LEAD AUDITORS’ TRAINING COURSE

Darren Freestone

Senior Consultant

SeerPharma (Singapore) Pte, Ltd

Aug. 1-2, 2012 @ FDA Alabang ECHO SEMINARAugust 17, 2012

Training Course Outline

Audit ProgramAudit ProceduresLead 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:

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

1. Inspectorates meets requirements of

PIC/S PI 037-1

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)

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

Certification Audits – Certification bodies (TUV, BSI, ISO, HALAL, etc)

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 Authority

Provide resources

Require the establishment of a program

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) Disqualified New Approved Preferred Certified

Monitoring programs adjusted based on rating and performance

Vendor rating responsibility: both QA and Purchasing

Rate their “weighted” performance annually 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 left-hand 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

Patient Risk Factor

Patient Risk Factor

5. Parenteral / Sterile / Biotech4. Rx / prescription product3. OTC2. Complementary (HRP, Food Supplement)1. Excipient

5. Known poor quality4. Unknown history / New vendor3. Known quality - OK2. > 10 batches, all OK1. Long good supply history

5. No site assessment4. No international GMP audits3. International GMP audits2. QA reviewed1. 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 Calibration

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 Samplingo Validationo Trainingo Laboratoryo Calibrationo Maintenanceo Release for supplyo Purified watero Deviations and CAPAo Process Controlso Marketing Authorizationo Customer Complaints

Workshop #5 - continued

Refer to: “QSE Quality Risk Factors” (next

slide) “Risk Matrix (QSE) – Recommended

Actions (workbook)

1. Complete the Audit Team Schedule 2012/2013 in your workbook

2. 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

Category 2

Category 3

Parenteral/ Sterile / BiotechProcess is Complex in natureAcross all/most departmentsNo previous assessmentPoor previous assessmentHistory of Deviations / Complaints

Rx/Prescription productsProcess not overly complexPrevious assessment satisfactoryOccasional deviation/complaint

OTC / Complimentary productsSimple in complexityPrevious assessment excellentNo deviations / complaints

Prioritizing GxP Audits based on Risk

Compliance Product

Exposure

Assessment

CAPATrends / History

Consequences

Likelihood

Schedules/Priority

Mgmt

Facility Control Direct Impact

Equipment Personnel /

Training Quality

Systems Market

Authorization Cleaning /

Sanitation Materials /

Supply Production

Control Validation

Programs Laboratory

Controls Computer

Systems Specific Dosage

Forms

Write This Down !!

Make sure ALL concerned parties:

Includes: Quality Assurance

Area Head

Area Head of audit

team members

sign-off the Audit Team Schedule!!!

Audit Programme Written Procedures (1)

Audit program procedures should address the following:

a) Planning and scheduling audits

b) Assuring the competence of auditors and audit team leaders

c) Selecting audit teams assigning their roles and responsibilities

d) Conducting audits

e) Conducting audit follow-up, if applicable

f) Maintaining audit program records

g) Monitoring performance/effectiveness of the audit program

h) 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) Identifying operations/objectives and assessing the risk

b) Monitoring implementation of schedule

c) Escalation of findings

d) Linkage to CAPA

e) Assessing / classifying deficiencies

f) 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

Practices and Records

Verify Complian

ce

Verify System

A. Systems Audit Prepare list of required SOPs Compare SOPs to Regulations, Policies,

Guidelines Verify system is documented

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

Audit Methodology – Systems and Compliance

Has the system been

deployed

C. Training Records

5 Key Steps for Internal Auditing

1. Audit Intent and Purpose

2. Audit Planning3. Conducting the

audit4. Analyzing results

and preparing audit report

5. Response : Present results (CAPA)

1. Audit Intent and Purpose

5 Key Steps for Internal Auditing

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 non-conformities

2. Audit Planning

5 Key Steps for Internal Auditing

Planning –Utilizing Audit Standards

Regulations and Codes- Codes of GMP- Industry Guidance Docs. e.g. FDA OOS Guidance, PIC/S Utilities- Standards: Laboratory or ISO Standards

Internal Documents- Company Quality Policies- Standard Procedures- Master Instructions

Product and Material Specifications – EP/BP/USP

Product Registration Documents

The auditing process

compares an aspect of quality

performance against a

recognized standard

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 co-operatively

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. For example, by QSE2. Alternatively….industry issues exist, like “How

effective is our cleaning program?”, “Have we justified our incoming and in-process sampling?”

2. Document the audit scope and the objectives3. Select the team – technical specialists needed?4. Define the standards to be applied5. Work out the “critical

questions…..Checklist/SOPs6. Decide which documents and records to review7. Decide the audit approach8. Agree proposed audit plan and date(s) with the

auditee9. Finalise and document the audit plan

Understanding the Process

o Plan to audit the process, not the individual, or department

o Map the process before you starto Use SOPs, Wi’s, illustrations,

drawings, etc.

What is the design? Procedural Engineering Drawing Manufacturing instruction HACCP Analysis Specification

One Page Audit Plan for Change Control

“Critical” Questions 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?

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

Doc#

Title Record

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)

SOP # xxxx – Change Control

Validation reports

Reference Standards and Record Review

“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.

Scope The purified water system that

provides purified water to the oral liquids manufacturing

Example QSE – Purified water (1)

USP 34 – <1231> Water for Pharmaceutical Purposes

Standards PIC/S Code of GMP Part 1 and

applicable annexes

FDA Guide to inspections of high purity water systems

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?

Example QSE – Purified water (2)

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 #6.1

Refer to your workbook.

1. Work in groups of 2-4

2. Nominate a Lead Auditor

3. Lead Auditor responsible to Identify Team Composition

4. Team to prepare a one-page audit plan for each area

5. 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.

Workshop #6.2

Check Site Master File Manufacturing license /

certification…scope Review registration dossiers ADR reports, Post marketing

surveillance reports Previous inspections, including

Regulatory and Customer Records Complaints, Deviations and

Recalls

Preparation for Audit

…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 company GMP culture

Manufacturers should be aware that the Inspectorate…..

3. Conducting the Audit – Tips and Common Mistakes

5 Key Steps for Internal Auditing

Some useful audit tools

1 Audit Plan

2 Clipboard

3 Note pad and pens

4 Copy of cGMP or other standards

5 Sharp mind!

6 Good Humor!

7 Audit checklist

8 Calculator

Auditor Attributes (competencies)

1 Objective and independent

2 Competent and experienced

3 Friendly but firm

4 Basic understanding of Technology

5 Thorough and methodical

6 Atmosphere of environment (Can handle Conflict)

7 Communication and Interpersonal skills

8 Clear and established Authority

9 Understanding of Quality Systems / Code Requirements

10 Leadership

11 Excellent Time Management Skills

Lead Auditor Attributes

Time Management Delegation of auditing activities and

STRICT adherence to timelines described in the agenda

Avoidance of “scope-creep” Communication

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

* ”It’s 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 Write this down in your notes.

If you cannot associate a deficiency with a specific clause in the Code, then its likely to NOT be a deficiency (opportunity for improvement?). The procedure process is not efficient… I don’t 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

4. Analyzing Results and Preparing Audit Report

5 Key Steps for Internal Auditing

Analyse Observations and Results

1 Allow time to summarize findings

2 Group observations that are related

3 Many observations are symptoms of system failure

4 Focus on critical items first

5 Classify issues as critical, major and other

6 Be balanced – state positives!!

7 Be clear on deficiencies – give evidence!!

8 Listen to responses

9 Be prepared to change findings

10 Avoid personal statements – system focusNote : These will form the basis of the ‘draft’ report

GMP Audit Deficiencies

•Consumer Safety issue (identity, purity, performance/strength or

safety)• Directly observable

Critical

• May impact safety “related or indirect”

• Non compliance with basic GMP principles

Major

• General Housekeeping• Unlikely to impact

product quality

Minor/Other

5. RESPONSE: Present Results Corrective & Preventive Actions

5 Key Steps for Internal Auditing

Corrective Action

Do the Actions meet the following: Address the root cause and

contributing factors

Measurable (Corrective Action did in fact occur)

“All improvement will require change, but not all change will result in improvement”

Specific Easily understood and

implemented Developed by process owners

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

Continuity of supply Rejected deliveries Company profits

Customer complaints Product recalls

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!!!

Don’t 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.

Don’t 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 2 3

1 1 (low) 2 (low) 3 (med)

2 2 (low) 4 (med) 6 (high)

3 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 andFrequency

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 yearsB: Moderate frequency, 1 – 2 yearsC: 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 ResultsCritical – 1Major – 3Minor – 5

Scope of Inspection

Part F of PI 037-1Recommendations 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