PDF Downloads...   Winding Directions This simple guide will assist you in determining specific wind directions with regard to printing.   1999 FDA ruling A brief summary outlining the permissiblility for pharmaceutical manufacturers to switch suppliers of primary packaging materials without the need for full stability protocol testing. The FDA only requires that equivalency be proven that meets its requirements on interchangeability of packaging materials.   CDER Statement A describtion of the information requested by the Center for Drug Evaluation and Research (CDER) in an Annual Report to a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Abbreviated Antibiotic Application (AADA) submitted pursuant to 21 CFR 314.81(b)(2). The primary objective is to ensure consistency and completeness of information in the Annual Reports submitted by the pharmaceutical industry and to standardize the general format.   FDA-Pallet pesticide letter The FDA recently issued Warning Letter SJN-2010-01 to a major pharmaceutical company’s operation in Puerto Rico. While the warning addresses specific issues exclusive to this manufacturing site, it has raised industry-wide concern regarding contamination of drug product with 2,4,6 Tribromoanisole (TBA). TBA is a byproduct of the breakdown of 2,4,6, Tribromophenol (TBP), a pesticide and flame retardant used to treat wooden pallets.   Packing Specifications This provides a quick reference of our standard packing specifications. It is also helpful in visually identifying special features that are specific to roll packaging.   3D CAD This is a good example of 3D CAD and the value it can bring to creating new packaging ideas.