Question & AnswerQ&A (BFAD MEMORANDUM CIRCULAR NO. 4)
The purpose is to facilitate the batch certification process of antibiotics by requiring specific documents and samples for validation from applicants.
Applicants must submit the complete production record of the batch, in-process control record, complete terminal quality control record including all requirements of the official monograph, and samples for validation.
It must include all requirements of the official monograph related to the antibiotic batch concerned.
Six (6) bottles of the suspension or syrup must be submitted.
One (1) bottle of 100 capsules/tablets, or two (2) bottles of 50 capsules/tablets, or an equivalent number in stripped or blister-packed form must be submitted.
Six (6) vials or ampules of the injectable antibiotic form must be provided.
Four (4) tubes of ointment or cream must be submitted as samples.
Cecile P. Gonzalez, Director, signed and adopted the circular.
The circular was adopted on May 7, 1990.