PHARMACEUTICAL WASTE MANAGEMENT IN INDIA

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  • 1. PREPARED BY: Aakashdeep Raval M.Pharm sem-2 QARA L.J.INSTITUTE OF PHARMACY GUIDED BY: Ms. Krupa Thula Asst. Professor QARA DEPARTMENT L.J.INSTITUTE OF PHARMCY Waste disposal Scrap Disposal Procedure & Records
  • 2. CONTENTS o INTRODUCTION o DEFINITIONS o PHARMACEUTICAL WASTE o TYPES OF PHARMACEUTICAL WASTE o WASTE DISPOSAL METHODS o COLOUR CODING FOR WASTE STORAGE o WASTE DISPOSAL PROCEDURE o INTEGRATED SOLID WASTE MANAGEMENT o LIQUID WASTE MANAGEMENT o SCHEDULE M GUIDELINES o WHO GUIDELINES o RECORDS o REFRENCES 02/31 o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES
  • 3. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 03/31
  • 4. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 04/31
  • 5. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 05/31
  • 6. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 06/31
  • 7. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 07/31
  • 8. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 08/31
  • 9. INTRODUCTION o Hospital pharmacies in the United States purchase over 4 billion hazardous pharmaceuticals annually, generating more than 84,000 tons of hazardous waste. o According to a U.S. Geological survey, pharmaceutical contaminants were found in 80% of sampled water, contaminating drinking water. o In India, a city like New Delhi with about 40,000 beds generates about 60 metric tons of hospital waste per day. o The sorting of pharmaceutical waste is a challenging issue. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 09/31
  • 10. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES DEFINITION Pharmaceutical waste is synonymous with o drug waste o unused or expired drugs o unused or expired prescription and over-the- counter human drugs, veterinary drugs, diagnostic agents, and nutritional supplements. Scrap: Materials like rejected foils, bottles, cans, tins etc. which have a resale value. Trash: This material is to be discarded or disposed of by suitable means and don’t have a resale value. e.g. dust, unsalable materials. 10/31
  • 11. PHARMACEUTICAL WASTE o All unsealed syrups, creams, ointment or eye drops (expired or unexpired) o All cold chain damaged unexpired pharmaceuticals that should have been stored in a cold chain but were not (for example: insulin, polypeptide hormones, gamma globulins and vaccines) o All bulk or loose tablets and capsules. If unexpired these should only be used when the container is still sealed, properly labeled or still within the original unbroken blister packs; o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 11/31
  • 12. o Any items used in cleaning up a spill (vermiculite, paper towels, etc.) must be treated as a waste pharmaceutical, either hazardous or non-hazardous. o Waste materials containing chemotherapy drug residues or excess drugs (syringes, i.v bags, tubing, vials, etc.) o Open containers of drugs that cannot be used o Containers that held acute hazardous waste drugs. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 12/31
  • 13. TYPES OF PHARMACEUTICAL WASTE 1. Controlled substances (Special disposal needed): o Cytotoxic waste: Cytotoxic substances and residues (includes all items contaminated by such substances, or used in the delivery of chemotherapy for cancer treatment, and unused or discarded preparations). o Following category of drugs were also required some special consideration required for disposal o Narcotics, o Psychotropic substances; o Anti-infective drugs, o Antiseptics and disinfectants etc.. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 13/31
  • 14. 2. Chemical Wastes: o Includes Pharmaceutical wastes (includes outdated, contaminated and discarded medicines) 3. Potentially infectious wastes (Biomedical wastes): o Includes Microbiology and Biotechnology Waste o Wastes from laboratory cultures, stocks or specimens of micro- organisms, live or attenuated vaccines, human and animal cell culture used in research and infectious agents from research and industrial laboratories o Wastes from the production of biological, toxins, and dishes and devices used for the transfer of cultures) o Sharp wastes includes o Needles o Scalpels o Blades o IV spikes o other sharp objects that are potentially contaminated with infectious and/or chemical agents and which may cause puncture or cuts o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 14/31
  • 15. 4. Other pharmaceuticals: (a) solids, semi-solids and powders: – tablets, capsules, granules, powders for injection, mixtures, creams, lotions, gels, suppositories, etc. (b) liquids: – solutions, suspensions, syrups, etc. (c) ampoules: – Aerosol canisters: including propellant-driven sprays and inhalers. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 15/31
  • 16. WASTE DISPOSAL METHODS o Waste management is the collection, transport, processing, recycling or disposal of waste materials. o The term usually relates to materials produced by human activity, and is generally undertaken to reduce their effect on health, the environment or aesthetics. o Waste management can involve solid, liquid, gaseous or radioactive substances, with different methods and fields of expertise for each. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 16/31
  • 17. o Waste management methods vary widely between areas for many reasons, including type of waste material, nearby land uses, and the area available. o Constraints in funding for disposal of waste pharmaceuticals necessitate cost-effective management and methods. o The main way to achieve this is to sort the material to minimize the need for expensive or complicated disposal methods. o NEXT SLIDE HAVE methods FOR IT o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 17/31
  • 18. DISPOSAL METHODS TYPES OF PHARMACEUTICAL COMMENTS (1) Return to manufacturer All bulk waste pharmaceuticals It’s a time consuming method. (2) Incineration: o High temperature incineration (> 1200°C) Solids, semisolids, powders, antineoplastic Expensive method. Mainly for antineoplastic agents. o Medium temperature incineration (max 850°C) Powders, solids, controlled substances. Not for antineoplastic agents. (3) Immobilization: o Waste encapsulation Powders, liquids, solids. Inexpensive and performed by unsophisticated equipments. o Inertization Solids, liquids, semisolids, antineoplastic. Inexpensive and performed by unsophisticated equipments. (4) Landfill: o Highly engineered sanitary Landfill Limited quantities of untreated solids, Semi-solids and powders. Disposal of waste pharmaceuticals after Immobilization preferable. PVC plastics. Worst option as it pollutes land and reduce its fertility percentage. o Engineered landfill Waste solids, semi-solids and powders, Preferably after immobilization. PVC Plastics. Worst option as it pollutes land and reduce its fertility percentage. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 18/31
  • 19. Open uncontrolled non engineered Dump As last resort untreated solids, semisolids, powders - must be covered Immediately with municipal waste. Immobilization of solids, semi- solids, Powders are preferable. Not for untreated Controlled substances (5) Sewer and fast -flowing watercourse Diluted liquids, syrups, intravenous fluids, small quantities of diluted Disinfectants (supervised). Antineoplastic, and undiluted disinfectants & antiseptics not Recommended (6) Burning in open containers As last resort, packaging, paper, Cardboard Not acceptable for PVC plastics or Pharmaceuticals 7) Chemical decomposition Not recommended unless special chemical expertise & materials Available Not practical for quantities Over 50 kg. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 19/31
  • 20. COLOR CODING FOR STORAGE OF WASTE IN PHARMACEUTICAL COMPANY. Colour coding Types of container Waste categories Yellow Plastic bags •Human anatomical waste •Animal waste •Microbiological waste •Solid waste Red Disinfected container, plastic bags •Microbiological waste •Solid waste Blue/ White Plastic bags/ puncture proof containers •Sharp wastes(needles, blades etc.) Black Plastic bags •Discarded waste •Incineration waste •Chemical waste o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 20/31
  • 21. WASTE DISPOSAL PROCEDURE o Any product requiring disposal should initially be separated from its packaging. e.g. glass, plastic, other containers delay destruction o Risks associated with destruction of the product -potential for product to get diverted, legitimately or otherwise during disposal sequence and contamination of ground water o Ideally, Incineration procedures have preference over landfill. When incineration procedure is used, product in plastic or other flammable packaging may not need to be returned to bulk. o Disposal procedure should involve agents with a proven record of dealing with such sensitive materials or use of the company personnel to accompany the material from plant to disposal. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 21/31
  • 22. PRINTED PACKAGING DISPOSAL o Disposal of printed packaging components (labels, inserts, and cartons) poses no health risk. o Ineffective disposal such as in the public landfill, can give rise to public concern that product may be associated with the packaging. o Such materials should preferably be incinerated. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 22/31
  • 23. GENERAL TRASH AND SEWAGE o Normal local services should be adequate. o Ensure that product and the packaging waste does not get intermixed. o Internal procedures should be sufficiently rigorous and monitored o Containers used within the plant to accumulate waste materials should be clearly marked to denote their designated use. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 23/31
  • 24. INTREGATED SOLID WASTE MANAGEMENT o It takes an overall approach to creating sustainable system that are economical, affordable, socially acceptable and economically effective. o The key function of this system is collection and sorting of waste. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 24/31
  • 25. LIQUID WASTE MANAGEMENT Description and Purpose Liquid waste management includes procedures and practices to prevent discharge of pollutants to the storm drain system or to watercourses as a result of the creation, collection, and disposal of non-hazardous liquid wastes. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 25/31
  • 26. SUITABLE APPLICATION Liquid waste management is applicable to construction projects that generate any of the following non-hazardous by-products, residuals, or wastes: o Drilling slurries and drilling fluids o Grease-free and oil-free wastewater and rinse water o Dredging o Other non-storm water liquid discharges not permitted by separate permits. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 26/31
  • 27. LIMITATIONS o Disposal of some liquid wastes may be subject to specific laws and regulations or to requirements of other permits secured for the construction project (e.g. Army Corps permits, Coastal Commission permits, etc.). o Liquid waste management does not apply to dewatering operations (NS-2 Dewatering Operations), solid waste management (WM-5, Solid Waste Management), hazardous wastes (WM-6, Hazardous Waste Management), or concrete slurry residue (WM- 8, Concrete waste management). o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 27/31
  • 28. SCHEDULE M GUIDELINES o The disposal of sewage and effluent from manufacturing shall be in conformity with requirement of Environmental Pollution Control Board. o All biomedical waste shall be destroyed as per provisions of Bio-medical Waste (Manufacturing and Handling) Rules, 1996. o Additional precautions shall be taken for storage and disposal of rejected drugs. o Records shall be maintained for all disposal of waste. o Provision shall be made for proper and safe storage of waste materials. o Hazardous toxic substance and flammable materials shall be stored in suitably designed and segregated enclosed areas in conformity with central and state legislation. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 28/31
  • 29. WHO GUIDELINES o Provision should be made for proper and safe storage of waste materials awaiting disposal. o Toxic substance and flammable materials should be stored in suitably designed, separate, enclosed cupboards as required by national legislation. o Waste materials o Should not be allowed to accumulate. o Should be collected in suitable receptacles for removal to collection points outside the building o Disposed of safely and in a sanitary manner at regular and frequent interval. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 29/31
  • 30. RECORDS o It shall contain authorized procedures for differentiating recoverable and non-recoverable rejects. o Should include o Date of destruction o Name of product to be destroyed o Type of destruction o Place of destruction o Cause of destruction o Procedures for scrap which are disposed/sold on commercial basis, and precaution to be taken thereof e.g. defacing of labels on empty bulk containers. o Quantities rejected and destroyed must be recorded and reconciled in relevant batch documents. o Safety precautions taken while carrying out destruction must be included in the records. o Signature of authorized person after completion of the destruction must be included in records. o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFRENCES 30/31
  • 31. REFERENCES o Willing H. S, Stoker R J, “Good Manufacturing Practices For Pharmaceuticals” Fourth Edition, 47-48. o Potdar A. M, “Pharmaceutical Quality Assurance” Nirali Prakashan, First Edition, 7-8. o Sharma P P “How To Practice GMPs”,Vandana Publication, Third Edition, 134. o http://epa.gov/climatechange/wycd/waste/downloads/over view.pdf o http://www.dot.ca.gov/hq/construc/stormwater/NS02Upda te.pdf o INTRODUCTION o DEFINITIONS o PHARMA WASTE o TYPES o DISPOSAL METHODS o COLOUR CODING o WASTE DISPOSAL o INTEGRATED SOLID o LIQUID WASTE o SCHEDULE M o WHO GUIDELINES o RECORDS o REFERENCES 31/31
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