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


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


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.


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


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


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


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


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


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!


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


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


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


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


Examples of Practical Application

Packaging or logistics operations

Purchasing process

Planning of excipient realization


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.


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?


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


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


Questions?

multiple stakeholders; the nsf/ipec/ansi 363 and...

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