Today, USFDA published a new batch of sixty-nine product-specific guidances (PSGs).
These PSGs provide recommendations for developing generic drugs and generating the evidence needed to support Abbreviated New Drug Application (ANDA) approval, thereby helping to streamline generic drug product development by industry and ANDA assessment by FDA.
The batch of 69 PSGs includes:
This requires pharmaceuticals and allied organizations to keep pace and revisit their Kaizen strategies around the products impacted (if at all) by the above regulatory changes.
The batch of 69 PSGs includes:
- 26 new and 43 revised PSGs.
- PSGs for generic products for important treatments for diseases such as: Human Immunodeficiency Virus (HIV), Leukemia, Opioid Use Disorder, Post-Partum Depression. Read details about the guidances here.
This requires pharmaceuticals and allied organizations to keep pace and revisit their Kaizen strategies around the products impacted (if at all) by the above regulatory changes.
By the way, are you employing Kaizen at your workplace? Because now more than ever, pharmaceutical companies must implement appropriate business improvement methodologies as they drive thru the Covid-19 situation and its aftermath. |
There are eighteen top business improvement techniques- Kaizen being the most propitious.
Kaizen has its origins in Japan and is one of the most promising business improvement tool for pharmaceutical, medical device and biotech companies. It can be implemented in innovator as well as generic pharma set ups.
Moreover, Kaizen works equally well with at-site and remote operations.
Kaizen involves making small improvements at all levels within a product’s lifecycle. These incremental changes then bring-on exponential benefits such as-
Kaizen is based on cooperation and commitment (vis-à-vis radical or top-down changes) where employees at all levels of a company work together proactively to achieve regular, incremental improvements. Kaizen thus combines the collective talents within a company to create a powerful engine for continuous business growth.
To learn more on how Kaizen can help your organization successfully drive thru the rough patch posed due to Covid-19 check here.
Kaizen has its origins in Japan and is one of the most promising business improvement tool for pharmaceutical, medical device and biotech companies. It can be implemented in innovator as well as generic pharma set ups.
Moreover, Kaizen works equally well with at-site and remote operations.
Kaizen involves making small improvements at all levels within a product’s lifecycle. These incremental changes then bring-on exponential benefits such as-
- Good quality affordable medicines.
- Lower operational costs.
- Error-free processes.
- Increased safety, productivity.
- High speed product development and
- First-to-file.
Kaizen is based on cooperation and commitment (vis-à-vis radical or top-down changes) where employees at all levels of a company work together proactively to achieve regular, incremental improvements. Kaizen thus combines the collective talents within a company to create a powerful engine for continuous business growth.
To learn more on how Kaizen can help your organization successfully drive thru the rough patch posed due to Covid-19 check here.
Related Topics:
- Book on Kaizen for Pharmaceutical, Medical Device and Biotech Industries; released as Paperback and Digital editions!
- How to Speed-up Pharmaceutical Generic Product Development?: Continuous Improvement Case Study
- Mistake-Proofing Pharmaceutical Products: What can we learn from Valsartan, Losartan and Irbesartan recalls?
- Continuous Business Improvement with mastermind Shruti Bhat series- Advantages of Gemba Kaizen.
- Mistake-Proofing Pharmaceutical Product Development, Manufacturing and Logistics, Cost Savings via Poka Yoke
- 7 Important tools to identify a "Quality" problem.
- Continuous Improvement with mastermind Shruti Bhat series: Advantages of Kaizen methodology
