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