LEAD AUDITORS

TRAINING COURSE
Darren Freestone
Senior Consultant
SeerPharma (Singapore) Pte,
Ltd
Aug. 1-2, 2012 @ FDA Alabang

ECHO SEMINAR
August 17, 2012

Training Course Outline

Audit Program
Audit Procedures
Lead Auditors

REFERENCE GUIDELINES

Inspectorates
PIC/S PI 037-1
Companies (Manufacturers)
PIC/S PE 009-9

ICH Q9
ICH Q10
GMP Guideline
Harmonized Tripartite
Guidelines

INSPECTORATE
Two Roles:
1.

Inspectorates meets
requirements of
PIC/S PI 037-1

2. Companies
(Manufacturers) program
meets requirements of
PIC/S PE 009-9

PIC/S Expectations for Audits

Principles for Internal Audit

All aspects of GMP should be audited

periodically and thoroughly by an
independent competent person, team or
consultant, according to a written
program
A rolling audit of individual sections
that nevertheless covers all aspects in a
prescribed time is preferred to a single,
exhaustive audit
A written report of each audit should be
prepared. Evidence should be available
that the program is written and followed
and that follow-up activity results

Q9 Expectations for Audits

Principles for Internal Audit

All aspects of GMP activities should be assessed

for risk to product quality. This include Supply
Chain and Distribution Chain

Audit frequency, duration and allocation of

resources to be based on risk

Deficiencies should be assessed in terms of risk to

the product and customer, not just against GMP
clauses. Deficiencies and appropriate escalation
should be in place

Residual risk should be assessed upon completion

of corrective actions

Q10 Expectations for Audits

Principles for Internal Audit

Demonstrated management commitment

to effective implementation of Internal
Audit program (commitment clearly
communicated, provision of adequate
resources, authority of auditor/team)
Regular management review of the
effectiveness of the Internal Audit Program
Results of reviews and recommendations /
actions are documented
Follow-up from previous recommendations /
actions are documented

Audits types

Regulatory by Legal Agencies (FDA,

HSA, EMEA, etc)
Certification Audits Certification
bodies (TUV, BSI, ISO, HALAL, etc)
Vendor / Supplier and Sub-contractor
audits
Internal Audits or Self Inspections

GMP Compliance
Specific / focused (e.g. deviation or
customer complaint)
Analyzing process, environmental data
Corporate

External, e.g. Customers

Audit intent and Purpose

Irrespective of the audit type, the

purpose is:

To establish and monitor the

implementation and compliance of the
quality assurance systems and to ensure
that the requirements of cGMP are met
To propose necessary corrective and
preventive actions
To improve the quality systems
One way to demonstrate commitment to
continuous improvement

Responsibility (1)
Senior Management (Q10)

Set direction (Formal Policy)

Provide resources

Require the establishment

of a program

Provide Authority

Responsibility (2)

Quality Assurance (Q9)

Define and formalize program

methodology (SOPs)
Allocate program resources
Establishes competencies base
Determine measures
Implements the program
Monitor performance

Responsibility (3)
Lead Auditor (PIC/S and Q9)

Reviews and implements program based

on risk
Plans and implements audits
Allocates audit resources
Ensures auditor competencies
Documents metrics
Reviews performance

Responsibility (3.1)

Additional
Responsibilities
(outside audits)

Organizing the
logistics
Travel
Accommodation
Liaising with the
Auditee
Working out time
and costs of the
audit

Vendor /
Supplier
Audits

Scope of Vendor / Supplier

Assurance Programs
Audits/evaluation are typically carried out on:

API manufacturers
Sub-contract manufacturers
Contract test laboratories
Excipient suppliers
Warehouse and distribution train cold chain system
Pre-printed (coded) matter suppliers
Component/packaging suppliers
Processing aids providers (filters, resin)
Calibration service providers
Contract research organizations
Software developers
Etc..

Purpose of Vendor / Supplier

Assurance Programs
Regulatory Requirement

Clause 5.26 Starting materials should only be purchased from

approved suppliers.And, where possible directly from the
producer. It is recommended that the specifications established by
the manufacturer for the starting material be discussed with the
supplier

Contract Manufacture

Clause 7.3 The contract giver is responsible for assessing the

competence of the contract acceptor to carry out successfully the
work required for ensuring.that the principles and guidelines of
GMP

Clause 7.5 The Contract giver should ensure that all products and
materials delivered by the Contract acceptor comply with their
specifications or.

To monitor the implementation and compliance of the

suppliers quality assurance systems and to ensure that
suppliers meet the requirements of cGMP, product quality, and
To propose necessary corrective and preventive measure.

Who should assess vendors?

Quality Assurance oversight the

program
QA responsible to conduct internal
reviews and external audits
Lead Auditor usually part of QA
QA assign status to GMP related
vendors
Purchasing (PIC/S 5.25)

* Should be supported by a company

procedure

Requirements of Vendor /
Supplier Assurance Programs

Must include the identification, evaluation and

approval of suppliers and subcontractors:

New supplier assessment and evaluation sample

testing and preliminary evaluation eg quality
survey
Qualification, requalification and disqualification
SOPs
Establishment of GxP Technical Agreements /
contracts
Ongoing evaluation of supplier and material /
service / components by combination of testing and
site audits

The comprehensive testing of goods is no

substitute for an efficient site supplier audit
program
Vendor program must be planned and ongoing

Strategies for Vendor / Supplier

Assurance Programs

Vendor /Suppliers assurance programs

typically encompass one or combination
of

Quality and GxP Surveys

Monitoring of incoming materials
Site audits (do not always have to audit)
Feedback into CAPA and Purchasing systems

The type / method is dependent on the

product and process risk
Program of vendor performance trending
(quality, cost and timeliness)

Vendor / Supplier
Rating Example

Categories of Vendors (Vendor Rating System)

Monitoring programs adjusted based on rating

and performance
Vendor rating responsibility: both QA and
Purchasing
Rate their weighted performance annually

Disqualified
New
Approved
Preferred
Certified

Quality x Delivery Performance x Cost

Vendor / Supplier rating can be influenced by the

results of Inwards Goods Surveillance and other
Vendor/Supplier assurance programs

Quality Surveys typically include

requests for information on:

Company profiles (size, sites) and

management structure
Types of products manufactured on site
Dedicated or multi-product plant
Manufacturing history
Regulatory Licenses
Regulation Audit History
References to DMFs and Site Information
Files
Quality System Information List of SOPs,
Manuals
Subcontracting / other sites arrangements
Quality Control
Policies to allowing clients to audit
operations

Outcomes of Vendor Surveys

(QA report)
Vendor surveys should lead to an initial
risk rating for the supplier.
Document decisions / risk mitigations
e.g.
Should more information be requested
Whether a direct qualifying audit is
required
Whether initial samples should be
evaluated
What level of inward goods sampling
and test should initially occur

Should the vendor be dis-qualified

Building a
PROFILE

Workshop # 1

As applicable to your own experience, list down

as many examples as you can in the lefthand column- under each of the
headings/titles below:
Contract (Toll) Manufacturer
API Manufacturer
Excipient Manufacturer
Contract Laboratory
Printed Matter Suppliers
Unprinted Primary Packaging Suppliers
And enter these into the 2012 Profiles
(workbook provided)

Must Use Risk-Based Decision

Making
To Determine:
What type of audit
Frequency of audit
Team composition
Duration of the audit
In order to:
Prepare the schedule
Which must be:
Authorized by all Department Heads
Adhered- to absolutely
Under Change Management

Workshop # 2
Using the example Supply Chain Quality
Factors (next slide) and the example
Risk Matrix Vendors/Suppliers
Recommended Actions in your workbook,
complete the 2012 profile for each of the
manufacturers previously identified.

Contract (Toll) Manufacturer

API Manufacturer
Excipient Manufacturer
Contract Laboratory
Printed Matter Suppliers
Component Suppliers

Possible Supply Chain Quality

Risk Factors

Patient Risk
Factor

5.
4.
3.
2.
1.

Parenteral / Sterile / Biotech

Rx / prescription product
OTC
Complementary (HRP, Food Supplement)
Excipient

Patient Risk
Factor

5.
4.
3.
2.
1.

Known poor quality

Unknown history / New vendor
Known quality - OK
> 10 batches, all OK
Long good supply history

Patient Risk
Factor

5.
4.
3.
2.
1.

No site assessment
No international GMP audits
International GMP audits
QA reviewed
QA vendor audited > 1 cycle

Workshop #3 Audit Schedule

Now we know:

Manufacturer (Workshop #1)

Associated Risk
Audit type
Audit frequency
Audit Team Composition
Audit Duration

Determine the audit schedule of your vendors

and suppliers based on risk.
Enter each into applicable Audit schedule for
2012/2013

Audit Frequency and Scheduling

The frequency of audit of manufacturers of therapeutic
gods is based on the degree of risk to patients and
consumers
Ongoing basis, the risk factors taken into account when
scheduling audits are:

Result of previous GxP audit [ no NCs vs. critical NCs]

Regulatory Agency Intelligence:

Product recalls since last audit

Medicine adverse reaction reports
Adverse comments from other agencies that have an
impact on GMP

Product complaints since last audit

Deviations
Trend reviews
Significant changes within the company

Workshop #4 Metrics
What metrics could we use for the
schedule?
How do we rate these metrics?
Example.
On-time Audits

1, 2, 3, 4, 5

Missed Audits

5, 4, 3, 2, 1

Closed on Time

1, 2, 3, 4, 5

Supplier Audit Programs in

summary

Must have SOP + schedule under GMPs

Based on risk management
Define term supplier vs manufacturer
Define term audit and assessment
carefully

Direct site visit by QA

Inward goods QC program
Surveys and profiles

Document the supplier qualification results

in records
Must be annually reviewed for
effectiveness and opportunity for
improvement

Internal
Audits

Common Mistake
Manufacturers have the advantage of time.
Should not try to audit everything in one
large auditing session

WHY?

Break it up and spread it out over the

year
Prioritize according to risk
Some areas may be required to be
audited 2, 3 or more times per year (if
high risk)

Be specific

Try to avoid auditing areas like:

Production
Facilities
Quality Systems
Scope is LARGE, need a lot of experience

For Example..
Quality System Elements (QSEs)

HVAC
Equipment
Personnel and Training
Customer Complaints
Market Authorization
Cleaning / Sanitation
Materials Storage and
Handling
Production Controls
Validation Programs
Laboratory Controls
Computer Systems
Solid Dose
Sterile aseptic filling
Preventive maintenance
Change Control
Purified water

Movement of Personnel
Document Control
CAPA
Product Quality Review
Validation Master Plan
Out of specification
Inwards Good receipt
Release for supply
Stability
Retention samples
management
Control of NCP
Housekeeping
Deviations
Risk Management
Sampling
Supplier Management

Use Risk-Based Decision Making

To determine:
What QSE to audit
Frequency to audit
Team composition
Duration of the audit
In order to:
Prepare the schedule
Which must be:
Authorized by all Department Heads
Adhered-to absolutely
Under Change Management

Workshop #5
Assume that the following QSEs are
applicable to your manufacturing
operations:
o Inwards Good and Sampling
o Validation
o Training
o Laboratory
o Calibration
o Maintenance
o Release for supply
o Purified water
o Deviations and CAPA
o Process Controls
o Marketing Authorization

Workshop #5 - continued
Refer to:
QSE Quality Risk Factors (next
slide)
Risk Matrix (QSE) Recommended
Actions (workbook)
1.

2.

Complete the Audit Team Schedule 2

012/2013 in your workbook
Using the completed Audit Team
Schedule 2012/2013, develop the
final Internal audit schedule for
2012/2013 in your workbook

QSE Quality Risk Factors

(examples)

Category 1

Parenteral/ Sterile / Biotech

Process is Complex in nature
Across all/most departments
No previous assessment
Poor previous assessment
History of Deviations / Complaints

Category 2

Rx/Prescription products
Process not overly complex
Previous assessment satisfactory
Occasional deviation/complaint

Category 3

OTC / Complimentary products

Simple in complexity
Previous assessment excellent
No deviations / complaints

Prioritizing GxP Audits based

on Risk

Facility Control

Direct Impact
Equipment

Personnel /
Training

Quality Systems

Market
Authorization

Cleaning /
Sanitation

Materials /
Supply

Production
Control

Validation
Programs

Laboratory
Controls

Computer
Systems

Compliance
Product
Exposure
Consequenc
es

Assessment

Schedules/Prior
ity
Mgmt

Likelihood

CAPA
Trends / History

Write This Down !!

Make sure ALL concerned parties:

sign-off the Audit

Team Schedule!!!
Includes:

Quality Assurance
Area Head
Area Head of audit
team members

Audit Programme Written

Procedures (1)
Audit program procedures should address the
following:
a)
b)

c)

Planning and scheduling audits

Assuring the competence of auditors and audit
team leaders
Selecting audit teams assigning their roles and
responsibilities

d)

Conducting audits

e)

Conducting audit follow-up, if applicable

f)

Maintaining audit program records

g)

h)

Monitoring performance/effectiveness of the

audit program
Reporting to top management on the overall
achievements of the audit program

Audit Programme Written

Procedures (2)
Audit program procedures
should address the
following:
a)

b)

Identifying
operations/objectives and
assessing the risk
Monitoring implementation
of schedule

c)

Escalation of findings

d)

Linkage to CAPA

e)

f)

Assessing / classifying
deficiencies
Monitoring effectiveness of
corrective actions

Lead Auditor Competencies

Suite of SOPs to describe the
Audit Program

Basis to develop Lead Auditor

Training Needs Analysis

Establish Competencies of
Team and Lead

Defines the scope of the

program

Defines how the program is

implemented

Requires review of
effectiveness (performance)

So far.
Vendor and Internal Audits

Pre-requisites in
place:

Company Policies
(Commitment)
SOPs (System)
Competencies
(Resources)
Schedule (Plan)

Internal
Audits

GxP Compliance Audit

Processes
Irrespective of the audit type or reason, all audits
are generally structured in the following
sequence:
1. Determine audit scope and Intent
2. Define the Audit Team select specialist(s)
3. Develop and Audit Plan
4. Identify audit standards (establish criteria)
5. Formally notify the auditee
6. Conduct the audit
7. Categorize deficiencies
8. Conduct exit meeting
9. Finalize the audit report
10. Request a documented auditee CAPA response
11. Verify closure (linked to CAPA) if warranted

Why do we conduct internal

audits?
To verify
compliance

To improve
systems

Compliance Audit

Systems Audit

Document
Deficiencies

Document
Improvement

System and Compliance Audits

Referenced
Regulatory
Standards

Standard
Operating
Procedures
Verify
Complian
ce
Practices and
Records

Verify
System

Audit Methodology
Systems and Compliance
A. Systems Audit
Prepare list of required SOPs
Compare SOPs to Regulations, Policies,
Guidelines
Verify system is documented
Has the system
been
deployed

C.
Training
Records

B. Compliance Audit
Choose SOPs of particular interest*
Review related or exhibit records
Verify compliance (evidence) of records to SOPs
*These could be used as checklists

5 Key Steps for Internal Auditing

1.

2.
3.

4.

5.

Audit Intent and

Purpose
Audit Planning
Conducting the
audit
Analyzing results
and preparing audit
report
Response : Present
results (CAPA)

5 Key Steps for Internal Auditing

1. Audit
Intent
and
Purpose

Audit Intent & Purpose of

Internal Audits
The intent and purpose of the audit will
define the audit scope:

Routine scheduled GMP audit

(surveillance or full) verify compliance
Audit culminating from nonconformities,
customer complaints, etc
Audit to investigate a specific product
or problem
Preparative audit for upcoming
regulatory audit
Verification audit to close-out nonconformities

5 Key Steps for Internal Auditing

2. Audit
Planning

Planning Utilizing Audit

Standards
Regulations and Codes

Lead Auditor : Audit Team

Selection

Audit must be objective independence of

audit team members from activities being
audited
Ensure there is no potential conflict of
interest
Ensure auditor and auditees can work cooperatively
Ensure auditors comply with confidentiality
Determine numbers of auditors and skills
needed

Two auditors, if possible, works best

Appoint one as the Lead Auditor
Technical expertise in the area need
experience to identify and rate issues
Consider including auditors in training (under
direction)

Checklists

Advantages

Provide a guide to the auditor

Provide a memory jogger
Focuses the auditor and auditee on
the issues
Provides background for future
audits

Disadvantages

Can breed lazy (blurr) auditors

focus on checklist only
Standard checklists may not fit
Can narrow the audit focus too much
Must be supplemented with
observation/judgement

Audit Plan Structure

1.

Choose the System to review.

1.
2.

2.
3.
4.
5.

6.
7.
8.

9.

For example, by QSE

Alternatively.industry issues exist, like How
effective is our cleaning program?, Have we
justified our incoming and in-process sampling?

Document the audit scope and the objectives

Select the team technical specialists needed?
Define the standards to be applied
Work out the critical
questions..Checklist/SOPs
Decide which documents and records to review
Decide the audit approach
Agree proposed audit plan and date(s) with the
auditee
Finalise and document the audit plan

Understanding the Process

Plan to audit the process, not
the individual, or department
Map the process before you start

Use SOPs, Wis, illustrations,

drawings, etc.

What is the design?

Procedural
Engineering Drawing
Manufacturing instruction
HACCP Analysis
Specification

One Page Audit Plan for Change

Control
Scope: To evaluate the scope and effectiveness of the site change control
program. The audit covers Equipment, Processes, Quality Control, Materials
and GMP Procedures. It does not cover computerized systems
Reference Standards

Doc
#

Title

and

Reco
rd

Record Review

Title

CFR 820 Part 30

Design Control

Engineering Change
Notes

FDA Guide QSIT Section

xxx

Change Register 2004

Policy # - Change
Management

Selected change Note(s)

Critical
SOP Questions
# xxxx Change

Validation reports

Control
Is there
a documented change control program in place?

Are there silos or one integrated system?

Do change update decisions involve cross-functional areas for

significant changes?

Does change maintain validation, training and registration integrity?

Management of change control records?

Critical Question
Construction and Development
Critical questions should be
probing,
Must be structured around the
audit intent and scope,
Regulatory guidance documents
are useful in developing
questions.
Questions usually begin with Is,
Does, Are, and usually the
following:

Effectiveness or adequacy
The presence / availability or
absence
Responsibilities
Mechanisms

Questions may be linked or stand

alone.

Example QSE Purified water (1)

Scope

The purified water system that

provides purified water to the
oral liquids manufacturing

Standards

PIC/S Code of GMP Part 1 and

applicable annexes

FDA Guide to inspections of

high purity water systems

USP 34 <1231> Water for

Pharmaceutical Purposes

Example QSE
Purified water (2)
Records

System description
As-built drawings
Specifications of the water, for Conductivity and TOC
Qualification and re-qualification reports and protocols
Trend reviews micro, chemical, conductivity, TOC
SOPs for operation, sanitation, maintenance + training records
SOPs for establishment and monitoring of Alert and Action
Limits

Questions

Who owns the PW system?

Who has the responsibility for ongoing quality and routine
monitoring?
How do you know water is performing appropriately?
How is the release for sale function notified of an OOT or OOS?
How do you manage OOS or OOT?
Any recent changes to the PW system?
Can you show me previous 2 years data trending reports?
Can you show me the raw data for the previous 12 months?

Workshop #6.1
Refer to your workbook.

The following internal audit has

been scheduled:
QSEs to be audited:

Equipment

Inwards Good Receipt

Sampling

Testing

Storage and Handling

Workshop #6.2
Refer to your workbook.
1.
2.
3.

4.

5.

Work in groups of 2-4

Nominate a Lead Auditor
Lead Auditor responsible to Identify
Team Composition
Team to prepare a one-page audit
plan for each area
Lead auditor responsible to prepare
an agenda to cover the entire audit

By the way, you only have one (1) day to complete the
audit.

Preparation for Audit

Check Site Master File

Manufacturing license /
certificationscope
Review registration dossiers
ADR reports, Post marketing
surveillance reports
Previous inspections, including
Regulatory and Customer
Records
Complaints, Deviations and
Recalls

Manufacturers should be aware

that the Inspectorate..

may bring specialists eg.

Laboratory, Microbiology, IT
you should too!
have special interests and
views
have the authority to audit
to registration information
and to verify marketing
authorization
may include industry issues
on the audit agenda
are also assessing the
attitude of management, and

5 Key Steps for Internal Auditing

3.
Conducti
ng the
Audit
Tips and
Common
Mistakes

Some useful audit tools

Audit Plan

Clipboard

Note pad and pens

Copy of cGMP or other

standards

Sharp mind!

Good Humor!

Audit checklist

Calculator

Auditor Attributes (competencies)

1

Objective and independent

Competent and experienced

Friendly but firm

Basic understanding of Technology

Thorough and methodical

Atmosphere of environment (Can

handle Conflict)

Communication and Interpersonal

skills

Clear and established Authority

Understanding of Quality Systems /

Code Requirements

10

Leadership

11

Excellent Time Management Skills

Lead Auditor Attributes

Time Management

Communication

Delegation of auditing activities and

STRICT adherence to timelines described
in the agenda
Avoidance of scope-creep
Agreement of audit agenda by all parties
Clear explanations of deficiencies at the
time of observance
Communications to QSE owner

Experience and Authority

Understands the difference between facts

and opinions
Knows when to move-on during an audit
Professional and *systems* focused

* Its business, not personal

If a serious / critical observation is made,

IMMEDIATELY make sure that the Area Head and
Quality Assurance Head are made aware of the
issue

If you cannot associate a deficiency with a

specific clause in the Code, then its likely to NOT
be a deficiency (opportunity for improvement?).

Write this down in your notes.

The procedure process is not efficient

I dont like the template you are using
The equipment was too old

Be specific in your observations during the audit

and point out the evidence clearly to the auditees.

The warehouse was overcrowded

Sampling was inadequate
The equipment was dirty
Training records were not detailed enough

5 Key Steps for Internal Auditing

4.
Analyzin
g
Results
and
Preparin
g Audit

Analyse Observations and Results

1

Allow time to summarize findings

Group observations that are related

Many observations are symptoms of

system failure

Focus on critical items first

Classify issues as critical, major and

other

Be balanced state positives!!

Be clear on deficiencies give

evidence!!

Listen to responses

Be prepared to change findings

10

Avoid personal statements system

focus

Note : These will form the basis of the draft report

GMP Audit Deficiencies

5 Key Steps for Internal Auditing

5.
RESPON
SE:
Present
Results
Correctiv
e&

Corrective Action
Do the Actions meet the following:
Address the root cause and
contributing factors

All improvement will require

change, but not all change will
result in improvement

Specific
Easily understood and
implemented
Developed by process owners
Measurable (Corrective
Action did in fact occur)

Audit Closure

Follow-up corrective actions:

VERIFY Actions completed (Critical,
Major)
Everything

verified as closed

Pro-active follow-up
Report missed timeliness to
management

Target dates are set for completion

Auditing a PRINTER
Generally:
Printers are NOT
required to follow GMP
Printers are NOT
required to have any
Quality certification
Good quality
printers are
Sometimes

hard to find
Generally more
expensive

Auditing a PRINTER
Generally, Printers need
to:
Understand company
requirements
Understand the RISKS
for customers and
company
Be educated / guided /
assisted to implement
the controls needed to
be in place

Auditing a PRINTER
What are the risks:
Death, serious injury
to consumers

Customer complaints
Product recalls

Continuity of supply
Rejected deliveries
Company profits

Auditing a PRINTER
What are the hazards:
Mix-ups with other
products
Mix-ups with different
strength of same product
Wrong version /text
Incorrect counts
Batch variation (Color,
missing text, faded,
illegible)

Auditing a PRINTER
Some points to consider:
Control of Master Plates and specifications
Control of color standards
Version control
Line clearances
Program of Maintenance
Print-run records and in-process checks
Segregation and control of WIP (un-cut
and cut)
Verification of count
Release to customer
Training / competencies

Auditing a PRINTER
IMPORTANT!!!
Dont forget Capability of the process
(variation)
Discuss your critical attributes and
variables

Agree on % defect level allowable (critical defects)

Agree on % defect level allowable (minor defects)
Agree on allowable color variation (light and dark)

Inwards Goods and In-process sampling strategies

will be based on this.
Dont forget: Bring along someone from
PURCHASING.

INSPECTORATE

Inspectorate
program meets
requirements of
PI 037-1

Overview: PI 037-1

Published 1 January 2012

A recommended model for scheduling
routine inspections based on risk
Methodology to assign a risk rating
then use this to assign a frequency
for routine inspections
The intrinsic risk associated with a
site and the compliance risk (based
on the last inspection); is used to
assign a risk rating
The risk rating is then used to
recommend a frequency for routine
inspections at the site

Intrinsic Risk
(1st page)
A combination of:

Complexity (of site, process and product)

Large/small

sites
Number of different operations on site
Dedication of facility and equipment
Organizational (# staff)
Contract manufacturer or not
Sterile process
Number of unit operations and critical steps
Extent of rework and repackaging
Special storage

Criticality
Manufactures

as essential product not readily

available elsewhere
Major or sole supplier of essential product
Service (eg. Testing) cannot be performed
elsewhere

Intrinsic Risk
(1st page)
After these points are considered:
Rated:
Complexity: 1, 2, or 3
Criticality: 1, 2, or 3
Criticality
Complexity

1 (low)

2 (low)

3 (med)

2 (low)

4 (med)

6 (high)

3 (med)

6 (high)

9 (high)

Intrinsic risk:

Low, Medium, High

Compliance Risk
(1st page)
Simple Rating:
From the most recent inspection:
Low : No critical or major
deficiencies
Medium : 1-5 Major deficiencies
High : 1 or more Critical
deficiencies or more than 5
Major deficiencies

Risk Rating and

Frequency
Intrinsic risk
Compliance
risk

Low

Medium

High

Low

Risk Rating
=A

Risk Rating
=A

Risk Rating
=B

Medium

Risk Rating
=A

Risk Rating
=B

Risk Rating
=C

High

Risk Rating
=B

Risk Rating
=C

Risk Rating
=C

Risk Rating:
A: Reduced frequency, 2 3 years
B: Moderate frequency, 1 2 years
C: Increased frequency, <1 year

Workshop for PIC/S PI 037-1

JM Tolmann Laboratories, Inc
One site (QC)
Manufacturer of own range and a specialty Toll
Manufacturer
Approximately 130 people
Approximately 100 different products
Approximately 250 SKUs
Solid Dose, liquid preparations (Prescription,
OTC and Household remedies)
Vitamins/Supplements

Most Recent Inspection Results

Critical 1
Major 3
Minor 5

Scope of Inspection
Part F of PI 037-1
Recommendations of Lead Auditor for
the next routine inspection:
Focus and depth
Where deficiencies where found
Areas not inspected
Areas inadequately resourced at site
Areas where LA believes a more detailed
inspection is needed for next inspection

Duration
Number of inspectors
Specific expertise

Thank you for listening

What you want to be confident of

is usually more important than

how confident you want to be