SmartInspect :

 

Pfizer Inc. in the US is a SmartInspect customer to ASSIST them with their global GMP API Sourcing quality oversight  while  Bristol Meyers Squibb have also acquired SmartInspect to assist with biologic Technology transfer with their “String of Pearls, outsourced CMOS,CRAMS.

 There’s a pattern here. There must be something to this ?
When it comes to pharmaceutical FDA inspections or GMP Audits—there is now a “Trust but Verify” attitude within the  global pharma industry.

Question is how do you do that with Limited Resources and the mandates to cut costs? How do you maintain that US or ICH  GMP compliance is assured from your China API Source? How do you monitor your outsourced Contract Manufacturers  or Collaborative Partners are not cutting Quality corners Risking future 483s on your next inspection or Import Alerts or even worst --adverse events with your finished formulations on the market ?
 During our Cphi Show Daily interview, Ram Balani, CEO-Founder
 of FDASmart was asked:

Among the challenges the industry faces, which do you think are the most pressing?

The pharmaceutical supply chain is under siege from globalization, manufacturing outsourcing, and the tectonic shift of new drugs’ market growths away from the West into emerging regions like China and India. Big pharma is no longer a monolithic entity that performs all stages of drug development in-house, but has instead outsourced anything and everything that is not considered the company’s core competency including research, clinical trials, manufacturing, and distribution.

Estimates are that in the U.S. alone, 40 percent of drugs are manufactured overseas and close to 80 percent of APIs (Active Pharmaceutical Ingredients) are now sourced from foreign suppliers, primarily China and India. Though India boasts of having the most U.S. FDA approved manufacturing plants outside the U.S., there is a wide gap between Western and emerging regions’ GMP (Good Manufacturing Practice). Chinese SFDA is making progress with improvements to harmonize their local GMP closer to the West, but more needs to be accomplished.

Pharma companies need to enter into a new era of pro-active and holistic vigilance with their direct and indirect supply chain no matter the location and hold all parties accountable. A “trust, but verify” policy towards the supply chain is now considered mission critical.

Challenges to deliver more quality oversight and outsourc­ing collaboration with manageable time and resource costs will demand new business processes, new technologies, and innovative solutions relying on the latest collaboration and data sharing. State-of-the-art information technolo­gies—such as secure cloud computing and wireless free-roaming conferenc­ing systems to create manufacturing plant-site real-time, remote mobile supervisory tele-presence—ease the cost of global oversight. These technologies exist today, but a new out-of the-box mindset is required.

 And what do you believe are the most creative solutions?
New levels of industry collaboration and secure audit sharing amongst regulatory agencies and pharmaceu­tical companies are becoming more and more acceptable. The U.S. FDA, recognizing their limited resources, is now in full swing with utilizing cer­tified 3rd party inspectors overseas and have established their presence in international regions like China, India, the Middle East, and Latin America. Regulatory agencies in Europe, Australia and U.S. are in the midst of a pilot program to assess best practices with inspections and audit sharing, as well.

New creative solutions will hinge on leveraging the significant informa­tion technology progress made, such as robust secure collaboration data­bases and software, cloud computing to minimize cost robust IT systems, and wireless conferencing systems that render a real-time, virtual remote tele-presence without the travel costs.

SmartInspect can be an answer to your GMP audit or Warning Letters (483) remediation WITHOUT THE TRAVEL COSTS !


The Director of  DMPQ at the US FDA (Division of Manufacturing & Product Quality) had this to say about Smartinspect:
This technology does sound like it has some promise to help a firm's external auditors with additional expertise in some cases, without being at the audited site

The Editor in Chief of Pharmaceutical Technology, Iselin, New Jersey in the US  made the comments below:
It’s very exciting to hear about all of your success with SmartInspect, and with increased concern about supply-chain security, I’m sure you’ll only increase your demand”


 What is SmartInspect ?
SmartInspect…. is a new, wearable , wireless, mobile video-audio technology (VoIP)  that works with standard wireless technology (Wifi 802.11b/g) using Internet broadband or 3G cellular phone connection (Mobile telepresence in real time).

In a nutshell, it’s  a wearable “seeing”, “talking”  VoiP conferencing system with “feet”, YOURS !
   
Using SmartInspect, one can REMOTELY Monitor, Guide or “Police” GMP quality audits for APIs  specially those  sourced from emerging ASIAN regions – Internet is (almost) FREE ! 
   
Transmit headset camera, real time video via the Internet  while you communicate by audio using a Skype like service
   
  Record real-time, live video and audio  for archiving
or 
Keep  video/audio  recording as part of your  Quality Systems validation process
or
Re-purpose for training others in real-time or on demand
   
 Here’s how Leading Big Pharma intends to use it:
Remote audit assistance on Emerging Market Suppliers and Contractors
Scan in non-english documents for real time interpretation
Conduct Mock PAI inspections
Global Training Resource
Leverage EHS, SMEs, QPs and other critical audit team members from Leading Big Pharma sites
Prepare Leading Big Pharma PGM Sites for FDA inspection readiness
Real time gap analysis on potential critical audit observations
Build partnerships with Emerging Market sites to leverage Leading Big Pharma expertise to assist in their ability to comply with US, EU and Leading Big Pharma standards.
Protect Leading Big Pharma Supply Chain

We invite you to email us at  rbalani@fdasmart.com  to SCHEDULE a FREE fifteen (15) minute, REAL-TIME DEMO  over the WEB.

We will be using the  actual SmartInspect gear itself  ……while YOU view on your desktop  What Our  Handheld, VGA  quality   video camera  SEES  as We Move About  While Talking with us LIVE Remotely!
 

SmartInspect was featured in the January 2012 issue of "Pharmaceutical Manufacturing", Available here: http://www.pharmamanufacturing.com/articles/2012/007.html

SmartInspect Demo




DEMO - Remote Inspections


SmartInspect Presentation

OR

Download SmartInspect Presentation