Pharmaceutical Manufacturing QC Whistleblower Receives $96 million

Pharma whistleblowers don't always fare too well...especially those who deal with the invisible world of manufacturing.  Remember Mark Livingston and the Wyeth Sarbanes-Oxley case? However, Cheryl Eckard, who pointed out manufacturing deficiencies at GSK's Cidra, Puerto Rico, plant has received a $96-million payment.  For more from The Guardian, read on.  They've included the text of the actual lawsuit.  Apparently Ms. Eckard contacted CEO Garnier, who refused to take her call.  Pharmalot recently posted a local TV video interview with her shortly after the decision. She says she lost all her friends from work, and went through financial turmoil after her decision to reveal problems.  Clearly, a very sympathetic, extremely ethical professional, she is being described as "a model" whistleblower. To view, click here.

Her lawsuit reads like a textbook cGMP case study...touching on many of the same trends we've seen recently in other cases. Note "calibration", "documentation", process validation, inadequate investigation of OOS results...and the ever-popular "inadequate staffing of QA."

We'll be covering this in greater depth in an article on Data Integrity that will be published soon.  Stay tuned.

Some highlights:

GSK’s chronic quality assurance problems and ongoing, serious
cGMP violations went to the heart of Cidra’s manufacturing,
processing and packaging systems...They included and/or resulted
in:

a. Product mix-ups, i.e., a drug of a different type or
strength found in the same bottle (see paragraphs 87 through 92
below);
b. Inadequate investigation of out-of-specification (“OOS”)
results detected during laboratory testing
c. Inadequate process validation and non-existent validation
review processes for some products
d. Inadequate or non-existent calibration of equipment and
instruments and incomplete investigations relating to equipment
found to be out-of-calibration
e. Overdue process investigations, at times numbering in the
hundreds ;
f. Understaffing in the Quality Assurance Unit
g. Poor documentation quality, including unsigned, undated
and/or lost or missing validation, investigation and change
control documents, and hundreds of SOPs overdue for revision
h. Contamination in products manufactured in the sterile
facility, including Kytril injection and Bactroban ointment
i. Substandard quality and control of the plant’s water
systems, resulting in build up of stagnant water and microbial
contamination
j. Manufacturing areas and purportedly clean equipment that
repeatedly failed routine environmental testing and exhibited
microbial contamination
k. Destruction of internal audit reports immediately after
discussion with the responsible personnel, contrary to GSK policy
and industry practice requiring 3 year retention
l. Serious deficiencies in the functioning of the
Microbiology Laboratory, where testing of products and equipment
for contamination by objectionable organisms is conducted
m. Substandard air handling systems not meeting cGMP
standards and creating the potential for cross contamination
n. Inadequate monitoring to ensure containment of a
cytotoxic product (Topotecan, a chemotherapy drug) manufactured
in the facility
o. Various other cGMP violations and quality assurance
failures, including inadequate identification, control and
storage of drug materials, waste and cleaning agents, poor
disinfection procedures, leaking equipment, and inadequate
verification of product labels ...

AMS

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