procedures include criteria for
determining whether or not material is contaminated.
Emission Control for
Reactors, Crystallizers, and Centrifuges
This is procedure developed to
control air emissions from reactors, crystallizers, and centrifuges.
Fugitive Emissions
Monitoring
This procedure was developed to ensure that the
Organic Vapor Analyzer (OVA) unite is calibrated properly.
Recycling of Fiber Lever-Paks
This document provides procedures for reusing fiber
pak drums
10.b Product Formulation Areas (SDFMD)
Formulation of the product will take place in the
Solid Dosage Formulations Manufacturing Department (SDFMD). Following is a list of SOPs by title, and a
brief description, for DFMD:
Dress Code and Safety
Precautions for SDMFD
These procedures cover quality and safety procedures
for granulating, compressing, caoting, and encapsulation areas. Instructions are provided for containing all
clothes coverings that may have come in contact with product.
Procedure to Ensure CGMP
Compliance in SDFMD
This procedure covers the training plan for properly
training employees on Current Good Manufacturing Practices contained in 21 CFR
parts 210 and 211.
Response to Audible Alarms in the Solid Dose
Formulations Manufacturing Department
Ensures correct action and responsibilities when the
SDFMD Audible Alarms are set off. The
procedure covers steps to be taken should an alarm sound indicating a potential
problem in the vault where product is held.
Removal of Product Waste from the SDFMD
This SOP covers management of product waste in
accordance with Current Good Manufacturing Practices including labeling and
disposition of product waste.
Volatile Organic Compound (VOC) Emission Reporting
for SDFMD Coating
This procedure provide instruction for properly
recording and reporting VOC emissions from SDFMD coating.
GCPV/93/0011/03 17
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