3.5 Quality Assurance Solutions

8/12/2019 3.5 Quality Assurance Solutions

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3.5 SQC as Pharmaceutical

Quality Assurance Solution


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Internal usage only2

Content

SQC in Pharma means Quality Assurance

Tablet Testing

Packaging

SQC Product Range

FreeWeigh.Net

Success Examples


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Application Areas for Quality Assurance Solutions

4. Packaging3. Tableting1. Dispensing 2. Mixing

Quality control of tablets or capsules

directly in the tableting room and/or

nearby in a dedicated in-process control

(IPC) Lab

Filling control of single blisters and

completeness control of entire consumer

packages (box, blisters & leaflet)


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Weight Quality Control in Pharma Preparations

The exact mixture and concentration of API

and excipients is crucial for consumer health

A tablet or capsule must be pressed or filled

with the precise quantity

Both underfilling and overfilling are a health

risk and must be avoided at all costs:

- Underfill can render the treatmentineffective

- Overfill could endanger the health of thepatient

Therefore tolerance systems usedfor pharmaceutical products follow

strict rules of over AND underfill.

Fill weight

Tolerance limit T1-

Tolerance limit T2-

Average

Tolerance limit T1+

Tolerance limit T2+

X

X


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For Pharma SQC equals Quality Assurance (QA)

QUALITY = Consumer Health and

public safety: The tablet weight is a direct function ofpotency and therefore crucial for the drugs

effect

Besides the weight, many other tablet

characteristics are checked during quality

control: Hardness, Thickness, Diameter,

Disintegration, Dissolution, Friability, etc.

Quality and consumer health is also

maximized by foreign body inspection

(metal detection)

Furthermore, attributes are also

checked during packaging: Blister pack full

? Expiration date OK? Package inletexisting ?

ASSURANCE = GMP regulatory

requirement: Processes must be validated andquality must be built into processes

Good Documentation Practice (GDP):

Who did what, when and according to

which SOP

Operators must be trained andprocesses must be fail-proof

See chapter 3.1 GMP for further

information

For pharmaceutical applications doing just statistical quality control is not enough

Quality must be ASSURED by Good Manufacturing Practice and validation

With FreeWeigh.Net we can offer the customer an integratable, electronic quality control

solution, which only after being validated becomes a complete Quality Assurance solution !


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Typical integrated Quality Assurance Solution


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Major Benefits of FreeWeigh.Net QA Solution

1. Accelerated tablet testing

through integration andautomation:

Automatic weight control and

further tablet data integration

into one central quality report

2. Paperless, electronic, part 11-

conform documentation:

Error free, consistent, archivable batch

documentation, saving resources and

speeding up release procedures, while

ensuring Good Documentation Practice

3. Fully validated:

Comes with easy to execute, proven

best-practice validation manuals and

consulting support



Further Benefits

- Less user errors with streamlined proceduresEnforced and unified procedures are more easy to learn. Computer

supported data collection and automated data processing prevents errors

and misinterpretations!

- Less danger of insufficient quality or lost batches thanks to online controlOnline monitoring and availability of data can save a batch while it is in

production! Countermeasures can be taken immediately!

- Timesavings through automated and predefined reportingAutomated reporting is a huge saving potential for companies because

manual data recording can be abandoned!

- Note: The reduction of loss through overfill, which is an important argumentin food applications, is not really relevant here. Of course, potential savings

could be realized by minimizing overfill, but this becomes neglectable in

relation to the quality assurance aspects.



Tablet Testing

HardnessDiameter &

Thickness

All-in-one

Quality Assurance

solution

Press force, weight, diameter, thickness, hardness,

dissolution, friability and other characteristics are

monitored and controlled by electronic in-process

control solutions.

Dissolution

tester

Disintegration

tester

Weight

Friability

tester



European Pharmacopeia: Uniformity of Mass

European Pharmacopeia says:

Weigh individually 20 units taken at random (...) and determine the average

mass. Not more than 2 of the individual masses deviate from the average mass

by more than the percentage deviation shown in table and none deviates by

more than twice the percentage.

Pharmaceutical Form Average Mass Percentage deviation

Tablets (uncoated and film-coated)

80mg and less 10

More than 80mg and less than 250mg 7.5

250mg and more 5

Capsules, granules (uncoated, single-dose) and powders

(single-dose)

Less than 300mg 10

300 mg and more 7.5

Powders for parental use (single-dose) More than 40mg 10

Suppositories and pessaries All masses 5

Powders for eye-drops and powders for eye lotions

(single-dose)

Less than 300mg 10

300mg and more 7.5



US Pharmacopeia: Uniformity of Dosage Units

US Pharmacopeia specifies two methods to ensure "Uniformity of dosage units,

depending on the galenical form of the product.

- Weight variation:Under the assumption that the formulation of the substance is known and

homogeneous, weighing is considered suitable for the measurement.

Weigh accurately 10 ("units") individually. From the result of the Assay, obtained as

directed in the individual monograph, calculate the content of active ingredient in each

of the 10 tablets, assuming homogeneous distribution of the active ingredient.

Unless otherwise specified in the individual monograph, the requirements for dosage

uniformity are met if the amount of the active ingredient (...) lies within the range of

(e.g.) 85.0% to (e.g.) 115.0% of the label claim and the relative standard deviation is

less than equal to (e.g.) 6.0%.

- Content uniformity:This method requires an analysis of the substance in order to determine the contents

of active ingredient, e.g. a titrator or an HPLC. This analysis cannot be carried out by

weight or mass determination only.



SQC Solutions for Tablet Testing

Quality Control

SQC14 & SQC-AX- Suitable weighing ranges available- LV11Tablet feeder connectable- Quick and easy documentation

on the spot

QUALITY ASSURANCE

- Connectivity to precision balances,(also with LV11), Metal Detectors and

Checkweighers

- Device Integration Utility for all types oftablet testing equipment

- 21 CFR Part 11 compliance module- Huge saving potential with

reporting capabilities

- Comes with ready-to-use validationdocumentation



Weight Hardness

ThicknessDiameter

Length/

Diameter

Metal

detection

pHMoisture Temperature

Automated

tablet tester

Special Equipment for Tablet Testing

A wide range of special equipment is used

for in-process control tablet testing

Many of them can be integrated into a FreeWeigh.Net system by meansof the Device Integration Utility if they have a communication interface

Disintegration Dissolution



Filling control of single blisters or completeness

control of entire consumer packages (box, blisters

and leaflet)

This stage of quality assurance is mainly used for

completeness checks.

Typically checkweighers are used here, however,

for smaller batch sizes and/or smaller companies

manual equipment can be used as well.

Packaging



Final Check of the Product

There is more in a product than just the declared contents!

In addition to the control of each individual tablet and its correct amount

of active ingredient the following elements make a pharmaceuticalproduct to a sellable product:

- The correct amount of dosage units (tablets) for a complete treatment- No contaminants in the product, such as metallic parts- Damage-free packaging for safe transportation and to guarantee cleanliness

and durability- Product leaflet in each package- Correct expiry date- Batch identification for traceability- Proper package to bring the healthy

image towards the consumer



Integrated Quality Control

Product Quality Control beyond weighing for all applications

Product QualityA function of countless individual attributes



SQC Solutions for Packaging Control

SQC14 & SQC16

-Wide range weighing ranges available

- Quick and easy documentationon the spot

FreeWeigh.Net and/or intrinsic checkweigher specific SQC functionality- Connectivity to Garvens and Hi-Speed CheckWeighers

as well as Safeline Metal Detectors

- Online data acquisition fromin-process devices

- Collection of attribute data fromvisual checking

- 21 CFR Part 11 compliance- Comes with ready-to-use validation

documentation


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Brief SQC and QA product overview

Single station Network system

SQC14

(4-Series, AG, AX)

SQC16

(4-Series/Viper)

SQC-AX

(AX)

FreeWe

igh.Net

FreeW

eigh.Ne

t

Compac

t

Single station Network system

SQC14

(4-Series, AG, AX)

SQC16

(4-Series/Viper)

SQC-AX

(AX)

FreeWe

igh.Net

FreeW

eigh.Ne

t

Compac

t Focus


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Embedded SQC system as optional

firmware for top-level analyticalbalance line

Statistical quality control in

pharmacy production and laboratory

Easy operation with touch-screen

Alphanumeric keyboard on screen

Clearly arranged display

8 users, individual password

protection

Weighing range

AX: 22g - 510g

MX/UMX: 2.1g/5.1g

Readability

AX: 0.01mg-1mg

MX/UMX: 0.1g/1g

SQC-AX

SQC Compact SystemsI


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Up to 60 articles in SQC14/60

Printer and controller in one unit

For balances from micrograms to

tons:

MX, AX, MT, AT, AB, AG, PG-S, PB,

4-Series, Spider, Viper, MultiRange

Graphical representation of the

sample mean values, standard

deviation, histograms

User definable Tolerance Systems

EU Tolerance System

SQC14

SQC Compact SystemsII


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300 Articles

Individual tare:Up to 20 Articles, resp. Different random

samples series with a maximum of 50 individual

values can be done at the same time

Statistics:

3 long-term statistics / 2 with selectable

duration, 1 batch (selectable per article)

MonoBloc or Strain-gauge Technology:

For every application the suitable weighing technology

With and without W&M approval availableA4 Printer:

Not only a stripe printer, but also an A4 printer can be connected

PC Backup / Restore:

Safeguarding data and time

Keyboard and Barcode reader:Easy and quick data input

SQC16

SQC Compact SystemsIII

3000g to 35kg balances:

Allows the control of goods with a nominal

weight from 5g up to 30kg


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Brochures

The following brochures are available for SQC Compact Systems,

peripherals and product know-how:

SQC14 SQC16 LV11 METTLER TOLEDOSQC Competence

Further information and documents can be obtained from the product

manager in charge. Please write to [email protected]!
mailto:[email protected]:[email protected]


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Features and Functions

Statistical methods for analyzing and

controlling process variance

Qualitative and quantitative production

& laboratory data acquisition

Production planning, product data management and test planning

FDA 21 CFR Part 11 compliant functions

Online multi-language support

Open client server architecture

MS SQL database

Ethernet networking

SAP interface

FreeWeigh.NetQuality Assurance Software

x

n

ss


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Manual Automatic

Data Acquisition


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Manual Online Status, messages andadjustment suggestions

Process Control

Adjustment +0.3


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Manual with questionabletraceability!

Automatic and fully traceable!

Batch Reports and Records

R ti C biliti


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Configurable Reports

for...

- Samples- Statistics

Hourly

Daily

Weekly

Monthly

Yearly

Batch

-Alarms-Activities

Reporting Capabilities

Al d M it i


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Alarms

- T-- T+- Mean > UCL

- Mean < LCL- Range / Standard-

deviation > UCL

- Range / Standard-deviation < LCL

- Hourly, Shift, Daily,Weekly mean < Nominal

Monitoring

- Mean, Standard deviation, Range,

Range / Standard deviation

Alarm and Monitoring

Bi S i ith t ti R ti ( l *)


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Big Savings with automatic Reporting (only*)

Cost for manua l

reporting

Cost with

FreeWeigh.Net

a)Total number of charts per month

(one chart per line x 9 lines x 20 days per month

180 180

480 300

(sampling) (sampling)

35 0

(collection) (automatic)

1'545 900

d) Average hourly pay for line operator EUR 50.00 EUR 50.00

EUR 77'250.00 EUR 45'000.00

e) Number of reports per month 30 30

0

(automatic)

10 0

g) Average hourly pay of staff EUR 50.00 EUR 50.00

EUR 500.00 EUR 0.00

EUR 77'750.00 EUR 45'000.00

New System InvestmentTotal Monthly Savings

1. Cost of preparing line control charts

FreeWeigh.Net provides online monitoring and automatic report generation.

2. Cost of preparing daily and monthly reports

3. Return on investment

Total time preparing reports [hours]

e) x f) / 60

f) Average time to prepare each report [min.]

EUR 32'750.00

5.91 Months

Total monthly labor cost (1. + 2.)

Total monthly savings with FreeWeigh.Net

ROI =

Customer investment for Freeweigh.Net system EUR 193'520.00

b) Average time to record data per chart [min.]

c) Average time for chart calculations [min.]

20

Total time preparing charts [hours]

[b) + c)] x a) /60

Monthly cost to prepare charts

Monthly cost to prepare reports

* Savings due to

improved quality,

prevention of bad

batches and increased

line operation data

availability not included

Bi S i ith t ti R ti ( l *)


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Investment example of customer A: Total EUR 193520.--

Big Savings with automatic Reporting (only*)

Enduser (1 unit) units Enduser (Total)

EUR EUR

XP4002S + Remote + Ethernet 4'700.00 6 28'200.00

LV11 3'530.00 6 21'180.00

Barcode Scanner 440.00 3 1'320.00

Schleuniger 8M 15'000.00 2 30'000.00

Garvens S2 18'000.00 3 54'000.00

ID30 6'000.00 1 6'000.00

PC Hardware 1'500.00 2 3'000.00

MS SQL Server 1'800.00 1 1'800.00Connectivity (IT stuff, cables, hubs) N/A N/A 500.00

FreeWeigh.Net Basic License 3'608.00 1 3'608.00

FWN Device License 362.00 11 3'982.00

FWN Testplace Module 362.00 1 362.00

FWN Batch 504.00 1 504.00

FWN Attributes & Testplans 1'804.00 1 1'804.00

FWN CheckWeigher 1'660.00 1 1'660.00

FWN Device Integration Utility 1'082.00 1 1'082.00

FWN FreeReporting 1'082.00 1 1'082.00FWN Audit Trail 3'246.00 1 3'246.00

FWN Errors & Interventions 1'442.00 1 1'442.00

FWN Monitoring Process 722.00 1 722.00

FWN Validation Manual I 1'896.00 1 1'896.00

FWN Validation Manual II 2'652.00 1 2'652.00

Installation 1'122.00 7 7'854.00

Validation 1'302.00 12 15'624.00

Total EUR 193'520.00

* Savings due to

improved quality,

prevention of bad

batches and increased

line operation data

availability not included


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The networked SQC system, for factory wide data acquisition, MS SQL

database and vast expansion flexibility.

F W i h N t O ti


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The following modules are available:

Attributes and test plan module

Adjustment algorithms module

TestPlace module

Free reporting module

Batch handling module SPC module

Device integration utility module

Audit trail, 21 CFR Part 11 module

Data I/O module

SAFRIN - SAP Interface - module

CheckWeigher / CombiChecker module

Schleuniger AT4 module

FreeWeigh.NetOptions

F W i h N t D i F il


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Dynamic

weighing

Static

weighing

Hardness

ThicknessDiameter

LengthMetal

detection

pH Moisture Temperature Automated

tablet testing

Broad range of integrated data acquisition equipment for any application

FreeWeigh.NetDevice Family

Dissolution

FreeWeigh Net Static Weighing


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Remote Balance TestPlace module

Compact and easy solution withonly one device

Easy to install and maintain

Less cost

Less effort for validation

"Plug and play"

No Testplans

No graphical statistics

Possibility to execute Testplans

Graphical mean charts andhistograms

Expandability with additional 3rdparty devices or software

Easy software updates

Additional hardware Higher cost

More maintenance

FreeWeigh.NetStatic Weighing

Remote Balance or TestPlace module?



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Remote XP

Remote AX

PR with RemoteR option

PM with Keypad option

4-Series Remote

ID5 with DataPac

ID7 with DataPac

Spider 3S

Remote 4-Series

Remote XP


A wide range of remote balances and terminals are now available for

FreeWeigh.Net:



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XP XS

AX AT

PR PM

PB AG / PG

4-Series Viper/Spider

IDNet platform connected to ID30


All these balances can be locally connected to FreeWeigh.Net or

FreeWeigh.Net Compact with TestPlace module:

FreeWeigh Net Dynamic Weighing


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CheckWeighers:

- Garvens CheckWeigher TopLine(VL, VS, VS+, VO)

- Garvens S-Series

- Garvens S-Series CombiChecker

- Garvens E-Series

FreeWeigh.NetDynamic Weighing

FreeWeigh Net Metal Detection


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FreeWeigh.NetMetal Detection

Contaminant

FreeWeigh Net Tablet Tester AT4


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The tablet tester Dr. Schleuniger AT4 measures 4 parameters

Thickness, Weight, Diameter, Hardness

The AT4 is fully integrable into FreeWeigh.Net

- A TestPlace module is required

FreeWeigh.NetTablet Tester AT4


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Options Monitoring Process Module


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Online monitoring

Quick overview about

- Current activities in eachdepartment and filling line

- Alarms of qualitycharacteristics

- Number of metaldetections

Fast access to

monitoring screens

- Quality Status

OptionsMonitoring Process Module

Options Errors & Interventions Module


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Complements thorough quality

control with an assessment why

quality problems occur

Generates predefined handling

instructions for appropriate actions in

order to overcome quality problemsin production

OptionsErrors & Interventions Module

Options Free Reporting Module


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Simultaneous display of selected related product information in one

report:

- Activities / Alarms- Combined variable / attribute - samples / statistics- Variables: mean value, standard deviation, range control

charts, histograms

- Attributes: pareto, trend graphicfor individual attributes, c-charts,

u-charts

Freely selectable time period

Data pin-pointing

allows filtering

tolerance violators

from the report.

OptionsFree Reporting Module

Options Attributes & Testplans Module


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Input of product quality attributes from visual inspection and execution

of Testplans - linking individual measurements and checks together to

a "Macro"

- Ensures completeness ofquality data

- Simple operation

- Graphical representation with Paretocharts showing the frequency of errors

OptionsAttributes & Testplans Module

Options Batch Handling Module


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Raw material

Batch1 = 23278

time

Batch 23278 Batch 23277

C564 C563C565C566C567C568C569

Customer/Delivery order (Batch2) = Cxxx

Ideal for customers working with batch oriented processes

- Authorization of batch release in the batch catalog- Batch oriented statistics- Possibility for two concurrent

batches

OptionsBatch Handling Module

Options Audit Trail / Part 11 Module


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The Audit Trail / Part 11 module provides all necessary functions

needed for compliance with the FDA 21 CFR Part 11 regulations:

- Electronic Signatures- Audit Trail- User profiles and access control- Device control

See also Chapter 3.1 for more information

OptionsAudit Trail / Part 11 Module

Options Adjustment Algorithms Module


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Control / EvaluationAdjustment

+ -

Automatic monitoring of filling

and display of messages foradjustment of the filling head

without violation of QA tolerances

- Optimize Product Quality Algorithm regards scatter and

calculates a configurableadjustment message

OptionsAdjustment Algorithms Module

Filling/Tabletting

Filling / Tablet Pressing IPC

Options SPC Module


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Statistical Process Control with

- Control limits for mean value of random sample- Control limits for std. deviation and range of random sample- CuSum- Cp/Cpk

OptionsSPC Module

Options Data I/O Module


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Seamless data import and export from FreeWeigh.Net with other

systems:

- Text file (e.g. Tab-Text format)- Database access

Automatic and manual exchange of:

- Product data

- Statistics data- User data- Activities log- Alarms / Warnings

- MoreData I/O module

Text file or Database Interface

Host program

(e.g. ERP system)

Import/Export module

Options Data I/O Module

Options SAFRIN Module


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SAP data interface for download of Testplans and upload of results

(measurements, statistics and alarms acquired by FreeWeigh.Net)

or

SAFRINMETTLER TOLEDO SAP

FreeWeigh Interface

Data I/O moduleASCII File or Database

Interface

LIMS, JD Edwards,

POMS, Oracle or

AS400 applications ....

Import/Export Program

ERP

MES

Enterprise resource

planning- host system

In-process and net

weight control system

Instrumentation for

product quality

management

SAP R/3Module QM quality

management

Stand. Interface QM -IDI

Metal detection

CheckWeigher

pH and

Temperature

Moisture

analysis

Net weight

control

Hardness

and length

In-process and net weight

control system

Options SAFRIN Module

Brochures


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Brochures

The following brochures and documents are available for FreeWeigh.Net,

peripherals and product know-how:

METTLER TOLEDO

SQC Competence

FreeWeigh.Net

Product Brochure

FreeWeigh.Net

Compact

Product Brochure

FreeWeigh.Net

Pharma BrochureFreeWeigh.Net

Sales Brief

Further information and documents can be obtained from the product

manager in charge. Please write to [email protected]!
mailto:[email protected]:[email protected]


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Successful Pharma Installations &Happy Customers

Successful Pharma Audits


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We have been successfully audited on-site by the following major

pharmaceutical companies:

This shows that our processes are in accordance with pharmacustomers GMP requirements

It confirms us as competent supplier into the pharmaceutical

industry.

2004 2004

2001 2003

Successful Pharma Audits

- C O N F I D E N T I A L -

Success of FreeWeigh Net in Pharma I


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Pfizer has deployed 33 FreeWeigh.Net test places in Brooklyn with

ID30 terminals for:

- Tablet testing

- Laser room- Encapsulation- Packaging control

Contract value: USD 500'000.--

The number one in pharma uses FreeWeigh.Net in their Brooklyn

plant because it is the only system providing the 21 CFR Part 11

readiness required by FDA.

Success of FreeWeigh.Net in Pharma I


Success of FreeWeigh.Net in Pharma II


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Roche uses 6 FreeWeigh.Net test places with ID30 terminals in theirPenzberg plant in Germany.

They ordered services for:

-5 days process analysis, specification meeting

- 2 days pilot installation- 3 days training- 3 days validation consulting

Contract value: EUR 100'000.--

Roche, number one in diagnostics, was not only looking for an

outstanding SQC system, but also for professional project

management and validation support.

Success of FreeWeigh.Net in Pharma II


Success of FreeWeigh.Net in Pharma III


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GSK has ordered a FreeWeigh.Net system including integration into

SAP PP module with the FWN Data I/O.

The system went alive in January 2005 and will globally be rolled-out

in a standardized configuration.

GlaxoSmithKline audited BASY on-site by their centralized auditing

specialists for their global SQC project started in Germany.

Success of FreeWeigh.Net in Pharma III


Computer System Validation & Consulting Support


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p y g pp

See Chapter 3.1 GMP for more information !

User requirements

specification

Functional

specification

Design

specification

Implementation

Installation

qualification

Operational

qualification

Performancequalification

Project-cycle of a

computerized system

Validation is the hottest GMP topic and one main

if not the biggestvalue-add in our solution offering !

3.5 Quality Assurance Solutions

Documents

Transcript of 3.5 Quality Assurance Solutions