Author: Jeremiah Genest

Quality professional with over 20 years of experience. Gamer and storyteller with forty years of practice.

Voluntary Standard Organizations and You

A consensus standards organization, also known as a voluntary consensus standards body, is an entity that develops and publishes technical standards through a collaborative, consensus-based process involving various stakeholders. Here are the key characteristics of consensus standards organizations:

  1. Voluntary participation: Involvement in the standards development process is voluntary for interested parties.
  2. Consensus-based approach: Standards are developed through a process that seeks general agreement among participants, considering the views of all parties and reconciling conflicting arguments.
  3. Openness: The procedures and processes for developing standards are open to interested parties, providing meaningful opportunities for participation on a non-discriminatory basis.
  4. Balance: The standards development process aims to achieve balance among different stakeholder groups, ensuring no single interest dominates.
  5. Due process: The organization follows established procedures that include provisions for appeals and addressing objections.
  6. Transparency: The procedures for developing standards and the standards themselves are transparent and accessible.
  7. Non-profit status: Many consensus standards organizations operate as non-profit entities.
  8. Diverse stakeholder involvement: Participants typically include industry experts, government representatives, academics, and consumer groups.
  9. Accreditation: In some cases, these organizations may be accredited by national bodies (e.g., ANSI in the United States) to ensure they follow proper procedures.
  10. Wide range of applications: Consensus standards can cover various fields, including product specifications, testing methods, management systems, and more.

Examples of well-known consensus standards organizations include:

  • International Organization for Standardization (ISO)
  • American National Standards Institute (ANSI)
  • ASTM International (formerly American Society for Testing and Materials)
  • British Standards Institution (BSI)

These organizations play a crucial role in promoting quality, safety, and interoperability across various industries and sectors by developing widely accepted standards through collaborative processes.

The Unique Role of Inter-Governmental Agencies in Pharmaceutical Standards

While discussing consensus standard organizations, it’s important to highlight a distinct category that operates similarly but doesn’t quite fit the traditional mold: inter-governmental agencies like the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

These organizations share some key characteristics with consensus standard bodies:

  1. They focus on harmonization efforts in the pharmaceutical industry.
  2. They operate internationally, involving multiple countries and regulatory authorities.
  3. They provide frameworks for collaboration among stakeholders.

However, ICH and PIC/S differ from typical consensus standard organizations in several ways:

  • Membership: They primarily comprise regulatory authorities rather than a broad range of industry stakeholders.
  • Authority: While not legally binding, their guidelines and standards often carry significant weight with regulatory bodies worldwide.

These organizations play a crucial role in shaping global pharmaceutical regulations, bridging the gap between formal regulatory requirements and industry-led standards. Their work complements that of traditional consensus standard organizations, contributing to a more cohesive and harmonized global regulatory environment for pharmaceuticals.

Good Engineering Practices Under ASTM E2500

ASTM E2500 recognizes that Good Engineering Practices (GEP) are essential for pharmaceutical companies to ensure the consistent and reliable design, delivery, and operation of engineered systems in a manner suitable for their intended purpose.

Key Elements of Good Engineering Practices

  1. Risk Management: Applying systematic processes to identify, assess, and control risks throughout the lifecycle of engineered systems. This includes quality risk management focused on product quality and patient safety.
  2. Cost Management: Estimating, budgeting, monitoring and controlling costs for engineering projects and operations. This helps ensure projects deliver value and stay within budget constraints.
  3. Organization and Control: Establishing clear organizational structures, roles and responsibilities for engineering activities. Implementing monitoring and control mechanisms to track performance.
  4. Innovation and Continual Improvement: Fostering a culture of innovation and continuous improvement in engineering processes and systems.
  5. Lifecycle Management: Applying consistent processes for change management, issue management, and document control throughout a system’s lifecycle from design to decommissioning.
  6. Project Management: Following structured approaches for planning, executing and controlling engineering projects.
  7. Design Practices: Applying systematic processes for requirements definition, design development, review and qualification.
  8. Operational Support: Implementing asset management, calibration, maintenance and other practices to support systems during routine operations.

Key Steps for Implementation

  • Develop and document GEP policies, procedures and standards tailored to the company’s needs
  • Establish an Engineering Quality Process (EQP) to link GEP to the overall Pharmaceutical Quality System
  • Provide training on GEP principles and procedures to engineering staff
  • Implement risk-based approaches to focus efforts on critical systems and processes
  • Use structured project management methodologies for capital projects
  • Apply change control and issue management processes consistently
  • Maintain engineering documentation systems with appropriate controls
  • Conduct periodic audits and reviews of GEP implementation
  • Foster a culture of quality and continuous improvement in engineering
  • Ensure appropriate interfaces between engineering and quality/regulatory functions

The key is to develop a systematic, risk-based approach to GEP that is appropriate for the company’s size, products and operations. When properly implemented, GEP provides a foundation for regulatory compliance, operational efficiency and product quality in pharmaceutical manufacturing.

Invest in a Living, Breathing Engineering Quality Process (EQP)

The EQP establishes the formal connection between GEP and the Pharmaceutical Quality System it resides within, serving as the boundary between Quality oversight and engineering activities, particularly for implementing Quality Risk Management (QRM) based integrated Commissioning and Qualification (C&Q).

It should also provide an interface between engineering activities and other systems like business operations, health/safety/environment, or other site quality systems.

Based on the information provided in the document, here is a suggested table of contents for an Engineering Quality Process (EQP):

Table of Contents – Engineering Quality Process (EQP)

  1. Introduction
    1.1 Purpose
    1.2 Scope
    1.3 Definitions
  2. Application and Context
    2.1 Relationship to Pharmaceutical Quality System (PQS)
    2.2 Relationship to Good Engineering Practice (GEP)
    2.3 Interface with Quality Risk Management (QRM)
  3. EQP Elements
    3.1 Policies and Procedures for the Asset Lifecycle and GEPs
    3.2 Risk Assessment
    3.3 Change Management
    3.4 Document Control
    3.5 Training
    3.6 Auditing
  4. Deliverables
    4.1 GEP Documentation
    4.2 Risk Assessments
    4.3 Change Records
    4.4 Training Records
    4.5 Audit Reports
  5. Roles and Responsibilities
    5.1 Engineering
    5.2 Quality
    5.3 Operations
    5.4 Other Stakeholders
  6. EQP Implementation
    6.1 Establishing the EQP
    6.2 Maintaining the EQP
    6.3 Continuous Improvement
  7. References
  8. Appendices

The Hallway Track at a Conference

BOSCON 2024 starts tomorrow, so in honor of the local section’s juggernaut of a conference, I want to talk about the hallway track, my favorite part of a conference.

The hallway track at a conference refers to the informal networking, discussions, and spontaneous interactions that occur outside of scheduled sessions. It is often considered one of the most valuable aspects of attending a conference, as it facilitates connections that can lead to professional opportunities and insights that are not typically available in formal presentations.

How to Maximize the Hallway Track

To make the most of the hallway track, consider the following strategies:

1. Plan Ahead

  • Review the Agenda: Before the conference, identify key sessions you want to attend but also mark open slots for networking opportunities.
  • Set Goals: Determine what you hope to achieve through networking—whether it’s meeting specific individuals or learning about new trends in your field.

2. Engage with Others

  • Start Conversations: Use simple icebreakers like asking about someone’s favorite session or their plans for the day. This can lead to deeper discussions.
  • Introduce Yourself: Don’t hesitate to approach people you know from social media platforms like LinkedIn or Twitter. This can help solidify online connections in person.

3. Attend Social Events

  • Participate in Informal Gatherings: Join social events or activities that may be outside your comfort zone. These settings often foster more relaxed and meaningful conversations.

4. Be Open to New Experiences

  • Change Your Plans if Necessary: If someone recommends a session or event, be flexible enough to adjust your schedule. You might discover valuable insights or connections by following these leads.

5. Leverage the Environment

  • Use Common Areas: Spend time in hallways, lounges, and vendor areas where informal interactions are likely to occur. These spaces are conducive to spontaneous conversations.

6. Network with Purpose

  • Follow Up After the Conference: Collect contact information and follow up with new connections after the event. This helps solidify relationships formed during the hallway track.

By actively engaging in these practices, attendees can significantly enhance their conference experience and build lasting professional relationships through the hallway track.

Not all Equipment is Category 3 in GAMP5

I think folks tend to fall into a trap when it comes to equipment and GAMP5, automatically assuming that because it is equipment it must be Category 3. Oh, how that can lead to problems.

When thinking about equipment it is best to think in terms of “No Configuration” and ” Low Configuration” software. This terminology is used to describe software that requires little to no configuration or customization to meet the user’s needs.

No Configuration(NoCo) aligns with GAMP 5 Category 3 software, which is described as “Non-Configured Products”. These are commercial off-the-shelf software applications that are used as-is, without any customization or with only minimal parameter settings. My microwave is NoCo.

Low Configuration(LoCo) typically falls between Category 3 and Category 4 software. It refers to software that requires some configuration, but not to the extent of fully configurable systems. My PlayStation is LoCo.

The distinction between these categories is important for determining the appropriate validation approach:

  • Category 3 (NoCo) software generally requires less extensive validation efforts, as it is used without significant modifications. Truly it can be implicit testing.
  • Software with low configuration may require a bit more scrutiny in validation, but still less than fully configurable or custom-developed systems.

Remember that GAMP 5 emphasizes a continuum approach rather than strict categorization. The level of validation effort should be based on the system’s impact on patient safety, product quality, and data integrity, as well as the extent of configuration or customization.

When is Something Low Configuration?

Low Configuration refers to software that requires minimal setup or customization to meet user needs, falling between Category 3 (Non-Configured Products) and Category 4 (Configured Products) software. Here’s a breakdown of what counts as low configuration:

  1. Parameter settings: Software that allows basic parameter adjustments without altering core functionality.
  2. Limited customization: Applications that permit some tailoring to specific workflows, but not extensive modifications.
  3. Standard modules: Software that uses pre-built, configurable modules to adapt to business processes.
  4. Default configurations: Systems that can be used with supplier-provided default settings or with minor adjustments.
  5. Simple data input: Applications that allow input of specific data or ranges, such as electronic chart recorders with input ranges and alarm setpoints.
  6. Basic user interface customization: Software that allows minor changes to the user interface without altering underlying functionality.
  7. Report customization: Systems that permit basic report formatting or selection of data fields to display.
  8. Simple workflow adjustments: Applications that allow minor changes to predefined workflows without complex programming.

It’s important to note that the distinction between low configuration and more extensive configuration (Category 4) can sometimes be subjective. The key is to assess the extent of configuration required and its impact on the system’s core functionality and GxP compliance. Organizations should document their rationale for categorization in system risk assessments or validation plans.

AttributeCategory 3 (No Configuration)Low ConfigurationCategory 4
Configuration LevelNo configurationMinimal configurationExtensive configuration
Parameter SettingsFixed or minimalBasic adjustmentsComplex adjustments
CustomizationNoneLimitedExtensive
ModulesPre-built, non-configurableStandard, slightly configurableHighly configurable
Default SettingsUsed as-isMinor adjustmentsSignificant modifications
Data InputFixed formatSimple data/range inputComplex data structures
User InterfaceFixedBasic customizationExtensive customization
Workflow AdjustmentsNoneMinor changesSignificant alterations
User Account ManagementBasic, often single-userLimited user roles and permissionsAdvanced user management with multiple roles and access levels
Report CustomizationPre-defined reportsBasic formatting/field selectionAdvanced report design
Example EquipmentpH meterElectronic chart recorderChromatography data system
Validation EffortMinimalModerateExtensive
Risk LevelLowLow to MediumMedium to High
Supplier DocumentationHeavily relied uponPartially relied uponSupplemented with in-house testing

Here’s the thing to be aware of, a lot of equipment these days is more category 4 than 3, as the manufacturers include all sorts of features, such as user account management and trending and configurable reports. And to be frank, I’ve seen too many situations where Programmable Logic Controllers (PLCs) didn’t take into account all that configuration from standard function libraries to control specific manufacturing processes.

Your methodology needs to keep up with the technological growth curve.