SOPs: smush out pests
Our GMP Agent-in-Place overheard this story at a conference; the topic was FDA inspections: "I saw a cockroach on the floor during an inspection, and I tried to stand between it and the inspector. But it was noticed anyway, so I stepped on it, cleaned it up, and then said to the inspector, 'When you cite it on the Form 483, you can say that 'management took immediate corrective action.'"
Who done it?"We had taken a potency-test sample from a portable vessel to the lab for testing," reports our GMP Agent-in-Place. The manufacturing group moved the vessel down the hall for further processing the next day. The method is highly variable, and we always did a confirmatory test the next day on a new sample before processing is started. The first test result was in the usual range, but the second test result was 0. A new sample was taken, and the retest again resulted in 0. Our investigation provided no clue as to what had happened. Our best guess was that the original sample had the wrong batch ID on it, somehow. The mystery remains to this day."
"We had complaints in the winter of 'granules' or 'sand' in our liquid product," notes our GMP Agent-in-Place. "When we realized it was an unusually cold winter, we ran tests and found that the product did permanently precipitate out if frozen. The frozen product wasn't dangerous, just not effective. It took a while to convince logistics to make a change in shipments, but after a couple of big returns they saw the need.
"We began shipping using trucks with temperature control during the coldest six months of the year to be sure the product wouldn't freeze, which reduced the number of complaints and returns. This was a huge success."
"We called our complaint analyst 'Trend Man' and he would do a great job of investigating," says our GMP Agent-in-Place. "One complaint was for a stained dress caused by our topical pain spray. Although the label noted that the spray may stain some materials, we still reimbursed the complainant for the dress. Trend Man took the dress home, washed it, and the stain came out. The dress was also returned, so the complainant got the money and the dress. I always wondered what his wife first thought when he brought a dress home from work."
"It was an old low-volume product that no one had evaluated for years," says our GMP Agent-in-Place. "In our million-square-foot facility, it took only a little space and was in an area that otherwise made no GMP products. This area had not been audited for at least a decade.
"Finally the quality department got around to auditing the area and found numerous deficiencies: the air quality was not sufficient for the type of product being manufactured, vessels for the liquid product were placed on the floor and did not have lids, and there was no process validation, just to name a few issues. The cost of some of these, such as HVAC/HEPA upgrades, were large enough that the company planned to discontinue the product rather than fix them. When FDA was informed of this, they noted the critical need for the product and wouldn't allow discontinuation. In the end, we agreed to make modest improvements each year, and FDA would allow continued production even with the known GMP deficiencies. But we did manage to sell the product to another company and facility. Whew!"
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]