SOP for Handling of Laboratory Reagents

Standard Operating Procedure (SOP) for Receipt, Storage, and Handling of Laboratory Reagents, Buffers, Solvents, Glasswares and other consumables in QC.

Receipt, Storage, and Handling of Laboratory Reagents

1.0      Purpose :

    • The purpose of this SOP ( Standard Operating Procedure) is to describe the procedure for the receipt, storage, and handling of laboratory reagents.

2.0      Scope :

    • This procedure is applicable to laboratory reagents used at Quality Control Department in the pharmaceutical manufacturing plant.

3.0      References and Annexures :Laboratory Reagents-Chemicals

    • References :

    • In House.
    • SOP for Disposal of waste generated in Quality Control
    • Annexures :

    • Sticker Label at the time of receipt (Annexure -1)
    • Reagent Requirement and Issuance Register (Annexure -2)
    • Receipt and Stock detail of Chemical/Reagent (Annexure -3)

4.0      Responsibilities : (Laboratory Reagents)

    • Analyst :

    • To provide information about chemical/reagent for procurement and follow the procedure as per the SOP.
    • To maintain the related documents as per the SOP.
    • Quality Control Head or Designee :

    • To procure the required chemical/reagent.
    • Receiving of procured chemicals in proper condition.
    • Store the received chemicals as per their required storage condition
    • Handling of Chemicals with proper safety as per the respective SDS.
    • Perform the documentation as per the SOP.
    • Provide training to the concern persons before the implementation of the SOP.
    • Quality Assurance :

    • To check the SOP.
    • The implementation of the system as per the SOP.
    • Regulatory Affairs Quality Head and Plant Head :

    • To review and approve the SOP.

5.0      Abbreviations and Definition of Terms : (Laboratory Reagents)

    • PPE: Personal Protective Equipments
    • SDS: Safety Data Sheet.
    • SOP: Standard Operating Procedure
    • NA: Not Applicable
    • Definition of terms: NA

6.0      Procedure for Handling of Laboratory Reagents :

    • Laboratory Reagents Procurement Procedure :

    • The analyst shall inform the designated QC person in case of the requirement of any Laboratory reagent /chemicals.
    • The analyst shall mention the details of the required Laboratory chemical/ reagent in the Reagent requirement register as per  Annexure-2.
    • The designated QC person shall inform the supplier about the desired chemical and its required quantity for its procurement.
    • Laboratory Reagents Receiving Procedure :

    • On receipt of the reagents/chemicals, the designee from QC shall verify it against the reagent requirement /issuance register.
    • The designed QC person shall observe the physical condition of the container/bottles/packs before receiving the reagent/ chemicals.
    • If any discrepancy is observed (e,g damaged container, improper storage condition, quantity mismatch, etc.) the QC person shall immediately inform to Head QC or designee and return the material to the supplier.
    • After the required laboratory reagent/chemical is received. its receipt and stock details shall be maintained as per Annexure- 3 by the designed QC person.
    • After receipt of Laboratory glasswares, its receipt and stock details shall be maintained as per Annexure- 4 by the designed QC person.
    • QC person shall paste the label on the laboratory reagent/container as shown in Annexure -1 and put the details of  “Date of Receipt along with the signature.
    • The analyst shall put the date of “First time opened on” along with the sign and assign an expiry date to the chemicals.
    • The expiry date for solid laboratory reagents, solvents and acids shall be as provided by the manufacturer.
    • In case the expiry date is not provided by the manufacturer, then the expiry date shall be assigned as three years from the date of opening.
    • The designated person shall arrange SDS and certificate of analysis if required.
    • Storage of Laboratory Chemicals / Reagents :

    • Store the chemicals/reagents as per the manufacturer’s instructions on the container considering safety precautions.
    • If the manufacturer does not mention any recommended storage condition, store the chemicals/reagents in a designated reagent/chemical storage room controlled at 25°C ± 2°C.
    • In the case of general reagent, where specific storage condition is not required, shall be stored at ambient temperature.
    • If the recommended storage condition of any laboratory reagent is below 15°C, it shall be stored in the refrigerator.
    • In the case where the recommended storage condition of any laboratory reagent is below 0°C, store in a deep freezer.
    • Handle the chemical/ reagent with proper precautions as per its SDS.
    • Acid corrosive chemical bottles/containers shall be opened after wearing proper PPE’s.
    • General Usage Procedure of Laboratory Reagents / Chemicals:

    • The analyst shall take the required reagent for usage from its designed storage place/ chemical store.
    • The analyst shall put the date of opening with signature and expiry date on the label affixed at the time of receipt.
    • If the label is not affixed, Do not use such reagents.
    • The analyst shall codify the reagents and arrange them in alphabetical order on the cupboard of the working table of the respective location.
    • Do the coding of reagents coding at the time of its receipt, the Designated person shall give the specific code to the reagent and maintain the list of reagents with code.
    • Code: the first alphabet of the reagents with serial number

      • e.g. 3-Aminopyridine Code: A01
      • Aluminum GR Code: A02
      • Barium chloride 2-hydrate GR Code: B01
      • Zinc Acetate extra Pure Code: Z01
    • After opening the reagent bottle, if any abnormal observation is found in the physical appearance of reagent, the analyst shall immediately inform to Head QC or designee.
    • Discard such reagents/chemicals as per the procedure defined in the SOP for  “ Disposal of waste generated in Quality control” by taking proper precautions as per its respective SDS.
    • The analyst shall use a new chemical/reagent bottle.
    • After using the required reagent/ chemical, Keep the bottle/container back to its designed place.
    • Maintain the minimum stock of laboratory reagents/chemicals to prevent any delay in the analysis.
    • Precautions during Handling of Laboratory Reagents:

    • Always assure the intactness of the reagent bottle before use.
    • Always check the physical condition and appearance of the reagent before use
    • Ensure the expiry date of a particular reagent before using it. Do not use any reagents after the expiry date as mentioned on the label of the bottle/container.
    • Tighten the mouth of the reagent container both before and after use.
    • Always use suitable PPE’s (like hand gloves, mask, goggle, etc.) required as per the SDS of the chemical/reagent.
    • Always refer to SDS and handling precautions while handling poisonous and toxic chemicals/reagents.
    • Consumption of Acetic Anhydride :

    • Controlled usage of  Acetic Anhydride.
    • Keep Acetic Anhydride under control and secured with lock and key.
    • Destruction Procedure of Laboratory Reagents:

    • If the reagents are left after the expiry date is over, Destroy the remaining quantity as per the procedure mentioned in the SOP for “ Disposal of waste generated in Quality Control.
    • Destruction of Acids :

    • Take plenty of water in a container and add the acid slowly with stirring through sides of the beaker.
    • If the temperature is observed in the container, add more water, cool it and drain it.

 

Note: Some reagents/chemicals/acids may be reactive when treated with water.  Hence, it mandatory to refer to the SDS of the particular reagent before following any discardation procedure. 

Sticker Label at the time of receipt (Annexure -1)

Sticker - Laboratory Reagents

Reagent Requirement and Issuance Register (Annexure -2)

 

Annexure 2

 

Receipt and Stock detail of Chemical/Reagent (Annexure -3)

Name of Material:

Code No.:                                                                                                                    

Sr.

No.

Date of

Receipt

Received

Qty.

Withdraw

Qty.

Withdrawal

By and Date

Balance

Qty.

Checked

By

Remark

 

Receipt and Stock detail of Laboratory Glasswares (Annexure -4)

Name of Glassware :

The volume of Glassware:

Sr. No.

Date of Receipt Received qty. Received by. Checked By

Remark

 

 

pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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