Pharmaceutical – Qualification of a packaging line

Manostaxx

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SOURCE: http://gmpua.com/World/Manu/13/c.htm

Just like all production equipment, a packaging line must also be qualified. The general process for a qualification is described in chapter 6 Qualification. The following pages contain examples for establishing qualification plans for a blister packaging line and the possible test items. These are only a sample and do not claim to be complete; the content of the qualification plans in particular must be adapted to the individual facility.

“Master qualification plan”

“Design qualification protocol”

“Design qualification report”

“Installation qualification protocol”

“Installation qualification report”

“Operational qualification protocol”

“Operational qualification report”

“Performance qualification protocol”

“Performance qualification report”

13.C.1 Master qualification plan

Company name Logo
Master qualification plan Doc.no.
Blister pack line Page x of y
valid from:
compiled
Name/function Date Signature
Head of qualification    
checked
Head of project    
Head of process technology    
approved
Head of packaging company    
Head of quality assurance    
Archiving
Quality assurance (original) Packaging unit (copy)
Document version index
Version Changes Date
1 New facility see signature
Contents

“Objectives”

“Responsibilities”

“Archiving”

“Short project description”

“Documents”

“Carrying out the qualification”

“Qualification phases”

“Test plans”

“Documentation of deficiencies”

“Result of the qualification levels”

Objectives

Only machines and facilities that are suitable for the specific purpose and for which this suitability can be demonstrated may be used to manufacture pharmaceutical products. The qualification of the machines and facilities is an adequate means of providing this proof. The various requirements and areas are described below with reference to the general master qualification plan (MQP) (SOP A1000-1). The objective of the qualification plan is to provide a summary of the qualification project.

Responsibilities

The allocated responsibilities for the various activities within the qualification project are listed below.

The personnel in the qualification team may be increased or modified, if necessary, within the qualification phase. If this is the case, the basic roles must still be guaranteed.

Role Description of tasks Name Company
Project manager
  • Responsible for the co-ordination of the entire project
Peter Luchs GMP-V
Head of qualification
  • Responsible for the co-ordination of the qualification activities
  • Planning measures
  • Managing the tests
  • Documentation checking
Ludwig
Qualle
GMP-V
Documentation representative
  • Compiling qualification documents
  • Documentation of the tests
  • Archiving (Q-Dok)
Dieter Bär GMP-V
Electrical engineering technician
  • Implementing measures and tests with regard to electrical equipment
Edgar
Tiger
Electrotest
Data
technician
  • Implementing measures and tests with regard to control technology
Detlef Trudel Data-test
Machine technician
  • Implementing measures and tests with regard to mechanical equipment
Martin Tappsig GMP-V
Safety
engineer
  • Implementing measures and tests with regard to safety equipment
Siegfried Fuchs GMP-V
Archiving

Qualification documents are archived in their original form in the packaging area (Q-Dok file) once they have received final authorisation from quality assurance. Copies of the qualification results are archived in the quality assurance, production management and packaging management departments. Quality assurance distributes the documents.

The documents are electronically stored under Q:\2003-01-VP\10003\ via the document management system.

Project planning

The objective is to start up the facility in October 2004. A rough outline is provided for information purposes.

Short project description

There follows a short description of the project.

The detailed description of the requirements can be found in the corresponding documents. An additional packaging line must be installed to increase the capacity of solid, oral dosage forms. The entire modular facility consists of a thermoforming line, cartoning machine and bundling machine.

The machine is primarily for the processing of aluminium cover foil and aluminium thermoforming foil. It must be possible to process other standard foils, e.g. PVC foils. All the processing steps and process data must be able to be visualised during production. Data and fault messages must be documented.

The design must allow separation of the GMP and engineering areas.

It must be possible to observe the production process from outside.

The product feed must be realised in a simple way which protects the product and which is part of the facility equipment.

All surfaces that come into contact with the product must be of adequate quality, e.g. electro-polished stainless steel.

A more precise definition of the requirements is presented in the user requirements and/or required specifications.

Documents

The following documents have already been compiled during the initial stages of the project or are available as a draft version.

Document File path
Qualification plan Q:\2003-01-VP\10003\MQP-01A01.pdf
User requirements Q:\2003-01-VP\10003\DQP-LHA03.pdf
Technical specifications Q:\2003-01-VP\10003\DQP-PH01A02.pdf
DQ protocol Q:\2003-01-VP\10003\DQP-DQP01A02.pdf
Carrying out the qualification
Qualification phases

The following phases will run throughout the entire qualification process:

  • Design qualification
  • Installation qualification
  • Function qualification
  • Performance qualification

Individual plans are compiled for these phases. The subsequent qualification phases cannot be commenced until the previous phase is complete. Completion is to be formally recognised by the authorisation and release of the report that is to be compiled. Deficiencies are permitted, insofar as they are not relevant to quality.

Plans and reports are compiled in the established format (SOP A1000-1).

Test plans

The test plans relating to the individual qualification levels are compiled and authorised accordingly by the persons responsible. The plans of the qualification levels contain references to the relevant authorised test plans.

Documentation of deficiencies

Deficiencies lists are to be drawn up to document deficiencies in a given qualification phase. The measures for remedying the deficiencies are also established in these lists. The deficiencies are evaluated and the measures are established by the qualification team. If the documented deficiencies are not relevant to quality, they may be passed on to the subsequent qualification phase.

The format for deficiencies lists is described below.

Aspect Description Measure
xxx xxx xxx
Result of the qualification levels

A result is generated for the qualification activities based on the associated plan for the qualification level.

The level for the relevant qualification is:

x complete.
o not complete

A deficiencies list is an integral part of the document and is included as part of the plan for the subsequent qualification level.

The overall result of the qualification includes an evaluation of the performance qualification.

The level of operational qualification is

x complete.
o not complete

A list of deficiencies has been finalised.

The facility is qualified and released for production.

All changes to the facility are subject to the change control procedure (SOP A1000CC05).

13.C.2 Design qualification (DQ)

13.C.2.1 Design qualification protocol

Company name Logo
Design qualification protocol Doc.no.
Blister pack line Page x of y
valid from:
compiled
Name/function Date Signature
Head of qualification    
checked
Head of project    
Head of process technology    
approved
Head of packaging unit    
Head of quality assurance    
Archiving
Quality assurance (original) Packaging unit(copy)
Document modification index
Version Changes Date
1 New facility see signature
Contents

“Objectives”

“Responsibilities”

“Checks”

“Documents”

Objectives

The objective of the design qualification is to define the requirements on the facility to ensure that the facility is suitable for the intended production stage.. The associated specifications must be adapted to the precise facility in each individual case.

The requirements are documented in the user requirements and/or the technical specifications, which are used to draw up a quote.

Responsibilities

The responsibilities for this project are established in MQP.

Checks

Checks and activities are carried out as part of the design qualification:

Document check regarding presence, completeness and approval:

  • User requirements
  • Technical specifications
  • Order, order confirmation
  • Status of the supplier qualification
  • Component list
  • Installation plan
  • Electro plans, pneumatics plans
  • Project plan

Comparison of:

  • Technical specification/order confirmation

Compilation of a:

  • Risk analysis
  • Deficiencies list (DQ)
Documents

The following documents have already been compiled during the initial stages of the project or are available as a draft version.

Document File path
Qualification plan Q:\2003-01-VP\10003\MQP-01A01.pdf
User requirements Q:\2003-01-VP\10003\DQP-LHA03.pdf
Technical specifications Q:\2003-01-VP\10003\DQP-PH01A02.pdf
DQ protocol Q:\2003-01-VP\10003\DQP-DQP01A02.pdf

13.C.2.2 Design qualification report

Company name Logo
Design qualification report Doc.no.
Blister pack line Page x of y
valid from:
compiled
Name/function Date Signature
Head of qualification    
checked
Head of project    
Head of process technology    
approved
Head of packaging unit    
Head of quality assurance    
Archiving
Quality assurance (original) Packaging unit (copy)
Document modification index
Version Changes Date
1 New facility see signature
Contents

“Documentation checking”

“Risk analysis”

“Framework documents”

“Deficiencies list”

“Result of the design qualification”

Documentation checking

The presence, completeness and approval have been checked in accordance with the qualification plan.

Document Testing File path
User requirements complies Q:\2003-01-VP\10003\DQP-LHA03.pdf
Technical specifications complies Q:\2003-01-VP\10003\DQP-PH01A02.pdf
Order, order confirmation complies Q:\2003-01-VP\10003\DQB-AUF04A03.pdf

Q:\2003-01-VP\10003\DQB-AB01A01.pdf

Status of the supplier qualification complies Q:\SuppQual\VP05.pdf
Component list complies
see list of deficiencies
Q:\2003-01-VP\10003\DQB-FL01A01.pdf
Installation plan complies Q:\2003-01-VP\10003\DQB-AUFPL01A03.pdf
Electro plans, pneumatics plans complies

see list of
deficiencies

Q:\2003-01-VP\10003\DQB-ELEK03B01.pdf

Q:\2003-01-VP\10003\DQB-PNEU02B04.pdf

Project plan complies Q:\2003-01-VP\10003\DQP-PP02C02.pdf

The technical specification and order confirmation were compared with the following result:

Deviation Evaluation Measures
Compressed air requirement is higher than defined Non-critical Available pressure is sufficient. Exceeded by 12 %. Overall capacity is not jeopardised.
Control balance: change of type (successor) Non-critical Check as part of OQ
Risk analysis

The following risk analysis was carried out and documented by the project team based on the available data and experiences.

 

Company name Logo
Design qualification report Doc.no.
Blister pack line Page x of y
valid from:
No. Aspect/action Effect Solution Critical Measures
Moulded foils
1. End of foil Machine continues to run, products not packaged. Fault detected by sensor: Machine stop or prevention of start; Failure message yes OQ-check
2. Adhesive parts Moulded foil adheres to packaging Sensor: no product supply, ejection of packages yes OQ-check
3. Tear in aluminium moulded foil Machine continues operating Tear check: sensor to detect faults,interruption in product feed yes OQ-check
Cover foils
4. End of foil Machine continues to run, products not packaged. Fault detected by sensor: machine stop or prevention of start; failure message yes OQ-check
5. Adhesive parts Cover foil adheres to packaging Sensor: no product supply, ejection of packages yes OQ-check
6. Incorrect positioning of printed cover foil Package has incorrect printing Control of printed marks yes OQ-check
Foil feed
7. Foil inserted incorrectly unsuitable parameters, incorrect packages are rejected Monitoring of rollers yes OQ-check
Heating station
8. Temperature deviation Insufficient heating or damage to the moulded foil Sensors for automatic control of the actual temperatures (calibrated measuring system). Machine stop or prevention of start yes OQ-check,
measuring point calibration
Moulding station
9. Low compressed air level Incorrect shape of wells Monitoring of the compressed air, machine stops or start-up is prevented if there is negative pressure yes OQ-check,
measuring point calibration
10. Insufficient cooling Moulded foil damaged Sensors for automatic control of the actual temperatures (calibrated measuring system). Machine stop or prevention of start yes OQ-check,
measuring point calibration
11. Clamping force insufficient Incorrect shape of wells Readjustment of the clamping force yes OQ-check,
measuring point calibration
Product supply
12. Product feed not activated or in incorrect position Empty packages Linking of product feed (taking the pre-dosing option into consideration) and machine start-up in automatic mode yes OQ-check
13. Holding tank empty Empty packages Content control for detection. Ejection of detected packages; Machine stop after defined number for production error yes OQ-check
14. Imprecise positioning of the product in the wells Product is protruding Sensor: ejection of detected packages; Machine stop after defined number for production error yes OQ-check
15. Incorrect, faulty products Size of product and packaging material are incompatible Content control, sensors yes OQ-check
Content control
16. Incorrect camera position Inadequate fault detection Permanent fault detection, .machine stop after defined number for production error yes OQ-check
17. Incorrect alignment of the lens Inadequate fault detection Permanent fault detection, .machine stop after defined number for production error yes OQ-check
18. Content control not activated No fault detection Failure message yes OQ-check
19. Content control defective Inadequate fault detection Machine stop or prevention of start yes OQ-check
Sealing station
20. Anomalous sealing temperature display Inadequate seal Calibration of measuring system, test for tightness yes OQ-check,
measuring point calibration
21. Anomalous sealing pressure display Inadequate seal Calibration of measuring system, test for tightness yes OQ-check,
measuring point calibration
22. Imprecise positioning of the moulded and cover foil inadequate seal Alignment, tightness testing yes OQ-check
Coding
23. Imprecise positioning Coding in the wrong place or coding incomplete Alignment, sample test yes OQ-check
24. Deviating temperature Inadequate coding or blister damage Sensors for automatic control of the actual temperatures (calibrated measuring system). Machine stop or prevention of start yes OQ-check

Measuring point calibration

25. Incorrect types Incorrect variable data Sample test yes not applicable
Perforation station
26. Blunt knife Inadequate perforation Sample test yes not applicable
27. Incorrect tool Incorrect perforation Correction, sample test yes not applicable
Die-cutting station
28. Blunt knife Inadequate die cutting Sample test yes not applicable
29. Incorrect tool Incorrect die cutting Correction, sample test yes not applicable
Discharge
30. Sucker damaged Undamaged product falls into collecting tray for damaged product Ejection controls yes OQ-check
31. Ejection control fault No detection of damaged product, which is not ejected Failure message: machine stop or prevention of start yes OQ-check
Sorting device
32. Incorrect alignment Imprecise transfer to the subsequent process Sensor monitoring yes OQ-check
33. Sensor fault Multiple transfer problems Failure message to control yes OQ-check
Folding cartons
34. Incorrect folding carton Incorrect folding carton Code reader yes OQ-check
35. Low compressed air level Incorrect sorting, stacking, transfer Monitoring of the compressed air and vacuum control, machine stops or start-up is prevented yes OQ-check
36. Incorrect number of blisters Under or overfilling of folding cartons Control balance, sensors yes OQ-check

Balance calibration

Folding carton coding
37. Imprecise positioning Coding in the wrong place or coding incomplete Alignment, sample test yes not applicable
38. Deviating temperature Inadequate coding or blister damage Sensors for automatic control of the actual temperatures (calibrated measuring system). Machine stop or prevention of start yes OQ-check

Measuring point calibration

39. Incorrect types Incorrect variable data Sample test yes not applicable
Package insert
40. Incorrect package leaflet Incorrect package insert Code reader yes OQ-check
41. Package insert missing No package insert Code reader, lumat controls, ejection control, control balance yes OQ-check
42. Packages closed incorrectly Packages open and damaged Sample control yes not applicable
Code reader
43. Code reader not activated No fault detection Failure message yes OQ-check
44. Code reader faulty Inadequate fault detection Machine stop or prevention of start yes OQ-check
45. Reject control, ejection control insufficient Incorrect packages Failure message, machine stops yes OQ-check
Lumat reader
46. Lumat reader not activated No fault detection Failure message yes OQ-check
47. Lumat reader defective Inadequate fault detection Machine stop or prevention of start yes OQ-check
Transfer, control balance
48. Control balance not activated No fault detection Failure message yes OQ-check
49. Control balance defective Inadequate fault detection In-process check yes not applicable
50. Reject control, ejection control insufficient Incorrect packages In-process check yes not applicable
Bundling machine
51. Congestion transferring to bundling machine Congestion in the shrinking tunnel: package bundles are heated before the outlet Time recording and alarm if time is exceeded yes OQ-check
52. Incorrect temperature Insufficient shrinking or thermal load Temperature monitoring yes OQ-check;
measuring point calibration
53. Incorrect counting Incorrect number of packages in the bundle Sample test yes not applicable
Control
54. Incorrect function process and displays Machine functions faulty Testing yes OQ-check
55. Incorrect parameters Machine functions faulty Testing yes not applicable
56. Critical functions or parameters are not adequately protected (password) Settings made and modified by unauthorised (unqualified) personnel. Hierarchical password system yes OQ-check
57. System validity lacking Reproducibility and product safety not guaranteed Testing yes IQ, OQ-check
Energy supply
58. Interruption in supply voltage Loss of data. Restarting results in incorrect packages Memory protected against zero voltage; noting and detecting positions and ejection volumes yes OQ-check
Generalities
59. Operator error Incorrect packages Training, operating procedures, displays, messages, documentation procedures yes not applicable
Framework documents
Document File path
Qualification plan Q:\2003-01-VP\10003\MQP-01A01.pdf
DQ protocol Q:\2003-01-VP\10003\DQP-DQP01A02.pdf
DQ report Q:\2003-01-VP\10003\DQB-DQB01A02.pdf
Deficiencies list
Aspect Description Measure
Component list Update after change is still outstanding. No effect on GMP aspects, therefore non-critical Update
Pneumatics plan Agreed change still to be updated in drawing. No effect on GMP aspects, therefore non-critical Update
Result of the design qualification

The checks and activities have been carried out in accordance with the specifications of the qualification plan for the design qualification.

The level of design qualification is

x complete.
o not complete

A deficiencies list is an integral part of the document and is included as part of the plan for the installation qualification.

13.C.3 Installation qualification (IQ)

13.C.3.1 Installation qualification protocol

Company name Logo
Installation qualification protocol Doc.no.
Blister pack line Page x of y
valid from:
compiles
Name/function Date Signature
Head of qualification    
checked
Head of project    
Head of process technology    
approved
Head of packaging unit    
Head of quality assurance    
Archiving
Quality assurance (original) Packaging unit (copy)
Document modification index
Version Changes Date
1 New facility see signature
Contents

“Objectives”

“Responsibilities”

“Checks”

“Documentation checking”

“Component checking”

“Test plans”

“Documents”

Objectives

The objective of the installation qualification is to document the correct implementation of the previously defined requirements for the manufacturing and assembly operations of the facility. The documentation contains information about identification of the overall scope of delivery of the pharmaceutical process equipment and confirmation that the supplied components correspond to the specifications that were defined during the draft phase.

Responsibilities

The responsibilities for this project are established in MQP.

Checks

Checks and activities are carried out as part of the installation qualification:

Documentation checking

Document check regarding presence, completeness and approval:

  • DQ report
  • DQ deficiencies list
  • Installation drawing
  • Certificates (ISO, CE, free from asbestos)
  • Material specification of parts coming into contact with the product
  • Calibration list: List of measuring points, calibration procedures, suitability of measuring instruments
  • Technical documentation (maintenance schedule, user instructions, list of lubricants, list of filters, MSR list, pneumatics plan, media supply, equipment list, spare parts list)
  • QA machine acceptance by the suppliers
  • FAT records
Component checking

Check for the correct installation of the defined components:

  • Completeness and conformity with the plans
  • Pressure test (moulding station)
  • Test of the direction of rotation (motors)
  • Calibration (GMP-relevant measured sections for temperatures and pressures, balances (dynamic, static), camera systems, code readers; each with min./max./target value)

Check of aspects subject to CSV:

  • Software: version number
  • Plan for input/output, electrical diagram
  • Function plan with parameter list
  • Explanation of symbols and variables
  • Back-up file
Test plans

The relevant test plans including the acceptance criteria and specifications for execution are in the documents listed below. The defined checks are carried out as part of the FAT. The various individual test plans are referred to in the FAT plan document.

FAT File path
Specification for execution Q:\QZ\FAT03A01.pdf
FAT protocol Q:\2003-01-VP\10003\IQP-FAT01A01.pdf
Calibration File path
Specification for execution Q:\Kalib\TEMP04D01.pdf
Q:\Kalib\PRESSURE03C02.pdf
Foil heating, upper plate Q:\2003-01-VP\10003\IQP-KAL01A02.pdf
Foil heating, lower plate Q:\2003-01-VP\10003\IQP-KAL02A02.pdf
Moulding station cooling Q:\2003-01-VP\10003\IQP-KAL03A02.pdf
Moulding station heating Q:\2003-01-VP\10003\IQP-KAL04A02.pdf
Perforation heating Q:\2003-01-VP\10003\IQP-KAL05A02.pdf
Coding heating Q:\2003-01-VP\10003\IQP-KAL06A01.pdf
Sealing pressure 1 Q:\2003-01-VP\10003\IQP-KAL01B01.pdf
Sealing pressure 2 Q:\2003-01-VP\10003\IQP-KAL02B01.pdf
Manometer Q:\Kalib\PRESSURE02E01.pdf
Component check File path
Specification for execution Q:\QZ\COMP03A02.pdf
Utilities Q:\2003-01-VP\10003\IQP-COMP01A01.pdf
Electrics Q:\2003-01-VP\10003\IQP-COMP02A02.pdf
Pneumatics Q:\2003-01-VP\10003\IQP-COMP03A03.pdf
Overall configuration Q:\2003-01-VP\10003\IQP-COMP04A02.pdf
CSV analysis File path
Specification for execution Q:\QZ\CSV04A01.pdf
Testing Q:\2003-01-VP\10003\IQP-CSV01A03.pdf
Documents

The following documents have already been compiled during the initial stages of the project or are available as a draft version.

Document File path
Qualification plan Q:\2003-01-VP\10003\MQP-01A01.pdf
DQ protocol Q:\2003-01-VP\10003\DQP-DQP01A02.pdf
DQ report Q:\2003-01-VP\10003\DQB-DQB01A02.pdf
IQ protocol Q:\2003-01-VP\10003\IQP-IQP03A01.pdf

13.C.3.2 Installation qualification report

Company name Logo
Installation qualification report Doc.no.
Blister pack line Page x of y
valid from:
compiled
Name/function Date Signature
Head of qualification    
checked
Head of project    
Head of process technology    
approved
Head of packaging unit    
Head of quality assurance    
Archiving
Quality assurance (original) Packaging unit (copy)
Document modification index
Version Changes Date
1 New facility see signature
Contents

“DQ deficiencies list”

“Checks”

“Documentation checking”

“Calibration”

“Component checks”

“Framework documents”

“Result of the installation qualification”

DQ deficiencies list

The following deficiencies have been documented as part of the design qualification. The current status has been checked.

Document DQ status IQ status
Component list Update after change is still outstanding. No effect on GMP aspects, therefore non-critical complete
Pneumatics plan Agreed change still to be updated in drawing. No effect on GMP aspects, therefore non-critical complete
Checks

Checks and activities are carried out as part of the installation qualification:

Documentation checking

The presence, completeness and approval have been checked in accordance with the qualification plan.

Document Testing File path
DQ report complies Q:\2003-01-VP\10003\DQB-DQB01A02.pdf
DQ deficiencies list complies Q:\2003-01-VP\10003\DQB-DQB01A02.pdf
Installation drawing complies Q:\2003-01-VP\10003\IQB-INSTZ02A03.pdf
Certificates (ISO, CE, free from asbestos) complies
see list of deficiencies
Q:\2003-01-VP\10003\IQB-CERT01A03.pdf
Material specification of parts coming into contact with the product complies Q:\2003-01-VP\10003\IQB-CERT02A02.pdf
Calibration list: List of measuring points, calibration procedures, suitability of measuring instruments complies Q:\2003-01-VP\10003\IQP-CERT01K02.pdf
Document Testing File path
Technical documentation (maintenance schedule, user instructions, list of lubricants, list of filters, MSR list, pneumatics plan, media supply, equipment list, spare parts list) complies

see list of deficiencies

Q:\2003-01-VP\10003\IQB-DOC05T01.pdf

Q:\2003-01-VP\10003\IQB-DOC07T01.pdf

Q:\2003-01-VP\10003\IQB-DOC08T01.pdf

Q:\2003-01-VP\10003\IQB-DOC10T01.pdf

Q:\2003-01-VP\10003\IQB-DOC12T01.pdf

Q:\2003-01-VP\10003\IQB-DOC13T01.pdf

Q:\2003-01-VP\10003\IQB-INST01A01.pdf

Q:\2003-01-VP\10003\IQB-INST02A02.pdf

Q:\2003-01-VP\10003\IQB-INST03A03.pdf

Q:\2003-01-VP\10003\IQB-DOC22T01.pdf

QA machine acceptance by the suppliers complies Q:\2003-01-VP\10003\IQB-DOC01QA01.pdf
FAT records complies Q:\2003-01-VP\10003\IQB-FAT01A01.pdf

Q:\2003-01-VP\10003\IQB-FAT02A01.pdf

Q:\2003-01-VP\10003\IQB-FAT03A01.pdf

Q:\2003-01-VP\10003\IQB-FAT04A01.pdf

Q:\2003-01-VP\10003\IQB-FAT05A01.pdf

Q:\2003-01-VP\10003\IQB-FAT06A01.pdf

Q:\2003-01-VP\10003\IQB-FAT07A01.pdf

Q:\2003-01-VP\10003\IQB-FAT08A01.pdf

Q:\2003-01-VP\10003\IQB-FAT09A01.pdf

Q:\2003-01-VP\10003\IQB-FAT10A01.pdf

Aspects subject to CSV complies Q:\2003-01-VP\10003\IQB-CSV01D01.pdf
Calibration
Document Testing File path
Film heating, upper plate complies Q:\2003-01-VP\10003\IQP-CAL01A02.pdf
Film heating, lower plate complies Q:\2003-01-VP\10003\IQB-CAL02A02.pdf
Moulding station cooling complies Q:\2003-01-VP\10003\IQB-CAL03A02.pdf
Moulding station heating complies Q:\2003-01-VP\10003\IQB-CAL04A02.pdf
Perforation heating complies Q:\2003-01-VP\10003\IQB-CAL05A02.pdf
Coding heating complies Q:\2003-01-VP\10003\IQB-CAL06A01.pdf
Sealing pressure 1 complies Q:\2003-01-VP\10003\IQB-CAL01B01.pdf
Sealing pressure 2 complies Q:\2003-01-VP\10003\IQB-CAL02B01.pdf
Manometer complies Q:\2003-01-VP\10003\IQB-CAL0D01.pdf
Balances (dynamic, static) complies Q:\2003-01-VP\10003\IQB-CAL01W01.pdf
Component checks
Document Testing File path
Code reader (see FAT) complies Q:\2003-01-VP\10003\IQB-FAT01B01.pdf
Pressure vessel (see FAT) complies Q:\2003-01-VP\10003\IQB-FAT02B1.pdf
Motor test (see FAT) complies Q:\2003-01-VP\10003\IQB-FAT03B01.pdf
Utilities (see FAT) complies Q:\2003-01-VP\10003\IQB-FAT04B01.pdf
Electrics (see FAT) complies Q:\2003-01-VP\10003\IQB-FAT05B01.pdf
Pneumatics (see FAT) complies Q:\2003-01-VP\10003\IQB-FAT06B01.pdf
Total configuration
(see FAT)
complies
see list of
deficiencies
Q:\2003-01-VP\10003\IQB-FAT07B01.pdf
Framework documents
Document Testing
Qualification plan Q:\2003-01-VP\10003\MQP-01A01.pdf
DQ plan Q:\2003-01-VP\10003\DQP-DQP01A02.pdf
DQ report Q:\2003-01-VP\10003\DQB-DQB01A02.pdf
IQ plan Q:\2003-01-VP\10003\ICP-IQP03A01.pdf
IQ report Q:\2003-01-VP\10003\ICB-ICB02A02.pdf
IQ deficiencies list

The following deficiencies have been determined based on the checks.

Aspect Description Measure
Certificates (free from asbestos) Certificate to prove that there is no asbestos is still outstanding. Clarification from the vendor from his supplier. Update
Technical documentation (maintenance schedule, spare parts list) Maintenance schedule and spare parts list are not current Update
Total configuration (see FAT) Configuration could only be checked on individual machines. Total configuration is checked as part of OQ. Check in OQ
Result of the installation qualification

The checks and activities have been carried out in accordance with the specifications of the qualification plan for the installation qualification.

The level of installation qualification is

x complete.

o not complete

A deficiencies list is an integral part of the document and is included as part of the plan for the operational qualification.

13.C.4 Operational qualification (OQ)

13.C.4.1 Operational qualification protocol

Company name Logo
Operational qualification protocol Doc.no.
Blister pack line Page x of y
valid from:
compiled
Name/function Date Signature
Head of qualification    
checked
Head of project    
Head of process technology    
approved
Head of packaging unit    
Head of quality assurance    
Archiving
Quality assurance (original) Packaging unit (copy)
Document modification index
Version Changes Date
1 New facility see signature
Contents

“Objectives”

“Responsibilities”

“Checks”

“Documentation checking”

“Function check”

“Test plans”

“Documents”

Objectives

The objective of the operational qualification is to check the correct operation of components in accordance with the operational specification.

Responsibilities

The responsibilities for this project are established in MQP.

Checks

Checks and activities are carried out as part of the operational qualification:

Documentation checking

Document check regarding presence, completeness and approval:

  • IQ report
  • IQ deficiencies list
  • SOPs (cleaning, calibration, maintenance) available in at least draft format
Function check

Test for correct operation:

  • Safety devices (emergency off, etc.)
  • Test under normal and maximum conditions
  • Checks of the reaction to malfunctions
  • Aspects subject to CSV
Test plans

The relevant test plans including the acceptance criteria and specifications for execution are in the documents listed below.

Safety devices File path
Specification for execution Q:\SFK\SFK05A04.pdf
Checks Q:\2003-01-VP\10003\OQP-SFK01A01.pdf

The defined checks are carried out as part of the SAT. The various individual test plans are referred to in the SAT protocol document.

SAT File path
Specification for execution Q:\QZ\SAT02A01.pdf
SAT protocol Q:\2003-01-VP\10003\OQP-SAT01A01.pdf

 

Check of the reaction to malfunctions File path
Specification for execution Q:\QZ\STOER03A02.pdf
Check of splice point control (moulded foil) Q:\2003-01-VP\10003\OQP-STR01A01.pdf
Check of splice point control (cover foil) Q:\2003-01-VP\10003\OQP-STR02A01.pdf
Aluminium crack control check Q:\2003-01-VP\10003\OQP-STR03A01.pdf
Check of end of foil control (moulded foil) Q:\2003-01-VP\10003\OQP-STR04A01.pdf
Check of end of foil control (cover foil) Q:\2003-01-VP\10003\OQP-STR05A01.pdf
Temperature control (lower heating plate) Q:\2003-01-VP\10003\OQP-STR06A01.pdf
Temperature control (upper heating plate) Q:\2003-01-VP\10003\OQP-STR07A01.pdf
Temperature control (sealing temperature) Q:\2003-01-VP\10003\OQP-STR08A01.pdf
Temperature control (coding) Q:\2003-01-VP\10003\OQP-STR09A01.pdf
Temperature control (perforation) Q:\2003-01-VP\10003\OQP-STR10A01.pdf
Temperature control (moulding station cooling) Q:\2003-01-VP\10003\OQP-STR11A01.pdf
Content control check Q:\2003-01-VP\10003\OQP-STR12A01.pdf
Packaging rejection check (under sealer roller during machine stop) Q:\2003-01-VP\10003\OQP-STR13A01.pdf
Machine stop (production error) Q:\2003-01-VP\10003\OQP-STR14A01.pdf
Ejection control check Q:\2003-01-VP\10003\OQP-STR15A01.pdf
Transfer control check Q:\2003-01-VP\10003\OQP-STR16A01.pdf
Compressed air control check Q:\2003-01-VP\10003\OQP-STR17A01.pdf
Vacuum control check Q:\2003-01-VP\10003\OQP-STR18A01.pdf
Interruption of power supply check Q:\2003-01-VP\10003\OQP-STR19A01.pdf
Triggering of motor protecting switch Q:\2003-01-VP\10003\OQP-STR20A01.pdf
Print mark control outer web sensor check Q:\2003-01-VP\10003\OQP-STR21A01.pdf
Leaflet feed check Q:\2003-01-VP\10003\OQP-STR22A01.pdf
Folding carton feed check Q:\2003-01-VP\10003\OQP-STR23A01.pdf
Incorrect package sorting check Q:\2003-01-VP\10003\OQP-STR24A01.pdf
Blister stack check Q:\2003-01-VP\10003\OQP-STR25A01.pdf
Overload check Q:\2003-01-VP\10003\OQP-STR26A01.pdf
Code reader check (leaflet) Q:\2003-01-VP\10003\OQP-STR27A01.pdf
Code reader check (folding carton) Q:\2003-01-VP\10003\OQP-STR28A01.pdf
Lumat check Q:\2003-01-VP\10003\OQP-STR29A01.pdf
Blister pack control Q:\2003-01-VP\10003\OQP-STR30A01.pdf
Folding carton coding control Q:\2003-01-VP\10003\OQP-STR31A01.pdf
Folding carton closure control Q:\2003-01-VP\10003\OQP-STR32A01.pdf
Control (product in folding carton) Q:\2003-01-VP\10003\OQP-STR33A01.pdf

 

CSV analysis File path
Specification for execution Q:\QZ\CSV04A01.pdf
Testing Q:\2003-01-VP\10003\OQP-CSV02A02.pdf
Documents

The following documents have already been compiled during the initial stages of the project or are available as a draft version.

Document File path
Qualification plan Q:\2003-01-VP\10003\MQP-01A01.pdf
DQ protocol Q:\2003-01-VP\10003\DQP-DQP01A02.pdf
DQ report Q:\2003-01-VP\10003\DQB-DQB01A02.pdf
IQ protocol Q:\2003-01-VP\10003\IQP-IQP03A01.pdf
IQ report Q:\2003-01-VP\10003\ICB-ICB02A02.pdf
OQ protocol Q:\2003-01-VP\10003\OQP-OQP02A01.pdf

13.C.4.2 Operational qualification report

Company name Logo
Operational qualification report Doc.no.
Blister pack line Page x of y
valid from:
compiled
Name/function Date Signature
Head of qualification    
checked
Head of project    
Head of process technology    
approved
Head of packaging unit    
Head of quality assurance    
Archiving
Quality assurance (original) Packaging unit (copy)
Document modification index
Version Changes Date
1 New facility see signature
Contents

“IQ deficiencies list”

“Checks”

“Documentation checking”

“Function checks”

“Framework document”

“OQ deficiencies list”

“Result of the operational qualification”

IQ deficiencies list

The following deficiencies have been documented as part of the installation qualification. The current status has been checked.

Aspect IQ status OQ status
Certificates
(free from asbestos)
Certificate to prove that there is no asbestos is still outstanding. Clarification from the vendor from his supplier. complete
Technical documentation (maintenance schedule, spare parts list) Maintenance schedule and spare parts list are not current complete
Total configuration (see FAT) Configuration could only be checked on individual machines. Total configuration is checked as part of OQ. complete
Checks

Checks and activities are carried out as part of the operational qualification:

Documentation checking

The presence, completeness and approval have been checked in accordance with the qualification plan.

Document Testing File path
IQ report complies Q:\2003-01-VP\10003\ICB-ICB02A02.pdf
IQ deficiencies list complies Q:\2003-01-VP\10003\ICB-ICB02A02.pdf
SOP: complies
Maintenance

Calibration

Cleaning

SOP T1111-1draft

SOP T1111-15draft

SOP R1003-57draft

Function checks
Safety devices Testing File path
Analyses complies Q:\2003-01-VP\10003\OQP-SFK01A01.pdf
SAT Testing File path
SAT records complies Q:\2003-01-VP\10003\OQB-SAT01A02.pdf

Q:\2003-01-VP\10003\OQB-SAT02A02.pdf

Q:\2003-01-VP\10003\OQB-SAT03A03.pdf

Q:\2003-01-VP\10003\OQB-SAT04A01.pdf

Q:\2003-01-VP\10003\OQB-SAT05A02.pdf

Q:\2003-01-VP\10003\OQB-SAT06A01.pdf

Q:\2003-01-VP\10003\OQB-SAT07A01.pdf

 

Test under normal/maximum conditions Testing File path
Specification for execution complies Q:\QZ\NORM04Q03.pdf
Test of automatic operation (normal conditions) complies Q:\2003-01-VP\10003\OQB-NOR01A02.pdf
Test of automatic operation (maximum conditions) complies Q:\2003-01-VP\10003\OQB-NOR02A02.pdf
Test of inching operation (normal conditions) complies Q:\2003-01-VP\10003\OQB-NOR03A02.pdf
Test of inching operation (maximum conditions) complies Q:\2003-01-VP\10003\OQB-NOR04A02.pdf
Test of set-up operation complies Q:\2003-01-VP\10003\OQB-NOR05A02.pdf
Test of manual operation complies Q:\2003-01-VP\10003\OQB-NOR06A02.pdf
Timer test complies Q:\2003-01-VP\10003\OQB-NOR07A02.pdf
Check of production data collection complies Q:\2003-01-VP\10003\OQB-NOR08A02.pdf
Print mark control check complies Q:\2003-01-VP\10003\OQB-NOR09A02.pdf
Compressed air filter check (moulding station) complies Q:\2003-01-VP\10003\OQB-NOR10A02.pdf
Pre-dosage check complies Q:\2003-01-VP\10003\OQB-NOR11A02.pdf
Leaflet feed check complies Q:\2003-01-VP\10003\OQB-NOR12A02.pdf
Folding carton feed check complies Q:\2003-01-VP\10003\OQB-NOR13A02.pdf
Boxing check complies Q:\2003-01-VP\10003\OQB-NOR14A02.pdf
Balance check complies Q:\2003-01-VP\10003\OQB-NOR15A02.pdf
Bundling machine check complies Q:\2003-01-VP\10003\OQB-NOR16A02.pdf

 

 

Check of the reaction to malfunctions Testing File path
Specification for execution complies Q:\QZ\STOER03A02.pdf
Check of splice point control (moulded foil) complies Q:\2003-01-VP\10003\OQB-STR01A01.pdf
Check of splice point control (cover foil) complies Q:\2003-01-VP\10003\OQB-STR02A01.pdf
Aluminium crack control check complies Q:\2003-01-VP\10003\OQB-STR03A01.pdf
Check of end of foil control (moulded foil) complies Q:\2003-01-VP\10003\OQB-STR04A01.pdf
Check of end of foil control (cover foil) complies Q:\2003-01-VP\10003\OQB-STR05A01.pdf
Temperature control (lower heating plate) complies Q:\2003-01-VP\10003\OQB-STR06A01.pdf
Temperature control (upper heating plate) complies Q:\2003-01-VP\10003\OQB-STR07A01.pdf
Temperature control
(sealing temperature)
complies Q:\2003-01-VP\10003\OQB-STR08A01.pdf
Temperature control (coding) complies Q:\2003-01-VP\10003\OQB-STR09A01.pdf
Temperature control (perforation) complies Q:\2003-01-VP\10003\OQB-STR10A01.pdf
Temperature control (moulding station cooling) complies Q:\2003-01-VP\10003\OQB-STR11A01.pdf
Content control check complies Q:\2003-01-VP\10003\OQB-STR12A01.pdf
Packaging rejection check (under sealer roller during machine stop) complies Q:\2003-01-VP\10003\OQB-STR13A01.pdf
Machine stop (production error) complies Q:\2003-01-VP\10003\OQB-STR14A01.pdf
Ejection control check complies Q:\2003-01-VP\10003\OQB-STR15A01.pdf
Transfer control check complies Q:\2003-01-VP\10003\OQB-STR16A01.pdf
Compressed air control check complies Q:\2003-01-VP\10003\OQB-STR17A01.pdf
Vacuum control check complies Q:\2003-01-VP\10003\OQB-STR18A01.pdf
Interruption of power supply check complies Q:\2003-01-VP\10003\OQB-STR19A01.pdf
Triggering of motor protecting switch complies Q:\2003-01-VP\10003\OQB-STR20A01.pdf
Print mark control outer web sensor check complies Q:\2003-01-VP\10003\OQB-STR21A01.pdf
Leaflet feed check complies Q:\2003-01-VP\10003\OQB-STR22A01.pdf
Folding carton feed check complies Q:\2003-01-VP\10003\OQB-STR23A01.pdf
Incorrect package sorting check complies Q:\2003-01-VP\10003\OQB-STR24A01.pdf
Blister stack check complies Q:\2003-01-VP\10003\OQB-STR25A01.pdf
Overload check complies Q:\2003-01-VP\10003\OQB-STR26A01.pdf
Code reader check (leaflet) complies Q:\2003-01-VP\10003\OQB-STR27A01.pdf
Code reader check (folding carton) complies Q:\2003-01-VP\10003\OQB-STR28A01.pdf
Lumat check complies Q:\2003-01-VP\10003\OQB-STR29A01.pdf
Blister pack control complies Q:\2003-01-VP\10003\OQB-STR30A01.pdf
Folding carton coding control complies Q:\2003-01-VP\10003\OQB-STR31A01.pdf
Folding carton closure control complies Q:\2003-01-VP\10003\OQB-STR32A01.pdf
Control (product in folding carton) complies Q:\2003-01-VP\10003\OQB-STR33A01.pdf

 

CSV test Testing File path
Testing complies Q:\2003-01-VP\10003\OQB-CSV02A02.pdf
Framework document
Document File path
Qualification plan Q:\2003-01-VP\10003\MQP-01A01.pdf
DQ protocol Q:\2003-01-VP\10003\DQP-DQP01A02.pdf
DQ report Q:\2003-01-VP\10003\DQB-DQB01A02.pdf
IQ protocol Q:\2003-01-VP\10003\ICP-IQP03A01.pdf
IQ report Q:\2003-01-VP\10003\ICB-ICB02A02.pdf
OQ protocol Q:\2003-01-VP\10003\OQP-OQP02A01.pdf
OQ deficiencies list

The following deficiencies have been determined based on the test/checks.

Aspect Description Measure
not applicable not applicable not applicable
Result of the operational qualification

The checks and activities have been carried out in accordance with the specifications of the qualification plan for the operational qualification.

The level of operational qualification is

x complete

o not complete

A deficiencies list is an integral part of the document and is included as part of the plan for the operational qualification.

13.C.5 Performance qualification (PQ)

13.C.5.1 Performance qualification protocol

Company name Logo
Performance qualification protocol Doc.no.
Blister pack line Page x of y
valid from:
compiled
Name/function Date Signature
Head of qualification    
checked
Head of project    
Head of process technology    
approved
Head of packaging unit    
Head of quality assurance    
Archiving
Quality assurance (original) Packaging unit (copy)
Document modification index
Version Changes Date
1 New facility see signature
Contents

“Objectives”

“Responsibilities”

“Checks”

“Documentation checking”

“Function check”

“Test plans”

“Documents”

Objectives

The objective of the performance qualification is to check the correct operation of the facility in accordance with the technical specifications.

Responsibilities

The responsibilities for this project are established in MQP.

Checks

Checks and activities are carried out as part of the performance qualification:

Documentation checking

Document check regarding presence, completeness and approval:

  • OQ report
  • OQ deficiencies list
  • SOPs (cleaning, calibration, maintenance)
  • Personnel training
Function check

The performance tests are carried out essentially for blister thickness and running characteristics in the upper, middle and lower adjustment ranges of the facility (temperature, pressure, speed) which are defined in the technical specifications. The tests use the target formats for contents and packaging material (folding carton, leaflets) that are established in the technical specifications.

Test plans

The relevant test plans including the acceptance criteria and specifications for execution are in the documents listed below. The placebo batches used for the tests are documented in the records.

Tests File path
Specification for execution Q:\QZ\PQ02Q03.pdf
Format 1 (min, max. average), packaging material format 1 Q:\2003-01-VP\10003\PQP-T01A01.pdf
Format 2 (min, max. average),
packaging material format 1
Q:\2003-01-VP\10003\PQP-T02A02.pdf
Format 2 (min, max. average),
packaging material format 2
Q:\2003-01-VP\10003\PQP-T03A01.pdf
Format 1 (min, max. average),
packaging material format 2
Q:\2003-01-VP\10003\PQP-T04A02.pdf
Control systems check Q:\2003-01-VP\10003\PQP-T05A03.pdf
Documents

The following documents have already been compiled during the initial stages of the project or are available as a draft version.

Document File path
Qualification plan Q:\2003-01-VP\10003\MQP-01A01.pdf
DQ protocol Q:\2003-01-VP\10003\DQP-DQP01A02.pdf
DQ report Q:\2003-01-VP\10003\DQB-DQB01A02.pdf
IQ protocol Q:\2003-01-VP\10003\IQP-IQP03A01.pdf
IQ report Q:\2003-01-VP\10003\ICB-ICB02A02.pdf
OQ protocol Q:\2003-01-VP\10003\OQP-OQP02A01.pdf
OQ report Q:\2003-01-VP\10003\OQB-OQB02A02.pdf

13.C.5.2 Performance qualification report

Company name Logo
Performance qualification report Doc.no.
Blister pack line Page x of y
valid from:
Name/function Date Signature
Head of qualification
checked
Head of project    
Head of process technology    
approved
Head of packaging unit    
Head of quality assurance    
Archiving
Quality assurance (original) Packaging unit (copy)
Document modification index
Version Changes Date
1 New facility see signature
Contents

“OQ deficiencies list”

“Tests”

“Documentation checking”

“Function checks”

“Framework document”

“Result of the operational qualification”

“PQ deficiencies list”

“Result of the performance qualification”

OQ deficiencies list

No deficiencies have been determined based on the tests.

Document File path Document
not applicable not applicable not applicable
Tests

Tests and activities are carried out as part of the operational qualification:

Documentation checking

The presence, completeness and approval have been checked in accordance with the qualification plan.

Document Testing File path
OQ report complies Q:\2003-01-VP\10003\OQB-OQB02A02.pdf
IQ deficiencies list complies Q:\2003-01-VP\10003\OQB-OQB02A02.pdf
SOP:

Maintenance

Calibration

Cleaning

complies SOP T1111-1

SOP T1111-15

SOP R1003-57

Personnel training complies Q:\TRAIN\VP\1753A1.pdf
Function checks
Aspects Testing File path
Format 1 (min, max. average), packaging material format 1 complies Q:\2003-01-VP\10003\PQB-T01A01.pdf
Format 2 (min, max. average), packaging material format 1 complies Q:\2003-01-VP\10003\PQB-T02A02.pdf
Format 2 (min, max. average), packaging material format 2 complies Q:\2003-01-VP\10003\PQB-T03A01.pdf
Format 1 (min, max. average), packaging material format 2 complies Q:\2003-01-VP\10003\PQB-T04A02.pdf
Control systems check complies Q:\2003-01-VP\10003\PQB-T05A03.pdf
Framework document
Document File path
Qualification plan Q:\2003-01-VP\10003\MQP-01A01.pdf
DQ protocol Q:\2003-01-VP\10003\DQP-DQP01A02.pdf
DQ report Q:\2003-01-VP\10003\DQB-DQB01A02.pdf
IQ protocol Q:\2003-01-VP\10003\ICP-IQP03A01.pdf
IQ report Q:\2003-01-VP\10003\ICB-ICB02A02.pdf
OQ protocol Q:\2003-01-VP\10003\OQP-OQP02A01.pdf
OQ report Q:\2003-01-VP\10003\OQB-OQB02A02.pdf
PQ protocol Q:\2003-01-VP\10003\PQP-PQP01A01.pdf
PQ deficiencies list

The following deficiencies have been determined based on the checks.

Aspect Description Measure
not applicable not applicable not applicable
Result of the performance qualification

The checks and activities have been carried out in accordance with the specifications of the qualification plan for the performance qualification.

The level of operational qualification is

x complete.

o not complete

A list of deficiencies has been finalised.

The facility is qualified and released for production.

All changes to the facility are subject to the change control procedure (SOP A1000CC05).

Summary

As part of the preparation, measures must be established before commencing the actual packaging process to prevent confusion or mix-ups.

The first stage of facility approval is line clearance after cleaning out the previous product. Once the facility has been set up, step by step, a first process sample is checked with regard to the specifications and the variable data so that production can be approved if the results are consistent.

During operation, the process is constantly checked by test devices in the facility and repeated verification of the functionality of control devices by the personnel. This is supplemented by checks of packaged products.

The function check and controls of packaged products, together with the approval of the facility for production, can be seen as in-process controls. The allocation of designated groups of people within the personnel is unit specific.

Variable data, which is afixed during the packaging process, must meet requirements with regard to readability, accuracy and constancy. There are various techniques which can be used for this purpose.

An important step at the end of a packaging process is the reconciliation of the packaging material. The significance of this process depends on the overall design of the facility and the process.

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