SOP for Safety in Laboratory : Pharmaceutical Guidelines

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SOP for Safety in Laboratory

Standard Operating Procedure of safety in quality control laboratory during analysis of pharmaceutical products and raw material.

1.0 OBJECTIVE

To describe a procedure for maintaining safety in the laboratory.

2.0 SCOPE

This procedure applies to the quality control laboratory in the manufacturing facility.

3.0 RESPONSIBILITY

3.1 Officer – Quality control
3.2 Executive –Quality control

4.0 ACCOUNTABILITY

Manager - Quality control

5.0 PROCEDURE

5.1 Guidelines for personal laboratory safety

5.1.1 Eating, drinking or smoking in the laboratory should be strictly prohibited.
5.1.2 Use safety goggles for eye protection while handling corrosive and highly toxic materials.
5.1.3 Wear lab coats when handling corrosive, toxic, or flammable materials.
5.1.4 Wear gloves when handling corrosive and highly toxic materials.
5.1.5 Know where safety equipment (eyewash, extinguishers) is located and how to use it.
5.1.6 Do not carry corrosives by the mouth of the bottle.
5.1.7 Never pipette corrosive liquids by mouth. Use a pipetting bulb or other mechanical pipetting devices.
5.1.8 Do not attempt to identify chemicals by smell or taste. Never sniff reagents, especially corrosive ones.
5.1.9 Know how to clean up spills of the chemicals that you use.
5.1.10 Wash your hands after handling chemicals and before leaving the lab.
5.1.11 Bare legs are not acceptable when handling hot, cold, toxic or corrosive chemicals.
5.1.12 Eyewash facilities should be within easy access.
5.1.13 Keep appropriate safety equipment readily available and properly maintained to prevent or respond to such laboratory emergencies as personal contamination, fires, spills or splashes.
5.1.14 Obey the "two person" rule. A second person should be aware that you are working in the laboratory.

5.2 Checklist for preliminary hazard analysis

5.2.1 Always check the safety precautions for the material you are using to understand the specific hazards involved.
5.2.2 Review the characteristics of all reagents, reactants in terms of flammability, toxicity and reactivity hazards. Where information is not available, treat the materials as hazardous.
5.2.3 What is the type of hazard (inhalation, ingestion, eye or skin contact)? What protective measures are required?
5.2.4 What is the recommended first aid in case of accidental exposure?
5.2.5 Can waste be safely handled and arrangements for disposal completed?

5.3 Safety controls

5.3.1 Engineering controls are always the best choice for regulating hazardous materials; Use wherever applicable:
5.3.1.1 Fume hoods
5.3.1.2 Local exhaust hoods

5.4 Chemical storage

5.4.1 Chemical storage should be under the supervision of a qualified person; store rooms must have adequate security.

5.5 Conduct an annual inventory

5.5.1 To remove surplus hazardous chemicals.
5.5.2 To remove chemicals that will not or have not been used in the past 1-3 years.
5.5.3 To correct incompatible storage.
5.5.4 To identify which chemicals are present.
5.5.5 To conduct a regular clean-up of containers and shelving.

5.6 General rules

5.6.1 Shelving should be accessible with chemicals at eye level or lower; no high shelf storage.
5.6.2 Avoid floor chemical storage.
5.6.3 Do not overcrowd shelves.
5.6.4 Chain compressed gas cylinders.
5.6.5 Keep solvent containers closed. Ensure chemical containers are intact. Ensure container lids are intact and closed. Regularly vent materials capable of building up pressure; e.g. formic acid.
5.6.6 For emergencies have fire extinguishers of the approved type positioned near an
escape route spill control and clean-up materials.

5.7 Label properly

5.7.1 Label contents clearly.
5.7.2 Labels must be intact and legible.
5.7.3 Do not overwrite labels.

5.8 Refrigerator storage

5.8.1 In the event that chemicals need to be stored in a refrigerator, follow the rules listed below:
5.8.1.1 The materials must be securely packaged, tightly sealed and properly labeled.
5.8.1.2 Ensure that materials, especially those that are highly reactive or corrosive, are inspected regularly and that lids are intact.

6.0 ABBREVIATIONS

6.1 NA - Not Applicable
6.2 NO. - Number
6.3 SOP - Standard Operating Procedure
6.4 QC - Quality Control
6.5 B. No. - Batch number
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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