Global Supply Chain From ASQ

Global Supply Chain

In today’s global economy, most organizations know they can’t go at it alone. To build products and services that customers demand, businesses must forge partnerships with each other. So how do you ensure you’re adding the right partners to your supply chain process?… more

Academic and Industry Partnerships

As reported by Inside Indiana Business, Purdue Research Foundation and Cook Medical officials  announced on February 4, 2014 plans to establish a $12 million evergreen investment fund to support Purdue-based life sciences companies.  The purpose of this fund is to help capitalize innovations developed within academia.  … more

How not to craft a response to a FDA observation

In a recently posted FDA warning letter, the FDA cited a firm for failure to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation, as required by 21 CFR 820.30(b).  Items missing in the Standard Operating Procedure (SOP) included identifying who is responsible for the design and development planning activities, how the design project will be planned, and the requirements for design planning.… more

GMP and Data Integrity Issues; Wockhardt Ltd, India

On November 25, 2013, the FDA posted a warning letter issued to the Wockhardt Limited company.  This warning letter addressed issues at both Wockhardt’s facilities located in Chikalthana and Waluj,  India.  Wockhardt previously received warning letters in July 2013 and February 2006

Key findings include:

  1. The use of “trial” HPLC injections prior to running actual samples. 

Insulin Manufacturing Expansion

Eli Lilly and Company (NYSE: LLY) today (Nov 14) announced it will invest more than $700 million to enhance its global insulin manufacturing capacity in Puerto Rico, France and China, as well as in Indianapolis, home to Lilly’s global headquarters. Today’s news raises Lilly’s manufacturing commitment in the past year to more than $1 billion in planned investments in response to the growing diabetes epidemic and increasing demand for insulin around the world.… more

IMDMC Meeting – Indianapolis

The Indiana Medical Device Council will be hosting their Annual Meeting November 7th at the Montage Banquet Center.  The following speakers and topics have been confirmed:

  • Mike Pence, Governor of Indiana: state government and the medical device industry;
  • Joann Givens, FDA Regional Director (Chicago)(Acting): what’s happening within FDA and around the region;
  • Jay Crowley, FDA CDRH Senior Advisor for Patient Safety:  final UDI rule. 

Q3D – ICH Guideline for Elemental Impurities

The International Committee for Harmonization (ICH), released Q3D July 2013 for comment. This guideline is available here, and establishes Permitted Daily Exposure (PDE) for each element of concern and provides guidance on the types of controls, which may be implemented if the PDE is exceeded.… more

A review of FDA warning letters posted on October 8, 2013

This week six warning letters were posted to the FDA website.  None of the warning letters were applicable to pharmaceutical manufacturing.  However, three of the six warning letters were applicable to medical device manufacturers.  Of the three medical device warning letters there were a total of 16 citations identified with the following breakdown:

Section    Title / # of Citations

820.100    CAPA – 2
820.184    DHR  – 2
820.40     Document Control – 2
820.75     Process Validation – 2
820.198    Complaints -2
820.90     NCR – 1
820.120    Label & Pkging Control – 1
820.20     Mgt Responsibility – 1
820.30     Design Controls – 1
820.70     Production Process Controls – 1
820.80     Acceptance Activities – 1

Lessons learned:
Corrective and Preventive Action & Complaint:  Review your CAPA & Complaint procedures and make sure that:
a) They contain all the required elements of the QSR.… more

Performance Validation – 25th Year Anniversary

Performance Validation
25th Anniversary of Performance Validation








Performance Validation Associates at the 25th Anniversary Party held September 7th, at the Sheraton in Indianapolis.  PV Associates from across the company (and country) attended, including members from the Indiana, Michigan, Illinois, and Georgia offices.… more

Regenerative Medicine

A fascinating news story on the use of extracellular matrix and its use in regenerative medicine.

As reported by Andy Coughlan of the Sydney Morning Herald (link here) Several researchers have used this material. Harold Ott of Massachusetts General Hospital in Boston built the world’s first functioning artificial kidney.… more