Multiple stakeholders; the NSF/IPEC/ANSI 363 and...
Transcript of Multiple stakeholders; the NSF/IPEC/ANSI 363 and...
International Pharmaceutical Excipients Council
Collaborative solutions for excipient industry stakeholders
Multiple
stakeholders;
one objective.
Practical Application of the NSF/IPEC/ANSI 363 and EXCiPACT Standards
Ann Van Meter IPEC Americas
GMP Committee Chair
Copyright © 2015, All Rights Reserved IPEC-Americas 2
Topics
Introduction
Benefits of implementing the standards
Risk Assessment – How to apply and the
power of WHY
Specific applications
Copyright © 2015, All Rights Reserved IPEC-Americas 3
Introduction
NSF/IPEC/ANSI 363 and EXCiPACT standards
for excipient GMPs are finalized
Basis for both standards is the IPEC/PQG
guide for excipient GMP
Primary difference between guide and
standard is the requirement for documented
risk assessment
There are real benefits associated with the
process of documenting risk assessments
associated with the guide
Copyright © 2015, All Rights Reserved IPEC-Americas 4
Practical Application of the Standards
Development of a new standard provides an
opportunity to review your operations and Quality
Managements Systems(QMS) to ensure compliance
The practical application of the standards can
include:
Deciding whether to become certified to the standard
Documenting the basis of the QMS
Developing and prioritizing a list of capital improvements
related to excipient quality
Communicating the risks associated with operations to
personnel performing the work
Ultimately, gaining a deeper level of understanding of how
the process can impact excipient quality and how those
impacts are addressed.
Copyright © 2015, All Rights Reserved IPEC-Americas 5
Benefits of the standard
Benefits can be realized from the practical
application of the standard at many levels of
an organization
Business level
Quality Personnel
Manufacturing/Production Leadership
Shop Floor
Copyright © 2015, All Rights Reserved IPEC-Americas 6
Business benefits
Certification to a standard is a clear
indication to customers that the excipient
manufacturer is in full compliance with
applicable GMPs
For smaller customers for whom the “spend”
does not justify an on-site audit, certification
can be used for their supplier qualification
verification
Conveys a manufacturer’s commitment to
providing high quality excipients
Copyright © 2015, All Rights Reserved IPEC-Americas 7
Quality Personnel
Thorough understanding of risks to excipient
quality and the mitigations, either in place or
needed, to minimize
Enhanced ability to represent the Quality
Management System (QMS) to auditors and
customers
Enhanced ability to represent the QMS and
excipient quality improvement needs to
manufacturing and leadership
Copyright © 2015, All Rights Reserved IPEC-Americas 8
Manufacturing/Production Leadership
Documented risk assessments provide focus
on areas where improvements may be
needed
NOTE: Improvement opportunities can be
procedural, equipment or facility improvements,
process related, etc.
Provide justification to leadership for capital
investments
Greater understanding of risks associated with
products marketed for use as excipients
Copyright © 2015, All Rights Reserved IPEC-Americas 9
Shop Floor
Perhaps the biggest benefits come at the
shop floor – operators, packagers, loaders,
maintenance, etc.
Involving these groups in risk assessments of
their work environment builds understanding
of the associated risks to the product
Understanding the risks and the
procedures/work processes in place to
address the risks is foundational to a GMP
focused culture
Copyright © 2015, All Rights Reserved IPEC-Americas 10
Practical Application Biggest Benefit
The biggest benefit to the practical
application of the GMP standard is the in-
depth understanding of WHY we do the
things we do and WHAT can impact excipient
quality.
GMP quality culture at all levels of the
organization is enhanced by this deeper
understanding of our excipient manufacturing
processes and Quality Management Systems
Harness the power of WHY!
Copyright © 2015, All Rights Reserved IPEC-Americas 11
Risk Assessment
IPEC Americas is developing an in-depth Risk
Assessment guide. Some excerpts are included here
Begin with the fundamental questions
What might go wrong?
What is the likelihood it will go wrong (probability)?
Can the presence of the hazard be identified (detectability)?
What are the consequences of the hazard (severity)?
Evaluation of the responses to the questions against
established risk criteria determines need to implement
risk controls or reductions
Involve personnel most familiar with the process or
procedure
Copyright © 2015, All Rights Reserved IPEC-Americas 12
Risk Control
Based on results of assessment and evaluation, additional
questions to ask:
Is the risk higher than a level deemed acceptable?
What measures will reduce or eliminate a risk that exceeds an
acceptable level?
What is the proper balance between the benefits, risk and resources
needed to affect reduction?
Will the risk increase as a consequence of risk reduction?
Risk Acceptance recognizes that the level of risk is not high
enough to negatively impact either the customer or patients
Where the risk may impact the customer or patient, risk reduction should be considered.
Reduction measures can reduce the severity or probability,
increase detectability, or any combination of these
Copyright © 2015, All Rights Reserved IPEC-Americas 13
Risk Assessment requirements Documented risk assessments or risk based decision
making are required for the following GMP elements:
Hygienic
practices
Building and
Facilities
Equipment
Construction
Equipment
Maintenance
Utilities Water Air Handling
Systems
Special
Environments
Cleanliness and
Sanitary
Conditions
Waste
Segregation and
Disposal
Pest Control Planning for
Excipient
Realization
Customer
Expectation
Purchasing
Process
Verification of
Purchased
Product
Preservation of
Product
Excipient
Packaging System
Control of
Monitoring and
Measuring
Equipment
Investigation of
Non-conforming
Finished Excipient
Reworking
Copyright © 2015, All Rights Reserved IPEC-Americas 14
Practical Application of Risk Assessment
Best Practices for operations/manufacturing
based risk assessment Participants should include those who actually perform the
work
Train on the risk assessment process to be used and the
standard requirements related to the operation, such as:
Hygienic Practices
Equipment maintenance
Pest Control
Etc.
As a team, go to the manufacturing area for an in-depth
walk-through,
THEN, begin documenting the risk assessment
Copyright © 2015, All Rights Reserved IPEC-Americas 15
Examples of Practical Application
Packaging or logistics operations
Purchasing process
Planning of excipient realization
Copyright © 2015, All Rights Reserved IPEC-Americas 16
Packaging or Logistics Operations Several of the standard requirements can apply to packaging or
logistics operation, such as:
Hygienic practices, building and facilities, equipment construction, air handling systems, cleanliness and sanitary conditions, pest control
Operations can range from drumming and bagging to filling rail or tank
cars, can be inside or outside
The team should look at the entire operation, preferably actually
observing a packaging or loading operation
The advance training will guide the focus areas for the team
Don’t be surprised of the number of opportunities or risks identified
Many items will be below the risk threshold or will be easy to fix by
training or procedural changes
For items identified that will require investment, the rationale for the
capital is essentially developed through the process.
Copyright © 2015, All Rights Reserved IPEC-Americas 17
Purchasing
Materials and services required by the excipient manufacturing
process need to be assessed for their potential to impact excipient quality
Can include contract manufacturers and packagers,
laboratories and raw material suppliers
Where operations that can impact quality are performed, are applicable elements of the standard in place?
Have the material and service providers been audited? Is there
a qualification or evaluation process?
Are the relevant requirements and expectations documented in
a quality agreement or equivalent document.
Is an audit or re-approval process for continuing evaluation in place?
Copyright © 2015, All Rights Reserved IPEC-Americas 18
Planning of Excipient Realization Identifies the processes and controls needed
for excipient manufacture.
The implementation of identified actions from
risk assessments described in all sections of
the standards is required for excipient
realization
How are the identified actions documented
and reviewed for assessment of completion
and implementation?
Brings it all together into a cohesive GMP
compliant QMS
Copyright © 2015, All Rights Reserved IPEC-Americas 19
Summary
The standards are based on the IPEC/PQG
guide that has been in place for many years
The risk assessment requirements provide an
opportunity to develop a deeper
understanding of the risks that can impact
excipient quality
There are definite benefits from the practical
application of the standards