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PC Pharma Limited - Colombo Stock Exchange

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Risk associated with the Manufacturing Process<br />

Given the nature of the products there are several manufacturing related risks can be<br />

identified,<br />

The manufacturing of pharmaceuticals is subject to a very strict process which consists of<br />

strict regulations on the quality of raw material supplied, quality control through the<br />

formulation process, and packaging of the finished products as well as the distribution<br />

process. The process and standards will vary according to the product hence careful<br />

attention should be paid to each product at each stage any mishap in the process would<br />

result in a low quality products this will be harmful to the patient and have an adverse<br />

impact on the company.<br />

Scrap disposal will be one of the biggest issues in maintaining a pharmaceutical<br />

manufacturing plant as each item of waste will have to be disposed in such a way so that it<br />

won’t be harmful to the environment or the people hence the process of disposing will be<br />

costly. Another potential risk is the risk of recalls, if a product is not up to the required<br />

quality standards the company will have to recall the products from the distributors and<br />

this will have a severe impact on the company’s financials.<br />

Given the nature of production there will be strict regulations and quality tests imposed by<br />

the government in order to ensure the quality of the products, the company will be<br />

required to obtain licenses from the required authorities and if the company fails to<br />

maintain the quality standards then they will be exposed to the risk of losing the license.<br />

Any of the said risks would have a negative impact on the company’s immediate and longterm<br />

profitability.<br />

30 Introductory Document – <strong>PC</strong> <strong>Pharma</strong> <strong>Limited</strong>

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