The “Good Manufacturing Practices Guidelines, 2009 Edition (GUI-0001)” indicate that a number of
measures be taken to maintain the integrity of a drug product from the moment the various relevant raw
materials enter the plant to the time the finished dosage form is released for sale. These measures seek to
eliminate as many sources of error as possible so that only those drugs which have met established
specifications are distributed.
One of the approaches proposed to achieve this goal is to have written procedures that ensure that each
ingredient added to a batch is subjected to one or more checks for identity and quantity by qualified
personnel.
If by its design, construction, operations and security features the procedure is such that the company assures
that it is impossible to make an error, an independent check by another operator may not be considered
necessary.
Checks for identity and quantity of dispensed materials also require independent checks by a second
individual.
However, independent checks that materials have been added to the batch have traditionally been assumed to
take place at the time of actual addition of the materials.
Other means of verifying the addition of materials may be considered. One alternative involves checking
staged materials in the immediate compounding area prior to starting processing and then afterwards,
verifying the empty containers before clearing the compounding area. This would be in conjunction with the
use of individual processing rooms, otherwise we would need to be satisfied that there was very good
separation of compounding operations.
