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3.5 SQC as Pharmaceutical
Quality Assurance Solution
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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
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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.
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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
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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
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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.
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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
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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
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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
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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
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Integrated Quality Control
Product Quality Control beyond weighing for all applications
Product QualityA function of countless individual attributes
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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]!
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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?
FreeWeigh Net Static Weighing
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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
FreeWeigh.NetStatic Weighing
A wide range of remote balances and terminals are now available for
FreeWeigh.Net:
FreeWeigh Net Static Weighing
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XP XS
AX AT
PR PM
PB AG / PG
4-Series Viper/Spider
IDNet platform connected to ID30
FreeWeigh.NetStatic Weighing
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]!
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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
- C O N F I D E N T I A L -
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
- C O N F I D E N T I A L -
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
- C O N F I D E N T I A L -
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 !