Hill battles the batch record
As Apotex and others can tell you, batch records can be a nasty business. Hill Dermaceuticals might say the same thing after receiving warning letter FLA 09-13 in April.
The letter was prompted by a September 2008 inspection of Hill's prescription dermatological drug manufacturing facility in Sanford, FL. Inspectors objected to the facility's procedures and controls used for manufacturing, processing, packing, and holding drug products.
Specifically, the letter says Hill failed to follow its own procedures for the preparation of master production and control records that state only blue or black ink can be used to record information in the batch record book. Yet inspectors found penciled reconciliation and disposition data that had been erased and rewritten in ink. Worse, some of the rewrites were different from the original data written in pencil.
Although Hill responded that the pencil-carrying employee no longer worked for the company, it neglected to propose corrective action that included a review of other production and control records to ensure no additional erasure incidents, "particularly where the quality control inspector could have advised production employees to use pencil."
Both the Hill and the Apotex warnings reinforce our earlier reporting on the need for automated means to produce master batch records.