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.

(Must be a member to download Concept Papers)

TitlePublished Date
Process Events for the Life Science Industry Information Model Concept on OPC UA for Alarms and Audit TrailsFeb 2024
A Simplified Integration of Qualified Laboratory Devices with the Asset Administration Shell as the Digital TwinMay 2023
Bio-Fluorescent Particle Counter (BFPC) Continuous Environmental Viable Particle Monitoring Strategy for Aseptic FillingFebruary 2023
Connectivity between Shopfloor & Manufacturing Operations Management Systems with OPC UA – A Tangible Step Toward Plug & ProduceApril 2021
Investigator Initiated Trials (IIT) – Considerations and Guidance from the Perspective of Clinical Trial Supplies and GMPJune 2019
Remote Observation Technologies in the Pharmaceutical Manufacturing SpaceJune 2018
Data Privacy: A Compliance Blind SpotJune 2017
Role of Process Capability in Monitoring Product QualityMay 2017
Leveraging PaaS in a Regulated EnvironmentJuly 2016
Saas in a Regulated Environment: The Impact of Multi-tenancy and SubcontractingJuly 2016
Using SaaS in a Regulated Environment – A Life Cycle Approach to Risk ManagementJuly 2016
Considerations for a Corporate Data Integrity ProgramMarch 2016
Improving Access for Patients with Unmet Medical NeedsJune 2014
Validation & Data Integrity in eClinical PlatformsJune 2014
GAMP 5: Implementation & Operation of GxP Compliant Clinical SystemSeptember 2013
Controlled Temperature Chamber MappingApril 2012
Implementing Knowledge Management in BioprocessesMarch 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.

(Must be a member to download Discussion Papers)

TitlePublished Date
Unique Identification on Primary Containers to Drive Product Traceability & QualityFebruary 2021
Process Validation Lifecycle for Packaging Oral Solid Dosage FormsFebruary 2020
Process Validation in Context of Small Molecule DS and DP Continuous Mfg ProcessesJanuary 2019
Overview of Packaging Validation for Drug ProductsAugust 2017
Process Validation Lifecycle Implementation for Existing ProductsMarch 2016
Determining Number of Process Performance Qualification Batches Using Statistical ToolsJanuary 2016
Implementing Lifecycle Validation Practices at Contract Manufacturing OrganizationsNovember 2015
Impact of Statistical Tools on Process Performance QualificationAugust 2014
Lifecycle Approach to Biotech Process ValidationAugust 2014
Stage 2 Process Validation: Process Performance Qualification BatchesFebruary 2014
Stage 3 Process Validation: Applying Continued Process Verification ExpectationsAugust 2012