GMP Services - US FDA Audits & Gap Assessments:

 
Do you export APIs, OTC drugs or generics or sell medical devices to the USA?

A violation or non-compliance with US FDA 21 CFR 210 or 211 is a SERIOUS problem that could cause your business COSTLY DELAYS or even an Import Refusal from the US FDA ?

Let FDASmart assist you !

A US FDA GMP Compliance Mock-Audit will allow you to avoid delays in bringing product to market due to not passing a GMP audit. The cost and time associated with regulatory re-audits if an audit outcome is not satisfactory can also be avoided or minimized.

Here’s HOW FDASmart can Assist you with GMP compliance:
I. On-site US FDA GMP Audits

An on-site GMP audit will identify any GMP non-compliance (gap analysis) and recommend how they should be addressed. This is by far the best way to ensure that a company is GMP compliant and regulatory audit ready.

Your on-site facility  audit involves the following:

Pre-GMP  audit discussion with senior or QC management to determine the audit plan for your manufacturing facility
Audit preparation: review of some of your key documents such as Standard Operating Procedures, Site Master File, Previous regulatory audit reports, deficiencies noted and responses provided
An onsite China audit by an FDASmart Inc. Expert consultant. Length of the audit will depend on complexity of the manufacturing process, size of the company and history of compliance.
Discussion of audit findings and coaching/training your staff involved in the audit
Compiling a report of audit findings and discussion with management.
UNIQUE OFFER – ONLY from FDASmart – for 1st time Customers – one of our Senior GMP Experts   (FORMERLY employed at the US FDA!) will REVIEW our GMP gap assessment report of YOUR FACILITY !
(it’s as THOUGH THE US FDA were auditing your facility before the US FDA Audits Your Facility !)
FDASmart Services to Assist Foreign Clients- US FDA Inspection on GMP Compliance
CHINA/INDIA US FDA GMP Services:

US FDA Standard GMP  Inspections/Audits:

FDASmart Inc. operating out of New York, India and now China/India has several In-COUNTRY consultants who have years of experience as US FDA GMP experts and auditors, i.e. Local to China and India so NO COSTLY TRAVELS !

FDASmart Advantages that benefits you:

GMP Experts located within China and speaking Chinese language for easy communication.
India based GMP Experts who HAVE INSPECTED manufacturing sites in India Approved by the US FDA
English speaking - GMP experts -- so they can inter-act  with the US FDA if needed for post US FDA site inspection 483 CAPA or remediation steps prior to US FDA granting site inspection approval.
A number of our GMP experts in the US served in the US FDA itself as employees and have become expert auditors serving  FDASmart for emerging regions like India and China.
Only FDASmart can assist with US FDA GMP Inspections or Quality Audits in TWO WAYS:
On-site  at your Manufacturing Location
  OR
Alteratively – a TWO-man GMP TEAM approach ( Your Internal QC Local China/India personnel at YOUR  FACILITY  Assisted in REAL-TIME by  Our USA located  GMP expert REMOTELY ------using (FREE ) our new Exclusive SmartInspect technology   
( allows our US based American GMP experts to assist  Your Local virtually/remotely1
 (Smartinspect below)
 
       

SmartInspect creates mobile REMOTE REAL-TIME telepresence, i.e. as though our experts are there with you in CHINA/INDIA !

Our USA-based GMP auditors/experts CAN conduct GMP “site” audits virtually using our unique wearable technology WHILE ASSISTED by your own facility QC personnel.

A SmartInspect unit will be SHIPPED  to your company (Shipping extra charge) so that our USA located GM Expert can INSPECT your ENTIRE  facility virtually with specialized video and 2-way audio real-time voice talking  to CONDUCT THE ACTUAL INSPECTION as though our US expert was there at your facility.

This is  a TRAVEL-FREE & Cost-effective  way to RETAIN USA caliber professional FDA GMP Auditors from FDASmart WITHOUT THE COST of travel to China/India  typically estimated at $ 4000.00 -$ 6000.00 USD for a 2-3 day site inspection plus hotel accommodations, meals, etc.

For further details , please see  link below   to see how the SmartInspect technology works and why Pfizer, world’s largest pharma company uses it in China ! http://www.fdasmart.com/smartinspect/index.html

For further details on how a session might look like – see  www.fdasmart.com/smartinspect/SmartInspect.html  – click “view video. FDASmart will arrange for the equipment to be sent to your site , will walk your IT or computer personnel to prep and set up and provide remote technical support ALL during the remote tour/visit (rental extra charge).

⏏ ALL Local China/India FDASmart GMP auditors/experts  have in-depth knowledge of the relevant  US FDA CFR (Code for Federal Regulations) used by the USA regulators to assess GMP compliance as well as knowing how to interpret the requirements in order to apply the GUIDANCE SPECIFIC TO YOUR FACILITY.

⏏ Your Company will  benefit greatly from their knowledge of what US FDA  regulators expect and their GMP priorities, therefore making sure when the US FDA comes to do the actual site inspection, your company will pass with “flying colors” and received US FDA approvals immediately without costly 483 findings that need correction or even worst, being denied US FDA approval.

II. SmartInspect Assisted GMP Audits

A BETTER & LESS expensive option is using one of our USA based GMP experts but WITHOUT Travel Costs to China via SmartInspect technology cited above.

SmartInspect assisted GMP Audit with USA experts involves:

You company sending key documents e.g. validation master plan, batch release records etc to the auditor.
A FDASmart US FDA GMP expert  auditing in the US for best experience and know-how with US FDA GMP CFRs compliance
The auditor reviewing the documents for compliance.
FDASmart shipping our SmartInspect technology to your site (technology rental charges by the day and shipping/insurance costs will be charged your company, still a savings of $ 5000- $ 7000 by avoiding the US expert travel to China)
The auditor will visit your site virtually using SmartInspect
  Once all the issues have been discussed and a course of action agreed, the auditor will compile a final report that you can then provide to your management.
   
 

 

The benefits – whether you select Option I or II above:
FDASmart Inc.'s GMP compliance audit will allow you to:
Gain greater knowledge of the quality issues affecting your organisation
Develop increased awareness of regulatory expectations
Recognize commonly seen GMP deficiencies and learn how to reduce them in your organisation
Understand the inspection process and how you can prepare for it
Identify quality-critical areas in your own organisation e.g. technical agreements, training, record keeping, delegation
Receive guidance on changing legislation and increasing complexity in the manufacturing and distribution chain for medicinal products.