Reagent and Powder Filling / Labeling Procedure
$19.95
This package contains two separate SOPs that work in conjunction with each other. The first document is a general reagent and powder filling procedure. It is appropriate for most manufacturers of chemicals, medical devices, or pharmaceuticals that have reagent or powder filling operations. The second document is a hardware-specific SOP for the operation of an automated powder filling system (the Hierath & Andrews ISO-G 4104 Direct-Weight Filler). Note that these documents need to be customized and tailored to your specific operations, but do provide an excellent template/example for how these documents should be drafted.
Raw Material Receipt and Disposition
$39.95
This document describes the process for the receipt, disposition, and release of raw materials used in or supporting GMP production at a manufacturing facility. It covers the controls necessary for proper material flow and labeling as well. This document can apply for pharmaceutical or medical device manufacturing firms.
QA Hold System
$39.95
This document describes the steps for initiating, processing, and closing Quality Assurance (QA) Hold Reports associated with suspect non-conforming product or material. It allows for the quarantine of materials so that they can be investigated and given final disposition (approve or reject). This package includes the standard operating procedure (SOP) as well as the associated QA Hold Report form.
Post Marketing Surveillance / Recalls
$39.95
This document describes the procedure for performing post marketing surveillance and market actions (i.e., recalls) affecting products cleared for commercial distribution by the firm. It creates the requirements and sets the responsibilities for appropriate functional groups during a product recall.