Скачать или смотреть Final guidance released on Alternative Tools: Assessing Drug Manufacturing Facilities

Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry

In September 2025 FDA published the guidance in Pharmaceutical Quality/Manufacturing Standards (CGMP).

The guidance is on “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry.”

It contains the topics:
1. Risk Based use of alternative tools.
2. Consideration of Alternative Tools.
3. Remote Regulatory Assessment.
4. Inspections Conducted by Trusted Foreign Regulatory Partner.
5. PAIs and PLIs With FDA Remote Subject Matter Experts.
6. The Effects of using Alternative Tools.

The standard and traditional way of FDA Inspection is that they physically visit site and perform the inspection wrt six systems of quality. They review documents, interview people and check whether there is GAP between the submitted information and the actual?

Is Whether production of drug product is in compliance with cGMP?

Whether the manufacturing company is manufacturing the product of good quality?

But after Covid FDA has decided that after evaluating the Risk alternative tools can be used to perform the inspection.

The Alternative Tools can be online audit is performed virtually, live video tours, online review of documents and data base, conferences and means to audit virtually.

These Tools are applicable for New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), Biologics License Applications (BLAs), Supplements to the above

This guidance does not apply to other drug inspection programs including:
Postapproval inspections
Surveillance inspections without preapproval or prelicense components
Follow-up and compliance inspections (e.g., for-cause inspections)
Bioresearch monitoring inspections

For more details, please refer the guideline.

Dr. Rupali Paranjape
Auditor, Trainer & Mentor for Pharma Companies & Professionals
📧 [email protected]
🌐 www.drrupaliparanjape.com

Blue Ocean of Compliance
Holistic Approach Towards Achieving Regulatory Compliance for Pharmaceutical Industries with No-Observation
________________________________
Blue Ocean of Compliance
Holistic Approach Towards Achieving Regulatory Compliance for Pharmaceutical Industries with No-Observation

Are you struggling to solve the problems of non-compliances on your site?
Even with putting your best technologies, Knowledge, and efforts do you feel clueless?
If you want to protect your site from risks & huge losses due to non-compliances,
If you want to know the thought process & path which would lead you to qualify a Regulatory Inspection with no-observation in a cost-effective way,
Then do not miss "Blue Ocean of Compliance" #1 Best Seller book on Amazon by Dr. Rupali Paranjape.

Why you must read this

👉By reading & implementing this you will be able to avoid more than 492, 483s on your site.
👉You will be able to avoid many circumstances that lead to Warning letters.
👉You will become more familiar with the enforcement actions, reasons of non-compliances & ways to overcome them in cost-effective ways.
👉You will come to know many factors which might not be discussed before to solve the non-compliance issues on the site.
👉You will know one new thought process “Blue Ocean of Compliance”
👉At the end of each Chapter Practical Assignments: Exercise is given for implementation.

The beautiful part of the book is, that it is written by an experienced doer that has spent years on the shop floor in a very simple manner, in easily understandable language with examples, case studies, 492 FDA 483 observations, and many Warning Letter Case studies and much more.
You may buy this book from amazon in India & globally.

To book your copy click the below link;
For India;
Blue Ocean of Compliance https://amzn.in/9CNUVoz

Out of India, you may book your copy from amazon.com.
Blue Ocean of Compliance https://a.co/d/fu1fhjs
_____________________________________________
#cgmp #pharmaindustry #ceos #founders #manufacturers #pharmaceuticalindustry #qualityassurance #qualitycontrol #qualityculture #quality #regulatory #manufacturing #ceomindset #ceoinsights #audits #auditor #compliancesolutions #sops #MPharm, #bpharmacy, #mpharmacy, #pharmajobs, #procedures #analytical #validation #laboratory #21cfrpart11 #dataintegrity #documentation #gdprcompliance