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Welcome to the second edition
of Since you asked...All about
GMPs and Validation. We are
pleased to report that our March
...
In 1984, Congress passed the
Drug Price Competition and Pat-
ent Term Restoration Act , better
known as the Waxman-Hatch
A...
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Since you asked...All about GMPs and Validation

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Our April 2016 newsletter...a free publication from William Garvey and Associates, Lexington, MA.

This month we discuss compressed air, the Waxman-Hatch Act, Word controls and charge-in of components.

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Since you asked...All about GMPs and Validation

  1. 1. Welcome to the second edition of Since you asked...All about GMPs and Validation. We are pleased to report that our March newsletter was very well received and we hope to expand our read- ership with each new edition we publish. This month we have focused on compressed air (CA) systems. Compressed air has multiple uses in manufacturing facilities of all types. However, there are special requirements for drugs, devices and biologics. These are dis- cussed later in this publication. A fact from the US Department of Energy (DOE)...CA“leaks are a sig- nificant source of wasted energy in a compressed air system, often wasting as much as 20%-30% of the compressor’s output.” Iden- tify and fix those leaks to reduce system costs! With continued success in the important work we all do, WELCOME FROM THE EDITOR THIS MONTH’S FEATURED TOPIC - COMPRESSED AIR There are two types of compressed air systems operating in drug and biotech facilities—instrument air (IA) and clean compressed air (CCA). These systems have signifi- cant differences. Instrument air is a motive force commonly used to open valves and HVAC dampers. IA makes no product contact and consequent- ly, has minimal quality require- ments. These systems are oper- ated at 110-125 PSIG and the air has a dewpoint less than 35°F. IA systems are usually not oil-free. Clean compressed air makes direct or indirect product contact. CCA is used to dry wet equipment, for sterilizer air-overpressure (AOP) and to transfer liquids between holding tanks. In 1976, FDA issued draft regulations describing CCA quality requirements. Since then, common system design specifica- tions are dewpoint less than -40°F and oil/hydrocarbon content less than 1 mg/m3. COMPONENT CHARGE-IN GMP regulations specifically state that a“batch shall be formulated with the intent to pro- vide not less than 100 percent of the labeled or established amount of active ingredient.” Although obvious, consider this example. USP requires a tablet to contain active ± 10% of label claim. A 100 mg tablet containing 90-110 mg meets USP requirements. A well-controlled op- eration produces tablets with 95 ± 5 mg active. A manufacturer could charge-in 5% less active ingredient and still comply with USP. LABEL RECONCILIATION When labeling operations are completed, label reconciliation is required. Reconciliation helps prevent product misbranding. If a discrepancy occurs, immediately investigate. Did labels get applied to the wrong drug product? Since you asked... All about GMPs and Validation Volume 1 Issue 2 April 2016 Sterilizer Performance Qualification Air-operated diaphragm valve Since you asked...All about GMPs and Validation is a publication of William Garvey and Associates. Copyright © 2016 William Garvey and Associates
  2. 2. In 1984, Congress passed the Drug Price Competition and Pat- ent Term Restoration Act , better known as the Waxman-Hatch Amendments. This important leg- islation was designed to increase the availability of generic drugs. It also created the abbreviated new drug approval (ANDA) process. One incentive to create a generic was 180-day market exclusivity. The first ANDA filed with FDA challenging the brand name pat- ent was entitled to 180-day exclu- sivity after ANDA approval—no other identical generic could be sold.“First to market”essentially assured large market share for life of the product. The same benefit applied to the first approved ge- neric for an off-patent drug. Given these financial incentives and the outcome of“being sec- ond or third,”many generic com- panies decided to cheat. ANDA data was falsified and FDA review- ers were bribed...To be continued. GENERIC DRUGS - ANDAs, EXCLUSIVITY AND CHEATING MICROSOFT WORD AND PROTOCOL MANAGEMENT It is estimated that Word users only utilize about 15% of Word’s features. Developer is an over- looked ribbon tab containing con- tent controls that expedite and manage protocol development. Validation protocols and reports are QA documents that must be consistently formatted and visu- ally appealing. Individuals cannot be allowed to revise boilerplate text to suit personal preferences. Problems often arise when ap- proved protocols, not templates are edited. Unless editing restric- tions are imposed, protocols of- ten drift away from the template. Restrict Editing and Controls are two useful features in Devel- oper. Select template boilerplate text and prevent revisions with Restrict Editing. Controls limit what variable information can be added to a protocol or report. William Garvey and Associates Lexington, MA williamgarvey@outlook.com 781.698.9215 www.wgarvey.com Display Developer by going to File/ Options/Customize Ribbon, and then select the Developer checkbox. William Garvey and Associates provides validation and Quality-related services to the regulated industries—pharmaceuticals, biologics and medical devices. Our services include protocol development and execution, GMP and technical training, and validation project management. Follow us on Google+, Facebook or LinkedIn, or on the web at www.wgarvey.com. OIL IN COMPRESSED AIR There are currently two common ways to de- termine oil content in compressed air—Dräger oil mist tubes and gas chromatography (GC). Dräger tubes are single- use and inexpensive. GC is rarely used, although it is more accurate and precise. Dräger testing or GC sample collection is performed at usepoints far from the compressor. Courtesy of Atlas Copco Mixer/Granulator/Microwave Dryer

Our April 2016 newsletter...a free publication from William Garvey and Associates, Lexington, MA. This month we discuss compressed air, the Waxman-Hatch Act, Word controls and charge-in of components.

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