Why we follow the batch record
GMP Agent-in-Place (matter-of-factly): "The CFR is pretty clear. You must have tested the bulk sterility sample for the batch. What happened to it?"Manufacturing employee (harried): "We took the sample and the backup sample just like the batch record required. See, it's documented right here in the batch record. The laboratory must have lost the sample."
Microbiology laboratory employee (defensive): "We never got it (the bulk sterility sample). It wasn't even logged into the incoming sample logbook."
Manufacturing employee (now distressed): "Look at the batch record. The sample was pulled at night when the laboratory was empty, so check their refrigerator where we would have put it!"
Microbiology laboratory employee (terse and tense, after looking in the refrigerator): "Nope, it isn't there either. Don't you (manufacturing) keep a backup in your fridge?"
Manufacturing employee (updating his resume): "We looked there and in the freezer with our duplicate in-process samples we stored there. Nothing."
Agent-in-Place: "The batch is dead then—$1,000,000 lost sales."
Why we read the fine print
"Being hardheaded, I refused, and the HR manager said I should talk to the company lawyers in headquarters, which I did. At their request I sent them a copy of my comments, and heard nothing.
"Now fast-forward a year. HR asked where my signed form was, and I gave them the history. When they asked to see my comments, I gave them a marked up copy. HR didn't find this satisfactory, so I was told, 'Sign or be fired.' I had, by this time, talked to my lawyer and he said such an agreement, coerced as it was after hiring, wouldn't stand up in court, so Iwas free to sign away—and so I did."
Why we word answers carefully
"It was a typical inspection," sighs our GMP Agent-in-Place. "FDA sent four inspectors, and the inspector I was hosting wanted water-monitoring data, which included all data for the past 12 months on 12 water for injection loops, 10 hot loops, and 2 cold loops. The data for each loop was a stack of printouts 18 inches tall!
"She looked through the data from one hot loop, noted that it passed all criteria throughout the year, and then asked, 'Are the other hot loops the same?' When I said they were, she bypassed the next 13 feet of data that she had asked to be printed out. She then looked through the cold loop data for one loop.
"The inspector then asked 'Do you realize that the cold loop was worse than the hot loop? There are bacteria found more frequently, and in higher numbers, than in the hot loop I examined.'
"I replied, 'The cold loop passed USP criteria.' But this didn't satisfy the inspector, who repeated her question. This time she was told that it was realized, but that it had still passed USP criteria just the same. Although no observations were given for the microbial and chemical monitoring data, she did find our temperature control deficient ... but that's another story."
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]