Just mix it together, no one will notice
"People should just tell us when an accident happens. It would be cheaper to fix it right away than to have to investigate and correct the batch," complained our GMP Agent-In-Place. "For example, an operator was supposed to sample material in the tank using a sterile, plastic 50-mL pipette. In doing so, he dropped the pipette into the tank. Instead of fessing up, he used another pipette, took the requisite sample, and left the facility. The tank was set to mix. Later, the contents had to be moved to the next process and the flow was low, resulting in a long transfer time. Operators speculated that the valve might be blocked. The added length of time for movement was cause for a deviation to be initiated.
"As part of that deviation, the valve was removed, and the broken pieces of the pipette were found, but not all of them. At this point, we not only had a time deviation, but a contaminated product deviation, and needed to account for the remainder of the pipette, as well as be cautious for the downstream equipment for potential blockages and damage."Our Agent added, "If the original operator had come forward immediately, we could have made an earlier and much less costly correction and investigation."
Chalk it up to a $50,000 lesson
"Sometimes people are morons," reports our GMP Agent-In-Place. "GMPs and our standard operating procedures (SOPs) tend to have the four-eyes principle built into critical steps. For example, to make an addition to a particular batch, an operator would grab the chemical from the storage shelf and weigh it. A second qualified person would check the chemical container label and weight, and the batch record requirements for weight. In one case, the second person followed this procedure and counter-signed the materials as being 'ready to add.' However, the material weighed by both individuals was incorrect—it was aluminum sulfate instead of tris (hydroxymethyl) aminomethane. The company delivered a written warning to employees for the lost $50,000 batch," reports our Agent. "Shall we call it a training expense?"
"We had two sites quite close together," noted our GMP Agent-In-Place. "So we often would get the same FDA investigators at both sites. The other site was notorious for telling the investigator what they could not see, primarily the head of the site who was a big man: 6 ft, 8in and 280 lbs with an extremely loud voice. On my site, we always chatted with the investigators, if for no other reason than to try to divert them from their investigation," smiled our Agent. "The investigator complained about the other site saying, 'If that big #@$!% stood up and leaned over me again, I was leaving and returning with the Federal Marshals.'"
"Human plasma, used as a raw material for many biological products, can be considered hazardous because it may contain virus and other pathogens," explains our GMP Agent-In-Place. "Processing plasma entails moving it from room to room through transfer piping. On one occasion, a plasma processing hose was mistakenly connected to the air line in a processing area, and a positive displacement pump was used to pump the plasma. The operator thought the plasma was being pumped into a vessel in the next room. Unfortunately, it was being forced back up the air line, and ultimately pooled onto the floor of a cleanroom. We had to reject and destroy all materials in process in the cleanroom, decontaminate the room and equipment, and replace the air line. When we replaced the air line, we made sure the fittings were physically different and would not connect properly with the air line; they were also color-coded to prevent recurrence."
Pharmaceutical Technology's monthly "Agent-in-Place" column distills true-life cautionary tales from the secret files of Control, a senior compliance officer. If you have a story of clueless operators, oblivious management, inopportune lapses of judgment, or Murphy's Law in action, please send it to Control at [email protected]