As we all witness during COVID 19, supply of all necessity medicines was disturbed and all countries made their boundaries for import and export. Which were major impact on pharmaceutical supply and revenue.
1. Required qualified workforce
➡️ Investment in pharmaceutical industries has been growing day by day after COVID 19. More investors are attract to this pharmaceutical field and make their own small manufacturing units and give competition to bigger and old players in the market.
➡️ Nos. of qualified workforce required to new under develop small pharmaceutical industries and need to train them properly on daily basis and fill the skill gaps in current industries.
➡️ So, this is one of the challenge for industries to improve company’s productivity with high grade quality.
➡️ Indeed, the more properly trained the staff, the more productive they become and reduce the gaps in the routine process.
2. Data collection and statistical evaluation
➡️ Now, pharmaceutical industries come in industry 4.0 and it's time for statistical data analysis and comes out for decision.
➡️ Nowadays, data gathering is a one of the crucial parts for every growing industry and make a stand in current competition.
➡️ After approval of pharmaceutical industries drug products in regulatory, data collection to be start from manufacturing, quality control and other maintenance services etc. This data collection is one of digitalized movement of industry and applied different statistic tools on collected data for taking proper assessment and focus on customer satisfaction.
➡️ Use well developed and regulatory approved statistical data evaluation software for routine data collection and take a preventive action during the manufacturing stage for improving product quality.
3. Supply chain disturbance
➡️ Currently, every industry is facing supply chain problems. Supply chains have witnessed an unprecedented disruption all around the world. In fact, this denotes one the major challenges facing the pharmaceutical industry.
➡️ Even though pharmaceutical company managers constantly seek to improve processes for maximum efficiency, technical contingencies might unfortunately cause a delay in the entire sector. Hence, to reduce the challenges of their pharmaceutical supply chain, they change their strategy and make the best use of their resources.
➡️ Even though we are in the midst of a global digital era, it is important that companies invest in monitoring software to improve efficiency. In fact, the monitoring software will help you see where your products are and the supply chain status. It also helps to predict potential problems. The software will also play a role in improving accountability and will help to avoid counterfeit products to be marketed.
4. Difficulties to manage brand against rising consumer expectation
➡️ Pharmaceutical frauds may major role to demonize brand values of giant pharmaceutical players.
➡️ This industry is under major scrutiny from customers and manage brand value may be more important than other tasks and At the same time, consumers are expecting more from the pharmaceutical industry.
➡️ Pharmaceutical companies will need to manage growing consumer expectations and be prepared to respond to brand crises throughout the year.
3.Establishment Investigation Report (EIR) of FDA- NAI/VAI/OAI
4. Stability and Stability Zone
5. Cleaning Validation
6. Drug product recalls
7. FDA Acronyms & it's meaning
8.Quality risk management for introduction of new product
9. Container closure integrity test
10.Lyophilization or Freeze Drying
11. Six Sigma
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