The vision of the PDA Standards Development Organization (SDO) is to become the leading developer and publisher of scientifically sound technical information to advance science and regulation for the pharmaceutical and biopharmaceutical industries. The published standards are recognized by the American National Standards Institute (ANSI) and are compatible with requirements of the International Organization for Standardization (ISO).

The American National Standards Institute (ANSI) is a private not for profit organization that oversees the development of voluntary consensus standards. These standards can be for products, services, processes, systems, and or personnel here in the United States. ANSI also coordinates U.S. standards with international standards so that American products can be used globally.

ANSI facilitates the development of these standards, known as American National Standards (ANS), by accrediting the procedures of standards developing organizations (SDOs). These groups work cooperatively to develop voluntary national consensus standards. ANSI accreditation indicate that the procedures used by the standards body and the development of the ANS meet ANSI essential requirements for openness, balance, consensus and due process.

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  • TR 42 Revision 2016
  • TR 60-3: Ongoing Process Verification
    Based on outstanding questions and observations from PDA members and industry in general, there is significant interest in the development of a Continued Process Validation/Ongoing Process Validation (CPV/OPV) PDA Technical Report. During recent Process Validation Interest Group discussions over the past several years, the following items were discussed and commented: There is a need to: • Expand and clarify the CPV/OPV requirement defined in TR60. • Clarification of terms, e.g. Continuous, Continued Process/Quality Verifications (CQV). • Suggest statistical tools and where and when to use (or not use) • Guide and understand how to apply CPV/OPV for both new and legacy products • Provide examples representing multiple dosage forms • Define the CPV/OPV versus Annual Product Reviews (APR) and Product Quality Review (PQR) relationship (They are not the same.) • Define what signals that should be tracked and trended within CPV such as critical quality attributes (CQAs), critical process parameters (CPPs), in-process controls (IPCs), critical material attributes (CMAs), etc. • Define how often CPV should be reported out • Define how signals and trends should be reacted to within CPV/OPV • Define how to apply quality risk management principles (QRM) to CPV/OPV • Define the relationship between stage 2b and stage 3. ▪ When and how to reduced enhanced sampling • Define short term and long term CPV (How to select long term control limits