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Pharmaceutical Technology Pii
PDA Publications

Explore the PDA Bookstore

With more than 345 publications, including 80 peer-reviewed technical reports, available for direct-download purchase, the PDA Bookstore gives you the ability to access leading industry resources from anywhere.

Edited and authored by industry and regulatory experts and thought leaders, publications found in the PDA Bookstore serve as practical guides and references for many topics in the industry, including aseptic processing, quality and regulatory compliance, biotechnology, and much more!

Check out the newest release!

Root Cause Investigations for CAPA

Root Cause Investigations for CAPA Clear and Simple

This text, based on workshops led by instructor and author James Vesper, provides practical tools for both a thorough understanding of risk-based CAPA investigations and regulatory acceptable applications.

The author explains training as a corrective action, evaluation of techniques, writing the report, review and approval, and communication and management responsibilities. It is the perfect companion for your library shelf or computer or, perhaps, both.

Save 10% when you pre-order Root Cause Investigations for CAPA Clear and Simple through July 15, 2020. Enter campaign code CAPA during checkout to apply the discount.

Member Price: $240 $216
Non-Member Price:  $299 $269.10
Government Price:  $240 $216


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The COVID-19 pandemic has disrupted supply chains that affect patients worldwide. It is important, now more than ever, that companies are purchasing high-quality materials from reliable suppliers to ensure that safe and effective products are available to patients.

PDA’s new standard can assist in this process by helping companies make the right decision about what material to purchase, where to get them, and who should be responsible for that purchase.

ANSI/PDA Standard 001-2020

ANSI/PDA Standard 001-2020
Enhanced Purchasing Controls To Support The Bio-Pharmaceutical, Pharmaceutical, Medical Devices And Combination Products Industries

This standard provides the quality organization with new tools to make sure that procurement organizations understand the GMP implications of their roles. Ultimately, it helps ensure a steady supply of material and decreases the likelihood of a company experiencing a product recall or drug shortage due to poor material quality.

It is the first guidance document to address assigning accountabilities for purchasing decisions. It is intended to expand on the requirements already defined under FDA regulations and should be viewed only as recommendations.

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Pharmaceutical Technology Pii

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