Abstract
Commercial viability of any drug product may often bring pain for patients who otherwise wait for their drug to improve their quality of life and breath. Dryness of drug products like thyroxin, warfarin, phenobarbitone, salbutamol inhalers, morphine etc. from the market leave patient on the mercy of nature. The heart wrenching healthcare professional burst out when lifesaving drugs are not available due to any reason. Voice of civil society rises in community where care of others is felt as a moral responsibility beside capitalism and/or socialism. It is also observed and quite possible that quality defects may create similar situations of drug shortage. Manufacturing facility or its control may go out unwittingly due to knowledge limitation. A quality defect that impacts delivery and performance of drug and/or carries harmful potential has always been a matter of top priority. In both cases, ability to detect, report and assess defines presence and thickness of protection wall for the public. Power to predict uncertainty and taking measures well in time is a challenge for industry and regulators to maintain uninterrupted supply of quality drugs.
Highlights
Nobody wants to see complain for their drug products early in the morning and do its best to maintain quality as its inherent attribute
Commercial viability of any drug product may often bring pain for patients who otherwise wait for their drug to improve their quality of life and breath
Drive and direction of regulatory and modern sciences, such as science of quality risk management, quality by design, continuous manufacturing, quality metrics and creating a culture of quality are itself forecasting the roadmap of future
Summary
Commercial viability of any drug product may often bring pain for patients who otherwise wait for their drug to improve their quality of life and breath. Voice of civil society rises in community where care of others is felt as a moral responsibility beside capitalism and/or socialism It is observed and quite possible that quality defects may create similar situations of drug shortage. A quality defect that impacts delivery and performance of drug and/or carries harmful potential has always been a matter of top priority. Current absence of the Drug Regulatory Authority of Pakistan (DRAP) in the international arena through membership, Memorandum of Understanding (MOUs), Mutual Recognition Agreement (MRAs), Mutual Reliance Initiatives (MRIs), collaborative and joint working with other counterparts is increasing the burden of resistance in progress to make pharmaceutical business credible and reliable on the scale of modern science. Proportionality placement of DRAP and industry requires quality education, current knowledge and enthusiasm to guarantee the prosperity
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