Dear Sir / Madam,
During number of years of very advanced /extensive construction, Company
installed very many new peaces of substantial equipment.
Amongst was a new Gallay Bin wash station (Gallay Bins- 80 cubic foot S.S.
Containers designed to hold a tone -2000 pounds of product). System
installed on two floors. As on almost all units, Installation Qualification
was executed but Operational Qualification was failing. Absence of any
Sanitation, Compliance, Supervision, very limited number of unskilled
Operators /Personnel /MAINTENANCE etc. as well as immense pressure to
submit new products to FDA as well as to accumulate huge quantities of
products in order to dump them at the right time on the market (as much as
it WAS possible, especially in/during Legislated 180 days of "window of
opportunity") forced Company to utilize unqualified and not SAFETY Station
into production, especially that those BINS while suppose to be
"dedicated" to particular product, were used for multiple products and had
to be sanitized.
Wash station was out of control. Due to strict confidentiality Manufacturer
/ Supplier of the Station was not supplied with specifications/ Recipes.
Wrong design of components, wrong/ under developed programs not controlling
cycle (temperatures, pressure, time, volume of water/ detergent (wrong
detergent not dissolving residual products living packets of hit
"encapsulated" - pounds at the time of it glued to the interior walls, which
were breaking off the walls during processing (tumbling /vibrating- on
discharge station) of the next Lot of product (often different) causing
MASSIVE /DEADELY CONTAMINATION of batches. Programs could not execute full
wash cycle- terminating it and getting in to faulty status. I am attaching
e-mail to FSS Manager expressing my concerns about safety / contamination.
Initially Manager had good will to act, but very fast he was faced with
reality and ordered me to stay away from the WASH STATION stating, that in
order to address my concerns new qualification had to be executed (new
detergent introduced etc.), new design of the plunger would have to be
commissioned etc. Eventually new Technician WITH OUT AUTORIZATION (?)
deleted original electronic program and installed short version which
resulted in period of almost one year of Bins not being sanitized but only
wetted in /out side.
Problem was discovered after one year.
Apotex’s Manufacturing Department
Apotex’s Manufacturing Department (MFG) was exclusively furnished with VERY FINE product handling /storage equipment manufactured by British company Gay Galley in Great Britain. All of it was manufactured in England and shipped over to Apotex to be installed. The engineering, workmanship, detailing and materials were at the finest.
In the name of good business relation sheep Galley foolishly supply to Apotex all of it on a “credit”.
After construction started and Apotex did run out of money Apotex decided to screw up Galley manufacturer / supplier and renege on all payments.
To get away from liabilities they utilized own software programmer/ engineer to “bag’ / contaminate with viruses programs on PLSs and to make equipment not performing up to specifications by not executing / faulting cycles etc.
Galley countless of times send from England own expert to correct problems, but EVERY TIME HE WAS OUT OF THE DOOR APOTEX’S “ SABOTEUR “ WAS BACK SCREWING / re - bagging EVERY PROGRAM AGAIN.
The final situation was a such that Apotex forced Galley to abound all discharge stations ( two floor systems), all filling stations ( two floor systems), bin wash station , all product holding bins (one tone s.s., half tone s.s units ) and other smaller pieces of equipment and go BANCRUPT.
Apotex then started to copy Galley with off market / generic copies fabricated locally which never worked and appeared remotely close/ LIKE Galley’s product.
That hardware looked more like for granular (sand, gravel or crashed rock handling / packaging systems in sand / rock pits not like pharmaceutical compliant at all!
Apotex’s decision caused years of contamination /cross contamination of products, personnel (hand scooping / handling products and hand washing holding bins / equipment etc.).