XPAIE002EN-D FirstInfoPharma

First Info
Pharma
Qualification Training
This document is for your internal, informative use only.
Do not pass to customers or third parties!
Version: February 2018

Document is subject to change.
Latest version is saved online.
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Confidentiality
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“Anton Paar”) and (2) Anton Paar distributors. This document is for your internal, informative use
only. Do not give or show this document to anyone who is not an employee of Anton Paar.
Disclaimer
This document may contain errors and omissions. If you discover any such errors or if you would
like to see more information in this document, please contact us at our address below. Anton Paar
assumes no liability for any errors or omissions in this document. This document does not alter
your contractual relationship with Anton Paar and you must not act or omit to act in reliance upon
the information contained in this document. Anton Paar assumes no liability for any losses or
damages in this regard.
Changes, copyright, trademarks etc.

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Further information
Published and printed by Anton Paar GmbH, Austria
Copyright © 2018 Anton Paar GmbH, Graz, Austria
Address of the instrument producer:

Anton Paar GmbH
Anton-Paar-Str. 20
A-8054 Graz / Austria – Europe
Tel: +43 (0) 316 257-0

Fax: +43 (0) 316 257-257
E-Mail: info@anton-paar.com
Web: www.anton-paar.com
Date: March 2018

Document number: XPAIE002EN-D
ATTENTION
This document is strictly CONFIDENTIAL and is intended for INTERNAL USE only!
Contents
1. Symbols in the Document ........................................................................................................ 5
1.1 Conventions for the Symbols in the Document ..................................................................... 5
2. About the First Info .................................................................................................................. 6
3. Pharma – Overview ................................................................................................................. 7
3.1 The Pharmaceutical Market ................................................................................................. 7
3.2 Abbreviations for the First Info and the Pharmaceutical Industry .......................................... 8
4. Regulations in the Pharmaceutical Industry ............................................................................. 9
4.1 Regulations along the Pharmaceutical Chain ....................................................................... 9
4.2 GMP .................................................................................................................................. 10
4.3 GAMP 5 ............................................................................................................................. 11
4.4 21 CFR Part 11 .................................................................................................................. 12
4.5 Data Integrity...................................................................................................................... 13
4.6 Pharmacopoeias ................................................................................................................ 15
4.6.1 US Pharmacopeia Chapter <1058>............................................................................ 15
4.6.2 US & European Pharmacopeia Chapter for Anton Paar Instruments .......................... 17
5. Anton Paar Pharma Qualification Packages .......................................................................... 18
5.1 General Knowledge............................................................................................................ 18
5.1.1 Location of the Qualification ....................................................................................... 18
5.1.2 Qualification Support at Anton Paar ........................................................................... 19
5.1.3 Products with Pharma Qualification Documents ......................................................... 21
5.1.4 Sales & Service Teamwork ........................................................................................ 22
5.1.5 Costs.......................................................................................................................... 22
5.1.6 Ordering Workflow ..................................................................................................... 22
5.2 Preparation and Installation of the Pharma Qualification Documentation ........................... 23
5.2.1 Preparation of the Installation ..................................................................................... 23
5.2.2 Persons Involved in the Qualification Procedure ........................................................ 23
5.2.3 Start of Qualification Procedure.................................................................................. 24
5.2.4 Qualification Instruction (QI) ....................................................................................... 25
5.2.5 Design Qualification (DQ) ........................................................................................... 25
5.2.6 Installation Qualification (IQ) ...................................................................................... 27
5.2.7 Operational Qualification (OQ) ................................................................................... 27
5.2.8 Performance Qualification (PQ) .................................................................................. 29
5.2.9 Final Qualification (FQ) .............................................................................................. 30
5.3 Aftersales Support for Pharma Customers ......................................................................... 30
5.3.1 Service Level Agreement (SLA) ................................................................................. 30
5.3.2 Requalification Documents ......................................................................................... 31
6. Marketing and Support Material ............................................................................................. 32
7. FAQ ....................................................................................................................................... 33
8. Glossary ................................................................................................................................ 35
9. Knowledge Check .................................................................................................................. 36
4/37 Contents XPAIE002EN-

1. Symbols in the Document
1.1 Conventions for the Symbols in the Document
The following conventions for the symbols are used in this document:
Required reading
This sign calls attention to a link to a document, video, etc. that you must read or watch
in order to complete the First Info. Please study the information provided. In text, the
required reading is marked with a grey line on the left and right side. In tables the red
font color is additionally used to mark the required reading rows. The content of these
sections is required to pass the test.
Did you know?

Here you will find some interesting stories behind the topics for your own interest.
Optional reading
This sign calls attention to a link to a document, video, etc. which might be of interest to
you. It is not obligatory to study the information provided.
NOTICE - Notice indicates a situation which, if not avoided, could result in damage to property.
TIP - Tip gives extra information about the situation at hand.
XPAIE002EN- 1. Symbols in the Document 5/37

2. About the First Info
When you are just getting started on a topic, you might sometimes be faced with an information
overload. This First Info you are holding in your hands is for you – available from your very first
work day. It is designed to ideally prepare you for subsequent training sessions. It is also meant as
a small reference that contains all the info you need before training – nothing more, nothing less. A
perfect starting point!
On Your Way to Becoming a Sales/Service Expert for Anton Paar Products:
First Info for Sales Qualification Training for Sales People Sales Experts Meeting
& Service People Qualification Training for Service People Service Experts Meeting
Learn the basic Become qualified in selling / servicing Anton Be invited by Anton Paar to
concepts of a Paar products by gaining deeper insight into the Experts Meetings to
product line. application knowledge, market/customer/ exchange knowledge,
competitor information, sales/service experience and new ideas in
strategies, technical/product knowledge. Above terms of product, application,
all, the trainings emphasize laboratory practice. market and sales/service
The autonomous learning process is supported developments on a high level.
by webinars, Anton Paar Knowledge Update A good opportunity to "talk
and information on the Anton Paar Extranet. shop" without distraction.
What the First Info Can Do for You

The First Info introduces you to a product line and serves as your basic reference book to look
things up. It is self-explanatory, full of interesting background stories and contains topics such as:
 measuring/operating principles and methods

 the instruments, their USPs and the most important applications
 the markets/customers/competitors/references
 contact persons & responsibilities at Anton Paar
The First Info addresses both Sales and Service persons at Anton Paar subsidiaries and
representations. It ensures that everyone enters the Qualification Trainings at the same level.
It’s the First Info – Not the Last Word

The First Info is the essential basis, but it cannot replace an actual Qualification Training with its
wealth of additional detailed information for successful customer contacts. The First Info does not
enable Service engineers to perform a service on Anton Paar instruments, and does not enable
Sales people to win projects against experienced competition.
 Before attending training you have to pass an online test on the contents of the First Info.
To help you prepare for this, the First Info contains study questions which you can use to
check your knowledge.
 Studying the First Info ensures that you get the most out of your training - the trainers at the
Qualification Trainings cannot consider participants who haven‟t studied the First Info
Any feedback on the First Info is very welcome – help us to further improve it.
And now, enjoy getting on with your First Info package!
6/37 2. About the First Info XPAIE002EN-D

3. Pharma – Overview
Knowledge about the needs of customers from the pharmaceutical industry is the door opener for
projects in this high-potential market. Since the Pharma Qualification often represents a USP
(unique selling point) for the requested equipment it can influence the purchase decision of the
customer. Qualification of equipment is a “must-have” in the pharmaceutical industry and is often
requested in the cosmetics, food and sugar industry. Anton Paar‟s Pharma Qualification Packages
(PQP, PQP-S and Requalifications) save the customer a lot of time and money and can be helpful
to attract new customers.
The Pharma Sales Qualification Trainings greatly support the selling process of Anton Paar
equipment to the pharmaceutical industry and other customers.
The Pharma Installation Qualification Training certifies you to perform the Anton Paar Pharma
Qualification Packages at the customer site.
3.1 The Pharmaceutical Market

The pharmaceutical industry is one of the world„s most profitable industries. The global
pharmaceuticals market comprised around US$ 940 billion in 2014. By 2018 IMS Health expects a
global annual turnover of US$ 1.3 trillion.
The continuing globally aging population, coupled with lengthening life expectancies, means that
the pharmaceutical industry is facing an increasing demand for life science products to treat age-
related diseases. Therefore, there is also an increasing pace of R&D for new products and also the
number of production locations is increasing.
Every pharmaceutical company involved in the manufacturing of medicinal products must make a
firm commitment to quality, patient safety and implementation of proper Good Manufacturing
Practice (GMP). This is ensured by national and/or international regulations that have to be
fulfilled. In this increasingly regulated and competitive environment the pharmaceutical industry is
always in need of better quality control and also to produce results with fewer errors and at lower
costs.
Compared to other industries the pharma market is continuously growing and is for us a market
with high potential, although we have to meet new requirements. The sales process usually takes
longer than for other customers and unfamiliar and detailed questions may be asked. Also,
installation and service procedures can be challenging and have to be prepared with extraordinary
diligence. However, once a pharma person is convinced that our instruments are of outstanding
quality and satisfied with our reliable service team, this will be a loyal customer.
XPAIE002EN- 3. Pharma – Overview 7/37

3.2 Abbreviations for the First Info and the Pharmaceutical Industry
Abbreviation Definition Abbreviation Definition

Modification Documentation =
AP Adjustment Protocol MOD
Requalification Documentation
AS As-built Specification OQ Operational Qualification
CAPA Corrective And Preventive Action OR OQ - Report
CFR Code of Federal Regulations of the FDA POX Diverse protocols in our PQP
CRM Certified Reference Material PQ Performance Qualification
CRS Customer Reference Sample PQP Pharma Qualification Package
CS Customer Sample PQP-S Pharma Qualification Package Smart
CP Calibration Protocol PR PQ-Report
DQ Design Qualification QA Quality Assurance
DL Deviation List QC Quality Control
EN European Norm QI Qualification Instruction
FDA Food and Drug Administration QMS Quality Management System
FMEA Failure Mode in Effects Analysis QP Qualification Plan
FR Final Qualification Report RA Risk Analysis
GAMP Good Automated Manufacturing Practice SLA Service Level Agreement
GCP Good Clinical Practice SOP Standard Operating Procedure
GLP Good Laboratory Practice TM Traceability Matrix
GMP Good Manufacturing Practice URS User Requirements Specification

Laboratory Information Management Unique Selling Point
LIMS USP
System and also US Pharmacopeia
IQ Installation Qualification SW Software
IR IQ-Report
8/37 3. Pharma – Overview XPAIE002EN-D

4. Regulations in the Pharmaceutical Industry
The pharmaceutical industry is highly regulated. There are national and international regulations
for pharmaceutical manufacturers to produce high-quality products. The rules and regulations such
as GLP, FDA, GMP, GCP, National Regulations, GAMP 5, 21 CFR Part 11, IHC, Pharmacopoeias
(USP, Ph. EU, JP) accompany the pharmaceutical manufacturers at every step.
The most important regulations and guidelines are:
 GMP/cGMP (c = current) - Good Manufacturing Practice

 GAMP 5 - Good Automated Manufacturing Practice
 FDA‟s 21 CFR Part 11 (US Food and Drug Administration)
 Pharmacopoeia: USP <1058> (United States Pharmacopeia)
and Ph. Eur. (European Pharmacopoeia)
4.1 Regulations along the Pharmaceutical Chain

It is important to know which areas in the pharmaceutical industry are regulated and have a need
for the comprehensive qualification procedure. Customers in these areas have special needs that
have to be considered.
The scheme below summarizes the regulations in the area of pharmaceutical manufacturing:
Qualification Qualification
optional required!
Figure 1: Summary of the pharmaceutical regulations
Although the basic research was not regulated in the past, nowadays more and more customers
also need qualified instruments for their research labs.
XPAIE002EN- 4. Regulations in the Pharmaceutical Industry 9/37

4.2 GMP
GMP = Good Manufacturing Practice
Good Manufacturing Practice is a commitment made by the pharmaceutical manufacturer to follow

well-documented production and hygienic guidelines and to check them regularly.
The focus of GMP is on hygiene, the suitability of production facilities and the traceability of the
documentation. Additional points are the qualification of the employees, regular inspections of the
pharma manufacturers, reliable process control & production documentation, work routines based
on SOPs (Standard Operating Procedures), the minimization of microbial contaminations, high
quality of raw materials, machines, instruments and the exclusion of confusion, contaminations and
cross-contaminations. For us the most important part of the GMP is to obtain instrument
compliance through complete and traceable documentation.
In the EU the GMP is not a legal document, only a very relevant recommendation. The
responsibility of the quality controlled production is solely with the pharmaceutical manufacturer
and not with the legislature. The basis of the GMP are essential core conditions to guarantee the
quality of the pharmaceutical product and there are no inspections by an authority. Within
individual EU countries the national laws are binding. EU directives have to be implemented in the
national law e.g. Germany: AMG, AMWHV (=§54 of AMG)
In the USA GMP is referred to as cGMP (current GMP). The rules are regularly published in the
CFR (Code of Federal Regulations) and they are legally binding. There are regular inspections by
the FDA (Food and Drug Administration). The GMP rules are mandatory for all pharmaceutical
companies who produce or import into the USA. The GMP rules are part of the 21 CFR.
Main purposes for GMP/cGMP:
 To meet legal requirements, including all GMP expectations

 To control and document the production of pharmaceutical products
 To form the basis of good scientific decision-making
GMP – 5 W rule:
 What needs to be done (the process)

 Way how to do it (the method)
 Why it needs to be done (the context)
 Who must do it (the responsibility)
 When to do it (frequency)
At the end: to ensure that there is an adequate record of who did what, when, how and why!
GMP or cGMP documentation is one critical aspect of our business and in most countries it is a
legal requirement. Inspection or audit observations frequently identify outdated documents,
inadequate version control, and poor documentation practices. This can lead to critical
consequences for our pharma customers, like product recalls or factory closures.
10/37 4. Regulations in the Pharmaceutical Industry XPAIE002EN-D

4.3 GAMP 5
GAMP = Good Automated Manufacturing Practice
GAMP was founded in 1991 and is a trademark of the International Society for Pharmaceutical
Engineering (ISPE). GAMP 5 was launched in 2008 and includes a set of procedures that help to
ensure that automation equipment/software meets required quality standards. GAMP is not a
regulation, but a set of guidelines for manufacturers and users of automated systems in the
pharmaceutical industry.
The key concepts of GAMP are product and process understanding, the whole life cycle from the
planning phase, the installation, the productive phase until the final phase of a system. The
supplier knowledge should be more involved especially in the part qualification of new
equipment.
One core element of GAMP 5 is risk management over the whole life cycle of an instrument.
Starting with risk-based decisions on whether a system has to be validated at all, if “yes” this
requires explicit and detailed risk assessments, the risk management ends with the controlled and
supervised system retirement.
GAMP 5 defines software categories due to the software‟s (SW) complexity shown in the following
table. These categories are used to determine the qualification and validation requirements.
Category GAMP 5
1 Infrastructure software (operating systems; middleware; DB managers; etc.)
(2) (Obsolete: simple instruments without software, only with firmware; not used any more)
3 Non-configurable SW configuration, off–the-shelf software (OTS)  Anton Paar instruments
4 Configured SW – configured to satisfy the business process
5 Customized SW
Figure 2 Category overview of the GAMP 5
All Anton Paar instruments are category 3, non-configurable SW, standard software.

4.4 21 CFR Part 11
CFR = Code of Federal Regulations
The FDA (US Food and Drug Administration) designed the 21 CFR Part 11 to define criteria that
permit the widest possible use of electronic records, ensuring that they are equivalent records to
those based on ink and paper.
An electronic record is any combination of text, graphics, data, audio, pictures, etc. in digital form
that is created, maintained, archived, retrieved or distributed by a computer system. The purpose
of the rule is to ensure the information‟s integrity, accuracy, trustworthiness and traceability.
The main issues of CFR Part 11 that our computerized instruments have to fulfill are access
control, electronic signature and audit trail.
Access control refers to the user level password authentication. It has to be ensured that only
persons who are allowed to log onto the instrument are able to log onto it. Anton Paar offers three
(with exceptions) types of user level: the administrator, the manager and the operator. The
operator may perform measurements, select a method, edit the sample list and perform checks.
The manager has the rights of the operator and may additionally perform adjustments. The
administrator has the right to access the whole menu.
The electronic signature is included in our software for most of our instruments. It has to be
unique for one individual, not reusable and must use at least two distinct identification components
(user ID and password).
The audit trail has to be a computer-generated file containing date and time stamp for all
actions/changes and the Who, When, What and How. For example starting the instrument, logging
on, changing the method, starting the measurement, logging off and all other relevant actions must
be listed and recorded in the audit trail. The audit trail is the part which is inspected by auditors,
making it a very important matter. In Anton Paar instruments it is saved in the memory and can be
exported to a PDF or an Excel file.
Other important issues of 21 CFR Part 11 are change control and archiving of electronic
records. Change control, which is a formal process to ensure that changes to a product or system
are introduced in a controlled and coordinated manner, ensures that a qualified status of the
instrument is maintained. If modifications (service, repairs) have to be done, a document is created
which shows the modifications, the reasons and all associated consequences. After this document
is checked and approved, the changes can be implemented. Furthermore, the reliable archiving
of electronic records has to be ensured. Change control and the archiving of the electronic
records are responsibilities that have to be covered by our customers themselves.

4.5 Data Integrity
The usage of electronic systems facilitates the work in a lab in many ways. As a side effect, new
challenges arise for the company to deal with. The produced electronic data sets must be handled
in a way, that there are no open questions about safety and error free transmission and
management of the data. The “ALCOA”-principle (see Table 1) was stated to help the users in their
work in fulfilling the regulation needs (FDA, OECD, ICH, …).
As a lab operator or lab manager my focus is on the efficient processing of my tasks. Therefore
computer based systems should support the users without increasing the workload. The QA
department wants safe systems where they can look up all generated data and reproduce all work
steps (audit trail). To fulfill these needs Anton Paar offers a tool which helps our customers in the
safe and reproducible management of their data. Anton Paar can show that all the electronic data
transmission and processing is done in a way that fulfills the “ALCOA”-principle. Moreover we
provide a solution to fulfill the needs of a paperless lab according to the regulations.
Data Integrity – ALCOA principle[1]
For the purposes of this guidance, data integrity refers to the completeness, consistency, and
accuracy of data. Complete, consistent, and accurate data should be attributable, legible,
contemporaneously recorded, original or a true copy, and accurate (ALCOA)
The acronym ALCOA has been widely associated with data integrity by FDA to help customers
remember compliance terms relevant to data quality.
Table 1: ALCOA principle
“ALCOA” Description / Explanation Comments

Who performed an action and when? If a
Who did it?
A Attributable record is changed, who did it and why? Link
Source data
to the source data.
Can you read it?
Data must be recorded permanently in a
L Legible Permanently
durable medium and be readable.
recorded
The data should be recorded at the time the
Was it done in “real
C Contemporaneous work is performed and date / time stamps
time”?
should follow in order.
Is the information the original record or a Is it original or true
O Original
certified true copy? copy?
No errors or editing performed without
A Accurate Is it accurate?
documented amendments.
All data including repeat or reanalysis
Complete 21 CFR 211.194
performed on the sample.
Consistent application of data time stamps
Consistent Date time stamps
in the expected sequence.
Common data integrity issue
Common passwords. Where analysts share passwords, it is not possible to identify who creates
or changes records, thus the A in ALCOA is not clear.

User privileges. The system configuration for the software does not adequately define or
segregate user levels and users have access to inappropriate software privileges such as
modification of methods and integration.
Computer system control. Laboratories have failed to implement adequate controls over data,
and unauthorized access to modify, delete, or not save electronic files is not prevented; the file,
therefore, may not be original, accurate, or complete.
Processing methods. Integration parameters are not controlled and there is no procedure to
define integration. Regulators are concerned over re-integration of chromatograms.
 Incomplete data. The record is not complete in this case. The definition of complete data
is open to interpretation--see references 13 and 14 for a detailed analysis of FDA 483
observations on complete data (21 CFR 211.194 and sub parts).
 Audit trails. In this case, the laboratory has turned off the audit-trail functionality within the
system. It is, therefore, not clear who has modified a file or why.

4.6 Pharmacopoeias
Pharmacopoeias are reference books including standards for the pharmaceutical drug
specifications. A pharmacopoeia is a legal document containing monographs and other texts for
general quality standards and individual quality standards for ingredients, dosage forms and
methods of analysis for medicines. It is an official reference to serve public health by the provision
of recognized common standards.
There are three Pharmacopoeias of international relevance:
EU Pharmacopoeia
US Pharmacopeia
JP Pharmacopoeia
The relevant Pharmacopoeia for your customer does not depend on the country where they are
located, it depends on the country where they want to sell their products (e.g. if a pharma
company in India wants to sell in the US  they have to be complaint to USP).
The methods that are described in the respective Pharmacopoeia force pharmaceutical
manufacturers to use defined measuring principles, parameters or specifications (e.g. certain
wavelengths, minimum accuracy, etc.). Therefore, they only buy instruments that fulfill these
expectations. If pharmaceutical manufacturers want to use measuring instruments with methods
that are not named explicitly in the Pharmacopoeia, they have to prove that the method is as
compatible as the named one. This can be extremely time-consuming, so they prefer to buy an
instrument stated in the Pharmacopoeia.
Figure 3 Screenshot of measuring principles of European Pharmacopoeia
Offering measurement techniques that are already implemented in the Pharmacopoeia is highly
advantageous.
4.6.1 US Pharmacopeia Chapter <1058>

The US Pharmacopeia (USP) is a non-profit, non-governmental agency that sets the public
standards for drugs and drug products for the US and many other countries. The FDA is a

governmental agency with regulatory authority for approving drugs and drug products that enforces
the standards published in the USP.
The chapter <1058> of the USP gives detailed information on how to do the qualification procedure
and describes the “4Q” model. The “4Q” model consists of 4 qualification parts, the Design
Qualification – DQ, the Installation Qualification – IQ, the Operational Qualification – OQ and
the Performance Qualification – PQ.
Did you know?

… that the Anton Paar Qualification Documentation is based on the chapter 1058 of
the US Pharmacopeia? We even provide a 6Q model which includes additionally the
Qualification Instruction (QI) and the Final Qualification (FQ).
The USP states three different classes of instruments that influence the effort required for
instrument qualification:
Figure 4 USP instrument categories
The exact grouping of an instrument must be determined by the user for their specific
requirements. Depending on individual user requirements, the same instrument may appropriately
fall into one group for one user and another group for another user. Therefore, a careful selection
of groups by users is highly encouraged.
Usually Anton Paar lab instruments like polarimeters, refractometers or density meters are
assigned by our customers to category B or C. To reduce efforts for instrument qualification in lab
environments some of our instruments offer a "Non-Storage Mode" that conforms to the United
States Pharmacopeia 1058 CAT-B, due to the simplification of the system. In this mode the data
memory is not available and the instrument does not store any measurements, checks or
adjustments. The results have to be either written down manually, exported, or printed directly after
every single measurement, check, or adjustment. If the instrument does not store any
measurement data it is usually not affected by the 21 CFR Part 11.

4.6.2 US & European Pharmacopeia Chapter for Anton Paar Instruments
US European
Instrument Chapter Name Chapter Name
Pharmacopeia Pharmacopoeia
DMA Gen. M 841 Specific Gravity 2.2.5 Specific Gravity, Relative Density
Nephelometry, Turbimetry and
HazeQC ME 855 2.2.1 Turbidity (check wavelength)
Visual Comparison
Abbemat (200)
831 Refractive Index 2.2.6 Refractive Index
300/350/450/500/550/650
MCP (100) 150/200/300/500 781 Optical Rotation 2.2.7 Optical Rotation
Carboxymethylcellulose Sodium Resistance of Consistency by
PNR 12 Monographs: 2.9.9
Paste, Microcrystalline Wax Penetrometry
Viscosity, Viscosity - Rotating
MCR & RheolabQC 912 Rotational Rheometer Methods 2.2.8, 2.2.10
Viscometer Method
Viscosity, Falling Ball and
Lovis M/ME 913 Rolling Ball Viscometer Method 2.2.8, 2.2.49 Automatic Rolling Ball
Viscometer Method
Globule Size Distribution in Lipid
Litesizer 729 N/A N/A
Injectable Emulsions
Multiwave PRO / Multiwave Elemental Impurities Limits, Metal Catalyst or Metal Reagent
232, 233 5.20, 2.4.8, etc.
GO Procedures Residues, Heavy Metals, etc.
SVM N/A N/A N/A N/A

5. Anton Paar Pharma Qualification Packages
5.1 General Knowledge

The term “qualification” is related to equipment or instruments. It ensures that the equipment
works correctly and that trustworthy data can be generated. In contrast the term “validation” is
related to a whole method, processes, applications, systems, software. The equipment
qualification is one part of the validation master plan of a pharma company. Anton Paar can
support the qualification procedure for our benchtop instruments. Nevertheless, the customer has
to include our documentation in the qualification system and has to ensure that our documentation
meets the company‟s internal requirements. In some cases the customer will have to perform
some additional tests.
Instruments that are used in the pharmaceutical industry have to be qualified. If the qualification is
created and performed by the pharma customer, it takes about weeks to months of skilled working
time. With the Anton Paar‟s Pharma Qualification Package and installation service the whole
procedure can be done in one to two working days, saving the customer a lot of time and money.
The Pharma Qualification Package offered by Anton Paar GmbH complies with all the relevant
pharmaceutical regulations: GMP, GAMP 5, 21 CFR Part 11, USP <1058> and uses a risk-based
approach. The instrument-specific Pharma Qualification Documentation is reviewed and approved
by the product manager. An external, independent Austrian institution, RCPE (Research Center for
Pharmaceutical Engineering), has certified the qualification documentation as being compliant with
the current pharmaceutical regulatory requirements and guidelines that apply to pharmaceutical
manufacturing companies and are relevant for equipment suppliers.
In general there are three different possibilities of instrument qualification, the Prospective
Qualification, the Retrospective Qualification and the Requalification.
The Prospective Qualification is usually the normal case, the qualification starts already prior to
buying the equipment by defining, for example, instrument specifications and software
requirements. The qualification should contain Design Qualification (DQ), Installation Qualification
(IQ), Operational Qualification (OQ) and Performance Qualification (PQ). We can support the
customer with PQP-S or PQP.
The Retrospective Qualification is performed if older equipment has to be qualified (that has not
been qualified yet). In theory no DQ, IQ and OQ are done, because the instrument is already
bought. Nevertheless, we try to support the customer with PQP-S or PQP, although some points
have to be discussed (e.g. documentation of the installation).
Requalification: see 5.1.2.
5.1.1 Location of the Qualification

The Design Qualification (DQ) is usually prepared by the customer together with the supplier.
Before the purchase it has to be ensured that the User Requirements Specification (URS) are
fulfilled. This is usually done by the sales person, who checks the needs of the customer and offers
the instrument and documentation accordingly. At the customer site the DQ is checked and
approved together with the customer. The DQ section of our PQP-S or PQP is filled in during the
installation procedure to document that the instrument specification meets the URS.
The Installation Qualification (IQ) checks and documents the correct installation and suitable
environment of the instrument and takes place at the customer site. The Operational Qualification
(OQ) ensures that the instrument operates as specified. The Performance Qualification (PQ) tests
the accurate operation of the instrument under the customer`s standard conditions with customer‟s
18/37 5. Anton Paar Pharma Qualification Packages XPAIE002EN-D

samples. Generally the PQ spans over the whole lifetime of the instrument but this is the user‟s
responsibility and not part of our provided Pharma Qualification Package. During the installation of
the PQP-S or PQP usually one or two samples are measured at the customer site.
The main part of the qualification procedure (IQ, OQ, PQ) actively happens at the customer site.
This qualification documentation can be done with or without the support of an Anton Paar
representative, but of course we highly recommend that a person that is trained by Anton Paar
performs the installation.
Figure 5 Overview of the Qualification Documentation including the places where they mainly happen
5.1.2 Qualification Support at Anton Paar

An overview of the different document and installation types available is given in the following
scheme:
Figure 6 Overview of the pharma packaged offered by Anton Paar
XPAIE002EN-D 5. Anton Paar Pharma Qualification Packages 19/37

Instrument Standard Installation: for all industry segments, including delivery and installation
without any documentation.
Instrument + IQ/OQ: for all industry segments, including delivery, installation and IQ/OQ report
(free of charge from Anton Paar – therefore supported by the product lines, not supported by the
pharma team).
PQP-S: for the cosmetics and food industry, hospitals, furthermore for R&D departments of the
pharmaceutical and biotechnological industry. In general the PQP-S is for customers who have to
follow GAMP5 and GMP but who do NOT have to be 21 CFR Part 11 compliant. In some cases it
can be sufficient also for customers who will use their instrument in “NonStorage Mode”.
Furthermore, the PQP-S is offered for Part 11 compliant instruments (e.g. DMA™ M) as a cheaper
option if 21 CFR Part 11 is not relevant. On the other hand it is also offered for instruments that are
not supported by a PQP due to lack of software compliance for 21 CFR Part 11 (e.g. DMA™ 35,
PNR 12, Abbemat 200).
Basically it has the same 6Q basis as the PQP - QI, DQ, IQ, OQ, PQ, FQ. The documentation has
approximately 50 pages and compared to the PQP the following documents are not included: As-
built specification, 21 CFR Part 11, Traceability Matrix, single chapter reports.
The average installation time is around 4 hours, depending on the instrument.
PQP: for the pharmaceutical, biotechnological, ambitious cosmetics and food industry based on
pharma-relevant regulations such as 21 CFR Part 11, GAMP5 and GMP. It covers all steps of a
complete instrument-specific pharma qualification procedure. The Qualification Package contains
documentation for QI, DQ, IQ, OQ, PQ, FQ (= “6Q”), Risk Analysis, 21 CFR Part 11 checklist, List
of Deviations and a Traceability matrix.
Requalification: (also “modification documentation”) is a special case dealing with an already

qualified instrument. The customer has to do a requalification if the instrument undergoes major
repairs or any other relevant modification. It might also be necessary if the equipment is
transported to another location or if the software is updated. The customer defines whether a
requalification is necessary and whether the whole qualification procedure has to be done or only
single tasks of the qualification tests (mainly OQ test).
We offer requalifications on enquiry and create a unique documentation depending on the reason
of the requalification and the needs of the customer. The basis is the first Anton Paar Qualification,
so requalifications are only done for instruments with PQP or PQP-S. Costs for requalification work
and regular maintenance are the responsibility of the Anton Paar subsidiary or distributor. To
ensure that the documentation meets the customer‟s requirements the pharma department needs
sufficient information (serial number, Pre-Fill Sheet, reason for requalification, list of testpoints that
should be redone).
Anton Paar‟s PQP-S and PQP are based on the “4Q” model, which is described by the US
Pharmacopeia chapter <1058> (see 4.6.1). The “4Q” model defines, among other things, the
responsibilities, all steps for qualification and testing (DQ, IQ, OQ, PQ), the criteria for risk
analysis, release procedure and the contents of qualification reports. Our documentation is a
comprehensive and detailed document providing all necessary documentation. With our “6Q”
model we even provide more than stated in the USP 1058, to ensure that all the customer`s needs
are satisfied:
 Qualification Instruction (QI)

 Design Qualification (DQ)
 Installation Qualification (IQ)
 Operational Qualification (OQ)
 Performance Qualification (PQ)
 Final Qualification (FQ)
In the following schema the differences between the document and installation types are shown.
The individual chapters and sections are described in chapter 5.1.3.

Figure 7 Overview of the documents in IQ/OQ, PQP-S and PQP
5.1.3 Products with Pharma Qualification Documents

At the moment the following instruments are supported with the Pharma Qualification Packages
(PQP/PQP-S/MOD):
 Abbemat 300/350/450/500/550/650 (Abbemat 3X00: PQP-S)

 MCP 150/200/300/500/5X00 (MCP 100: PQP-S)
 DMA™ 35 (PQP-S)
 DMA™ 501/1001 (PQP-S)
 DMA™ 4100 M / 4500 M / 5000 M (optional + Xsample™ / + pH ME)
 DMA™ M + Abbemat (optional + Xsample™ / + HazeQC / + pH ME)
 DMA™ M + Lovis 2000 M/ME (optional + Xsample™ / + HazeQC / + pH ME)
 Lovis 2000 M/ME (optional + Xsample)
 RheolabQC
 Multiwave PRO
 Multiwave GO (PQP-S)
 MCR xx1 and MCR xx2
 PNR 12 (PQP-S)
A list of part numbers is provided in the Extranet (XPAIE102). If a Pharma Qualification Package
for another instrument is needed, please inform us (pharma@anton-paar.com) or the respective
product management.

5.1.4 Sales & Service Teamwork
Quoting the suitable instrument, qualification package and installation combination to customers
from the pharmaceutical industry is the basis for a successful installation. The needs of the
customer have to be evaluated to ensure that all necessary regulations and wishes are fulfilled.
Otherwise, discussions and problems will arise during the instrument installation and qualification
procedure.
The responsibilities of sales and installation personnel have to be clearly structured and arranged
between all involved persons. The installation duration and necessary equipment (e.g. certified
thermometer, certified reference material, etc.) have to be discussed with the customer and
prepared accordingly.
5.1.5 Costs
Anton Paar‟s Pharma Qualification Packages save the customer a lot of time and money, therefore
each Pharma Qualification Documentation has a certain list price, which is around 10 % of the
instrument price (PQP-S even lower). This price is definitely cheaper than the costs which arise if a
customer compiles this document by himself/herself.
In most countries the installation time of the PQP is offered and charged separately. Therefore, the
customers also order the Qualification Support by an Anton Paar certified person. This ensures
that the installation is finished within 1 – 2 working days, depending on the instrument. Without the
documents and the Qualification Support an equipment qualification usually lasts over a month.
Therefore, the combination of the Pharma Qualification Documents plus the Qualification Support
saves customers a lot of time and money, since they do not have to allocate a person for the
paperwork and can use the instrument immediately after installation. It is the responsibility of the
sales person to quote a realistic installation time to ensure that all needs of the customer (and
costs of Anton Paar) are covered.
Did you know?

…that every single documentation is issued for each single instrument with the serial
number and customer details to ensure the traceability of the documentation?
5.1.6 Ordering Workflow

The Pharma Qualification Documentation should be ordered together with the instrument
(according to the pricelist, standard dealer‟s discount applies). In the Extranet you can find the Pre-
Fill Sheet (XPAIR001) with required details (company name, address, plant name, etc.), we need
to prepare the documentation. Please send it to the customer and forward the filled form to us
(pharma@anton-paar.com) before placing the order. Without the Pre-Fill Sheet an order
confirmation cannot be issued.
After receiving the order and all relevant data the Pharma Qualification Package is customized,
containing the customer data and instrument serial number. A pdf file is forwarded to the
responsible person in your country for the preparation of the installation. The hardcopy is shipped
together with the instrument to the customer.
Sometimes customers already have an Anton Paar instrument and want to qualify it after a few
months of use (retrospective qualification). Depending on the instrument, it is possible to perform a
PQP if we have all necessary details of the instrument (serial number, measuring systems, etc.),
although the instrument is already at the customer site.

5.2 Preparation and Installation of the Pharma Qualification Documentation
5.2.1 Preparation of the Installation

The successful preparation of an installation including a PQP-S or PQP requires a well-considered
sales procedure. Therefore, the installation person has to check all relevant points with the sales
person and the customer. The installation person (“authorized person”) has to ensure that the
suitable documentation and all necessary equipment is at the customer site on the day of
installation.
Required reading: Work through the “Checklist for Pharma Qualification Installations”
(XPAIE100). It can be found in the Extranet.
Further details will be discussed during the Pharma Installation Qualification training.
5.2.2 Persons Involved in the Qualification Procedure

There are three main people involved during the qualification procedure of Anton Paar‟s
qualification documentations:
Qualification Coordinator: The Qualification Coordinator establishes the Pharma Qualification

Documentation (authorized person) and coordinates the qualification procedure. He/she fills in the
paperwork and performs all necessary test points. Additionally, the Qualification Coordinator is
responsible for the training on the instrument. Typically an Anton Paar representative takes over
the role as Qualification Coordinator. He/she is a certified sales or service engineer who has
successfully completed the Pharma Installation Qualification Training and has a valid certificate.
Theoretically the customer can perform the installation of our Pharma Qualification Package by
him/herself. However, we highly recommend that a trained person from Anton Paar performs the
documentation as the qualification coordinator together with two people from the customer site.
Responsible User: The Responsible User is a responsible person from the customer site. Usually
he/she is also in future the lab person responsible for this instrument. During the qualification
procedure the responsible user performs the qualification documentation together with the
Qualification Coordinator and checks and signs all parts of the Pharma Qualification Documents.
Therefore he / she should be available for the whole qualification process.
Quality Assurance Officer: The Quality Assurance Officer is from the Quality Assurance
department at the customer site. He/she approves the qualification documents, inspects the
instruction, acceptance criteria and checks for compliance. The Quality Assurance Officer has to
approve with his/her signature all Qualification Reports and his/her signature completes the
Pharma Qualification Documentation. Measuring protocols (e.g. Calibration) do not have to be
approved by the Quality Assurance Officer.
Figure 8 The fields of report in the Qualification Documentation for signing and approving
In some cases two Anton Paar representatives (e.g. a service engineer and a product specialist)
perform a Qualification Documentation together at the customer site. One of them can take the role
as Qualification Coordinator and focus on the Pharma Documentation and the other one can take
the role as additional team member and focus on the practical part (installation, measurements
and training of the customer).

5.2.3 Start of Qualification Procedure
To avoid losing parts the instrument package should not be opened by the customer before
starting the qualification documentation. At the beginning of the Anton Paar Pharma
documentation you start with the Qualification Instruction (QI), where the instrument, sample cells,
accessories, software, etc. are defined. Furthermore, the qualification team is established and a
detailed description of all qualification steps is included. Therefore, the Qualification Instruction
represents the “roadmap” through the whole documentation.
Then the four main steps follow - DQ, IQ, OQ, PQ - with defined action for each step. The whole
qualification procedure ends with the Final Report (FQ). This document summarizes the outcome
of each main step of the qualification procedure. The Pharma Qualification Package can only be
ordered complete, we do not support splitting.
Figure 9 Content sheet of an MCP 500 PQP
As writing materials only non-erasable pens such as ballpoint or fountain pens in the colors
blue/red/green are allowed (in the UK, only black is allowed). All entries must be truthful, complete,
clearly and correctly signed and dated. Backdating or dating ahead is strictly forbidden.
The Anton Paar Qualification Documentation starts like a book at the first page. On the first page
you will find the Pre-Approval sheet, which has to be signed by you and the customer. Ask the
customer for a copy of the signed Pre-Approval sheet for your own evidence.
The next page is an overview on, how to go through the documentation. On the pages after the
cover sheet you will find the chapter Final Qualification, which will be done as the last qualification
step. The documentation starts directly in chapter 1 – Qualification Instruction (QI).

5.2.4 Qualification Instruction (QI)
The Qualification Instruction (QI) is the guideline for the complete qualification procedure. It
should be read carefully! The QI explains all following steps of the qualification documentation.
Ideally it should be studied by the Anton Paar representative before assisting or performing the
Pharma Qualification Documentation.
Inside the Qualification Instruction the responsible qualification team (Qualification Coordinator,
Responsible User and QA Officer) are listed.
The following points have to be filled in:
 The qualification team members

 Table of qualification (which chapters will be performed during the qualification procedure)
 General description of the instrument, accessories and software
User Requirements Specification (URS)
The supplier (Anton Paar) has the responsibility regarding the design, development and
manufacturing of instruments in a quality controlled environment. In addition, the supplier develops
functional and operational specifications.
The user (= customer) has the responsibility to develop a User Requirements Specification (URS)
prior to the purchase, to verify that the supplier‟s instrument meets the URS (product specification,
delivery, support) and to verify that the supplier works in a quality system environment (supplier
qualification - Anton Paar is ISO 9001:2008 certified).
Sometimes the customer sends the URS together with a questionnaire to the supplier. The
supplier answers the questions based on the instrument„s technical specifications including details
about service and support. This document is signed and sent back to the customer (the customer
signs it as well). This procedure ensures that the URS are in accordance with the As-built
Specifications.
Usually the customer checks himself/herself whether the URS are in accordance with the
instrument specifications released by the supplier and does not send the URS to the supplier. In
the QI there is the option to define whether the installation will be done without URS or with
existing URS. During the DQ the customer signs and approves that he/she accepts the received
instrument as specified and that the URS are in accordance with the As-built Specifications of the
instrument. In the Traceability Matrix there is the possibility to connect certain test points of the
URS to test points in the Pharma documentation.
5.2.5 Design Qualification (DQ)

The Design Qualification consists of the Qualification Plan, As-built Specification and the Risk
Analysis, which are the basis of the whole Pharma Qualification Documentation (with PQP-S: only
Qualification Plan and Risk Analysis).
Qualification Plan (QP)
The Qualification Plan can be found in chapter two of the Pharma Qualification map. It gives a
quick overview of the timetable, the scope of the qualification, the documentation, the requirements
for the qualification, the references, etc.

As-built Specification (AS)
The As-built Specification describes the technical specifications of the instrument and software
such as accuracy, design, environment for use, interfaces, performance parameters, material
quality, cleaning procedure, documentation and instrument qualification.
The specifications listed in the As-built Specifications are identical to those described in the
instruction manual.
By signing the As-built Specification the customer accepts the instrument as specified.
Risk Analysis (RA)
The Risk Analysis is performed to rate the risk of possible errors; it looks at all aspects such as,
among others, the delivery, configuration and operation. The Risk Analysis describes possible
errors, the effects and measures to avoid possible errors. In addition it defines the requirements
and the measures during the equipment qualification (IQ, OQ, PQ) to avoid these errors.
The Risk Analysis is one USP of the Pharma Qualification Package because it is not contained
in the Pharma Qualification Documents of our competitors.
The generally used Risk Analysis method is FMEA = Failure Mode in Effects Analysis, which lists
and assesses potential errors using a formal process. The Anton Paar Pharma Qualification uses a
variation of the FMEA, a simple text-based FMEA.
The Risk Analysis has to be checked together with the customer and irrelevant errors should be
crossed out. After signing and approving the Risk Analysis the Installation Qualification (IQ) can be
started.
Figure 10 As an example, a part of the Risk Analysis of the MCP 200

5.2.6 Installation Qualification (IQ)
Before the IQ can be started the DQ must be completed and all documents must be signed.
The Installation Qualification ensures that the instrument is delivered as ordered and correctly
installed (hardware and software). Additionally, it ensures that the environment is suitable for the
instrument. During the IQ, the instrument is assembled and installed. Initial tests are performed
and documented, but no measurements are performed.
The instrument package should be opened together with the customer at the beginning of the
Pharma Qualification Documentation.
The Installation Qualification Protocol (IQ) contains defined test points for the delivery,
documentation, identification (Serial Number), damage & cleanliness, the system, the material
quality, the installation, accessories and the software which have to be checked.
Every test point has a link to the appropriate document (Qualification Instruction (QI) or the As-built
Specification), which explains what to do and what is covered in this test point. Each single test
point has to be performed, marked, signed and dated.
For every test point which was performed, you need to check “□Yes” for passed, or if the test point
was not performed, check “□N/A”. If you check “□No” for not passed, a deviation arises.
If a deviation occurs the qualification documentation must be immediately paused. The

Qualification Coordinator has to explain the deviation to the other members of the qualification
team. Whether the qualification can be continued depends on the customer. The customer
decides whether the deviation is negligible or whether the qualification has to be stopped until
the deviation is eliminated.The deviation has to be written in the comment field of the related
protocol, the related Qualification Report, the List of Deviations and the Final Qualification
Report.
5.2.7 Operational Qualification (OQ)

Before the Operational Qualification can be started the Installation Qualification must be
completed, signed and approved.
The OQ is a documented collection of activities which are necessary to demonstrate that the
instrument will function according to its operational specifications in the intended environment. The
Operational Qualification Protocol lists all defined test points which ensure the correct operation of
the instrument in the defined environment.
The instrument is verified if it operates as it is specified by the supplier and required by the
customer. Additionally, the secure data handling, storage, back-up and archiving is tested. The
obtained results are evaluated and compared with the specifications that serve as acceptance
criteria and then documented in separate protocols.
The Operational Qualification of the PQP covers seven or more documents, the Operational
Qualification Protocol (OQ), Adjustment Protocols (AP), Calibration Protocols (CP),
Checklist 21 CFR Part 11 (CFR, only for PQP), User SOP (Standard Operating Procedure),
Customer Reference Sample (CRS) and the Operational Qualification Report (OR, only for
PQP). Depending on the individual instrument various protocols are additional parts of the
Operational Qualification.

If the First Check / First Measurement and Calibration are okay, no Adjustment is needed. You can
check □N/A and cross out the affected Adjustment pages. Also in the Traceability Matrix you can
check □N/A, because the Adjustment is not necessary.
During the Check and Calibration measurements not only the instrument specification are relevant
for the check and calibration limits. Also the uncertainty of the certified reference material
(standard) and the measuring handling have to be taken into account.
Check List 21 CFR Part 11 (included only in PQP)
If a customer`s instrument is affected by the regulations of 21 CFR Part 11 (this is a detail the
customer has to know), it is a must to do the 21 CFR Part 11 check list for compliance during the
qualification procedure of the instrument.
In our checklist the customer has to decide whether he/she will use the paper or the electronic data
as a legally binding document. This decision also influences the answers on the test points on the
following pages. In some cases, the customer has to be 21 CFR Part 11 compliant, but he/she
decides that one test point of the 21 CFR Part 11 checklist does not affect him/her (e.g. electronic
signature if a paper based system is used). In this case this test point will not be checked for
compliance during the Pharma Qualification Documentation and N/A will be checked. In most
cases a comment can help to keep everything traceable.
The complete checklist has to be answered together with the customer. By signing the check list
the system is checked for compliance.
In exceptional cases it might happen that the customer decides that he/she does not want to apply
21 CFR Part 11, although he/she has ordered a full PQP. If so, you check □N/A on the first page
and remove the relevant pages from consideration by crossing them out.
Figure 11 First page of the 21 CFR Part 11 checklist of the MCP 500

User Standard Operating Procedure (SOP)
User SOP refers to a short instruction manual for the instrument‟s use. It is a guideline for the
customer to handle the instrument correctly and is included in a transparent envelope at the end of
the documentation (printed and on a USB storage device). We offer it in English, but some SOPs
are also available in other languages (German, French, Spanish).
One SOP should be stored next to the instrument. Either the SOP recommended by Anton Paar
can be adapted or a customer-specific SOP can be created by the customer. The responsibility for
the creation and the correctness of this SOP lies with the Quality Assurance Office at the customer
site.
A Pharma Qualification Documentation containing an User SOP is not available from our
competition and therefore represents another USP of Anton Paar‟s package!
5.2.8 Performance Qualification (PQ)

The pre-requirement to start the Performance Qualification is that the Operational Qualification is
completed, signed and approved.
The PQ ensures that the instrument works under routine conditions (with customer samples)
according to the relevant specifications. Therefore, performance checks based on the instrument‟s
typical on-site applications are performed. The test should demonstrate trouble-free instrument
operation for the intended application.
Sometimes the Anton Paar representative is asked to leave before starting the PQ because the
customer wants to perform these measurements alone. There is an extra field at the beginning of
the PQ for such a case.
Before leaving do not forget to enter your name and signature in the Final Qualification Report
as the person who contributed to the qualification documentation.
The PQ covers 3 documents: the Performance Qualification Protocol (PQ), the Customer
Sample Protocol and the Performance Qualification Report (PR, only in PQP). It is finished as
soon as the test measurement of the customer sample was successful (decided by the
customer), both protocols and the Performance Qualification Report are filled in and the
Performance Qualification Report is signed and approved.
Basically after this the PQ is completed. Nevertheless, the performance check of the instrument
continues over the whole lifetime of the instrument to regularly test its accurate operation under
routine conditions. However, these tests are not covered in Anton Paar‟s Qualification
Documentation and have to be performed and documented by the customer. The type and
frequency of these tests, which depend on the sensitivity of the instrument and the criticality of the
tests, is user-specific. They can be done whenever the instrument is used or at regular intervals
e.g. at the start of every working day one standard is measured.

5.2.9 Final Qualification (FQ)
The Traceability Matrix (TM) is a final cross check to see whether all test points have been
performed. It is a good tool for you to finally check whether you performed everything or you forgot
something. This may save time during an audit, because it is easier for the customer or the auditor
to find all related test points and protocols.
The List of Deviations (DL) lists all deviations which have occurred during the qualification
documentation. It is good if this list is empty at the end of the installation. If a problem arises during
the installation, we recommend discussing it with the customer, finding a solution and documenting
everything traceably (e.g.: write a comment in the affected protocol). Deviation management will be
also discussed during the Pharma Installation Qualification Training.
If you check □not passed or □

not valid somewhere in the documentation this automatically
represents a deviation. As soon as a deviation occurs the problem has to be solved before the
qualification documentation can be continued. The deviation has to be written in the comment field
of the related Protocol, the Report, the List of Deviations and the Final Qualification Report.
Whether you are allowed to proceed with the qualification depends on the customer, because
he/she decides whether the deviation is negligible or whether the qualification documentation has
to be stopped until the deviation is eliminated.
In addition to the SOP and the Risk Analysis the Traceability Matrix is another USP of the Anton
Paar‟s Pharma Qualification Package.
In the Final Qualification Report (FR) you find a section, where all persons who actively
contributed to the qualification documentation have to sign and fill in their contact information.
Persons who were only trained are not included. It is very important that you sign in this section,
although you may leave before the installation is finished.
The Final Qualification Report summarizes the outcome of the complete qualification
documentation and therefore represents the most important part of the qualification procedure. As
soon as this document is signed and approved the qualification documentation is finished and the
instrument is qualified. The Anton Paar representative leaves the customer and asks for a copy of
the Qualification Documents, or at least a copy of the Pre-Approval Sheet for his/her own
documentation. The Pharma Qualification Folder stays at the customer site and he/she is
responsible for the storage of the folder.
The Final Qualification Report is the most important document for the pharmaceutical
manufacturer. This report is shown to the auditor or inspectors. Due to this fact the Final
Qualification Report is the first document in the Qualification map.
5.3 Aftersales Support for Pharma Customers
5.3.1 Service Level Agreement (SLA)

A service-level agreement (SLA) is the part of a service contract where the level of service is
formally defined. In practice, the term SLA is sometimes used to refer to the contracted delivery
time (of the service) or performance.
For the pharma customer it is essential to take care of maintenance issues over the whole lifecycle
of the instrument and to document how a trouble-free operation of the instrument over the whole

lifecycle can be guaranteed. A service contract should always be quoted together with the
equipment.
Anton Paar GmbH and all subsidiaries offer the following packages: the Anton Paar Standard,
Standard Plus and All Inclusive service contracts. These packages differ in the level of service and
price. Use the standard Anton Paar Certified Service folder (can be found on the Anton Paar
Extranet - XPAIP044) and define the ideal SLA for your customer‟s needs.
All Anton Paar service engineers are trained and authorized by Anton Paar. They have a certificate
that proves that they are trained.
The recalibration of equipment, maintenance, environmental monitoring and change control

procedures are additional user responsibilities and therefore not part of our offered PQ. However,
they can be part of a SLA. These topics can lead to a misunderstanding between customer and
supplier. It is definitely the customer„s responsibility to check the instrument„s performance on a
regular basis. He/she can ask the supplier to do it, but then it definitely has to be covered in a
Service Level Agreement which is separately offered and additionally charged.
Software (SW) upgrades, transportation to another location and major repairs are part of the
change control and therefore the customer‟s responsibility. Anton Paar as the supplier is only
partly affected due to assistance for SW upgrades and repairs. All these occurrences usually lead
to a requalification of the instrument. We offer also Requalification Documentations, which are
created individually for each customer, depending on the reason for the requalification.
5.3.2 Requalification Documents

Customers in the pharmaceutical industry have to do a requalification if the instrument undergoes
major repairs or any other relevant modification. It might also be necessary if the equipment is
transported to another location or if the software is updated. Sometimes a requalification is also
necessary after a certain time, even if no changes happen. The customer defines whether a
requalification is necessary and whether the whole qualification procedure has to be done or only
single tasks of the qualification tests (mainly OQ tests).
We offer requalifications on enquiry and create a unique documentation, depending on the reason
of the requalification and the needs of the customer. The basis is the first Anton Paar Qualification,
so requalifications are only done for instruments with PQP or PQP-S. Costs for requalification work
and regular maintenance are the responsibility of the Anton Paar subsidiary or distributor. To
ensure that the documentation meets the customer‟s requirements the pharma department needs
sufficient information (serial number, Pre-Fill Sheet, reason for requalification, list of testpoints that
should be redone).

6. Marketing and Support Material
As the pharma industry is identified as an important growing market for Anton Paar globally we
provide the following Sales and Marketing materials.
 Original documentations are without exception only available as hardcopy after the
purchase.
 Demo versions of the Qualification documents  pharma@anton-paar.com
The following documents can be found in the Extranet:
 Pre-Fill Sheet for the Pharma Qualification Package (XPAIR001)
 Pharma Installation Checklist (XPAIE100)
 Pharma Qualification Packages Part Numbers (XPAIE102)
 Pharma brochures & Poster can be found in the Extranet > Documents > Browse by branch
/ industry > Pharmaceutical industry / Medicine / Biotechnology
 Application Reports and Flashes:
o The Hidden Value of Instrument Manufacturers (XPAIA003)
o Polarimetric Determination of Amphetamine in Drugs (D02IA003)
o Determination of the Enantiomeric Purity of Dextromethorphan Hydrobromide
(D02IA015EN)
o Determination of glucosamine via polarimetry (D02IA017)
o Refractometric Analysis of Urine (D22IA016)
o Lovis 2000 M/ME goes for US Pharmacopeia (C72IA029)
o PNR 12 – Consistency of Pharmaceutical Products (H61IA006)
o Etc.
32/37 6. Marketing and Support Material XPAIE002EN-D

7. FAQ
Why are customers in the pharmaceutical industry sometimes harder to please than
others?
They have to fulfill certain rules and have to ensure that everything is traceable in the end. The
business in the pharmaceutical industry definitely differs from other industries like petro or
beverage.
Why is the chapter “Final Qualification” at the beginning of the qualification folder?
If an auditor would take the folder and open it, he/she would have to go through the whole map to
reach the requested Final Qualification Report, List of Deviations and Traceability Matrix. In our
folder the auditor finds his/her most important documents right at the beginning which simplifies
his/her work.
Who decides which standards and samples will be measured during the qualification?
Definitely the customer. The value, as well as the relevant temperature, volume and uncertainty
have to be considered.
Am I allowed to give the customer the Qualification Documentation in advance?

You have the possibility to show a protected pdf version or a hard copy with a watermark
“demonstration purpose only” to the customer. The files can be requested from pharma@anton-
paar.com.
What is the Audit Trail?

The Audit Trail is necessary if an instrument should be 21 CFR Part 11 compliant. The Audit Trail
is a function in the software to document all operating steps (Who, When, What and How) in a log
file with a computer-generated date and time stamp for all actions/changes.
Why is it important to send the end customer data (Pre-Fill Sheet) before the order to the
production site?
We need all relevant information together with the order of the instrument to ensure that the
customer‟s qualification documents are ready for shipment at the same time as the instrument.
Which software features are included in our instruments that are relevant for pharma
customers?
Depending on the instrument different software features are implemented. Relevant software
features are e.g.: user management, audit trail, electronic signature, non-storage mode. Ensure
that all features that are relevant for your customer are included in the quoted instrument.
Some of our instruments do not store data on a data storage instrument (data recording
plus storage), but on a separate computer (E.g. RheoCompass or Kalliope). Are these
instruments affected by the 21 CFR Part 11?
Most of the Anton Paar instruments have an implemented PC and during the qualification
documentation we check the instrument including the implemented PC for 21 CFR Part 11
compliance. In case of a separated computer which collects and stores the data external this has
XPAIE002EN-D 7. FAQ 33/37
to be handled in another way. Therefore, we check the whole system (instrument + software) for
compliance and you have to proceed the same way as for the other Anton Paar instruments.
Nevertheless, the customer has to qualify the computer on his/her own.
What happens if I write something wrong inside the qualification documents?

Try to fill in the qualification documents thoroughly. However, if a mistake occurs just cross out the
wrong phrase in a readable way, sign and date it. Check whether your customer has certain rules
for writing errors.
What should I do if a critical deviation arises during the qualification procedure?

If you can eliminate the deviation you proceed afterwards. For example, if the instrument is broken
and has to be sent back to Anton Paar the customer receives a second version of the
documentation free of charge provided the reason for the deviation is not the customer‟s fault.
What should I do if the customer wants changes made to the documents during the
qualification procedure?
It is no problem to make handwritten changes in the documents as long as they are traceable. E.g.
the customer wants more people signing the documents, just insert a new line on the relevant
pages.
What should I do with the copy of the Pre-Approval Sheet?

Store the copy of the qualification documents for your own documentation. We recommend to
store it in the CRM system.
What happens if the measuring results are outside the specifications?

During the calibration procedure not only the instrument specifications alone are relevant, also the
uncertainty of the certified reference material (standard) and in some cases handling uncertainty
have to be considered. The qualification can be completed although a result is outside the
specifications if it can be shown that the cause of the error does not originate from the instrument.
What can I do when the QA Officer wants to sign the documentation at the end of the day or
after I have left?
When the Qualification Assurance Officer says that he/she will sign the documentation later, you
have to trust him/her. But you must tell them that the date procedure must be traceable (no
backdating). When everything is cleared, you can work further through the whole documentation
without any approval from the Qualification Assurance Officer.
34/37 7. FAQ XPAIE002EN-D

8. Glossary
ALCOA-plus:
A commonly used acronym for “attributable, legible, contemporaneous, original and accurate”,
which puts additional emphasis on the attributes of being complete, consistent, enduring and
available – implicit basic ALCOA principles.
Data:
Data means all original records and true copies of original records, including source data and
metadata and all subsequent transformations and reports of these data, which are generated or
recorded at the time of the GXP activity and allow full and complete reconstruction and evaluation
of the GXP activity. Data should be accurately recorded by permanent means at the time of the
activity. Data may be contained in paper records (such as worksheets and logbooks), electronic
records and audit trails, photographs, microfilm or microfiche, audio- or video-files or any other
media whereby information related to GXP activities is recorded
Audit Trail:
The audit trail is a form of metadata that contains information associated with actions that relate to
the creation, modification or deletion of GXP records. An audit trail provides for secure recording of
life-cycle details such as creation, additions, deletions or alterations of information in a record,
either paper or electronic, without obscuring or overwriting the original record.
An audit trail facilitates the reconstruction of the history of such events relating to the record
regardless of its medium, including the “who, what, when and why” of the action.
For example, in a paper record, an audit trail of a change would be documented via a single-line
cross-out that allows the original entry to remain legible and documents the initials of the person
making the change, the date of the change and the reason for the change, as required to
substantiate and justify the change. In electronic records, secure, computer-generated,
timestamped audit trails should allow for reconstruction of the course of events relating to the
creation, modification and deletion of electronic data. Computergenerated audit trails should retain
the original entry and document the useridentification, the time/date stamp of the action, as well as
the reason for the change, as required to substantiate and justify the action. Computer-generated
audit trails may include discrete event logs, history files, database queries orreports or other
mechanisms that display events related to the computerized system, specific electronic records or
specific data contained within the record.
Computerized system:
A computerized system collectively controls the performance of one or more automated processes
and/or functions. It includes computer hardware, software, peripheral devices, networks and
documentation, e.g. manuals and standard operating procedures, as well as the personnel
interfacing with the hardware and software, e.g. users and information technology support
personnel
Data integrity:
Data integrity is the degree to which data are complete, consistent, accurate, trustworthy and
reliable and that these characteristics of the data are maintained throughout the data life cycle. The
data should be collected and maintained in a secure manner, such that they are attributable,
legible disaster recovery and may be periodically overwritten. Such temporary back-up copies
should not be relied upon as an archival mechanism.
XPAIE002EN-D 8. Glossary 35/37

9. Knowledge Check
1) GMP is the abbreviation of:
a) Give Me Paper c) Good Laboratory Practice
b) Good Manufacturing Practice d) Good Measurement Practice
2) Link the abbreviation for qualification with the correct names:

QP Operational Qualification
IQ Risk Analysis
PQ Deviation List
OQ As-built Specification
DL Performance Qualification
AP Installation Qualification
RA Adjustment Protocol
FR Customer Reference Sample
CRS Final Qualification Report
AS Qualification Plan
3) Which part of the Pharma documentation is the most important?

a) PQ c) FR
b) All d) IQ
4) Who is responsible for the qualification documentation before the start of the qualification?
a) Nobody c) Qualification Coordinator
b) Customer d) Pharma Team Graz
5) Who is responsible for the qualification documentation after qualification is finished?

a) Quality Assurance Officer c) Qualification Coordinator
b) Customer d) Responsible User
6) The PQP will be performed because:

a) …we must do it c) …we want to make money
b) …it‟s a legal requirement for the customer d) …it´s an Anton Paar guideline
7) What is the correct sequence of qualification steps during the installation of a Pharma
Qualification Documentation?
a) QP, AS, RA, IQ, OQ, PQ, FQ c) OQ, RA, IQ, FQ, QP, AS, PQ
b) FQ, IQ, OQ, PQ d) QI, DQ, IQ, OQ, PQ, FQ
36/37 9. Knowledge Check XPAIE002EN-D

8) Who will be part of the qualification team during a typical pharma installation?
a) Plant manager d) Responsible User
b) Members of the lab, who sign the reports e) Head of the Department of Anton Paar
c) Quality Assurance Officer f) Qualification Coordinator
9) If a deviation arises during the qualification procedure, what will you do?
Stop the qualification, wait until the next
a) Fill in the deviation list and continue c)
day, then continue the qualification
Stop the Qualification, talk to the
customer, solve the problem, if
b) Restart the Qualification d)
necessary fill in the Deviation List and
continue if the customer agrees
10) What is the aim of the Traceability Matrix?

To see if every point of the qualification
a) It´s part of the qualification documentation c)
have been checked
b) To have more paper in the PQP d) To save time during an audit
11) Do we need a copy of the signed Pre-Approval Sheet at the end of the qualification?
No, the customer is responsible for the
a) Yes, because we want to store more paper c)
documentation
Yes, because it proves that you
b) d) I will ask the QA whether I get one
successfully finished the qualification
12) The 21 CFR Part 11 is a guideline from

a) US-Pharmacopoeia d) FDA
b) Anton Paar e) GMP
c) Pharmaceutical Industry f) J- Pharmacopoeia
Solving: 1)b); 3)c); 4)c); 5)b); 6)b); 7)d); 8)c)d)f); 9)d), 10)c)d) ; 11b) 12)d)
XPAIE002EN-D 9. Knowledge Check 37/37

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XPAIE002EN-D FirstInfoPharma

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First Info

Version: February 2018

Changes, copyright, trademarks etc.

Address of the instrument producer:

Tel: +43 (0) 316 257-0

Date: March 2018

4/37 Contents XPAIE002EN-

1.1 Conventions for the Symbols in the Document

Did you know?

TIP - Tip gives extra information about the situation at hand.

XPAIE002EN- 1. Symbols in the Document 5/37

On Your Way to Becoming a Sales/Service Expert for Anton Paar Products:

What the First Info Can Do for You

 measuring/operating principles and methods

It’s the First Info – Not the Last Word

And now, enjoy getting on with your First Info package!

6/37 2. About the First Info XPAIE002EN-D

3.1 The Pharmaceutical Market

XPAIE002EN- 3. Pharma – Overview 7/37

Abbreviation Definition Abbreviation Definition

CAPA Corrective And Preventive Action OR OQ - Report

CRM Certified Reference Material PQ Performance Qualification

CRS Customer Reference Sample PQP Pharma Qualification Package

CS Customer Sample PQP-S Pharma Qualification Package Smart

CP Calibration Protocol PR PQ-Report

DQ Design Qualification QA Quality Assurance

DL Deviation List QC Quality Control

EN European Norm QI Qualification Instruction

FDA Food and Drug Administration QMS Quality Management System

FMEA Failure Mode in Effects Analysis QP Qualification Plan

FR Final Qualification Report RA Risk Analysis

GAMP Good Automated Manufacturing Practice SLA Service Level Agreement

GCP Good Clinical Practice SOP Standard Operating Procedure

GLP Good Laboratory Practice TM Traceability Matrix

GMP Good Manufacturing Practice URS User Requirements Specification

8/37 3. Pharma – Overview XPAIE002EN-D

The most important regulations and guidelines are:

 GMP/cGMP (c = current) - Good Manufacturing Practice

4.1 Regulations along the Pharmaceutical Chain

Figure 1: Summary of the pharmaceutical regulations

XPAIE002EN- 4. Regulations in the Pharmaceutical Industry 9/37

Good Manufacturing Practice is a commitment made by the pharmaceutical manufacturer to follow

Main purposes for GMP/cGMP:

 To meet legal requirements, including all GMP expectations

 What needs to be done (the process)

10/37 4. Regulations in the Pharmaceutical Industry XPAIE002EN-D

1 Infrastructure software (operating systems; middleware; DB managers; etc.)

3 Non-configurable SW configuration, off–the-shelf software (OTS)  Anton Paar instruments

4 Configured SW – configured to satisfy the business process

XPAIE002EN- 4. Regulations in the Pharmaceutical Industry 11/37

12/37 4. Regulations in the Pharmaceutical Industry XPAIE002EN-D

Data Integrity – ALCOA principle[1]

Table 1: ALCOA principle

“ALCOA” Description / Explanation Comments

Common data integrity issue

XPAIE002EN- 4. Regulations in the Pharmaceutical Industry 13/37

14/37 4. Regulations in the Pharmaceutical Industry XPAIE002EN-D

Figure 3 Screenshot of measuring principles of European Pharmacopoeia

4.6.1 US Pharmacopeia Chapter <1058>

XPAIE002EN- 4. Regulations in the Pharmaceutical Industry 15/37

Did you know?

Figure 4 USP instrument categories

16/37 4. Regulations in the Pharmaceutical Industry XPAIE002EN-D