Concept & Discussion Papers

Concept Papers

Concept Papers establish or clarify a concept (or framework); they often describe a potential solution or approach to an existing problem or area of discussion. These papers may interpret or clarify a regulatory position, and may seek to influence.



Title Published Date
A Simplified Integration of Qualified Laboratory Devices with the Asset Administration Shell as the Digital Twin May 2023
Bio-Fluorescent Particle Counter (BFPC) Continuous Environmental Viable Particle Monitoring Strategy for Aseptic Filling February 2023
Connectivity between Shopfloor & Manufacturing Operations Management Systems with OPC UA – A Tangible Step Toward Plug & Produce April 2021
Investigator Initiated Trials (IIT) – Considerations and Guidance from the Perspective of Clinical Trial Supplies and GMP June 2019
Remote Observation Technologies in the Pharmaceutical Manufacturing Space June 2018
Data Privacy: A Compliance Blind Spot June 2017
Role of Process Capability in Monitoring Product Quality May 2017
Leveraging PaaS in a Regulated Environment July 2016
Saas in a Regulated Environment: The Impact of Multi-tenancy and Subcontracting July 2016
Using SaaS in a Regulated Environment – A Life Cycle Approach to Risk Management July 2016
Considerations for a Corporate Data Integrity Program March 2016
Improving Access for Patients with Unmet Medical Needs June 2014
Validation & Data Integrity in eClinical Platforms June 2014
GAMP 5: Implementation & Operation of GxP Compliant Clinical System September 2013
Controlled Temperature Chamber Mapping April 2012
Implementing Knowledge Management in Bioprocesses March 2012
Use of Booklet Labels on Investigational Medicinal Products (IMPs) February 2012

Discussion Papers

Discussion Papers promote discussion and creates awareness on new or emerging topics; they often solicit feedback, gauge interest, and seek member or industry input. They may state a problem, provide the tentative exploration of solutions and options, and may suggest potential next steps.

Title Published Date
Unique Identification on Primary Containers to Drive Product Traceability & Quality February 2021
Process Validation Lifecycle for Packaging Oral Solid Dosage Forms February 2020
Process Validation in Context of Small Molecule DS and DP Continuous Mfg Processes January 2019
Overview of Packaging Validation for Drug Products August 2017
Process Validation Lifecycle Implementation for Existing Products March 2016
Determining Number of Process Performance Qualification Batches Using Statistical Tools January 2016
Implementing Lifecycle Validation Practices at Contract Manufacturing Organizations November 2015
Impact of Statistical Tools on Process Performance Qualification August 2014
Lifecycle Approach to Biotech Process Validation August 2014
Stage 2 Process Validation: Process Performance Qualification Batches February 2014
Stage 3 Process Validation: Applying Continued Process Verification Expectations August 2012