QUALITY MANAGEMENT OF WASTE AND SCRAP DISPOSAL

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About Authors:
Sahil Jasuja1*, Mahesh Kumar Kataria1
1 Department of Quality Assurance,
Seth G.L. Bihani S.D. College of Technical education (Institute of Pharmaceutical Sciences & Drug Research),
Sri Ganganagar, (Raj.), India.
*sahiljasuja@rediffmail.com

ABSTRACT
Regulatory involvement and environmental concerns are causing pharmacists to take a closer look at how their organizations are managing pharmaceutical waste. Each organization should evaluate its current waste management practices in comparison with state regulatory guidelines. Organizations must then develop a comprehensive plan for full compliance through segregation of waste into the appropriate waste streams. The discovery of a variety of pharmaceuticals in surface, ground, and drinking waters around the country is raising concerns about the potentially adverse environmental consequences of these contaminants. Pharmaceutical waste is not one single waste stream, but many distinct waste streams that reflect the complexity and diversity of the chemicals that comprise pharmaceuticals. Pharmaceutical waste is potentially generated through a wide variety of activities in a health care facility, including but not limited to intravenous (IV) preparation, general compounding, spills/breakage, partially used vials, syringes, and IVs, discontinued, unused preparations, unused unit dose repacks, patients’ personal medications and outdated pharmaceuticals. The consistent increase in the use of potent pharmaceuticals, driven by both drug development and our aging population, is creating a corresponding increase in the amount of pharmaceutical waste generated.

Reference Id: PHARMATUTOR-ART-1491

INTRODUCTION
In pharmaceutical unit there could be solid, liquid or gaseous waste. Out of these three physical forms of waste liquid waste is the most common in pharmaceutical industry. According to GMP there should be proper handling and subsequent safe disposal of waste and scrap materials. Industrialization is posing problem of pollution. This can affect public health adversely. It is therefore, necessary that waste and scrap materials should be disposed in safe manner and if required these may be treated before disposal.[1]

There are three aspects of pharmaceutical waste management:-
*  Management of regulated hazardous pharmaceutical waste;
*  Management of non-regulated hazardous pharmaceutical waste applying best management practices; and,
*  Minimization of pharmaceutical waste.[10]

Table 1: Limits of Pollutants for bulk drugs

COMPULSORY PARAMETERS

mg/l except pH

1)   pH

6.5-8.5

2)   OIL AND GREASE

10.00

3)   BOD (3 days at 27oC)

100.00

4)   TOTAL SUSPENDED SOLIDS

100.00

5)   BIOASSY TEST

90% survival after 96 hrs in 100 % effluent.

ADDITIONAL  PARAMETERS


6)   MERCURY

0.001

7)   ARSENIC

0.20

8)   CHROMIUM

0.10

9)   LEAD

0.10

10)         CYANIDE

0.10

11)         PHENOLICS

1.00

12)         SULPHIDES

2.00

13)         PHOSPHATES

5.00

HANDLING OF WASTE & SCRAP:
Objective

Handling of rejects from production assumes great significance in the pharmaceutical industry, since the use of incorrect destruction procedures have serious adverse consequences for the manufacturing unit, particularly if such material finds its way into the wrong hands, therefore, it is of utmost importance that the inherent dangers of mishandling of rejects/scraps is understood by all the persons concerned with production operations.

Scope
This part provides an overview regarding the generation of rejects/scrap, its collection and accounting, and recommends guidelines for dealing with rejects/scrap and their disposal.

Responsibility
The main responsibility for dealing with rejects/scrap shall rest with the employees directly responsible and accountable for production activities, however, other employees, such as representatives of quality assurance and the housekeeping staff who normally clear the rejects/scrap are equally responsible to ensure that the rejects/scrap are properly handled, right up to its final disposal, in such a manner that they can neither be misused nor can cause any accidents or injuries.

WASTE & SCRAP GENERATION
The following rejects are generated at various stages of manufacture of pharmaceutical products and should be systematically collected, accounted for, destroyed and disposed off in a manner suitable to prevent their misuse.
·         Product residues or rejects generated during sifting, milling, weighing, filtering, and transfer operations.
·         Product residues extracted into dust extraction system at the various stages of manufacture or leftovers in various processing equipment and machinery. Rejects generated during compression, encapsulation,, coating, filling, inspection, and packaging stages.[11]
·         Rejects generated from in-process checks such as weight variation, volume checks, vacuum testing of strips and other such processes.
·         Non-utilizable residues arising out of batches containing utilizable residues.
·         Excess or rejects printed packaging materials coded or non-coded, like labels, cartons, leaflets, foils, tubes leftover at the end of packaging operation.
·         Date-expired or damaged goods returned to the factory or depots.
·         Excess samples remaining with the quality control, after the testing is completed.
·         Control samples in the custody of quality control, after the mandatory storage period.
·         Product samples from R&D laboratories at any stage or development.
·         So called “Empty Containers” carrying residual material such as acids, alkalis, solvents, oxidizing or reducing agents.[11]

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