BETSY REDDEN

Plant Manager
You are the plant manager of a chemical manufacturing facility that has recently
been updated to provide specialized manufacturing services to specialty chemical
companies. Yours is one of the few plants in this part of the country that can quickly
manufacture very complex compounds - compounds that would take other facilities much
longer to manufacture. Management invested a great deal of money in upgrading the
facility, and it is now paying dividends.
BIM Chemicals is one of the companies you hope will use your plant more
frequently. BIM is a small (but growing) firm in the specialty-chemicals field. Several
months ago, you began talking with BIM about manufacturing one of their new products:
Alfa B. BIM’s researchers spent a considerable amount of time assessing your facility,
and seem to be satisfied. Shortly thereafter, Fred Gray, one of their auditors, came by to
check out the plant. During the exit interview, he pointed out what he called “several
GMP (Good Manufacturing Practices) deviations.” These are problems you already know
about and don’t find terribly important. Your facility might not follow the letter of the law
when it comes to government regulations, but you’re very close. In fact, no other
company has ever pointed them out as problems. Fred recommended an action plan to
address the deviations, and you get the impression that it wouldn’t take too long to meet
the standard. You agreed to see that the areas are immediately addressed. He, in turn, said
he would recommend approval of the facility to BIM management.
You received a letter from Fred outlining the exit interview and spelling out the
actions you agreed to during the meeting. When you saw them in print and discussed
them with your staff, they somehow looked much harder to accomplish. In fact, you’re
sure you won’t be able to get them all completed by the time the manufacture of Alfa B is
scheduled to begin. Several new contracts and other internal projects have limited your
ability to complete everything. You sent Fred a letter saying that you wouldn’t be able to
meet all of your commitments to BIM because of other corporate commitments. You
were deliberately vague in the letter, since you don’t want to be pinned down to a specific
schedule if you can avoid it. The deviations don’t seem terribly important or far off
standard; you are sure that he will still approve your site, even though he won’t be happy
about the deviations.
Fred called you yesterday, after he received your letter. He sounded very upset and
said that he would be here today to speak to you. You know there is no way to make the
required GMP upgrades within the present time frame. It would mean shutting down
some other manufacturing areas, and would certainly impact the deadlines of other
customers -customers who are not concerned with the GMP deficiencies noted by Fred.
Still, you are somewhat uncomfortable, because you did agree at the exit interview to
make the changes. Everyone would like BIM’s business. This company has the potential
to provide several million dollars’ worth of business each year. More, if everything goes
well.
 You are scheduled to meet with Fred in a few minutes.
Known to Both Parties
Here are the items that Fred referred to during the exit interview and in his letter:
• Temperature and humidity are not monitored in the compounding area. Alfa B is
very sensitive to minor fluctuations in humidity.
• There is no system for tracking equipment-calibration due dates. Fred noted that
several pieces of equipment are past due calibration.
• There is no master plan for equipment-cleaning validation. Most cleaning processes
have not been validated. The chemicals are water-soluble, so that is not an issue of
concern.
• There are no procedures for investigating failures.
• A new segment was added to the USP water system, but there has been no formal
validation of the entire system after this change was made. There have been serious
occasions of off-limit microbial counts in the USP water that have gone
uninvestigated.
FRED GRAY
Auditor for BIM Chemicals

You are Fred Gray, auditor, and have worked at BIM Chemicals for about five
years. You just audited an outside manufacturing facility that is scheduled to produce one
of BIM’s most-important new products, Alfa B. The company’s scientific research staff
assessed the capabilities of the operations several weeks ago and found them to be
acceptable. In fact, they recommended that the company use this facility. To quote their
report, “This is an excellent, well-run facility.”
The time line for this compound is extremely tight, but the facility has some unique
systems that enable its staff to meet tight manufacturing requirements. However, when
you audited the facility, you found some significant GMP deviations that you reviewed
during the exit interview. The facility’s management acknowledged the situation and
assured you that your findings and recommendations would be addressed immediately.
They did say that no one else had ever raised these issues and that they could not
understand why they are of such concern.
You documented your exit interview, including all audit comments and
recommendations agreed to by the plant manager, Betsy Redden. You requested an
immediate response confirming the actions to be taken, even though you hadn’t received
the written response. You recommended approval of this facility because of Ms. Redden’s
strong assurances during the exit interview.
Today, a week later, you received a letter from Ms. Redden. You are very surprised
to read that the “confirmation” does not adequately address the findings or the agreed-to
actions. In fact, the entire letter was vague and general. You are furious; the actions were
very clearly stated and agreed to in the exit interview. You can’t start looking for a new
facility now; production of Alfa B is scheduled to begin next month! You need to meet
with Betsy to come up with an acceptable resolution to this problem right away. GMP
standards must be met, and the production of Alfa B simply cannot be delayed. In your
mind, the GMP issues could be resolved if Betsy starts to address them immediately.
However, you realize that this might affect some of their other commitments. If Betsy had
started to address the deviations when she said she would, the problems would be well on
their way to being resolved.
You called Betsy to set up an appointment, and indicated your annoyance. You
spoke with your management and everyone was very clear: “We have no real options.
This needs to get resolved so that production can begin and we can stay on schedule.”
Everyone agreed that you have the authority to work out the problem.
You will meet Betsy at the facility in the next few minutes.

Known to Both Parties

Here are the items that Fred referred to during the exit interview and in his letter:
• Temperature and humidity are not monitored in the compounding area. Alfa B is
very sensitive to minor fluctuations in humidity.
• There is no system for tracking equipment-calibration due dates. Fred noted that
several pieces of equipment are past due calibration.
• There is no master plan for equipment-cleaning validation. Most cleaning processes
have not been validated. The chemicals are water-soluble, so that is not an issue of
concern.
• There are no procedures for investigating failures.
• A new segment was added to the USP water system, but there has been no formal
validation of the entire system after this change was made. There have been serious
occasions of off-limit microbial counts in the USP water that have gone
uninvestigated.