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Introduction
Critical Quality Attributes (CQAs) refers to a physical, chemical, biological, or microbiological featureof a product that must be within an appropriate range, or limit, or distribution to confirm the expected quality.1,2 CQAs are generally related to the active pharmaceutical ingredients (API), excipients, intermediates (in-process materials), and drug product. For solid dosage forms (SDFs) like tablets or capsules that are taken orally, CQAs are generally the aspects that determine the strength, purity, release of the API from SDFs, and stability. For other types of dosage forms, CQAs include additional aspects specific to that dosage form, for instance, sterility for parenteral products,aerodynamic features for metered dose inhalers (MDIs), and adhesion for transdermal patches. CQAs is an important factor in Pharmaceutical development.3The recently developed approach of drug development, ‘Quality By Design’ (QBD) include design involving the parameter ranges for all CQAs to ensure the product complies the quality target product profile (QTPP). 2
Substandard and counterfeit drugs have been a major concern in recent days. There are a number of instances that account for substandard and fraudulent medications in the global market. Substandard pharmaceutical products do not follow the specifications and are ineffective and even hazardous to the patients4,5. A study in 2017 showed that globally, about 10% of the pharmaceutical dosage forms were claimed to be counterfeit products, but this number increased to 25% for developed countries, and surpassed 50% in some countries, as reported by World Health Organization (WHO). The FDA reports that up to 25% of medications in developing states are not standard or fraudulent.In 2016, the volume of global trade in fraudulent pharmaceutical products was up to USD 4.4 billion, as per the OECD/EUIPO (2019) report which constitutes 0.84% of the estimated pharmaceutical goods imported worldwide 6.
By contributing more than 90 percent of the available drugs on the market, local pharmaceutical manufacturers have recently emerged as a game-changer. Bangladesh Pharmaceutical Market Future Opportunity Outlook 2025, a recentreport published in 2020, has demonstrated that Bangladesh Pharmaceutical Market has marketing prospects ofmore than US$ 6 Billion by 2025 with an absolute growth of 114% from 2019 levels and exports opportunity of more than US$ 450 Million by 2025. For the achievement of this goal, Bangladesh, like other countries,...