HUMIDITY PLAYS A KEY ROLE IN THE PACKAGING OF A DRUG PRODUCT Contract Pharmaceutical Services of Australia was audited by the FDA from October 30 through November 1, 2012. The FDA identified significant violations of cGMP for finished pharmaceuticals during the visit. Based upon these violations, the drug products were deemed to be … [Read more...]
FREQUENTLY ASKED QUESTIONS — USP GENERAL CHAPTER 62, PART I (REVISED)
COMMENT The USP has recently released a Summary of Frequently Asked Questions (FAQ) for both USP <61> and <62>. The FAQ for USP <61> was previously posted in another Blog. The FAQ listed below is the first of two Parts discussing additional FAQ from USP <62>. Additional FAQ will be posted later in the week. Microbial Examination of Nonsterile … [Read more...]
