Do it my way
"We hired the former senior vice-president of quality for a top-10 pharma company as a consultant," explained our GMP Agent-In-Place. "He demanded that we do things the way he had in his former position, including those actions that were required of him by a single Mid-Atlantic region national inspection expert. His procedures included having the vice-president review and sign every deviation in the company. Later on in his consulting period, he had the gall to note that we shouldn't react to the preferences of a single inspector."
Iced water"You wouldn't think cold weather would hurt a freeze-dried product," began our GMP Agent-In-Place. "But when we heard that our broker left our freeze-dried product out on the tarmac upon receipt at a Canadian airport, we knew we were in trouble. The product is packaged with sterile-water diluent, and if the diluent freezes, it can break the diluent vial or create a microsized crack that can provide an entry point for contamination. Either way, the product was no longer unusable."
"One of our injectable products had an unusual peak in a laboratory release test result," recalls our GMP Agent-In-Place. "Further analysis showed minute quantities of cadmium. We couldn't imagine where the cadmium was coming from, but we checked all the production materials that had been used.
"This particular injectable product underwent some filtration processes during purification that were assisted by the use of filter aid. Filter aid is a mined material (i.e., it comes right out of the ground)," explained our Agent. "It varies in quality as a result, and apparently one area that was mined has some cadmium contamination by unknown processes. We now have a more intensive test process for the incoming raw material."
Reaching the LIMit
"What a mess," groused our GMP Agent-In-Place. "We were retiring two older laboratory information management systems (LIMS) and replacing them with a global LIMS system for use at two sites. Unfortunately, our business requirements document turned out to be site-specific. In the implemented LIMS system, functions that would work well for the process flow on one site were all wrong on another. So each site had some gaps in what worked. This was particularly bad for one site which had to hire additional personnel because the workarounds for the new LIMS required manual rather than automatic functions. While we plan on fixing some of the issues, it may be just throwing good money out the door."
"During final inspection of an injectable product, we found hundreds of bottles with red specks on the bottle necks," our GMP Agent-In-Place reported. "We opened a deviation investigation and started looking for the cause of the specks. Our first thought was stopper material, but this proved wrong because the specks were imbedded into the glass. Analysis showed the specks to be ferric oxide, better known as rust. This finding confused us because we perform a 100% inspection of the glass bottles before filling them. We sent the containers to the glass manufacturer to investigate the source of the specks. It turned out that the glass manufacturer had set up the bottle-molding machinery poorly, and there was some rubbing of the neck molds, resulting in scraping small flakes of steel off of the molds and onto the molten glass where it solidified into place. Our prefill inspection process didn't catch the silver bits of metal, and only after the glass bottles went through the bottle washer and the high-temperature, dry-heat sterilizing tunnel did the steel turn to rust and become easy to see."
Pharmaceutical Technology's monthly "Agent-in-Place" column distills true-life cautionary tales from the files of Control, a senior compliance officer. If you have a story to share, please email it to Control at [email protected]