The following information is abstracted from our reprint, The Play's the Thing. This article originally appeared in The Essence of Training, Part II: The Play's the Thing in BioPharm Magazine in June 1998, with permission to reprint given by Advanstar Communications.
A Day in the Life of Bogus Pharmaceuticals
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Starring: The Narrator, Scott Nadams, Andy Nitpick, Rudy Balance, George Jungle, Han Demann, and Suzy Que.
Narrator: At last! The long-awaited day has arrived. Bogus Pharmaceuticals is having an FDA preapproval inspection after submitting an application for U.S. market approval of a product called Best Brain. FDA investigator Scott Nadams arrives and is ushered into a conference room. He meets with Bogus Pharmaceuticals senior management to restate the purpose of his audit, discuss what areas he wants to cover, and ask to see preliminary batch records and other documentation for Best Brain.
After reviewing the first set of documents, Scott goes on to visit the facility, asking questions of operators and other employees. His escort is Andy Nitpick, Bogus’s QA representative. Their first stop is the weighing area, where Scott meets Rudy Balance, the weighing operator. Let’s listen in.
Nadams: Can you tell me a little bit about the material you’re weighing?
Balance: Sure. This is a brand new material we just got in. We’re testing it in batches of Best Brain.
Nadams: I see. What revised batch record or protocol are you using?
Balance: Revised batch record? Nah. We just write how much we weigh here in red ink on the issued batch record. Yeah, supposedly there’s some material review board or something to change raw materials, but that takes forever. My boss has been after me to cut costs, and this new stuff is a lot cheaper than the stuff we used to use. So I’m even getting an award from my boss for finding this stuff. Pretty cool, huh?
Nadams: Yeah. (He makes some notes.) Did you say you’re already using this material in batches of Best Brain?
Balance: Yep. This is the third batch we’re going to make. We already used this new stuff in the two lots we made last week.
Narrator: Scott nods his head, makes a few notes, and thanks Rudy for his time. Andy Nitpick leads the way to the next area Scott has asked to see, which is Processing. As they enter the manufacturing area, they see Han Demann, a maintenance employee, painting the wall with fresh, white paint.
Nadams: Hi. I’m Scott Nadams, an investigator with the U.S. Food and Drug Administration. I see you’re painting inside the manufacturing area today.
Demann: Yeah, we really wanted to make it look nice for your visit, you know? My manager’s going to kill me, though, because I didn’t get this done before you showed up.
Nadams: Aren’t they manufacturing Best Brain today? Or do you have a work order for painting?
Demann: (shrugging his shoulders) A work order? I’ve been here for five years, and nobody’s ever said anything about a work order. This place is always making Best Brain. You should have seen what they did last month. They had to remake tons of that stuff because they didn’t do it right the first time. Look, I just do my job. I don’t criticize them; they don’t criticize me. (He winks.) You know.
Nadams: Did you say they reprocessed several lots of Best Brain last month?
Demann: Yeah. That’s what I heard. Shhh. (sotto voce) You didn’t hear it from me, though.
Narrator: Just then, George Jungle, the processing operator, comes in. He opens the top of a piece of processing equipment nearby and begins adding raw materials. Andy introduces Scott to him.
Nadams: So, George, are you making a batch of Best Brain today?
Jungle: Yep. Once you dump everything in, you turn on the equipment and it runs by itself.
Nadams: Do you usually have someone double-check your addition of materials?
Jungle: Nah. There is no one else. I’m the only operator on this shift.
Nadams: I see. You say the equipment runs by itself. Do you check it periodically?
Jungle: Nah, I don’t have to do that any more. A few months ago, they replaced the computer chip or something inside the equipment, and it runs much faster now. It doesn’t break down like it used to, either, so now it only takes four hours, instead of six, to do a run.
Nadams: I see. Has the equipment or process been validated?
Jungle: Validated? What’s that? Nobody ever tells me anything! (He mutters under his breath and looks down at the equipment.) Darn! I forgot to turn the dial to 2.5. I’m always forgetting something. My wife says I’d forget my head if it wasn’t screwed on. Ernie is the second-shift operator. He’ll be in tonight if you want to ask him about that validation thing.
Nadams: OK, I will. (He pauses.) Aren’t you going to record the dial setting you’re using or let your supervisor know?
Jungle: Nah, it’s close enough. My supervisor trusts me. I’ve been here for three years, so I know what I’m doing.
Narrator: Scott makes a few more notes, thanks George for his time, and then asks Andy whether he can see the QC laboratory. Once there, Scott strikes up a conversation with Suzy Que, an analyst.
Que: So, what can I help you with?
Nadams: Can you describe the analytical tests you use for Best Brain?
Que: Sure. We usually run an HPLC assay and an assay on the XYZ analyzer, but the analyzer next door broke down, so we lent them our XYZ analyzer.
Nadams: I see. Do they run the XYZ test for you then?
Que: No. Luckily, we had an old ABC analyzer in storage, so we pulled it out and started using it. We hadn’t yet used it for this product, though, so we had to tweak the method a lot to finally get it to work right.
Nadams: So have you been trained on the new method?
Que: (looking puzzled) What new method? We’re just using a different piece of equipment.
Nadams: Have you validated the method using the new equipment? And does your calibration department know that you’re using the ABC analyzer and that the lab next door has your XYZ analyzer?
Que: (scratching her head) I have no idea. You mean we have to revalidate the method if we’re just using another piece of equipment? I don’t even know if we still have a calibration group. The finance department has been going crazy cutting costs until we pass this inspection and get Best Brain on the market. Just the other day they asked if we could replace our QA manager with a temporary employee and then let the temp go as soon as we passed the inspection. Either that or hire consultants to release Best Brain. Can you believe that? They’d probably close the plant if they could – then we’d really save money!
Narrator: Scott feverishly takes notes, thanks Suzy, and walks with Andy into the hallway. He asks Andy for additional specific documents and records and then asks whether he can meet with senior managers again later today, after he has reviewed those documents.
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