or irretrievably damage human tissue when it comes into contact. Normally used corrosives are: Ammonium Hhydroxide, Acetic Acid, Chromic Acid, Hydrochloric Acid, Hydrotropic Acid, Hydrofluoric Acid, Nitric Acid, Perchloric Acid, Potassium Hydroxide, Phosphoric Acid, Sulfuric acid, Sodium Hydroxide.

YTD

Year-to-date. It can be defined as a period, starting from the beginning of the current year, and continuing up to the present day.

Chemicals and Reagents Management; Responsibilities:

The roles and responsibility is as follows

Officer/ Executive, QC

• To raise requisition for & receive all laboratory chemicals & reagents maintaining proper procedure.
• To confirm labeling with proper information, expiry dating of all laboratory chemicals, solvents, reagents and solutions after receipt or preparation.
• To maintain daily issue, usage & all records properly as per SOP.
• To confirm that procedures are followed during preparation of reagents & solutions.
• To confirm that this procedure is followed.

Manager, Quality Control

• To confirm that this procedure is kept up to date.
• To check that the SOP reflects the required working practices.
• To conduct training on the SOP to all concerned personnel & ensure implementation after training.
• To confirm effective assessment for expiry dating of laboratory chemicals, reagents and solvents.
• To track timely procurement of laboratory chemicals and reagents.

Manager, Quality Assurance

• Take initiative to Approval of the SOP.
• To confirm the overall implementation of the SOP.

Procedure:

Precaution(s):

• Follow the relevant MSDS & safety guidelines while handling chemicals & hazardous reagents.
• Proper protective clothing such as safety glasses, gloves & laboratory coat must be worn while handling chemicals in the laboratory.
• Use fume hood while handling acids, bases, hazardous & flammables substances.
• Try to minimum exposure to avoid contamination.
• Use sonication to degas HPLC mobile phase before use.
• Correctly label each unit container of chemicals & reagents.
• Read reagent label very carefully before any type of use.
• Don’t use any chemical or solvent when contaminated or change of physical appearance or precipitation observed.
• Never ingest toxic substances.
• Do not allow highly flammable liquids, toxic substances, corrosive substances to come into contact with the skin and eye.
• Keep away flammables substances from fire or ignition source.

General guidelines

• Never use beakers or measuring cylinders for precise volumetric measurement.
• Always use class a glassware for all volumetric application.
• Allow solutions temperature reduce to room temperature before any dilution to volume.
• Always use clean, inert PTFE stirring bar as magnetic stirrer.
• Reagent quality must be ACS[American Chemical Society] or AR or GR grade or equivalent, unless otherwise specified in relevant analytical method.
• To prepare reagent solutions always use distilled water or purified water (that complies with USP/ BP/ EP requirement).
• To avoid contamination even with best precaution, never return dispensed chemicals to stock bottle.
• Before mixing solutions together, measure each solution individually.
• Highly consumable like Methanol, maintain control of first in first out (FIFO) process.
• Checked Expiry dates of reagent solution be before use.
• To prevent contamination to the entire quantity and allocate the same expiry date as mentioned in the primary container, divide a large quantity of reagent into smaller containers. This is very useful for hygroscopic reagents.
• Light sensitive reagent solution is to be kept in plastic bottles or amber glass.
• Store chemicals in a designated place, away from heat or sunlight, return to the same location after each time of use.
• Never store chemicals or waste in fume hood.

Ordering of reagents and chemicals

• Review laboratory chemicals & reagents stock inventory on Monthly/Six monthly/Yearly basis / as when required.
• Prepare a list for purchasing of new reagents & chemicals to ensure uninterrupted analysis in laboratory operations.

Raise a purchase requisition considering the following elements:

• New method related to new product which is in product launching pipeline for commercialization of new product.
• Reagents or chemicals with short self life expiry.
• Pharmacopoeia (BP, USP & EP) requirements.
• If possible, to avoid powder handling, Order toxic materials in liquid form.
• Place requisition minimum three months earlier to the Procurement Department before the existing stock become nil.

Receipt of reagents and chemicals

• Just after receipt, check integrity of the container & ensure reagents & chemicals are received its standard condition.
• Check label on the bottle & tally with invoice / certificate / MSDS. If any discrepancy is found, report promptly to Store and Procurement Department.
• After receipt, record receiving information at “Reagent and Chemical Receiving Register” as per Annexure-II & “Reagent Stock and Issue Register” for Liquid/Solid as per Annexure-III respectively.
• Use ‘S- serial number’ for solid reagent & L- serial number’ for liquid reagent for reagent code numbering,.
• Affix a reagent label to each unit primary container as per Annexure-VI.
• Record the date of receipt & storage temperature mentioned on the label collected from manufacturer’s label/ certificate of analysis/ invoice. Assign the expiry date if found in manufacturer’s label.
• Allocate the expiry date from the date of opening as follows, unless otherwise stated in manufacturer’s label,
• Store reagents & chemicals in dedicated area where temperature at or below 30°C.
• Keep large quantities solvents in the solvent store at room temperature unless otherwise stated in manufacturer’s label.

 

 

Use of reagents and chemicals

• Issue unbroken bottle/container from stock against requisition as per Annexure-I & maintain issue record (issued quantity/ issued by/date/balance amount etc. as required) into the ‘Reagent Stock and Issue Register’ for Liquid or Solid as per Annexure-III.
• On the basis of critical stock position, raise requisition for chemicals & reagents to procurement department.
• Allocate opened date/expiry date sign on the previously affixed label for newly opened container.
• Not issued bottle/containers must not be mix with the opened bottle/container.

 Handling and storage of Toxic substances, highly flammable liquids

Toxic substances:

• All toxic substances/chemicals to be labeled as toxic & handled under fume cupboard.
• For weighing dry toxic powder, use container with lid. Add approximate amount of powder to the container & close lid in a fume hood. Back to the balance & weigh the powder. Back to the fume hood to prepare solution.
• Keep container closed as soon as possible with tightly fitting.
• Low dilute solution (<1% w/v) of toxic substances may be handled in the laboratory with appropriate care to avoid contamination of the area & individuals.
• All vessels/containers used for long-lasting storage of toxic substances/chemicals must be carefully labeled with the contents & hazard type.
• Vinyl/nitrile/latex gloves must be worn while handling toxic substances/chemicals. Properly fitted mask must be use to handle handling solid toxic substances.
• Adequate care should be taken during removing of PPE [Personal Protective Equipment] to avoid contamination of the hand/face.
• All contamination by toxic substances/chemicals must be washed off/cleaned up instantly as per instructions/guidelines/protective measures mentioned on MSDS [Material Safety Data Sheet].
• Disposal of toxic substances/chemicals must be conduct with extra care.

 Highly flammable liquids

• Majority of laboratory solvents and certain flavors, essence & film coating solutions are highly flammable liquids

can cause serious fires & explosions with subsequent injury to personnel & damage to goods.

• Must be stored in the isolated place of Solvent store area.
• An intact bottle shall be transferred to the laboratory by maintaining a record/requisition.
• Stored quantity in the Laboratory/ Production area must not exceed 20 litres.
• To avoid accumulation of vapor, must be stored in a suitable well ventilated place.
• Must be handled in a well-ventilated area such as a fume cupboard in the Laboratory.
• A suitable carrier to be use during carrying of Bottles to minimize the risk of breakage.
• Containers should not store in direct sunlight/near a source of heat/ignition. Store the containers in the isolated place on a metal/solvent resistant tray.
• Never use in the same working area near undressed flame, hot plate/any equipment that is legally responsible to produce a spark.
• Container must be closed at all times other than when the liquid is being transferred from it.

Download all Annexure Here: Chemicals and Reagents Management

Annexure I Requisition Form for Laboratory Chemicals and Reagents

Annexure II Reagent and Chemical Receiving Register

Annexure III Reagent Stock and Issue Register

Annexure IV List of Toxic Laboratory Chemicals

Annexure V List of Flammable Solvents

Annexure VI Label for Reagent

 

 

Handling of spillage; Purpose

The tenacity of this SOP is to define the handling of the spillages in the quality control laboratory to make laboratory safe, neat & clean.

Handling of spillage; Scope

This process is applicable to the chemical room, instrument room in the quality control laboratory of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[] MSDS: Material Safety Data Sheet

[] SOP: Standard Operating Procedure

[] QC: Quality Control

[] Spillage: The act of allowing a fluid or material to escape from the container.

Responsibilities

The roles and responsibility is as follows.

Lab attendant, QC

[] To clean-up the spills maintaining proper procedure.

Officer, QC

[] To ensure that this procedure is followed.

Manager, Quality Control

• To confirm that this process is kept up to date.
• To confirm that the SOP is reflects the required working practices.
• Place training on the SOP to all concerned personnel.
• To confirm implementation of the SOP after training.

Head of Quality Assurance

• Take initiative to Approval of this SOP.
• To confirm the overall implementation of the SOP.

 Procedure:

Precaution(s):

• Carefully handle the solvents & chemicals to avoid accidents & spillages.
• Use gloves, mask & eye protector while handling spillage.
• Be watchful while neutralization process of acid or base spills because it may be enthusiastic, cause splashes & yield large amount of heat.
• For spillage of flammable liquids, control all potential source of ignition near spillage area.
• Never generate dust or cause the contaminated powder to become airborne while cleaning of solid spills.
• If broken glass is involved, never pick it up with gloved hand rather than use tongs.
• Ensure that all forms of local exhaust i.e. fume hoods are operating.
• Water shouldn’t be used for chemicals which are water reactive.
• Never use a vacuum cleaner to clean up the spill.
• On spillage, personnel who caused the spill will instantly inform supervisor, all persons in the laboratory to take care & the lab attendant to clean spillage.
• Evacuate the specific area, if required.
• Limit access to spill area until total cleanup is completed.
• For water spillage use only mop with dry cloth.
• Wear suitable PPE[personal protective equipment] e.g. gloves, goggles, masks etc. while cleaning up spills.
• Use tongs to pick-up the broken glass, when spills involve broken glass, place it in plastic dustpan to place them in the bin dedicated for broken glassware.
• Use brush & the plastic dustpan to place materials into polyethylene bags & dispose it as chemical waste when spillage of solids.
• If spillage occurs due to liquids like acids or solvents, mop it up clearly.
• When needed, add adequate quantity of absorbent silica or precalcinated silica granules and let stand for few minutes, collect the material using hand gloves into polyethylene bags & dispose it as chemical waste.
• If needed, use sodium bicarbonate to neutralize acids. Use pH paper to check pH when acid spills have been neutralized. Then mop it up with water.
• For spillage of liquids like alkali, add adequate quantity of water to dilute it, mop with the help of dry cloth and finally wipe with wet cloth.
• In case of Mercury spills, begin cleanup procedure with collecting the droplets of mercury. The large droplets can be consolidated by using scraper or a piece of cardboard. For cleaning up small mercury droplets, pick up with a piece of adhesive tape. Slowly & carefully squeeze mercury onto a damp paper towel. Place paper towel into polyethylene bags & dispose it as chemical waste.
• While cleaning the area where spillage of hazardous chemicals & poisonous take precautions as per MSDS of respective chemicals.
• After bulk of the material is cleaned up, wipe up the area with previously mixed detergent water & then with tap water and then leave the area to dry.
• Rinse tools (plastic dustpan, tongs etc.) off plentiful amount of water.
• Dry tools off & keep in isolated place.
• Dispose of gloves as waste and place goggles back into the dedicated area.

Chemical laboratory safety procedure; Purpose

Chemical laboratory safety procedure, The tenacity of this SOP is to define the general laboratory safety procedure, which will confirm the safe working condition within the Quality Control Laboratory.

Chemical laboratory safety procedure; Scope

This practice is valid for laboratory operations in the quality control laboratory of XX Pharmaceuticals Limited.

Definition

[] MSDS: Material safety data sheet.

[] PPE: Personal protective equipment.

[] QC: Quality Control.

[] SOP: Standard Operating Procedure.

Responsibilities:

The roles and responsibility is as follows

User/Analyst

[] To use personal PPE [Protective Equipment] as per MSDS [Material safety data sheet].

[] To maintain appropriate procedure for safety.

Manager, Quality Control

• To confirm that this procedure is kept up to date.
• To check that SOP reflects required working practices.
• To organize training on the SOP to all concerned personnel.
• To confirm implementation of the SOP after training.
• To achieve the operational control.
• To confirm the availability of suitable PPE & safety equipment.

Head of Quality Assurance

• Take initiative to Approval of the SOP.
• To confirm the overall implementation of the SOP.

Procedure:

Precaution(s):

• Take a note of material hazard facts from the supplier’s information. Review any relevant hazard data in MSDS.
• Do not smoke, drink, chew gum, eat, or apply cosmetics in the laboratory.
• Do not keep food or beverages in the laboratory.
• Always keep the flammable chemicals away from sources of fire.
• Try to avoid unnecessary chemical exposure.
• Never use fume hood for storage.

General procedure

• Wear laboratory coat and dedicated laboratory shoes, before entering into the laboratory. Keep goggles/ eye protector in the pocket of lab coat and & when necessary. This will give protection against corrosive action of chemicals & contaminations.
• Check PPE prior to use & attire appropriate protective equipment as processes dictate & when required to avoid chemical exposure.
• Wear gloves when using any type of hazardous or toxic chemicals & respirator when handling solvents.
• Wash & clean gloves regularly during a hazardous job. Discard soiled gloves as hazardous waste after use. Remove them before leaving laboratory/at the end of the work.
• When handling/transferring solid chemicals only from one container to another, wear gloves dust mask and activity to be perform under fume cupboard.
• Treat anonymous chemicals as hazardous & before starting work, make sure the analysts are familiar with all known hazards of the chemicals & take proper precautions.
• Reject glass apparatus that is damaged, cracked/even scratched.
• Examine all glassware before use. Use washed & clean glassware. Always move gas cylinder on cylinder trolley. Gas cylinder when standing upright position should always be appropriately supported.
• Use fume hood to handle hazardous chemicals, volatile liquid and flammable compounds.
• If solvent extraction is perform by shaking in a separating funnel, release pressure at frequent intervals by reversing funnel. Point the funnel away from the eyes & naked flames.
• Avoid pipetting anything by mouth. Use mechanical pipetting device/pipette bulb/ aspirator.
• Always add the acid to the water when diluting acids; never add water to acid. Add the acid to water slowly.
• Conduct periodical inspection in laboratory refrigerators & storerooms, correctly label all collected samples.
• Confirm all electrical wires are properly insulated. Report all electrical faults to the reporting authority/supervisor.
• Instantly Report all type accidents to the Supervisor/Manager.
• Confirm that all personnel engage laboratory know about the fire exit from the chemical laboratory.
• Confirm eye showers & Fire extinguishers are located at easily accessible points.
• Confirm all personnel/user are aware about the locations & proper use of all safety equipments (e.g. eye shower, First-aid kit, fire extinguishers).
• Wash hands before leaving the laboratory, in case of chemical handling.
• Wash the exposed area with large amount of water in case of spillage of any acid, base or irritant material on skin and seek immediate medical support if required.
• Clearly sealed& labeled the dangerous materials and never leave it on the working bench unattended
• Visitors to laboratory should be under the direct supervision of a accountable personnel.

Spillages

• Spillages must be instantly dealt as per SOP for Handling of Spillages in the QC Laboratory.

Disposal of waste

• Waste must be disposed as per SOP for Waste Management in QC Laboratory.