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Laboratory Control System Operations in a GMP Environment
Laboratory Control System Operations
in a GMP Environment

David M. Bliesner, Ph.D.

Delphi Analytical Services, Inc.
Indian Rocks Beach, Florida
This edition first published 2020
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Library of Congress Cataloging-in-Publication Data
Names: Bliesner, David M., author.
Title: Laboratory control system operations in a GMP environment / David M. Bliesner.
Description: Hoboken, NJ : Wiley, [2020] | Includes bibliographical references and index.
Identifiers: LCCN 2019052264 (print) | LCCN 2019052265 (ebook) | ISBN
9781119529231 (cloth) | ISBN 9781119529279 (adobe pdf) | ISBN 9781119529293 (epub)
Subjects: LCSH: Medical laboratories–Quality control. | Laboratories–Management.
| Pharmacy–Research. | Manufacturing processes–Quality control.
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To my wife and best friend, Kathy.
 vii

Contents

Preface xi
About the Companion Website xvii

1 Introduction to the Quality Systems Based Approach to CGMP

Compliance 1
Overview of Quality Systems and the Laboratory Control System 1
Regulations and Regulatory Bodies 4
Regulatory Guidance 4
Application of This Text 5
Overlap and Redundancy 6
Tools and Templates 6
References 7

2 Components of the Laboratory Managerial and Administrative

Systems Sub Element (MS) 9
Description of the Laboratory Managerial and Administrative Systems
Sub Element 9
Contents of the Sub Element 10
Tools and Templates 23
Reference 23

3 Components of the Laboratory Documentation Practices and Standard

Operating Procedures Sub Element (OP) 25
Description of the Laboratory Documentation Practices and Standard
Operating Procedures Sub Element 25
Contents of the Sub Element 26
Tools and Templates 44
viii Contents

4 Components of the Laboratory Equipment Sub Element (LE) 45

Description of the Laboratory Equipment Sub Element 45
Contents of the Sub Element 46
Tools and Templates 68
References 68

5 Components of the Laboratory Facilities Sub Element (LF) 71

Description of the Laboratory Facilities Sub Element 71
Contents of the Sub Element 71
Tools and Templates 81
References 81

6 Components of the Method Validation and Method Transfer

Sub Element (MV) 83
Description of the Method Validation and Method Transfer Sub
Element 83
Contents of the Sub Element 84
Tools and Templates 93
Glossary 93
References 113

7 Components of the Laboratory Computer Systems Sub

Element (LC) 115
Description of the Laboratory Computer Systems Sub Element 115
Contents of the Sub Element 116
Tools and Templates 129
Glossary 130
References 133

8 Components of the Laboratory Investigations Sub Element (LI) 135

Background and Regulatory History of Out-of-Specification
Investigations 135
Description of the Laboratory Investigations Sub Element 135
Contents of the Sub Element 139
Common Problems Related to Laboratory OOS Investigations 148
Tools and Templates 149
Glossary 150
References 155
 Contents ix

9 Components of the Laboratory Data Governance and Data Integrity

Sub Element (DI) 157
Background 157
Precepts Regarding Data Governance and Data Integrity 159
Description of the Laboratory Data Governance and Data Integrity Sub
Element 162
Contents of the Sub Element 164
Policy for Data Governance 164
Procedural Controls 165
Technical Controls 166
Data Maps and Data Walks 166
Risk Identification, Ranking, and Filtering 171
Data Reviews 196
Data and Operational Audits 196
Employee Awareness and Training 208
Management Oversight 210
Tools and Templates 212
Glossary 212
References 214
Further Reading 215

10 Components of the Stability Program Sub Element (SB) 217

Description of the Stability Program Sub Element 217
Contents of the Sub Element 218
Model Standard Operating Procedures for Establishing and
Maintaining a Stability Program 218
Stability Chambers 246
Tools and Templates 261
Glossary 262
References 268

11 Components of the General Laboratory Compliance Practices Sub

Element (CP) 269
Description of the General Laboratory Compliance Practices Sub
Element 269
Contents of the Sub Element 270
Tools and Templates 284
x Contents

12 Summary for Establishing and Maintaining a Laboratory Control

System 285
A Brief Review of the Laboratory Control System and Its Sub
Elements 285
How Things Can Go Wrong: Examples of Some Regulatory Citations
Organized by Sub Element 285
Some Final Thoughts on Establishing and Maintaining a Compliance
Laboratory Control System 296

Index 297
 xi

Preface

Regulatory agencies such as the US Food and Drug Administration (FDA) and the
European Medicines Agency (EMA) mandate that companies who manufacture
drugs for human and animal use be operated in a state of control by employing
conditions and controls commonly referred to as good manufacturing practices
(GMPs). In the United States the GMPs or CGMPs (where C = current) are codi-
fied in 21 Code of Federal Regulations Parts 210 and 211. In the European Union
the GMPs are described in EudraLex – Volume 4, the Good Manufacturing Practice
(GMP) guidelines. Other Regulatory bodies, such as the World Health Organiza-
tion (WHO) and the International Council for Harmonization (ICH) also provide
requirements and guidelines with respect to GMPs.
At the turn of the twenty-first century the FDA was actively engaged in regu-
latory actions against pharmaceutical companies whom they determined to be in
significant violation of the CGMPs. As part of FDA’s actions, several large com-
panies entered into voluntary legal agreements referred to as Consent Decrees.
These agreements existed for the expressed purpose of correcting the deficiencies
related to CGMPs. Consent Decrees routinely require the contracting of indepen-
dent third-party expert consultants. These consultants’ duties include performing
a baseline audit of the offending facilities, documenting their findings and helping
the companies develop and implement corrective action plans.
To help collect evidence to support regulatory actions, FDA began using a Qual-
ity Systems approach to evaluate a firm’s level of GMP compliance.
The Quality Systems approach is a scheme of systems for the manufacture of
drugs and/or drug products. The general scheme of systems FDA used for auditing
manufacture facilities consists of the following:
1. Quality System
2. Facilities and Equipment System
3. Materials System
4. Production System
5. Packaging and Labeling System
6. Laboratory Control System
xii Preface

According to FDA “The Quality System provides the foundation for the manu-
facturing systems that are linked and function within it.”1
This approach is commonly referred to as the six-system model and is still used
today by the FDA to conduct inspections of GMP facilities.
During this time, Delphi Analytical Services, Inc. (Delphi) served as one of the
third-party expert consulting firms on several Consent Decrees at major phar-
maceutical companies. Delphi’s core competency is the practical understanding
of workings of the laboratory control system (LCS), the sixth quality system
mentioned in the FDA model. Delphi was extensively involved in performing
third-party audits of quality control (QC) and research and development (R&D)
laboratories for companies under Consent Decree.
While executing these consulting assignments it became apparent that the
CGMPs regulations, FDA Guidance Documents and FDA Internal Compliance
Program Guides offered little direction or specifics of what was expected of a
CGMP compliant LCS. Because of this, Delphi developed and documented a
systematic means for performing the baseline audits, capturing deficiencies,
reporting the results, and developing subsequent corrective action plans, for QC
laboratories. In addition, Delphi also created instructional materials and began
teaching courses on auditing QC laboratories at various client sites and scientific
conferences.
Due to the inherent complexity of the LCS, Delphi divided it into seven sub sys-
tems or sub elements. These included the following:
1. Laboratory Managerial and Administrative Systems
2. Laboratory Documentation Practices and Standard Operating Procedures
3. Laboratory Equipment Qualification and Calibration
4. Laboratory Facilities
5. Methods Validation and Technology Transfer
6. Laboratory Computer Systems
7. Laboratory Investigations
Based on real-world experiences, Delphi then, in turn, developed detailed audit
checklists for each LCS sub element. These became the basis for most of Delphi’s
consulting contracts and instruction material.
In March 2004 at the Pittsburgh Conference on Analytical Chemistry and
Applied Spectroscopy (PittCon© ), Delphi Analytical Services, Inc.’s president,
Dr. David M. Bliesner, Ph.D., taught a one-day course titled “How to Establish
a GMP Laboratory Audit System.” The course was well attended which led to
a meeting with a representative of Wiley-Interscience, John Wiley & Sons, Inc.
At the conclusion of that meeting, it was agreed that he would write a proposal

1 FDA Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations,
September, 2006.
 Preface xiii

for publication of a book. The proposal was accepted and became the book titled
Establishing a CGMP Laboratory Audit System: A Practical Guide in 2006.
Over the course of the next 12 years (2006–2018), the pharmaceutical industry
experienced a massive paradigm shift in its business and operational models. This
in turn resulted in changes to the manner in which regulatory agencies enforced
the GMPs. Some key elements of these changes included:
• Substantial outsourcing of drug development, manufacturing, testing, and other
functions
• Offshoring of manufacturing and testing of active pharmaceutical ingredients
(APIs) and drug products
• Profit versus quality driven decision making
• Reductions in experienced, permanent workforces
• Increased regulatory activity by US FDA at overseas plants
• Increased Global Regulatory Agency oversight, guidance, and cooperation
Because of these changes, and other factors, it became obvious that Establishing
a CGMP Laboratory Audit System: A Practical Guide had much broader utility than
just serving as an audit guide. In particular, the real value of the book over the years
has not been as an auditing guide but:
• A means to introduce auality assurance (QA) and QC personnel to the concept
of quality systems and the LCS in particular
• As a basis for instructing QA and QC personnel on Laboratory GMPs
• To assist in interpreting and clarifying regulatory expectations for the LCS
• As the basis for assisting laboratory management in implementing and main-
taining CGMP compliant practices in their own QC laboratories
Therefore, the purpose of this new book titled Laboratory Control System Oper-
ations in a GMP Environment is to focus on LCS operations versus auditing.
The goal in writing this book is to publish a text, which when implemented in
QC and R&D laboratories, provides the basis for operating a CGMP compliant LCS.
This will improve an organization’s chances for withstanding regulatory scrutiny
and enhance operational efficiency. This new book is designed to be used in several
ways, including:
• Designing and implementing a new, from scratch, CGMP compliant LCS
• Upgrading or tweaking an existing LCS
• Laying a basis for initial and periodic LCS GMP training
• Laying a basis for improving operational efficiency
• Serving as an operational reference guide: Third party “sanity” check to help
solve compliance challenges as they arise
Laboratory Control System Operations in a GMP Environment builds on the orig-
inal auditing text described earlier. However, instead of emphasizing auditing, this
xiv Preface

new text not only focuses and upgrades the operational aspects of the original
seven LCS sub elements but also expands the LCS to encompass three additional
sub elements, which are marked with an asterisk(*) in the following list. This
results in the following 10 chapters in the book:
1. Laboratory Managerial and Administrative Systems
2. Laboratory Documentation Practices and Standard Operating Procedures
3. Laboratory Equipment
4. Laboratory Facilities
5. Method Validation and Method Transfer
6. Laboratory Computer Systems
7. Laboratory Investigations
8. Data Governance and Data Integrity*
9. Stability Program*
10. General Laboratory Compliance Practices*
Each chapter in this text describes the critical functions of the LCS sub element
so the reader understands what is expected from the FDA and other Global Reg-
ulatory Agencies. In addition, each chapter links to tools, templates, checklists,
and Global Regulatory Agencies’ guidances. All of these tools and templates are
accessible for download online through a Wiley Interscience web portal for easy
modification and application by the end-user in their own laboratories.
Readers, in using this book, may accomplish the following:
• Fully implement a functional LCS which can withstand Global Regulatory
scrutiny
• Increase operational efficiency
• Stay current with GMPs and industry trends
• Save time by using the real-world tools and templates found in the book, which
can be modified and used by the reader
• Use the text as a benchmark reference to which they can assess the status of
compliance of their own laboratories
Laboratory Control System Operations in a GMP Environment is written for
a broad audience. It is applicable to both QC and QA professionals in small,
medium, and large companies within the pharmaceutical and biopharmaceutical
industries. R&D personnel working in non-GMP environments will also benefit
by applying the organizational schemes and principals presented in this text.
This book is particularly helpful for personnel who work in smaller companies
because they often do not have the financial, personnel resources, and existing
“corporate knowledge” that large US- and European-based companies may pos-
sess. This means that smaller organizations are often left to “figure it out” on
their own. For these smaller operations, this text is particularly valuable because
of the example-templates and checklists it includes.
 Preface xv

To our knowledge no such detailed operational text or guide exists in the

marketplace. We hope you find Laboratory Control System Operations in a GMP
Environment useful and wish you the best in your continuing quest to establish a
quality-minded culture, improve operational efficiency, and thrive under Global
Regulatory scrutiny.

January 2020 David M. Bliesner, Ph.D.

Indian Rocks Beach, Florida
 xvii

About the Companion Website

This book is accompanied by a companion website:

www.wiley.com/go/Bliesner/LabControl_GMPEnvironment

Scan this QR code to visit the companion website

The website includes Appendices and Weblinks.

 1

Introduction to the Quality Systems Based Approach to

CGMP Compliance

Overview of Quality Systems and the Laboratory Control

System

The US Food and Drug Administration (US FDA) mandates that a drug firm, and
therefore the laboratory, be operated in a state of control by employing condi-
tions and practices that assure compliance with the intent of the Federal Food,
Drug, and Cosmetic Act and portions of the Current Good Manufacturing Practice
(CGMP) regulations (e.g. 21 CFR Parts 210 and 211) that pertain to it. Activities
found in drug firms, including operation of the laboratory, can be organized into
systems that are sets of operations and related activities. Control of all systems
helps to ensure the firm will produce drugs that are safe, have the proper identity
and strength, and meet the quality and purity characteristics as intended [1, 2].
For drug firms, FDA has outlined the following general scheme of systems that
impact the manufacture of drugs and drug products:

(1) Quality System. This system assures overall compliance with CGMPs and
internal procedures and specifications. The system includes the quality
control (QC) unit and all of its review and approval duties (e.g. change con-
trol, reprocessing, batch release, annual record review, validation protocols,
reports, etc.). It also includes all product defect evaluations and evaluation of
returned and salvaged drug products. (See the CGMP regulation, 21 CFR 211
subparts B, E, F, G, I, J, and K.)
(2) Facilities and Equipment System. This system includes the measures and activ-
ities that provide an appropriate physical environment and resources used in
the production of the drugs or drug products. It includes:
(a) Buildings and facilities along with maintenance.
(b) Equipment qualifications (installation and operation); equipment cali-
bration and preventative maintenance; and cleaning and validation of
cleaning processes as appropriate. Process performance qualifications are

Laboratory Control System Operations in a GMP Environment, First Edition. David M. Bliesner.
© 2020 John Wiley & Sons, Inc. Published 2020 by John Wiley & Sons, Inc.
Companion website: www.wiley.com/go/Bliesner/LabControl_GMPEnvironment
2 1 Introduction to the Quality Systems Based Approach to CGMP Compliance

included as part of process validation, which is done within the system

where the process is employed.
(c) Utilities that are not intended to be incorporated into the product such
as heating, ventilation, and air-conditioning (HVAC), compressed gases,
steam, and water systems. (See the CGMP regulation, 21 CFR 211 subparts
B, C, D, and J.)
(3) Materials System. This system includes measures and activities to control fin-
ished products and components including water or gases that are incorporated
into the product, containers, and closures. It includes validation of comput-
erized inventory control processes, drug storage, distribution controls, and
records. (See the CGMP regulation, 21 CFR 211 subparts B, E, H, and J.)
(4) Production System. This system includes measures and activities to control
the manufacture of drugs and drug products including batch compounding,
dosage form production, in-process sampling and testing, and process valida-
tion. It also includes establishing, following, and documenting performance of
approved manufacturing procedures. (See the CGMP regulation, 21 CFR 211
subparts B, F, and J.)
(5) Packaging and Labeling System. This system includes measures and activities
that control the packaging and labeling of drugs and drug products. It includes
written procedures, label examination and usage, label storage and issuance,
packaging and labeling operations controls, and validation of these operations.
(See the CGMP regulation, 21 CFR 211 subparts B, G, and J.)
(6) Laboratory Control System. This system includes measures and activities
related to laboratory procedures, testing, analytical method development,
validation and/or qualification/verification, and the stability program. (See
the CGMP regulation, 21 CFR 211 subparts B, I, J, and K.)

According to FDA, “The Quality System provides the foundation for the manu-
facturing systems that are linked and function within it.” Graphically, the scheme
of systems looks like [1] (Figure 1.1):
This approach is commonly referred to as the six-system model and is still used
today by FDA to conduct inspections of good manufacturing practice (GMP)
facilities.
As stated in (6) earlier, FDA considers a firm’s Laboratory Control System (LCS)
to be a key element in CGMP compliance. Within the LCS are at least 10 additional
sub systems or sub elements, which may include:

• Laboratory Managerial and Administrative Systems (MS)

• Laboratory Documentation Practices and Standard Operating Procedures (OP)
• Laboratory Equipment (LE)
• Laboratory Facilities (LF)
• Method Validation and Method Transfer (MV)
 Overview of Quality Systems and the Laboratory Control System 3

lity syst
ua e Production
system
Q

m
Facilit ment
and laboling
Packaging

equip m
system

syste

ies an
d
or y
rat
M yst

bo rols
at em

a
s
er

L nt
co tem
ia
ls

sys

Figure 1.1 FDA guidance for Industry Quality Systems approach to pharmaceutical
CGMP regulations, September 2006 [1].

• Laboratory Computer Systems (LC)

• Laboratory Investigations (LI)
• Data Governance and Data Integrity (DI)
• Stability Program (SB)
• General Laboratory Compliance Practices (CP)
These 10 sub elements of the LCS are not part of any guideline document, inter-
national council, or inspection convention. Instead they have been created by the
author, to promote the establishment and maintenance of Quality Systems and sub
systems, which demonstrate you are in control of your laboratory operations and
thus in compliance with the CGMP regulations.
These 10 sub element topics constitute 10 chapters within this book. Each
chapter will describe the critical functions of the LCS sub element so the reader
understands what is expected from the US FDA and other Global Regulatory
Agencies.
A listing of the primary Global Regulations, the Agencies that enforce them, and
the international councils or inspection conventions that help to harmonize their
efforts are listed in the succeeding text.
4 1 Introduction to the Quality Systems Based Approach to CGMP Compliance

Regulations and Regulatory Bodies

The primary, globally significant, regulations related to the manufacturing,

processing, packing, or holding of drugs include:
• 21 Code of US Federal Regulations Part 210 and 211 Current Good Manufactur-
ing Practice Regulations
• EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines
The major regulatory bodies or organizations that enforce the regulations or
assist in harmonizing international regulatory efforts include:
• US Food and Drug Administration (US FDA, United States)
• European Medicines Agency (EMA, European Union)
• Medicines and Healthcare products Regulatory Agency (MHRA,
United Kingdom)
• Health Canada (Canada)
• Brazilian Health Regulatory Agency (ANVISA, Brazil)
• Pharmaceuticals and Medical Devices Agency (PMDA, Japan)
• Therapeutic Goods Administration (TGA, Australia)
• World Health Organization (WHO-International)
• Central Drugs Standard Control Organization (CDSCO, India)
• The International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH-International)
• Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspec-
tion Co-operation Scheme (PIC Scheme) (PIC/S-International)
There are numerous other country-specific bodies, which enforce their own laws
related to the manufacturing, processing, packing, or holding of drugs. The reader
is encouraged to consult the requirements of their own country’s laws and regula-
tions regarding the manufacture of pharmaceuticals.

Regulatory Guidance

Traditionally, Regulatory Agencies themselves have provided limited insight and

assistance into how organizations operating within the pharmaceutical industry
can comply with the regulations. However, over time, regulatory guidances and
other instruments have arisen and evolved and today consist of a fairly large body
of knowledge, which can be used by organizations to aid in compliance with the
CGMPs.
When it comes to regulatory guidance for Quality Control (QC) Laboratories,
the following documents may be helpful:
 Application of This Text 5

• US FDA Compliance Programs to FDA staff, Chapter 56: Drug Quality Assur-
ance 7366.002 Drug Manufacturing Inspections
• US FDA Guidance for Industry, Quality Systems Approach to Pharmaceutical
CGMP Regulations
• ICH Harmonised Tripartite Guideline, Q1A to Q1F Stability
• ICH Harmonised Tripartite Guideline, Q2 Analytical Validation
• ICH Harmonised Tripartite Guideline, Q3A to Q3D Impurities
• ICH Harmonised Tripartite Guideline, Q4 to Q4B Pharmacopoeias
• ICH Harmonised Tripartite Guideline, Q6A to Q6B Specifications
• ICH Harmonised Tripartite Guideline, Q7 Good Manufacturing Practice Guide
for Active Pharmaceutical Ingredients
• ICH Harmonised Tripartite Guideline, Q8 Pharmaceutical Development
• ICH Harmonised Tripartite Guideline, Q9 Quality Risk Management
• ICH Harmonised Tripartite Guideline, Q10 Pharmaceutical Quality System
• ICH Harmonised Tripartite Guideline, Q12 Lifecycle Management
• ICH Harmonised Tripartite Guideline, Q14 Analytical Procedure Development
• WHO Annex 2: Good Manufacturing Practices for Pharmaceutical Products:
Main Principles
• FDA Guidance for Industry Quality Systems Approach to Pharmaceutical
CGMP Regulations, September 2006

It should be noted that although not legally binding, violation of the principals
of ICH Harmonised Tripartite Guideline, Good Manufacturing Practice Guide for
Active Pharmaceutical Ingredients, Q7, are sometimes documented as findings
by FDA.
Additional FDA and ICH guidelines exist and can be located at: https://www.fda
.gov/drugs/guidances-drugs/all-guidances-drugs, https://www.ich.org/products/
guidelines/quality/article/quality-guidelines.html, and https://www.fda.gov/
drugs/guidance-compliance-regulatory-information/drug-compliance-programs

Application of This Text

The remainder of “Laboratory Control System Operations in a GMP Environment”

is dedicated to describing the critical functions of the LCS sub elements so the
reader understands what is expected from the FDA and the Global Regulatory
Agencies listed earlier. In addition, each chapter will present or link to tools, tem-
plates, checklists, and some of the Global Regulatory Agencies’ guidance listed
previously.
It should be noted that text is written for a broad audience. It is applicable to
both Quality Control and Quality Assurance professionals in small, medium, and
6 1 Introduction to the Quality Systems Based Approach to CGMP Compliance

large companies within the pharmaceutical and biopharmaceutical industries.

R&D personnel working in non-GMP environments will also benefit applying the
organizational schemes and principals presented in this text.1 Also, foreign firms
in China and India will find this book especially useful.
This book is particularly helpful for personnel who work in smaller companies
because they often do not have the financial, personnel resources, and existing
“corporate knowledge” that a large US- and European-based company may have
and are therefore often left to “figure it out” on their own. In this respect the guide
is particularly valuable in the example-templates and checklists it includes.

Overlap and Redundancy

As the reader progresses through this text, they will notice that some topics, notes,
and clarifications are addressed more than once and in different locations within
the book. This was done by the author on purpose to ensure that important topics
are addressed appropriately and reinforced.
Additionally, the QC laboratory is a very complex and dynamic entity, which
continually grows and evolves over time. This means that the 10 sub elements
into with the LCS is divided (which is purely a matter of choice on the part of
the author) can be reduced, modified, or expanded to address changes within the
organization and the evolution of Regulatory Agency expectations and standard
industry practices. This is why there is a “C” in CGMP: C means current, which is
today, not yesterday.

Tools and Templates

The following are provided in electronic format in the Chapter 1 Appendix

(www.wiley.com/go/Bliesner/LabControl_GMPEnvironment):

• 21 Code of Federal Regulations Parts 210 and 211 – Current Good Manufactur-
ing Practice Regulations, Revised as of April 1, 2005
• US FDA Compliance Programs to FDA staff, Chapter 56: Drug Quality Assur-
ance 7366.002 Drug Manufacturing Inspections, October 31, 2017.
• US FDA Guidance for Industry, Quality Systems Approach to Pharmaceutical
CGMP Regulations, September 2006.

1 In June 2018 the ICH Assembly endorsed ICH Q14 “Analytical Procedure Development
Guideline” and thus, by default, requiring a level of compliance with the GMPs by R&D
laboratories.
 References 7

References
1 21 CFR Parts 210 and 211 Current Good Manufacturing Practice for Finished
Pharmaceuticals.
2 US FDA (2017). Compliance Programs to FDA staff, Chapter 56: Drug Quality
Assurance 7356.002 Drug Manufacturing Inspections.
 9

Components of the Laboratory Managerial and

Administrative Systems Sub Element (MS)

Description of the Laboratory Managerial

and Administrative Systems Sub Element

The Laboratory Managerial and Administrative Systems are those sub elements
that provide the infrastructure for efficient and compliant operations of an
analytical laboratory. It is sometimes difficult to directly relate items within this
sub element to the Current Good Manufacturing Practices (CGMPs). However,
deficiencies within this sub element, which cannot be directly attributed to the
CGMPs, can lead to compliance failures. For example, 21 CFR Sections 210 and
211 do not specifically require that someone be assigned the duties of training
manager. However, failing to have an individual responsible for training and
consequently not having an effective training program can degrade the overall
quality of data that is generated by laboratory personnel, and US Food and Drug
Administration (US FDA) has cited companies for not having a training program
for laboratory personnel [1].
The Laboratory Managerial and Administrative Systems sub element includes at
least six individual topics. A laboratory that is in compliance with CGMPs should
at least address each of these topics (as applicable). These topics include (i) Organi-
zational Structure and Roles and Responsibilities, (ii) Training and Qualification,
(iii) Laboratory Budgeting, Purchasing, and Requisition, (iv) Laboratory Admin-
istration and Operations, (v) Laboratory Chemicals, Solutions, Reagents and Sup-
plies, and (vi) Laboratory Reference Standards and Solutions.
These six topics are listed within the text of the chapter along with some sug-
gestions on what items should be addressed in each topic. The list of items under
each topic is fairly comprehensive but may not be totally inclusive of all those
components, which may constitute the sub element.

Laboratory Control System Operations in a GMP Environment, First Edition. David M. Bliesner.
© 2020 John Wiley & Sons, Inc. Published 2020 by John Wiley & Sons, Inc.
Companion website: www.wiley.com/go/Bliesner/LabControl_GMPEnvironment
10 2 Components of the Laboratory Managerial and Administrative Systems Sub Element (MS)

Contents of the Sub Element

The six topics mentioned earlier are presented in Table 2.1 in the form of questions
related to each topic. For each topic, additional details, or “points to consider,” are
offered along with notes and clarifications as appropriate. The questions, notes,
and clarifications are all based on actual inspectional findings from Regulatory
Inspectors or points that have been found to directly or indirectly impact compli-
ant and efficient real-world Laboratory Control System operations.
It is envisioned that the below table may be used as a basis for:

• Evaluating your own laboratory’s managerial and administrative systems

• Upgrading your own laboratory’s managerial and administrative systems
• Establishing your own laboratory’s managerial and administrative systems if
it is a new laboratory or if you are making substantial changes to an existing
Laboratory Control System

Table 2.1 Components of the laboratory managerial and administrative systems sub
element.

Laboratory managerial and

administrative systems
# sub element topic Notes and clarifications

2.1 Organizational Structure and

Roles and Responsibilities
2.1.1 Are current organization charts Organizational charts will be one of
available for review and are they the first things an auditor will request
accurate? when your laboratory is being
inspected. Make sure the document is
current and correct in order to make a
good first impression.
2.1.2 Is there a policy/procedure that
defines the responsibility and
authority of the Quality Control (QC)
unit?
2.1.3 Have the responsibilities of each
functional group and supervisor been
clearly defined, including testing and
operational requirements, Standard
Operating Procedures (SOPs), and all
other critical functions?
(Continued)

Table 2.1 (Continued)
Laboratory managerial and
administrative systems
# sub element topic
2.1.4 Is an organizational structure in
place which is properly staffed to
assure that all required
testing/monitoring and support
activities are performed?
2.1.5 Is the span of control and authority
assigned to the QC laboratory
adequate to allow proper execution of
these activities?
2.1.6 Is the ratio of supervisors to analyst
appropriate? (A ratio of no more than
1 : 8 is recommended)
2.1.7 Are the roles and responsibilities for
each position within the laboratory
clearly defined?
2.1.8 Are the roles and responsibilities for
each position in the organizational
chart defined in formal, controlled,
accurate, and current job
descriptions?
2.1.9 Are signature authority,
responsibility, and accountabilities
appropriate and clearly defined?
2.1.10 Do systems exist to enhance
communications, understanding,
and working relationships between
laboratory and Quality Assurance
(QA) personnel?
Contents of the Sub Element 11
Notes and clarifications
Section 211.25 Personnel
qualifications of the Good
Manufacturing Practices regulations
states “(c) There shall be an adequate
number of qualified personnel to
perform and supervise the
manufacture, processing, packing, or
holding of each drug product.” This
applies to the laboratory and failing to
meet this requirement is often the root
cause of many issues which occur in
poorly operated QC laboratories.
If a supervisor has to supervise more
than eight employees directly, the
effectiveness of their ability to do so
decreases dramatically.
Up until recently, job descriptions
were considered the purview of the
human resources department and
therefore did not fall under the
umbrella of GMPs. This has now
changed, and the general expectation
of regulatory agencies is that job
descriptions should be maintained
and controlled like any other GMP
document.
A healthy, respectful relationship
between QC and QA will do wonders
for everyone’s ability to manufacture,
test, and, ship product. QC managers
should encourage QA personnel to
spend time in the laboratory and teach
QA personnel as much about product
testing and analytical techniques as
they can.
(Continued)
12 2 Components of the Laboratory Managerial and Administrative Systems Sub Element (MS)

Table 2.1 (Continued)

Laboratory managerial and

administrative systems
# sub element topic Notes and clarifications

2.1.11 Does a personnel performance Performance evaluation should not be

evaluation system exist, which tracks a one-time-a-year event. A good leader
laboratory personnel strengths and will continually evaluate and assist
weaknesses and establishes a means their employees to become the best
to improve technical, administrative, that they can be.
and managerial skills?
2.1.12 Does a master testing schedule or
similar document(s) exist to ensure
smooth and efficient work flow, and
minimize laboratory personnel
over-commitment?
2.1.13 Are current copies of CV’s and
resumes for all personnel, including
consultants, available for review?

2.2 Training and Qualification

2.2.1 Have the educational, training, and
work experience requirements for
each laboratory position been clearly
defined and do they reflect current
standards in the industry?
2.2.2 Is the requirement for training and Training is defined as an activity
qualification clearly described in an designed to provide the skills and/or
SOP or similar document for all knowledge that individuals need to
laboratory managers, supervisors, perform assigned job-related duties
analysts, support, temporary staff, and responsibilities.
and consultants? Qualification is defined as the process,
including documentation and
approval, whereby a person is trained
and demonstrates proof-of-proficiency
in specified tests, tasks, procedures, or
techniques.
2.2.3 Has a training and qualification
curriculum been developed for each
position that clearly identifies
training requirements for all required
SOPs and Policies, Test Methods,
Safety Procedures, and the GMPs as
well as all other internal and external
courses or programs?
(Continued)

Table 2.1 (Continued)
Laboratory managerial and
administrative systems
# sub element topic
2.2.4 Is there a system in place (e.g.
electronic, paper-based, or hybrid) to
capture, track, and manage training
and qualification of laboratory
personnel?
2.2.5 Does each employee have a training
file or similar record within the
training system?
2.2.6 Are the training histories for each
individual employee kept current?
2.2.7 Have all laboratory personnel been
properly trained and qualified?
2.2.8 Are the training histories for each
individual employee readily available
for review?
2.2.9 Is SOP training conducted in a
fashion other than “read and
understand” as appropriate?
Contents of the Sub Element 13
Notes and clarifications
Electronic training systems should
have a set of standard
file + curriculum for each unique
position on the organizational chart.
For example, the position for a
laboratory technician responsible for
glassware washing should be loaded
into the training system as if it was a
real person. It will include all the
necessary SOPs required for the
position, qualification tasks, safety
training, etc.
This “standard position” will serve as
a template. It then lays the basis for an
individual’s training record, which
will grow and change as the employee
is trained and qualified in that
position.
This point seems obvious; however
during auditing it is not unusual to see
someone who was “thrown into a
position” because of labor shortages,
who has never been trained on the
tasks they are preforming in the
laboratory.
Unfortunately, organizations have a
tendency to perform all SOP training
in this fashion. It is not effective in
many circumstances and the practice
should be restricted to review of minor
changes on previously trained-on
procedures.
(Continued)
14 2 Components of the Laboratory Managerial and Administrative Systems Sub Element (MS)

Table 2.1 (Continued)

Laboratory managerial and

administrative systems
# sub element topic Notes and clarifications

2.2.10 Are metrics, related to the execution

of training, collected, analyzed, and
used to determine the effectiveness of
the employee training system in
general?
2.2.11 Do the metrics used to evaluate Metrics can take many different
training system effectiveness include forms; these are just a few suggestions.
the following:
2.2.11.1 Number of courses completed versus
courses scheduled?
2.2.11.2 Percent of training that is overdue?
2.2.11.3 Evaluation of training course content
by attendees?
2.2.11.4 Evaluation of instructor effectiveness
by course attendees?
2.2.11.5 Evaluation of test questions to
determine their appropriateness and
effectiveness in evaluating
knowledge?
2.2.12 Is there an analyst qualification
program (e.g. proof-of-proficiency for
laboratory skills) in place?
2.2.13 Has an individual been designated as If the training manager or coordinator
the training coordinator or manager? is not someone with a laboratory
background, make sure they are
supported by someone who has a
science background with hands-on
laboratory experience.
2.2.14 Is there evidence of management
support for training and training
programs?
2.2.15 Does a formal training budget exist?
2.2.16 Do vendor and consultant training
records exist?
(Continued)

Table 2.1 (Continued)
Laboratory managerial and
administrative systems
# sub element topic
2.2.17 Is there evidence that newly hired
employees are evaluated for skill
level, competency, and
proof-of-proficiency with respect to
laboratory, supervisory, and
managerial skills as appropriate?
2.2.18 Is there evidence that newly hired
employees are evaluated for their
language and literacy skills?
2.2.19 Is there a formal training schedule in
place and is it being executed?
2.2.20 Is there evidence of employee
re-training and re-qualification?
Contents of the Sub Element 15
Notes and clarifications
One of the adages with respect to
finding qualified personnel is we hire
too quickly and fire too slowly. Take
your time when hiring and verify, to
the best of your organization’s ability
that who you are hiring truly does
possess the education, training, and
experience to do the job you need
them to do.
Also be aware that no matter how
competent and experience a new hire
is, it will most likely take them at least
six months to come fully up-to-speed
within your organization. And if you
doubt this, you are fooling yourself.
In culturally diverse workplaces, it is
not unusual to encounter personnel
who are not native speakers, readers,
or writers in the primary language
used at the facility. Since it is a GMP
requirement that procedures exist and
such procedures shall be followed,
personnel should be evaluated for
their ability to read, understand, and
execute the SOPs for which are
required to be followed in
performance of their job
responsibilities.
The GMPs in Section 211.25 (a) state
“Training in current good
manufacturing practice shall be
conducted by qualified individuals on
a continuing basis and with sufficient
frequency to assure that employees
remain familiar with CGMP
requirements applicable to them.”
Although this section of the GMPs is
targeted to GMP training, it should be
expanded to cover the broader arena
of job skills in general.
(Continued)
16 2 Components of the Laboratory Managerial and Administrative Systems Sub Element (MS)

Table 2.1 (Continued)

Laboratory managerial and

administrative systems
# sub element topic Notes and clarifications

2.2.21 Do managers, supervisors, or training

coordinators/managers periodically
meet with each employee and review
the employee’s training record and
discuss training and qualification
effectiveness and needs?
2.2.22 Is there a positive attitude with
respect to training on the part of
management and laboratory
personnel?
Experience has shown that most
employees will openly discuss their
pleasure (or displeasure) in the
content, effectiveness, and frequency
of training and qualification.
Employees are also the best to know
what needs to be done to upgrade
existing training efforts or what new
efforts need to be undertaken.

2.3 Laboratory Budgeting, Purchasing,

and Requisition
2.3.1 Are levels of approval defined and
appropriate for the purchasing and
requisitioning needs of the
laboratory?
2.3.2 Are items purchased from qualified
vendors (e.g. reagents, standards,
instruments, etc.)?
2.3.3 Does the laboratory have a defined
yearly expendables budget?
2.3.4 Is the expendables budget derived
from existing data and takes into
consideration projected changes in
manufacturing volume and its
impact on testing workloads?
2.3.5 Does the laboratory have a clearly
defined and functional capital
expenditure budgeting process?
2.3.6 Is the capital budget derived from
existing data and take into
consideration new product
introductions, changes in
manufacturing workloads, etc.?
There should be more than one person
who can sign, initiate requisitions, and
sign purchase orders in the laboratory.
This needs to be defined in writing.
Capital expenditures include
purchasing pieces of equipment and
instrumentation such as HPLCs, GCs,
balances, etc.
The age of equipment should also be a
consideration. Equipment and often
the software used to run it need to be
replaced from time-to-time. Aging
equipment can lead to unnecessary
laboratory investigations, which are
time-consuming and often not
value-added.
(Continued)
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1229 Spangler A 45 May
E 20
111 May
1281 Swineheart J W
B 22
89 May
1404 Seyman Aaron
D 27
June
1672 Sprague W L Cav 6K
6
22 June
1773 Simmons Jno Bat
- 9
35 June
2220 Shannon E
A 20
45 June
2230 Stanett J
C 20
93 June
2376 Stiver J
C 23
11 June
2524 Smith G W
K 26
89 June
2575 Sampson C
D 27
45 June
2638 Stults P
F 29
31 July
2783 Shiver L
B 2
July
2792 Smith N H 1H
2
21 July
3116 Smith G, S’t
I 10
100 May
42 Sabine Alonzo
A 11
July
3252 Short Jas, S’t Cav 4A
13
July
3288 Smith D 7H
13
3361 Saffle J 2E July
 15
33 July
3536 Steward C S
K 18
111 July
3602 Stevenson D
B 19
49 July
3298 Squires Thos
C 20
July
3744 Snyder Thos 9G
21
July
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22
July
3794 Sever H H 2C
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Shephard J H, July
4249 2E
Cor 29
July
4275 Smith J B, S’t 1B
29
July
4294 Steward J, S’t 2K
30
72 Aug
4745 Steiner J M
F 5
93 Aug
5018 Smock A
D 8
93 Aug
5054 Smarz A
E 8
Aug
5066 Shipple John Cav 6G
8
Aug
5133 Scott S E 4 I
9
Stevenson 111 Aug
5287
John B 11
14 Aug
5330 Spegle F
D 11
101 Aug
5373 Schem J 64
K 11
5455 Stevens G W 101 Aug
K 12
78 Aug
5896 Sullivan W
D 16
89 Aug
6010 Staley G
A 17
Aug
6032 Smith Wm Cav 9G
18
32 Aug
6178 Simpson W J
F 19
Aug
6199 Sheddy G 2K
19
105 Aug
6214 Shaw Geo W
A 20
24 Aug
6253 Shoulder E
F 20
72 Aug
6779 Soper P
G 25
89 Aug
6870 Scarberry O
D 26
Aug
7034 Sutton J 4A
27
Shoemaker J, 47 Aug
7065
S’t E 28
Stinchear F E, 101 Sept
7436
S’t A 1
Sept
7475 Shafer J 9G
1
125 Sept
7540 Sell Adam
E 2
19 Sept
7788 Stewart John S
B 4
Sept
7897 Smith H H Cav 2A
5
7986 Selb Jacob 28 Sept
 - 6
45 Sept
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Sept
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Sept
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8
Sept
8200 Stroufe A 7E
8
15 Sept
8229 Shaw W
I 9
121 Sept
8300 Smith N
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49 Sept
8319 Sheldon W
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135 Sept
8422 Sullivan Jno
F 11
18 Sept
8728 Sisson P B
H 14
51 Sept
8752 Sickles J
I 14
Sept
8914 Simmonds S P 1A
16
15 Sept
8931 Stull G
G 16
63 Sept
9009 Sharp F S
K 17
12 Sept
9244 Schmall J D
E 19
158 Sept
9386 Smith L
H 20
33 Sept
9645 Scott J H
H 24
9649 Skiver J 114 Sept
H 24
81 Oct
10250 Sheets W
A 3
Spencer S M, 89 Oct
10312
Cor E 4
Oct
10434 Shingle D Cav 2L
6
Stanford P W, Oct
10437 Cav 2A
S’t 6
51 Oct
10576 Stonchecks J D
F 9
101 Oct
10618 Schafer P
I 10
Oct
10703 Stout Samson 2F
11
34 Oct
10833 Sheppard Jno
D 13
72 Oct
11139 Shark H
F 17
45 Oct
11146 Smith G A, Cor
F 19
76 Oct
11249 Sullivan F
C 21
124 Oct
11433 Swaney E
A 24
69 Oct
11579 Smith P
I 28
20 Oct
11595 Sapp W N, S’t
E 28
122 Nov
11711 Spiker J
- 1
72 Nov
11797 Shaler F, Cor
E 4
12105 Sly F 89 Nov
 G 20
Dec
12281 Singer J 6G
13
49 Dec
12305 Sweet M, S’t
F 18
Jan
12441 Shoemaker C 8F 65
12
Jan
12538 Stewart A F 2D
27
71 Jan
12562 Sponcerlar Geo
B 31
89 Feb
12668 Shorter W
K 17
123 Mar
12769 Sloan L
D 13
50 Mar
12789 Stroup S
B 17
132 Mar
12793 Seeley N
D 18
75 Mar
12810 Scott R
G 24
April
730 Tweedy R Cav 1A 64
25
Trescott April
743 2C
Samuel 26
40 May
999 Trimmer Wm
H 10
May
1196 Turney U S Cav 2G 64
18
10 May
1496 Thomas Wm Cav
M 30
Aug
4784 Thompson J 2E
5
13 Aug
4951 Toroman W R
E 7
5356 Tierney W Art 1L Aug
11
90 Aug
5552 Tinsley M
B 13
12 Aug
5668 Terilliger N
C 14
32 Aug
6330 Tanner A, S’t
G 21
26 Aug
7224 Thompson V B
C 29
45 Aug
7246 Turner S B
B 30
44 Sept
7640 Thomas Jas
C 2
135 Sept
8850 Talbert R
F 15
103 Sept
9774 Thomas N
B 26
26 Sept
9945 Townsend J
C 28
153 Oct
10471 Tattman B
C 7
93 Oct
10800 Tinway R
- 12
Townsley E M, 89 Nov
11820
S’t B 5
Feb
12577 Tensdale T H Cav 2E 65
3
12 Dec
12251 Uchre S 64
E 9
45 June
2194 Vining W H H
G 19
123 July
3902 Valentine C
H 24
4450 Vaugh B 125 Aug
 F 1
103 Aug
4497 Vangrider H
H 1
Aug
5263 Vatier J F Cav 6 -
10
17 Aug
6170 Vail Jno L, S’t
C 19
21 Aug
6859 Vanaman M
E 26
Aug
6985 Vanderveer A 6H
27
Sept
7756 Victor H Art 1D
4
34 Sept
9576 Volis J
H 23
12 Oct
10252 Vail N
K 3
Oct
10389 Vail G M 7D
5
14 Oct
10472 Van Fleet H
I 7
135 Oct
11095 Van Kirk G
B 18
89 Oct
11097 Van Malley J M
G 18
Jan
12554 Vanhorn S Cav 9C 65
30
82 Mch
7 Wiley Samuel 64
A 5
111 Mch
185 Wickman Wm
B 27
45 April
779 Wooley Jno
B 28
45 April
807 Werts Louis
D 30
1085 Wood Wm 89 May
A 14
Wentling 100 May
1449
Joseph K 29
15 June
1604 Wood Joseph
B 4
Wilkinson W, 89 June
1836
Cor D 11
93 June
1913 Wilson Jas
I 13
44 June
2020 Way Jno
I 15
15 June
2041 Windgrove S R
- 15
45 June
2172 Webb E
A 19
June
2358 Walters F 9E
23
June
2536 Wing Cav 2M
26
89 July
2815 Willis A
A 3
89 July
2840 Wroten L
H 3
90 July
3188 Williams D
A 12
April
34 Wright Wm 7H
24
15 July
3310 White H
A 15
75 July
3325 Whitten G
K 14
89 July
4214 West J B
B 29
4681 Witt Jno T 93 Aug
 G 4
111 Aug
4688 Won J, Cor
B 4
33 Aug
4695 Wile A, Cor
D 4
70 Aug
5121 Winder I
D 9
Aug
5211 Wood N L Cav 4L
10
145 Aug
5726 Winters Geo
K 15
89 Aug
6314 Wainwright S G
G 20
35 Aug
6318 Wisser F J
A 20
Aug
6362 Wistman N 9G
21
Aug
6397 Wilson E 4A
21
21 Aug
6700 Watson G
A 24
123 Aug
6761 Wood S 64
A 22
59 Aug
7056 Wood W H
E 28
90 Aug
7373 Wyatt J
B 31
72 Sept
7582 Wentworth L
A 1
89 Sept
8298 Wright J S
E 9
14 Sept
8396 Warner T
C 10
73 Sept
8907 Wyckmann D
G 16
9384 Worte J 116 Sept
- 20
135 Sept
9527 Woodruff J M
F 22
93 Sept
9691 Wagner J
F 24
21 Sept
10007 Whitney E
K 29
Oct
10230 Williams Orland C 7K
2
72 Oct
10309 Weaver M
H 4
21 Oct
10402 Ward Francis
H 6
33 Oct
10464 Whitehead A B
E 7
26 Oct
10528 Wiley A
I 8
73 Oct
10733 White I
E 11
Westbrook R L, 135 Oct
10844
Cor F 13
65 Oct
11013 Walker C
I 16
14 Oct
11034 Waldron H
A 16
60 Oct
11417 Williams S M
F 24
122 Nov
11770 Worthen D
B 3
35 Nov
11874 Weason J
F 6
14 Nov
12042 Wickham J
H 16
12073 White R M 15 Nov
 D 18
35 Nov
12158 Warner B F
E 25
72 Feb
12584 Whitaker E 65
A 4
57 Mch
12722 Wella E
A 3
Mch McL’s
12759 Winklet T Cav - -
12 Sqn
102 Mch
12786 Warner M
G 16
Webricks Josh Aug
4833 9G 64
H 6
45 April
638 Yuterler W A
E 20
80 Aug
5477 Younker S
F 13
Aug
6068 Young Jno 7E
18
Sept
7816 Yeager Jno Cav 7B
4
Sept
7876 Young J 9F
5
Oct
10583 Young W 6G
10
15 Feb
12659 Young W 65
A 16
100 July
3225 Zubers J M 64
B 12
72 Oct
11253 Zink A J
E 21
Total
1031.
 PENNSYLVANIA.
Mch
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29
Mch
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April
468 Ackerman C 8B
9
April
758 Arb Simon Cav 4C
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May
846 Allbeck G B, S’t 52 F
3
May
975 Algert H K 54 F
9
May
1282 Arble Thos Cav 13 A
26
June
1837 Ait M 21 K
11
June
2348 Akers Geo 90 H
23
June
2398 Allison E 55 K
24
103 June
2547 Anderson D, S’t
K 27
June
2648 Able J 54 F
20
103 July
2956 Amagart Eli, S’t
F 6
July
3018 Ackley G B Art 3B
7
July
3917 Alexander M Cav 1F
14
July
3967 Ardray J F, S’t 13 F
25
4055 Anderson J, Cor 79 I July
 27
July
4143 Aches T J 7H
28
145 July
4149 Alcorn Geo W
F 28
July
4495 Archart H 51 C
29
Aug
4673 Allen C Cav 8K
4
Aug
4973 Andertin J Cav 4L
7
103 Aug
5286 Aler B
D 11
101 Aug
5511 Ault J L
C 13
Armstrong Cas, Aug
5862 Cav 4C 64
S’t 16
Aug
6029 Anersen Jno 91 C
18
184 Aug
7163 Arnold Daniel
C 29
Sept
7887 Angstedt Geo W 1F
5
101 Sept
8185 Allen J L
I 8
Sept
8232 Ambler C Cav 13 D
9
Sept
8388 Alexander W Res 2 I
10
Sept
8653 Armstrong A 7K
13
Sept
8655 Arnold L 73 A
13
Sept
8765 Altimus Wm 7E
14
1743 Ainley Wm Cav 3E June
8
Sept
9150 Alcorn J W “ 18 D
18
Sept
9896 Allison D B 55 K
27
135 Oct
10487 Anderson A
F 7
126 Oct
10570 Allen D
A 9
Oct
10823 Allin S Cav 7H
13
149 Oct
11419 Applebay T M
K 24
Oct
11607 Antill J 61 I
28
118 Nov
11710 Auger W
- 1
Nov
11852 Affleck T 2F
6
184 Nov
11860 Amandt J
D 6
142 Jan
12520 Atchinson W P 65
F 25
Mar
228 Bull Frank Cav 4H 64
29
Mar
249 Burton Lafayette C 18 D
30
April
332 Briggs Andrew C 13 H
2
April
427 Begler A 27 C
8
April
543 Breel Jacob, Cor 27 H
14
569 Black Jas A Cav 14 D April
 15
April
661 Bradley Alex “ 3F
21
April
671 Burns Sam 73 K
22
April
673 Barra J 54 F
22
145 May
822 Bayne Wm
I 1
May
874 Bradley M Art 3A
4
May
897 Brown Henry 90 H
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May
938 Brown D 4C
7
May
974 Batting Isaac, Cor Cav 8H
9
May
1046 Baker J D 57 F
12
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1188 Butler Wm 90 B
18
May
1300 Boyd Thomas 9D
23
May
1309 Bryson J Cav 2D
23
May
1327 Brining J “ 13 B
24
13 May
1375 Burney J “
G 26
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1393 Brown J B “ 4K
26
June
1576 Boman Sam’l Art 3B
3
103 June
1601 Berfert R
B 4
1654 Brumley Geo Cav 4 I June
5
June
1790 Butler J D 76 B
10
73 June
1859 Berkhawn H
G 12
June
1872 Brooks D S 79 -
12
183 June
1923 Brian Chas
F 14
June
1999 Bixter R 73 C
15
June
2026 Burns Owen Cav 13 C
15
June
2046 Bigler M “ 4 -
15
June
2127 Brown C “ 3B
17
June
2134 Buckhannan W Art 3B
18
June
2180 Ball L 26 K
19
June
2236 Barr J T Cav 4K
20
June
2323 Baker Henry “ 18 I
22
June
2483 Bisel Jno, S’t “ 18 K
25
June
2539 Balsley Wm “ 20 F
26
June
2610 Brown M “ 14 C
28
July
2727 Brenn J 73 K
1
2733 Bolt J H, S’t Cav 18 E July
 1
July
2741 Beam Jno 76 E
1
July
2816 Burns Jno Cav 13 A
3
108 July
2913 Bish J
F 5
115 July
2918 Belford Jno
F 5
July
3005 Bryan P Art 3A 64
7
103 July
3019 Barr S
G 7
July
3027 Braney J 48 E
7
101 July
3051 Barnes W, Cor
H 8
118 July
3097 Butler L J
E 10
110 July
3109 Brunt A
G 10
101 July
3216 Beraine A A
B 12
103 July
3294 Burns Jas
F 14
157 July
3442 Brinton J
D 17
103 July
3477 Baker Wm
F 17
July
3535 Burnside J, S’t 57 H
18
103 July
3600 Black W O
G 19
July
3693 Billig J L Cav 3H
21
3716 Brenlinger W R, “ 4D July
S’t 21
148 July
3808 Butter C P
A 22
July
3821 Batchell D 55 D
23
July
3917 Bright E 90 I
23
July
3988 Bradford L 10 I
26
July
4002 Berkley M 50 I
26
116 July
4084 Backner Adam
G 27
July
4330 Barrett J 6K
30
53 July
4360 Brown J
G 31
53 July
4402 Butler D
G 31
Aug
4494 Barton Jas Cav 4B
1
Aug
4500 Burke J 90 A
1
Aug
4610 Baker E, Cor 4K
3
Aug
4667 Behreas A 7E
4
Aug
4752 Bennett Geo 55 D
5
Aug
4989 Bowers J Art 2 I
7
Aug
5040 Bammratta —— 73 D
8
5071 Barber C 6D Aug
 8
Aug
5084 Buck B F Cav 2K
8
Aug
5113 Brown M 50 D
9
141 Aug
5324 Burlingame A J
K 11
Aug
5391 Bear Jno 79 D
12
101 Aug
5416 Bruce Jno
C 12
Aug
5526 Bower Benj Cav 6L
13
143 Aug
5587 Burnham H
F 14
Aug
5592 Broadbuck A Cav 11 A
14
Aug
5662 Buck B F “ 2K
14
103 Aug
5877 Browning Thos
A 16
115 Aug
5948 Bohnaberger A
G 17
Aug
5969 Boyer F 43 E
17
101 Aug
6061 Baker Jas
C 18
103 Aug
6074 Bower G W
K 18
Aug
6099 Baily J F 18 D
18
103 Aug
6127 Benhand J A
D 19
55 Aug
6229 Bear Sam’l
G 20