SOP for Handling Laboratory Reagents

In short: This illustrative SOP describes a controlled lifecycle for laboratory reagents, from procurement and receipt through use and disposal. Follow the supplier’s instructions, current safety data sheet (SDS), approved analytical method and site procedures for each specific substance. Do not apply one storage temperature or expiry period to every reagent.

Objective

Provide a template for receiving, identifying, storing, using, preparing and disposing of reagents and chemicals used in a pharmaceutical quality-control laboratory.

Scope

Adapt this example to the laboratory’s quality system and applicable requirements. It covers purchased reagents, transferred or subdivided reagents, and solutions prepared in the laboratory. It does not replace the product label, SDS, chemical risk assessment, pharmacopoeial method or approved test procedure.

Responsibility

Example in-house criterion (not a pharmacopoeial requirement): the laboratory designates trained staff for reagent procurement, receipt, inventory and storage; analysts check the reagent before use and document its use; and the laboratory quality lead approves the controlled procedure and investigates discrepancies.

Procedure

1. Specify and receive reagents

Identify the reagent quality and grade needed for the intended analysis. Use a verified and approved supplier under the laboratory’s supplier-control process. On receipt, compare the delivery with the order, check the container and seal, confirm any specified transport or storage conditions, and compare the label or certificate with the requested identity and quality. Segregate and report damaged, mismatched, improperly transported or questionable material while the discrepancy is assessed. WHO TRS No. 1052, Annex 4 (2024), §§5.47–5.54 describes reagent suitability, supplier control and receipt verification.

Example in-house criterion (not a pharmacopoeial requirement): the receiving analyst records the reagent name, manufacturer or supplier, batch number, quantity, date received and receipt decision in the site’s approved inventory system.

2. Identify and label containers

Keep reagents in their original containers whenever practical. Ensure the label or linked controlled record identifies the reagent, receipt and opening or preparation dates, expiry or justified retest date, applicable storage and protection conditions, concentration or purity when relevant, and hazard and precaution information. For purchased reagents, preserve the manufacturer, supplier and batch details. If a reagent must be transferred or subdivided, use a suitable clean container and label it with the identity, batch, transfer date and responsible person. WHO TRS No. 1052, Annex 4 (2024), §§5.55–5.60 gives the expected label information for purchased, transferred, prepared and volumetric solutions.

Example in-house criterion (not a pharmacopoeial requirement): use the laboratory’s approved label template and link the secondary-container label to the original manufacturer’s lot.

3. Store and handle safely

Store each reagent according to its product label and SDS. Organize storage to address the substance’s temperature, ventilation, fire, compatibility and other identified hazards; segregate incompatible or hazardous materials as required by the applicable risk assessment. Make the relevant SDS available before work begins, use suitable protective equipment and follow the laboratory’s specific safe-working and emergency procedures. Assign reagent-store oversight to trained personnel. WHO TRS No. 1052, Annex 4 (2024), §§5.66–5.67 and 7.1–7.9 covers storage, chemical safety, safety information and waste management.

Example in-house criterion (not a pharmacopoeial requirement): keep a current location and stock list, use hazard-appropriate storage areas, and restrict access where the site’s risk assessment or applicable controls require it.

4. Check and use reagents

Before use, check identity, batch, status, expiry or retest date, storage history where relevant, container integrity and visible condition. Use only material suitable for the approved test. If a label is missing or unreadable, a container is compromised, or the reagent appears changed, do not use it for routine testing; identify it as on hold and refer it for assessment under the laboratory’s deviation process. Document the reagent batch and expiry date in the analytical record to support traceability, as described in WHO TRS No. 1052, Annex 4 (2024), §5.51.

Example in-house criterion (not a pharmacopoeial requirement): dispense only the quantity needed for the immediate operation using a clean, compatible implement; do not return unused material to the original container.

5. Prepare laboratory solutions

Prepare solutions only under an approved procedure that specifies the intended quality, materials, preparation method, controls and suitable validity period. Assign the task to qualified personnel. Label prepared solutions with the identity, preparer, preparation date, validity period and relevant concentration or titre information. For volumetric solutions, include the standardization details required by the approved method. Establish a validity period from supplier information or a documented scientific assessment; do not assign a blanket period such as three years after opening. WHO TRS No. 1052, Annex 4 (2024), §§5.58–5.61 covers preparation and labelling of in-house reagents and volumetric solutions.

6. Manage expiry and disposal

Follow the supplier’s unopened expiry date. Where no expiry is supplied, or opening, transfer or preparation can affect reagent quality, establish and document a suitable period with a scientific justification. Do not use expired material for routine analysis unless an authorized, scientifically justified exception is allowed and the container is relabelled. Dispose of expired, unwanted or unsuitable reagents through the approved waste process, in line with the SDS and applicable legal requirements. WHO TRS No. 1052, Annex 4 (2024), §§5.68–5.73 addresses expiry policies and safe disposal.

Example in-house criterion (not a pharmacopoeial requirement): identify material awaiting disposition as not for use and keep it segregated until authorized disposal or other documented disposition.

7. Keep records

Maintain records needed to show reagent receipt, identity, status, preparation where applicable, use traceability and final disposition. For batch-associated GMP records, retain them for at least one year after the expiry date of the respective product batch, or longer where the applicable requirement calls for it. EU GMP Part I Chapter 4 §4.11 (revision 1, 2011) requires batch documentation to be retained for one year after expiry or at least five years after QP certification, whichever is longer. For covered U.S. drug-product records, 21 CFR §211.180(a) requires retention for at least one year after expiry, with a separate period for certain OTC products without expiry dating. WHO TRS No. 1052, Annex 4 (2024), §3.20 also recommends retaining original laboratory observations and analytical records for not less than five years. Apply the longer period required by the applicable jurisdiction, product authorization or contract.

Related procedures

• SOP on receipt, issue and control of laboratory chemicals
• SOP for safety in the quality-control laboratory
• SOP on disposal of waste generated in a quality-control laboratory
• SOP on reagents, chemicals and volumetric solutions

Abbreviations

• CoA: Certificate of Analysis
• GMP: Good Manufacturing Practice
• LIMS: Laboratory Information Management System
• PPE: Personal Protective Equipment
• QC: Quality Control
• SDS: Safety Data Sheet
• SOP: Standard Operating Procedure

References

1. World Health Organization. WHO Expert Committee on Specifications for Pharmaceutical Preparations: Fifty-seventh Report, WHO Technical Report Series No. 1052, Annex 4, WHO good practices for pharmaceutical quality control laboratories (2024), §§3.20, 5.47–5.73 and 7.1–7.9. Official WHO PDF.
2. European Commission. EudraLex Volume 4, Part I, Chapter 4: Documentation, revision 1 (2011), §4.11. Official PDF.
3. United States. 21 CFR §211.180(a), current eCFR text (2026). Official eCFR.