Driving pharmaceutical quality with digital standards

 Image designed by Tim Sandle

Pharmaceutical manufacturing is digitizing and with this transformation comes the need for quality standards that can integrate with digital ecosystems. 

USP is updating Chapter 11 to address developments with digital standards. 

USP is evolving how qualitystandards are integrated into digital environments, bringing science-based rigor, regulatory confidence, and seamless connectivity to pharmaceutical workflows. By embedding digital reference standards and compendial methods into connected systems, USP helps manufacturers advance digitization without compromising quality. 

USP is helping organizations navigate transformation complexity and support integration of digital quality systems with trusted standards, validated methods, and collaborative innovation.

What are digital standards? 

USP digital standards are machine-readable digitally structured versions of established USP reference standards and test methods. Digital standards bring the same science-based rigor and confidence as USP’s physical standards but can be seamlessly integrated into digital workflows. 

Digital standards allow for: 

• Risk Mitigation & Traceability: Electronic capture of every step, version-controlled reference materials, and simplified reviews.
• Faster Tech Transfer: Standardized digital workflows and “digital twin” reference materials reduce variability across labs.
• Efficiency & Innovation: Automation and advanced analytics free resources and drive continuous improvement
• Why use USP digital standards?
• Regulatory uncertainty is the top barrier to adoption of digital standards. USP Standards are recognized and accepted by leading regulatory bodies and have been helping to ensure consistent quality across manufacturing sites, R&D facilities, and QC laboratories for more than 200 years. 

By evolving how these trusted standards integrate into digital environments, we can bridge science, regulation, and technology to ensure quality and increase confidence at every step. 

USP digital standards include: 

• dDS: USP digital Documentary Standards (dDS) are machine-readable in a validated, digital-first format, designed to power advanced laboratory workflows and enable the adoption of new technologies into quality systems.
• dRS: USP digital Reference Standards (dRS) are digital data demonstrated to have the appropriate qualities to support their intended use as references for comparison in compendial tests.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

USP Chapter 1115 Bioburden Control

After several years of discussion and debate the United States Pharmacopeia (USP) has issued a draft of a proposed new chapter: USP <1115> “Bioburden Control of Nonsterile Drug Substances and Products”. The draft has been released in the Pharmacopeial Forum July/August, 2013.

By appearing in the Pharmacopeial Forum the draft chapter is presented to the industry for comment, with a view to a final chapter being published sometime in 2014. The main basis to the chapter is the setting out of a risk-based approach to monitor and control of the manufacturing facility and process for non-sterile pharmaceutical products. These are important concerns for bioburden has been cited by the U.S. FDA in several warning letters over the past ten years in relation to batch rejection and recall*.

Scott Sutton has more information about the new chapter, including a link to a copy on the Microbiology Network: to view please click here.

*See: Sandle, T. (2012). Review of FDA warning letters for microbial bioburden issues (2001-2011), Pharma Times, Vol. 44, No.12, pp29-30



Posted by Tim Sandle

USP 1116 and its impact on Microbiology

Please register for USP 1116 and its impact on Microbiology on May 1, 2013 2:00 PM BST at:

https://attendee.gotowebinar.com/register/3091644528169260032

This is Pharmig's first webinar and is FREE to all Pharmig contacts.

The session will be presented by Dr. Tim Sandle (Site Microbiologist at BPL) and will cover:

• An in depth review of changes to USP 1116
• How will the recent changes to USP 1116 affect you?
• How are these changes viewed by the different regulators
around the world?
• Key changes include: references to ISO 14644

After registering, you will receive a confirmation email containing information about joining the webinar.

Posted by Tim Sandle

USP Microbiology Workshop

Microbiological Control of Compendial Articles: A USP Workshop on Current Status and Future Directions of Compendial Standards

March 18–19, 2013, USP Meetings Center, Rockville, MD

The workshop will present information on revisions to current USP Microbiology
chapters and potential and draft chapters in the areas of:

Bioburden control of nonsterile products, Microbiological Control and Monitoring of Aseptic Processing Environments.

Sterilization methods, Validation of alternate microbiological methods, Rapid/Modern microbiological
methods, Depyrogenation methods and Endotoxin Limits.

A roundtable on the recent contamination related issues in sterile compounding is also on the hot topics covered.

Key Objectives Include

• Providing an overview of recent and current work of the USP General
• Chapters Microbiology Expert Committee through new and revised
• chapters and chapter proposals in order to solicit feedback on the
• committee’s current and future standards-setting activities
• Fostering conversation that focuses on better understanding the needs
• of stakeholders

Speakers representing USP Microbiology Expert Committee, FDA, European Pharmacopeia and Japanese Pharmacopeia are scheduled to speak

For additional details visit the link USP Workshop on Compendial Microbiology

Or contact:

Radhakrishna Tirumalai

Posted by Tim Sandle

Pharmacopeia Forum Vol. 39 (2013)

A new edition of the Pharmacopeia Forum Vol. 39 No.1 Jan– Feb 2013 has been published. Among the items of interest for laboratory staff are:

Chapter 202 Identification of Fixed Oils by Thin-Layer Chromatography [NEW]

(Revision proposal target, USP37-NF32)

This new chapter proposes an orthogonal test to determine the identity of fixed oils. The procedure is harmonized with European Pharmacopoeia general chapter 2.3.2. Identification of Fatty Oils by Thin-Layer Chromatography

Chapter 231 Heavy Metals

(Revision proposal target, USP37-NF32)

To improve and harmonize monographs and general chapters, the USP proposes to omit Heavy Metals chapter 231 and all references to this general chapter from USP–NF monographs and other general chapters. USP is replacing <231> with two new general chapters on elemental impurities:

Chapter 232 Elemental Impurities—Limits

Chapter 233 Elemental Impurities—Procedures

These two chapters were published in the Second Supplement to USP 35–NF 30

Chapter 853 Flourescence Spectroscopy [NEW]

(Revision proposal target, USP37-NF32)

Spectrophotometry and Light–Scattering <851> will be replaced by a family of chapters pertaining to atomic absorption, UV–Vis, infrared, and fluorescence spectroscopy methods. Each of these chapters will be presented in pairs (one numbered below 1000 and one numbered above 1000). Chapter <853> is based on application of the method when applied to a procedure in a monograph. Its sections are Introduction, Instrument Qualification, Procedure, and Validation and Verification

Chapter 1853 Flourescence Spectroscopy – Theory and practice [NEW]

(Revision proposal target, USP37-NF32)

The general information chapter describes theory and instrumentation used to support development of a compendial procedure. That chapter's sections are Theory, Instrumentation, Factors That Affect Quantitation, Calibration of Fluorescence Instruments, and Procedure Validation