In this matter it would seem that the regulatory bodies are as vague as
possible until it comes to an inspection in which case a personal
interpritation is warranted by the regulatory officer. perhaps it is time
for the FDA and pharmacopeias to consult the people who work in the relevant
areas about the wording and interpritation of guidelines. Such vague wording
and innacuracy can only lead to more problems. this problem has been seen
several times before resulting in confussion and problems for all concerned.
Gary Barrett


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