SOP for Safety in a Quality Control Laboratory

In short: This illustrative SOP sets a framework for recognising and controlling hazards in a pharmaceutical QC laboratory. Before use, the site must assess its actual chemicals, equipment, biological materials, local law, safety data sheets, and emergency arrangements; the examples here do not replace site-specific EHS procedures or professional emergency response.

1. Purpose and scope

Describe how laboratory hazards are assessed, controlled, reported, and reviewed. Apply the procedure to routine QC activities and define additional controls for unusual or high-risk work. WHO’s Laboratory Biosafety Manual, 4th edition (2020), presents an evidence- and risk-based approach for biological laboratory risks; WHO TRS 957, Annex 3 (2010), addresses GMP for pharmaceutical products containing specified hazardous substances such as certain hormones, steroids, or cytotoxins. Neither document replaces applicable national safety law or the site’s chemical safety programme.

This template does not provide chemical-specific spill cleanup, first-aid, fire response, exposure limits, PPE selection, or waste-disposal instructions. Obtain these from current safety data sheets, trained safety personnel, equipment procedures, and applicable local requirements.

Related procedures: QC laboratory cleaning, compression machine operation and cleaning, and raw-material sampling.

2. Responsibilities

• Laboratory management: maintain the risk assessment, approved procedures, suitable facilities and equipment, training, and emergency arrangements.
• Analysts: review hazards before work, follow approved controls, use required equipment and PPE, label materials, and report incidents or unsafe conditions promptly.
• Safety/EHS personnel: advise on risk controls, chemical storage, exposure response, waste, fire protection, and local legal requirements.
• Quality Assurance: review controlled procedures and quality-system records where required.

3. Risk assessment and authorisation

Before starting an activity, identify chemical, biological, physical, electrical, fire, pressure, ergonomic, and equipment hazards. Consider quantity, concentration, volatility, toxicity, reactivity, exposure route, energy sources, waste, and credible failure modes. Select controls through the site’s approved hierarchy and document them in the method or risk assessment. Do not start unapproved work or proceed when required controls are unavailable.

For each hazardous material, consult its current safety data sheet and the approved chemical inventory. Confirm compatibility, segregation, containment, transfer method, storage, waste route, and emergency response. This example SOP’s PPE list, fume-hood conditions, storage rules, container-transport thresholds, and chemical-specific practices are example in-house criterion and require risk-based approval for each material and task.

4. General laboratory controls

• Keep work areas, exits, aisles, emergency equipment, and access to controls clear. Clean ordinary work surfaces under approved procedures and report unresolved hazards.
• Do not eat, drink, smoke, or store food in laboratory work areas or equipment designated for chemicals or biological materials.
• Use only correctly identified reagents, samples, waste, and secondary containers. Close containers when not in use and maintain required storage conditions.
• Use suitable pipetting devices; never pipette by mouth. Use protective equipment and engineering controls selected by the task risk assessment.
• Inspect glassware, electrical leads, instruments, gas connections, and guards before use. Remove damaged equipment from service and report it.
• Use fume cupboards, biological containment devices, or local exhaust only for their intended purpose and when verified as suitable and in service.
• Keep cylinders secured and use compatible regulators and fittings according to the gas supplier’s and site’s procedures. Do not modify connections or use damaged equipment.
• Keep incompatible chemicals segregated and manage flammable, corrosive, oxidising, reactive, and toxic substances under approved storage rules.

These controls are an example in-house criterion framework. Select exact PPE, engineering controls, storage limits, inspection intervals, and handling steps from the activity-specific assessment and applicable local requirements.

5. Spills, exposure, fire, and other emergencies

Follow the site’s emergency response plan and the substance-specific safety data sheet. Stop work, warn nearby personnel, raise the alarm, and evacuate or isolate the area when the risk assessment or response plan requires it. Do not attempt to clean an unknown, uncontrolled, or high-risk spill unless trained, authorised, and equipped for that specific material. Contact the designated response team.

For exposure or injury, summon the site’s trained first-aid or medical response and follow the relevant emergency procedure and safety data sheet. For a fire, activate the alarm and evacuate according to the site plan; only trained personnel should use firefighting equipment where the plan allows. Keep emergency routes and equipment accessible and report every incident and near miss.

This example does not give generic methods for neutralising acid splashes, cleaning solvent spills, incinerating absorbent, keeping antidotes, first aid after poisoning, artificial respiration, or choosing extinguishers. Follow the safety data sheet, local hazardous-waste rules and the site’s approved procedure.

6. Biological materials and waste

Assess biological work before it begins and use controls appropriate to the material, procedure, and potential exposure. Segregate biological and chemical waste according to approved procedures. Decontaminate or dispose of waste only by validated or otherwise approved methods and maintain required records. WHO Laboratory Biosafety Manual (4th edition, 2020) provides a risk-based framework and subject-specific guidance on PPE, decontamination, and waste management.

The source specifies disinfectant immersion of glassware, sterilisation of cultureware, weekly disinfection of laboratory surfaces, and incineration of biological waste. These are example in-house criterion and must be replaced by the current risk-assessed biosafety and waste procedures for the organism, material, and facility.

7. Records, training, and review

Maintain records for training and competency, risk assessments, inspections, incidents and near misses, equipment defects, waste handling where required, and corrective actions. Review the assessment after an incident, process or material change, new equipment, or a change in applicable requirements. Train personnel before they perform assigned work and refresh training according to the approved site programme.

Frequently asked questions

Which PPE should an analyst wear?

Select PPE from the activity-specific risk assessment, safety data sheet, containment needs, and applicable requirements. A single list cannot cover every chemical, biological material, or operation.

Should analysts clean every chemical spill themselves?

No. Follow the emergency plan and substance-specific procedure. Untrained staff should not attempt to clean unknown or uncontrolled spills; alert others and contact the designated response team.

What should the procedure say about poisoning or chemical exposure?

It should direct personnel to the current safety data sheet, site emergency plan, and trained medical response. Avoid general antidote or first-aid instructions that are not approved for the specific substance and exposure.

References

• World Health Organization. Laboratory Biosafety Manual, 4th edition, 2020, including the risk assessment, PPE, and decontamination and waste management monographs. Official WHO publication.
• World Health Organization. WHO good manufacturing practices for pharmaceutical products containing hazardous substances. WHO Technical Report Series No. 957, Annex 3, 2010. Official WHO publication.