Lead Auditors Training Course

LEAD AUDITORS’

TRAINING COURSE

Darren Freestone Senior Consultant

SeerPharma (Singapore) Pte, Ltd

Aug. 1-2, 2012 @ FDA Alabang

ECHO SEMINAR

Training Course Outline



Audit Program



Audit Procedures

REFERENCE GUIDELINES

INSPECTORATE

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

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

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

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

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

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

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

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

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

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

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

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

Possible Supply Chain Quality Risk Factors Patient Risk Factor Patient Risk Factor Patient Risk Factor

5. Parenteral / Sterile / Biotech 4. Rx / prescription product 3. OTC

2. Complementary (HRP, Food Supplement) 1. Excipient

5. Known poor quality

4. Unknown history / New vendor 3. Known quality - OK

2. > 10 batches, all OK

1. Long good supply history 5. No site assessment

4. No international GMP audits 3. International GMP audits 2. QA reviewed

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

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

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

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 o 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 2 012/2013 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 / Biotech Process is Complex in nature Across all/most departments No previous assessment

Poor previous assessment

History of Deviations / Complaints Rx/Prescription products

Process not overly complex

Previous assessment satisfactory Occasional deviation/complaint

OTC / Complimentary products Simple in complexity

Previous assessment excellent No deviations / complaints

Prioritizing GxP Audits based on Risk Compliance Product Exposure Assessment CAPA Trends / History Consequenc es Likelihood Schedules/Prior ity 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

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

So far….

Vendor and Internal Audits

Pre-requisites in

place:

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 Planning 3. Conducting the

audit

4. Analyzing results

and preparing audit report

5. Response : Present

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

2. Audit

Planning

Planning –Utilizing Audit Standards

Regulations and Codes 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

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

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

Audit Plan Structure

1. Choose the “System” to review.

1. For example, by QSE

2. 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 objectives 3. Select the team – technical specialists needed? 4. Define the standards to be applied

5. Work out the “critical

questions…..Checklist/SOPs

6. Decide which documents and records to review 7. Decide the audit approach

8. Agree proposed audit plan and date(s) with the

auditee

Understanding the Process

o Plan to audit the process, not

the individual, or department

o Map the process before you start

o Use SOPs, Wi’s, illustrations,

drawings, etc.

What is the design?

 Procedural

 Engineering Drawing

 Manufacturing instruction  HACCP Analysis

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

“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

 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

 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

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.

 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

 …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.

Conducti

ng the

Audit –

Tips and

Common

Mistakes

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

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

 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

4.

Analyzin

g

Results

and

Preparin

g Audit

Report

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 focus

5.

RESPON

SE:

Present

Results

Correctiv

e &

Preventi

ve

Actions

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

Audit Closure

Follow-up corrective actions:

 VERIFY Actions completed (Critical,

Major)

 Everything verified as closed

 Pro-active follow-up

 Report missed timeliness to

management

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

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

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

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

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 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

Thank you for listening

What you want to be confident of is usually more important than