Supplier and Contractor Qualification and Control for Life Science Industry
This two-day course focuses on the processes associated with the acquisition of products, materials and services that fuel and support the organization’s product manufacturing and marketing. These cross-functional processes are complex and result in conflicting objectives between decision-makers. Management is responsible for organizing and providing resources and the more they understand, the more effectively they can manage. This course begins with a discussion about quality and compliance and some of the regulations pertinent to supplier/contractor qualification and control. The primary regulations are:
Part 211, Subpart E-Control of Components and Drug Product Containers and Closures, ICH Q7A, Section VII, Materials Management Part 820, Subpart F, Purchasing Controls.
ISO 13485:2016, ISO 9001:2015, pertinent ICH & IMDRF (formerly GHTF) documents and pertinent FDA guidance documents. Quality concepts from “quality gurus” will also be presented.
Contract Testing Laboratories
Part 58, Good Laboratory Practices, (GLP) contractors.
Next, the course discusses how functions and personnel must be organized and an infrastructure established to ensure the “building blocks” of the products meet processing requirements and produce products that meet customer requirements. Management provides resources that ensure that these activities are properly managed and personnel are in place who have experience, qualifications, and knowledge to carry out the responsibilities. Procedures must exist that provides direction and structure to the process.
After the organization and infrastructure are in place, it must be implemented. So the next topic is a very detailed presentation and discussion of the entire qualification process beginning with the creation of the specification followed by a series of tasks that include testing material samples, researching and analyzing potential candidates, planning and conducting an audit. The audit data must be analyzed and used to form a conclusion concerning the qualification status. These activities must be monitored.
Finally, case studies, warning letters, experiences of the speaker will be presented. Class activities will encourage your participation.
This course is designed for personnel with all levels of material and supplier experience. Upon completion of this course, attendees will:
Understand that all the regulations have similarities and differences; and similarities outweigh the differences.
The requirements provided by each GMP regulation or even collectively do not meet minimum requirements in navigating today’s supply chain or achieving compliance. Therefore, they must be augmented by combining the total GMP requirements and applying quality concepts outside the regulations.
Learn and understand the terminology as well as the regulatory and quality concepts.
Suppliers and contractors are not equal. Suppliers produce items used in processing to manufacture products. Contractors perform operational processes that are part of the manufacturer’s inherent responsibilities or outsourcing.
Understand the scope of qualification activities includes any item that touches the process such as filters, cleaning agents, lubricants, etc. Qualification tracks are less strenuous for these items.
Be aware virtual and brick-and-mortar business structures require altered approaches to S/C. Virtual companies rely almost wholly on contractors. Brick & Mortar companies may use contractors to augment some processes. However, virtual companies retain many responsibilities when contracting.
Quality agreements must be in place when outsourcing and contracting.
Auditor certifications are helpful in learning audit techniques and objectivity. However, it is no guarantee of auditor success because experience, knowledge and understanding outweigh certification without these factors
Understand the responsibility to protect your company and if you make observations that could negatively impact the company, it is your responsibility to see the issue is addressed.
Understand that supplier qualification is a part of the material validation process. Process must exist for creating, developing, and changing material specifications in order to maintain material integrity. The supplier must also sign off on the specification including a change notification to the firm.
Understand the qualification of the supplier’s quality control testing operations is key to protect the integrity of the material. For critical items, collaborative testing between the supplier and the firm is required.
Must be aware reduced testing can only occur after a robust qualification and material validation has successfully been completed. This is a separate qualification in the sampling plan must be scientifically sound with established risk standards. Examples of these factors include criticality of the item, volume, difficulty of test method, supplier history, and analytical testing results.
An established criterion must exist for qualifying suppliers.
A process must exist for disqualifying suppliers.
DAY 01(8:30 AM - 4:30 PM)
08.30 AM - 09.00 AM: Registration
09.00 AM: Session Start
Introduction, Purpose, Objectives, & Scope
Importance of quality philosophy
Purpose and Objectives
Quality Versus Compliance
Lifecycles-Product, Manufacturing, & Material
Regulatory and Quality Requirements (Components & Supplier Qualification and Control)
Part 211 Finished Pharmaceuticals (1978)
Part 600 Biological
Part 820 Device GMPS (1978)
Part 820-Quality System Regulation(QSR) (1997)
International Conference on Harmonization (ICH)
International Medical Device Regulators Forum (IMDRF) formerly Global Harmonization Task Force (GHTF)
ISO 13485:2016 and& ISO 9001:2015
Applicable FDA guidance documents
Developing and Implementing the Supplier/Contractor Auditing and Qualification Function
Staffing & Organization-Quality Department and the Auditing Unit
Audit Interaction Team
Virtual & Brick-And-Mortar approaches to qualification
Material Specification Development, Review, & Approval
SOP & Policy-or SOP-Policy Combination (Flowchart Format)
Supporting Forms & Documents (Examples)
Audit Tracking Qualification Form
Targeted questionnaires (10)
Supplier/Contractor Rating Sheet
Audit Flow Worksheets
DAY 02(8:30 AM - 4:30 PM)
Flow-charting the supplier and contractor qualification and control process.
Note: Early in the process, potential S/C must have an approved final, draft, or developmental written specification.
Begin a targeted search for potential suppliers or contractors (Or existing suppliers)
Research and collect data to further differentiate the potential candidates
Analyze data to determine strongest candidates
For the strongest candidates do the following in tandem:
Test samples, prototypes, models, drawings, to confirm meeting specification requirements
Send a targeted questionnaire (i.e. Component, specialty chemical, API, and finished device,
Using the data collected, make a decision on the tasks required for qualification
If paper audit is required, follow paper audit protocol
If on-site audit is required, go to on-site audit protocol
Preparation and Planning-Audit Leader, Audit Team,
Developing a working relationship by developing a “mutual agenda,
Learn as much as possible about the auditee prior to the audit
Documentation review for audit
For contractors, make quality agreements a part of the agenda
Using the laboratory testing, research, and the targeted questionnaire to structure the agenda
Preparing the opening meeting presentation.
Finalize the agenda and make audit team assignments, as applicable.
Final planning for the audit
Conducting the on-site audit
Quality System quality system review
Quality System documentation review
The Laboratory, Utilities, IT, Documentation Management
A note on multiple day audits
Audit Team Meetings
Closing Meetings, presentation of findings, & corrective action plans(ROT)
Handling Difficult Situations
Update meetings (dependent on audit length)
Analyzing the data, corrective action plans, and preparing report
Audit Team post-audit wrap up
Responsibilities for preparation
Classifying criticality of findings
Plan Follow-Up as maybe needed
Audit Team-Audit Group review and approval of report
Three most probable outcomes—qualified, qualified with conditions, not qualified
Response to the report
Review response and note any disagreements
Negotiate but do not yield
Follow-Up & Verification
Tracking corrective actions
Maintaining and Monitoring
Audit reports filing and access
Periodic Reports to Management
Periodic meeting with management
Case studies not already covered
Warning letters not already covered