QUALITY

Smart Business Processes

Data Driven Decisions lead to Solid Compliance

Excellence in the various Quality processes is paramount throughout the whole life sciences industry. Medicinal products and devices, which have the potential to drastically change lives, must be developed with frictionless quality systems in place, to ensure controlled documentation and end-to-end compliance at any time. Quality assurance as such is a pretty broad concept. It covers all aspects of your process that can have an impact on patient outcomes.

The risk of not implementing comprehensive quality systems is well documented. The numerous yearly findings of authorities like FDA or EMA can still be devastating to a company with poor performance in quality.

Such findings can lead to substantial costs related to corrective measures, remediation and blocking of sites and product. Companies can face external costs like regulatory action, massive reputational damage, and a loss of market share.
US-based pharmaceutical organizations should work to assess and understand the following regulatory requirements from the Food and Drug Administration (FDA), including clinical requirements:

CFR Title 21, Part 210: Current Good Manufacturing Practice
CFR Title 21, Part 211: Current GMP for Finished Pharmaceuticals
CFR Title 21, Part 11: Electronic Signatures for Electronic Records
21 CFR, Part 50: Protection of Human Subjects (Informed Consent)
21 CFR, Part 54: Financial Disclosure by Clinical Investigators
21 CFR, Part 56: Institutional Review Boards
21 CFR, Part 58: Good Clinical Practice and Clinical Trials
21 CFR, Part 312: Investigational New Drug Application
21 CFR, Part 314: Applications to Market a New Drug

If your marketing ambitions post-approval include Europe, you should strongly consider aligning your quality system to ICH Q10 earlier in your development.

TOUCH

PROCESS

Continuous Improvement

Constantly verify the consistency of existing processes and whether existing specifications are appropriate and adequate.

TOUCH

PRODUCT

Current Good Practice

GxP - the implementation of quality principles for raw materials, the manufacturing process, packaging, transportation, and storage.

TOUCH

PEOPLE

Quality-Driven Culture

Besides the obvious process excellence, a proper product the quality-driven culture remains a main factor to achieve quality.

Related Sub-Processes in Quality

Audit Management

The increasing complexity and continuous changes in the regulatory environment push organizations to seek a more holistic and highly integrated approach to their audit management processes. Auditing is a vital function within a pharmaceutical company nowadays CAPA Management

HIGHLIGHTS

External audits
Internal audits
Regulatory audits

Details!

CAPA Management

To understand how to achieve quality in a regulated industry, you need to know that corrective and preventative actions (CAPA) are essential elements of quality management in GxP environments. The CAPA process is a commonly used tool to achieve operational excellence by identifying and mitigating non-conformances and deviations, both internally and externally.

HIGHLIGHTS

Event Mapping / Audit Scheduling
Structured Problem Analysis
Multidimensional (faceted) Search
Smart Follow-up Workflow
Effectiveness Check
Indicators and Signals

Details!

SOP Management

Life science organizations developing or manufacturing pharmaceutical products will typically create, maintain and execute large amounts of standard operational procedures (SOP). The solid change control and deployment of SOPs are a fundamental to achieve compliance excellence.

Properly designed Standard Operating Procedures include step-by-step instructions as well as the following:

HIGHLIGHTS

Objective (Purpose)
Scope
Responsibilities
Accountability
References
Task Instructions (Procedure)
Documentation

DETAILS!

Change Control

Change management is specifically designed to evaluate, redesign, and implement new business processes, where processes are defined in standard operating procedures (SOPs). A well implemented change management pays back into improved business processes, efficient workflows, decreased project overhead, a better risk profile and an improved company culture.

HIGHLIGHTS

Collaborative authoring and editing
Document review and approval
Document protection and monitoring
Document control and printing functions

Details!

Training Management

Post implementation training services often relateto process changes. With biomedion training services implementations are ready for success. The neuronOS Learning Management System (LMS) typically handles the processes related to ramp-up and adoption planning after larger implementations.

HIGHLIGHTS

Upload content
Deliver courses online
Onboarding process
User Enrollment, Learning plans
Ramp-up new users
Tracking and assessing learner performance

Details!

Deviation Management

As a common mechanism to discriminate events based on their relevance and to objectively categorize them, concentrating resources and efforts in good quality investigations of the root causes of relevant deviations.

HIGHLIGHTS

Control of components, drug product containers, and closures
Production and process controls
Packaging and labeling control
Holding and distribution
Laboratory controls
Complaints

Details!

Inspection Management

Audits, safety inspections, engineering surveys, and quality checks are common in life sciences. While they add overheads, they are necessary to keep organizations in business.

HIGHLIGHTS

GMP inspections
Contract manufacturers (CMO)
Contract laboratories

Details!