Biotech and Pharma Consultancy
Electronic Qualification Services Ltd.
GxP Drug Manufacturers
“Knowing the current validation status of all of the Facilities, Areas, Rooms, Systems, Equipment, Instrumentation, Utilities, Products, Manufacturing, Cleaning, Sampling and Testing Processes is a considerable challenge.”
However, this is an expectation for quality personnel involved in routine batch manufacture and release. An expectation that we can help you realise…
GxP Drug Manufacturer Validation & Quality Issues
We appreciate that money, time, and resources are not limitless commodities and that it is easy to fall into a spiral of firefighting in place of root cause analysis and mitigation.
Some of the common issues faced by GxP Drug Manufactures that we have developed continuous improvement solutions for include:
Board Member / Senior Leaders
Common issues experienced by Board Member / Senior Leaders include:
- Lack of live validation status data as a foundation for developing/refining business strategy
- One-off validation status projects being routinely required to support external inspections
- ROI for validation projects is often limited to point-in-time regulatory compliance
Validation / Quality Managers
Common issues experienced by Validation / Quality Managers include:
- Current validation state is unknown
- Validation is not visibly linked to process criticality
- An unacceptable amount of time is wasted firefighting
- Continuous improvement projects often face underfunding, lack of resources, and frequent deprioritisation
- Individual projects are completed independently and don't integrate into a single cohesive approach
- Lack of visible live validation status data
- Forces concurrent product release
- Makes it difficult to prioritise improvement projects
- Makes it difficult to justy improvement projects
- Makes it difficult to demonstrate compliance to external auditors
- Presents the ongoing risk of an external audit uncovering unknown but significant compliance observations
- Introduction of new products is time consuming requiring
- Extensive review of all validation documentation
- Unneccessary revision of documentation
- Update of large complex documents
- Review and approval of large complex documents
- Significant time, cost and resource
- Unnecessary review of unrelated documents due to a lack of clear document interrelationships
- Validation packages are difficult to maintain over time
- Validation packages are designed for on-off delivery rather than lifecycle maintenance
- Portions of tests are invalidated by maintenance and change
- Test are lumped together in the same document making separating current and superseded tests impossible
- No mechanism of demonstrating which product batches current and superseded tests support
- No rationalisation of different test approaches over time
- Auditors get to review superseded tests without explicitly requesting them increasing the likelihood of observations
- Variability in validation document formats and approaches
- Highlights different levels of compliance
- Reduces confidence during internal and external audits
- Requires justification of approach inconsistencies
- Increases the complexity of reviews
- Increases the complexity of re-validation
- Validation Master Plans that
- Require multiple draft revisions
- Cannot be signed off due to missing information
- Contain large volumes of one-off information
- Are continuously under change control
- Are difficult to review and approve
- Require extensive cost, time and resource to maintain
- Repeated criticality discussions
- Unnecessary waste of time, money and resource
- Deviation/CAPA review meetings involve the same repetitive discussions and arguments over process criticality
- Lack of formal Knowledge availability
- Cumulative submission commitments are not available in an easily reviewable form
- Cumulative process critical aspects, ranges and tolerances are not available in an easily reviewable form
- Lack of formally documented knowledge to reference when making key quality decisions
- Rationales supporting key quality decisions are not clearly documented for future reference
If any of the issues outlined resonate with your situation, we are equipped to enable the rapid and cost-effective implementation of proven continuous improvement solutions that can address them.
Contact us to find out more: enquiries@equaserve.com
Our Products & Services
Over the years, we have systematically developed and refined proven continuous improvement services and corresponding products, specifically designed to address previously identified quality issues. Our key offerings are outlined below:
Services
Consultancy
- Knowledge Compilation
- Current Site Validation State Documentation
- Future State Design Development
- Prioritised Mitigation Strategy Development
- Implementation Strategy Development
- Implementation
Products
Off-the-Shelf Site Validation:
- Traditional Protocol / Report / SOP / Training Format
- Site Validation Policy
- Site Validation Master Plan
- Facility Validation Plan(s)
- Site Systems Validation Plan
- Process Descriptions / Risk Assessments
- Manufacturing
- Cleaning / Sanitisation / Sterilisation
- Sampling
- Testing
- Facility / Area / Room / Utility / System / Equipment / Instrument Qualification
- User Requirements Specification (URS)
- System Boundary / Description
- Risk Assessment
- Qualification Strategy
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Process Validation
- Process Design
- Process Qualification
- Continued Process Verification
- Final Validation Reports
- Facility
- Site Systems
- Process
- Product
- E2500 Live Site Validation Status Solution
As an enhancement to our traditional Off-the-Shelf validation offering we have also developed a true science- and risk- based solution that:
- Provides the current validation status to support:
- Routine manufacture and release
- Prioritised improvement projects
- Internal audits
- Customer audits (contract manufacturer)
- Regulatory inspections
- Provides live links to:
- Regulatory submission commitments
- Documented knowledge
- Risk Assessments
- Generates live content for incorporation into:
- FDA Annual Product Reviews (APRs)
- EU Annual Product Quality Reviews (PQRs)
Due to the proprietary nature of this approach, we are unable to provide detailed information in this medium. However, we welcome the opportunity to discuss the solution in greater detail—please contact us directly for further information.
- Site SCRIBE Automation Software
Optional software solution developed to assist in the implementation of the traditional Off-the-Shelf Site Validation Solution.
- KAS Automation Software
Optional software solution developed to assist in the implementation of the E2500 Off-the-Shelf Live Site Validation Solution.
Contact us to find out more: enquiries@equaserve.com
Our Implementation Strategy
We understand that money, time, and resources are limited, and it can be challenging to justify large budgets for open-ended, one-off GxP compliance improvement projects.
That’s why we provide our compliance enhancement solutions as continuous consultancy-driven improvement initiatives, seamlessly integrated alongside ongoing manufacturing processes.
A typical implementation includes the following activities:
- Our customers commit to investing in a few weeks of external consultancy support, during which we aim to deliver an instant and measurable return on investment.
- Our proven methodologies are implemented against a small Scope of Work, requiring the input of limited internal resources for a minimum number of hours.
- Our consultancy commences with the Quality / Validation Manager to prioritise our scope of work for maximum return on investment.
- During these initial meetings, we will present proven rapid implementation solutions to address the site prioritised validation problems presented.
- If not immediately available we will propose a strategy to rapidly move towards a live validation status model.
- If our customer approves the solution we facilitate its rapid implementation.
- The life-cylce solution can then be seamlessly migrated across other areas of the site as required.
Given that our modular initiatives integrate to create a unified Site Validation approach, they can be implemented in various sequences while still contributing to a cohesive overall strategy.
Contact us to find out more: enquiries@equaserve.com
A Foundation of Knowledge
Formal documentation of knowledge, in a usable, referenceable, and maintainable format, forms the foundation of all our products and services.
Every decision is made with careful consideration of, and in reference to, this foundation, which evolves over time with accumulated manufacturing expertise, regulatory advancements, and continuous improvement initiatives.
Knowledge takes many forms, including:
- Processes
- Regulations
- Submission Commitments
- Corporate Procedures
- Site Procedures
- Facility Procedures
Over the years, we have observed that well-structured documentation and comprehensive knowledge compilation, when properly executed, deliver substantial long-term benefits, particularly in terms of time, resource, and cost savings. This approach helps to avoid the inefficiencies associated with repeated discussions on the same topics:
- Change control meetings
- Failure Investigations
- Customer Complaints
- Criticality Discussions
- Risk Assessment Discussions
- System Categorisation
Contact us to find out more: enquiries@equaserve.com