By William Hall

THE ANCIENT DARK AGES OF CLEANING - BEFORE GMP REGULATIONS

Prior to the issuance of the Good Manufacturing Practice (GMP) Regulations in 1978 (Reference 1), cleaning was mostly an "orphan" responsibility, meaning it was not considered very important. It was often relegated to the last activity of the day and sometimes performed on third shift. It was usually assigned to the newest employees, i.e., those with the least experience. In addition, the procedures were often very brief, ambiguous, and very much open to different interpretations. In fact, the procedures were often one sentence, "Clean with hot soapy water."

The cleaning agent often was not specified and it was usually perfectly acceptable and understood that ordinary tap water would be used. Most companies cleaned to a "visually clean" standard that was certainly not defined quantitatively. In most cases, a second person did not verify the cleaning. The documentation of the cleaning was not generally recognized as of critical importance. If the equipment was discovered to be insufficiently clean in the light of the next day, then it was simply recleaned - no big deal and no investigation. It was certainly not a widespread practice to determine the consistency of the cleaning process, i.e., process capability studies were not generally performed.