Material safety data sheet | Pharma Udyog Academy

 MATERIAL SAFETY DATA SHEETS(MSDS)

Material safety data sheet is an document which consists of detailed information regarding the product i.e

• Effects on Health in case of exposure to product.
  

  Material Safety Data Sheet

• Risk assessment of product handling and use.
• Measures to protect workers from exposure.
• Steps concluded in emergency case .

Occupational Health and Safety Agency(OHSA) obliges the pharmaceuticals under 21 CFR 1910-1200 to keep records of Material safety data sheets for products covered under act .

Material safety data sheets cover following points –

1. Product and Company Identification
2. Hazards Identification
3. Composition, Information on Ingredients
4. First Aid Measures
5. Fire Fighting Measures
6. Accidental Release Measures
7. Handling And Storage
8. Exposure Controls, Personal Protection
9. Physical And Chemical Properties
10. Stability And Reactivity
11. Toxicological Information
12. Ecological Information
13. Disposal Considerations
14. Transport Information
15. Regulatory Information
16. Other Information

           MSDS and Safety Data Sheets

The Data sheet of MSDS should not be more than 3 years old if pharmaceuticals are procuring the product from more than 3 years the personnel responsible should contact manufacturer to give new material safety data sheet.There is no minimum quantity of material which should contain Material safety data sheets as some compounds are dangerous at very low concentrations and some are dangerous at high concentration .

Before going for any Audit MSDS(Material safety data sheets) should be procured for materials like Disinfectants , Fumigating agents , Cleaning agents kept in premises because it may be asked by auditors to show them as Safety is main concern for many regulatory agencies and unavailability of MSDS would be major point in case of safety .

The Globally Harmonized System of Classification and Labelling of Chemicals contains a standard specification for safety data sheets. The SDS follows a 16 section format which is internationally agreed and for substances especially, the SDS should be followed with an Annex which contains the exposure scenarios of this particular substance. The 16 sections are:

• SECTION 1: Identification of the substance/mixture and of the company/undertaking
  • 1.1. Product identifier
  • 1.2. Relevant identified uses of the substance or mixture and uses advised against
  • 1.3. Details of the supplier of the safety data sheet
  • 1.4. Emergency telephone number
• SECTION 2: Hazards identification
  • 2.1. Classification of the substance or mixture
  • 2.2. Label elements
  • 2.3. Other hazards
• SECTION 3: Composition/information on ingredients
  • 3.1. Substances
  • 3.2. Mixtures
• SECTION 4: First aid measures
  • 4.1. Description of first aid measures
  • 4.2. Most important symptoms and effects, both acute and delayed
  • 4.3. Indication of any immediate medical attention and special treatment needed
• SECTION 5: Firefighting measures
  • 5.1. Extinguishing media
  • 5.2. Special hazards arising from the substance or mixture
  • 5.3. Advice for firefighters
• SECTION 6: Accidental release measure
  • 6.1. Personal precautions, protective equipment and emergency procedures
  • 6.2. Environmental precautions
  • 6.3. Methods and material for containment and cleaning up
  • 6.4. Reference to other sections
• SECTION 7: Handling and storage
  • 7.1. Precautions for safe handling
  • 7.2. Conditions for safe storage, including any incompatibilities
  • 7.3. Specific end use(s)
• SECTION 8: Exposure controls/personal protection
  • 8.1. Control parameters
  • 8.2. Exposure controls
• SECTION 9: Physical and chemical properties
  • 9.1. Information on basic physical and chemical properties
  • 9.2. Other information
• SECTION 10: Stability and reactivity
  • 10.1. Reactivity
  • 10.2. Chemical stability
  • 10.3. Possibility of hazardous reactions
  • 10.4. Conditions to avoid
  • 10.5. Incompatible materials
  • 10.6. Hazardous decomposition products
• SECTION 11: Toxicological information
  • 11.1. Information on toxicological effects
• SECTION 12: Ecological information
  • 12.1. Toxicity
  • 12.2. Persistence and degradability
  • 12.3. Bioaccumulative potential
  • 12.4. Mobility in soil
  • 12.5. Results of PBT and vPvB assessment
  • 12.6. Other adverse effects
• SECTION 13: Disposal considerations
  • 13.1. Waste treatment methods
• SECTION 14: Transport information
  1. 14.1. UN number
  2. 14.2. UN proper shipping name
  3. 14.3. Transport hazard class(es)
  4. 14.4. Packing group
  5. 14.5. Environmental hazards
  6. 14.6. Special precautions for user
  7. 14.7. Transport in bulk according to Annex II of MARPOL^[5] and the IBC Code
• SECTION 15: Regulatory information
  • 15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
  • 15.2. Chemical safety assessment
• SECTION 16: Other information
  • 16.2. Date of the latest revision of the SDS
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