GENERAL SPECIFICATIONS OF PACKING MATERIAL - METALLIC TINS

1.0 PROTOCOLS OF TEST
1 Description : Metalic Tins having smooth inner surface. The upper surface is sealed consists a clip to break the seal. The lower surface is open.
2 Dimensions : This test includes
a) Length : This test is not applicable for Metallic Tins
b) Breadth : This test is not applicable for Metallic Tins.
c) Height : Measure the height in mm of 10 Metallic Tins individually from the lower surface edge to the upper rim. Note it in the report sheet.
( Limits : It should meet as per the specimen Metallic. Tins with tolerance of 170 mm ± 10 mm )
3 Average This test is not applicable for
Weight : Metallic Tins.
4 Thickness : This test is not applicable for Metallic Tins.
5 Inner : Measure the inner diameter of 10
Diameter Metallic Tins individually from the lower open edge. It should be not less than 98 mm. Note it in the report sheet.
6 Outer : Measure the outer diameter of 10
Diameter Metallic Tins individually. It should be not more than 105 mm. Note it in the report sheet.
7 Text Matter : This test is not applicable for Metallic Tins.
8 Clean Liness : Check the cleanliness of 10 Metallic
Check Tins individually. It should not be dirty, damaged, stained or consist any foreign particles.
9 Folding / : This test is not applicable for Metallic
Flaps Tins.
10 Bursting : This test is not applicable for
Strength Metallic Tins.
11 Grammage : This test is not applicable for
Metallic Tins.
12 Over Flow : This test is not applicable for
Volume Metallic Tins.
13 Threading : This test is not applicable for
Metallic Tins.
2.0 OPINION
The sample complies if it meets all the requirements stated above. The sample does not comply if it fails to meet any of the requirement stated above.

CLEANING PROCEDURE OF CHANGE ROOM ( DAILY )

1.0 OBJECTIVE
To provide format & guidelines for individuals who participate in the implementation of standard operating procedure for cleaning of change room.
2.0 SCOPE
To provide the policy & guidelines for Change room.
3.0 RESPONSIBILITY
Sweeper & House keeping officer.
4.0 PROCEDURE
1. Undertake broom cleaning of change room.
2. Take 2.5% Dettol or Savlon or Phenyl soln. & undertake wet cleaning of floor with the help of Industrial cleaner or wet cloth. Daily two times a day
3. Undertake cleaning of Tablets, Benches, Basin, Cooler, Fan, Exhaust with the help of duster followed by wet cleaning with 2.5 % Dettol or Savlon soln.
4. Collect all waste of Change room in a dust bin.

PROCEDURE FOR CLEANING OF CENTRIFUGES

1.0 PURPOSE
This SOP describes the cleaning operation of centrifuge to ensure that the centrifuge is free from previous batch material.
2.0 RESPONSIBILITY
Operators and chargers are responsible for the cleaning of centrifuge.
3.0 PROCEDURE
a) Open the top cover of the centrifuge.
b) Wash nozzles and top of the centrifuge.
c) Remove centrifuge bag.
d) Wash the basket with DM water and start spinning the centrifuge and under these conditions wash the basket with DM water.
e) Stop the centrifuge.
f) Wash the bag with DM water.
g) Fix the bag in the centrifuge.
h) Start the centrifuge and again wash the bag in slow speed of the centrifuge.
i) Put back the cover and clamp it.
4.0 PERIODICITY
Cleaning should be done after every batch.
5.0 FORMAT
Equipment cleaning record format should be used.

PROCEDURE FOR CLEANING OF CENTRIFUGE FILTERS

1.0 PURPOSE
This SOP describes the cleaning operation of centrifuge filters to ensure that the filters are free from previous batch material.
2.0 RESPONSIBILITY
Operators are responsible for the cleaning of filters
3.0 PROCEDURE
a) Dismantle the filter.
b) Remove the filter element and discard.
c) Clean the filter bowl with DM water and dry.
d) Introduce fresh filter element.
e) Assemble and fix back in position.
4.0 PERIODICITY
Replacement of filter weekly.
5.0 FORMAT
Equipment cleaning format should be used for recording the cleaning operations.

PROCEDURE FOR CLEANING OF BLENDER

1.0 PURPOSE
This SOP describes the cleaning operation of blender to ensure that the blender is free from previous batch material.
2.0 RESPONSIBILITY
Operators and chargers are responsible for the cleaning of blender.
3.0 GENERAL CONDITIONS
Disconnect all the connections of blender and open top cover .During blender cleaning all the other operations around blender should be stopped.
4.0 PROCEDURE
4.1 BATCH CLEANING OPERATION:-
a) Disconnect the blender from power supply.
b) Open the top cover of the blender.
c) Clean the inner surface of the blender using dry mop and collect the material in acontainer.
d) Clean the discharge valve of the blender.
e) Close the top cover.
4.2 MAJOR CLEANING OPERATIONS
i) Open top cover completely.
ii) Clean the top cover and inner side of the blender using dry sponge
iii) Clean the shaft and ribbons.
iv) Clean the blender with the jet of compressed air.
4.3 PERIODICITY
a) Batch cleaning operation should be done after completion of every batch.
b) Major cleaning operation once in a month.

PROCEDURE FOR CLEANING OF AUTO LOADER

1.0 CAUTION
Switch off the electrical mains of the machine.
A PROCEDURE FOR PRODUCT TO PRODUCT CHANGEOVER
1 Dedusting external surfaces.
Use clean nylon brush and wipe with clean dry lint free duster.
2 Dismantling
Remove
a) Back and front cover.
b) Empty capsules hopper.
c) Magazine followed by pusher plate and raceway.
3 Cleaning of parts
Clean the above parts by washing with 0.1% Teepol solution and scrubbing with soft nylon brush. Rinse with jet of potable water followed by rinsing with 5 micron filtered water. Clean loading platform with wet duster. Clean back and empty capsules hoppers using clean dry lint free duster.
4 Drying
The cleaned parts as mentioned in step ( 3 ) are wiped and dried using clean dry lint free duster.
5 Assembling
Reassemble all the parts of the machine carefully checking the correctness of assembling.
NOTE
a) Fix the ‘cleaned’ label.
b) If the cleaned loader is not used within 24 hours after cleaning or there are signs of dust or powder settled on loader, then wipe the body by using a freshly laundered lint free duster.
B PROCEDURE FOR BATCH TO BATCH CHANGEOVER
1 Empty out the hopper.
2 Remove back and front cover.
3 Remove empty capsules from loading platform by brush
4 Dry-clean the loader with clean dry lint free duster.

CLEANING PROCEDURE FOR ALKALI PREPARATION TANK (FOR D.M. WATER PLANT)

1.0 AIM
To lay down a standard operating procedure for Alkali preparation tank ( for D. M. WATER PLANT).
2.0 SCOPE
Maintenance Department
3.0 AREA OF OPERATION
Demineralised Water Plant.
4.0 RESPONSIBILITY
Operator/Maintenance Supervisor concerned.
5.0 ACCOUNTABILITY
Maintenance Incharge.
6.0 PROCEDURE
6.1 Rinse the inside surface twice with D. M. Water.
6.2 Clean the inside and outside surface with 0.1% Extran or 0.1% Teepol solution.
6.3 Rinse the inside surface twice with D. M. Water.
6.4 Wipe the outside surface with duster.
6.5 FREQUENCY
AFTER USE.
6.6 RECLEANING FREQUENCY
Clean the tank after seven days if not used.
7.0 REVIEW DATE
After 2 years or when procedure is changed.

PROCEDURE FOR CLEANING AND SANITATION OF DUST BINS

1.0 AIM
To provide standard operating procedure for cleaning and sanitation of dust bins.
2.0 SCOPE
Production Department.
3.0 AREA OF OPERATION
Leak Testing Area.
4.0 RESPONSIBILITY
House Keeper/Production Supervisor.
5.0 ACCOUNTABILITY
Production Executive.
6.0 PROCEDURE
6.1 WEEKLY CLEANING:
a) Remove polybags containing scrap material from all dust bins for destruction.
b) Collect all dustbins for cleaning.
c) Wash dustbins by using tap water.
d) Then clean it by using soap solution & scrubber.
e) Then again wash it by tap water.
f) Then wipe it by using clean dry clothes.
g) Check for suarity of cleanliness.
h) Take it for use.
6.2 DAILY CLEANING
Wipe dust bin by using clean dry clothes from outside.
7.0 REVIEW DATE
After 2 years or when procedure is changed.

PROCEDURE FOR CLEANING AND MAINTAINANCE OF THE MILLI PORE FILTRATION UNIT

1.0 OBJECTIVE
To lay down the Standard Operating Procedure for cleaning and maintenance of the Millipore Filtration Unit.
2.0 SCOPE
The procedure is applicable to cleaning and maintenance of the Millipore Filtration Unit.
3.0 RESPONSIBILITY
Laboratory Technician, Scientific Assistant, Assistant Scientific Officer and Officer In charge of the Section.
4.0 PROCEDURE
1. The assembly should be checked every day for the leakage and the filters of the Swinny Filter holder ( 13 mm Millipore Filtration Unit ) before giving for sterilization.
2 The cups and the funnels also the stainless steel manifold must be washed and rinsed with the distilled water .
3 In case of leakage the O rings are to be changed
4 Once in two months clean the sintered funnels with chromic acid keeping them for over night. All the O rings are to be changed.
5 The sintered Funnels are to be cleaned thoroughly in distilled water after chromic acid treatment before assembling.
The rubber parts if they are deformed change them with new one.
6 After washing the Millipore Filtration Unit plug the unit with nonabsorbent cotton and keep ready for sterilization.

PROCEDURE FOR CLEANING AND HOUSEKEEPING OF STORES DEPARTMENT

1.0 PURPOSE
This SOP describes Housekeeping and cleaning procedures for stores department.
2.0 RESPONSIBILITY
Stores In-charge will be responsible for monitoring housekeeping and claening of stores department.
3.0 PROCEDURE
a) Arrange for cleaning of the area as per schedule.
b) Arrange for regular cleaning of the bags and containers.
c) The containers brought in the stores shall be free from dust.
d) All the containers are checked for any leakage and original labels.
e) Detailed sanitation program for stores is given below.
4.0 Daily – Cleaning and mopping of Floor, Drums and Racks cleaning.
5.0 Weekly - Doors and windows cleaning.

CLEANING PROCEDURE FOR MICROBIOLOGY LAB STERILE AREA

1.0 OBJECTIVE
To lay down the Standard Operating Procedure for Cleaning Procedure for Microbiology Lab Sterile Area.
2.0 SCOPE
The procedure is applicable to Cleaning Procedure for Microbiology Lab Sterile Area.
3.0 RESPONSIBILITY
Laboratory Technician, Scientific Assistant, Assistant Scientific Officer and Officer In charge of the Section.
4.0 PROCEDURE
1 Daily at the start of the shift and after every work, clean the table of laminar airflow using clean mop soaked in 70% Isopropyl Alcohol.
1) Disinfect floor with either of the solutions alternately using the same
mop after every work.
a) 2.5% v/v Dettol
b) 2.0% v/v Fairgenol
c) 2.5% v/v Savlon
2) Spray the area including floor and walls with 5% v/v phenol or 2% v/v Bacillocid.
3) At every weekend clean the walls, and floor using soap solution. Wash down with plenty of water. Remove excess of water using clean mop.
4) At every week end fumigate sterile area with formalin through A/C.

PROCEDURE FOR CLEANING OF FLUID BED DRYER

1 Before dismantling the equipment the electric supply must be turned off.
2. The strap retaining the filter bag unit is unclipped and the finger sleeves of the bag are detached from the holding hooks.
3. The bag is removed and taken to the washing area where the external surface of the bag is washed with hot water. The bag is turned inside-out and then washed with hot 1 water. Where material is adhering to the bags it will be necessary to scrub the surface with a detergent solution (such as Teepol) using a nylon brush.
4. After washing, the bag is placed on a hanger and allowed to dry in air.
5. The bag support frame as well as the sleeve supports are washed with hot water and the washed surfaces are then wiped with a clean, dry cloth.
6. The drier bowl should preferably be washed after every drying cycle although if the same product is being dried in lots it will be sufficient to wash at the end of the working shift. The bowl is wheeled to the washing area where it is freed from the wheel base. It is first flushed with hot water and then scrubbed, if necessary, with a nylon blush to dislodge all adhering solid material. Care should be taken while cleaning the sieve so that it is not damaged. A cleaning agent (such as Teepol) and/or a scouring powder may also be employed to facilitate cleaning. The bowl is finally rinsed with hot water in the form of a jet and then dried by wiping with a clean, dry cloth. The bow 1 is then covered with a nylon cloth or any other suitable cover and stored in a dust-free area.
7. Powder from the interior surfaces of the drier cabinet is removed by suction using vacuum. A nylon brush may be used to remove adhering powder. The surfaces are cleaned with a clean, damp cloth and then allowed to dry.
8. The air intake filter is removed and replace with a freshly cleaned filter.
9. The external surfaces of the fluid bed drier are wiped with a clean, damp cloth and then allowed to dry.
10. The drier should be switched on and the airflow adjusted according to the drying 'conditions specified for the process. It should be ensured that the material is adequately agitated and that channels are not formed in the mass of the wet material. Channel formation is normally recognized when the air outlet temperature is close to that of the air inlet temperature soon after the drying process staI1s.
11. At the end of the time cycle when the drier stops automatically, the air bags should be shaken by pulling the lever attached to the drier, in order to dislodge the fines which collect in the bags.
12. The main switch should be turned off, the bowl should be lowered and the trolley holding the bowl wheeled out. The contents of the bowl should be examined to know if any further drying is required.
13. If redrying is necessary, the material in the bowl should be stirred with a scoop and the bowl should be put back into the drier. Steps 7 to 12 should be repeated until the material complies with the relevant specifications at the stage of processing.
14. The details of drying, including the inlet and outlet air temperatures, the drying times of the cycle, the date of drying and batch details should be entered on the fluid bed drier log sheets.
CAUTION :
If a flammable liquid, such as, alcohol, has been used in preparing the granules, such granules should be exposed in trays in an explosion proof area, before being taken up for drying in fluid bed drier.

PROCEDURE FOR CLEANING OF SIFTER

1.0 PURPOSE
This SOP describes the cleaning operation of sifter to ensure that the sifter is free from previous batch material.
2.0 RESPONSIBILITY
Operators are responsible for the cleaning of sifter.
3.0 PROCEDURE

4.0 BATCH CLEANING OPERATION
Ensure isolation of the equipment electrically.
a) Remove hood from the top.
b) Remove the material stuck to the sieve top.
c) Clean the surface of top cover ,sifter sieve and the discharge cone with dry sponge.
d) Vacuum clean all the parts of the sifter.
e) Put the top cover.
4.1 MAJOR CLEANING OPERATIONS
i) Repeat all the operations of batch cleaning.
ii) Remove the sieve from the sifter and clean the cone and sieve joint area.
iii) Reassemble the sifter and proceed for operation.
5.0 PERIODICITY
a) Batch cleaning operation should be done after completion of every batch.
b) Major cleaning operation once in a month.
6.0 FORMAT
Equipment format should be used for recording the cleaning operations.

PROCEDRUE FOR CLEANING SCHEDULE FOR QC DEPARTMENT

 1.0         PURPOSE

This SOP describes the cleaning schedule for QC Department

 2.0              RESPONSIBILITY

Administration department is responsible for cleaning activities of the QC Department. QC Head should ensure that the cleaning activities are done as per schedule

 3.0       PROCEDURE

a)       Floor                     :         Clean Twice a day

b)       Windows/ Walls     :         Clean Once in week

c)       Ceiling                  :         Clean once a month

d)      Instrument/ equipment tops and surrounding area – Daily

e)       Working bech Tops :         In evry shift,

f)         Reagent/ Solution bottles        :           Once in a day

g)       Chemicals/ reagent bottles in stock      :         Once in a month

h)       Sample trays          :         daily

i)       Sample Drawers               :         Once in week

The schedule is applicable for control sample room, instrument room as well

4.0       RECORD

Maintain the log of cleaning performed as per schedule

PROCEDURE FOR CLEANING OF REACTION VESSEL

1.0 PURPOSE
This SOP describes the cleaning operation of reaction vessel to ensure that the vessel is free from previous batch material
2.0 RESPONSIBILITY
Operators and chargers are responsible for the cleaning of the reactor from the inner side. External cleaning is a continuous routine process.
3.0 PROCEDURE
a) Ensure that previous batch material is completely removed from the reactor.
b) Open manhole cover and close the bottom discharge valve.
c) Flush the reactor with water using spray nozzle .also wash the top dish with the help of spay nozzle.
d) Open bottom dish valve and drain the spray washings into the affluent tray .
e) Close the bottom valve ,fill the reactor with water ,stir for 10 min. and drain out the water.
f) Inspect and ensure that the reactor is clean.
g) If required repeat the above operations using detergents.
h) When the previous material is insoluble in water ,clean the reactor with solvent in which it is soluble and then with water.
i) Clean the manhole cover properly and dry it with sponge.
j) Dry the reactor by circulating steam in the jacket and by applying mild vacuum.
k) Ensure that the reactor is dry and fix the label “CLEAN” on the reactor.
4.0 PERIODICITY
The cleaning operation should be carried out after every batch.
5.0 FORMAT
Equipment cleaning format should be used.

DQ : COMPUTER SYSTEMS

1.0 Approval

Pre approval of this protocol will be the joint responsibility of the following functional areas.
Quality Assurance

Production
Engineering
Product Development
Post approval of this protocol will be the joint responsibility of the following functional areas.
Quality Assurance

Production
Engineering
Product Development
2.0 Statement of Purpose
The purpose of this protocol is to provide an outline for the design of the NEW Computer System be procured. The system shall be designed to fulfil the intended purpose without errors and shall meets the current Good Manufacturing Practices (cGMP) requirements and all other regulatory obligations
3.0 Design Input
3.1 Purpose of System
i) Clear statement of what the system is to do.
ii) Expected benefits.
iii) Relation to other system.
3.2 Controlled Function
Operating Modes
a) Automatic mode.
b) Manual mode.
c) Maintenance mode.
d) Operational interlocks.
Description of Operations.
a) Sequence of operation.
b) Modifiable parameters.
c) Limiting conditions.
Controlled elements.
a) Valves, heaters, motors……
b) I\P, relays, solenoids, motor starters ….
3.3 Computer System
Hardware.
a) CPU
b) Memory devices.
c) Recording devices.
d) Communication interfaces.
e) Operator terminals
Software
a) Operating System
b) Communication drivers.
c) Network Controllers.
d) Configurable Programs.
e) Application Programs

3.4 Information Input
Measured Inputs
a) Number, Type, and location of each sensor.
b) Type, Model Number, and software version of all transducers and
signal converters.
c) Model number and software version of all analog input modules.
d) Tag name, location, data type, and valid range of all analog inputs.
Discrete Inputs
a) Type, model number, and software version of all discrete input modules.
b) Tag name and location of all discrete inputs.
Operator Inputs
a) Entry and verification means.
b) Entry modes.
c) Error detection.
d) Error correction
e) Tag name, description, and range of parameters.
f) Electronic Signatures.
Recipe Inputs
a) Definition.
b) Loading.
c) Verification.
d) Security.
g) Tag name, description, and range of parameters.
e) Electronic Signatures.
Input from other Systems.
a) Source.
b) Communication mode.
c) Error detection.
d) Error correction
e) Tag name, description, and range of parameters.
Material Input

Loading
a) Manual Loading.
b) Automatic loading.
c) Input from other system.
Checks on Material Inputs
3.5 Data Processing
Input Data
a) Data conversions.
b) Scaling.
c) Calibration means.
d) Error detection and correction.
Calculations.
a) tag names and input parameters.
b) Algorithms.
c) Control strategies.
d) Tag names and ranges of output parameters.
e) Error detection and correction.
3.6 Information Output
Control
a) Tag name, location, range, and default value of analog outputs.
b) Model number, software version, and location of each analog output Module.
c) Type, model number, software version, and location of each output driver.
Alarms
a) Tag name, type, and location of alarm outputs.
b) Type and location of alarm indicator.
c) Acknowledgement means.
Displays
a) Tag name of the data values.
b) Tag name of status indicators.
c) Event indicators
d) Alarm indicator.
Printed Reports.
a) Tag name of the data values.
e) Tag name of status indicators.
f) Event recording.

g) Alarm recording
h) Report generation
3.7 Transmission to other systems.
a) Tag name of the data values.
b) Tag name of status indicators.
c) Event Transmission.
d) Alarm transmission
e) Report transmission.
f) External request of data.
Archived Data
a) Tag name of the data values.
b) Tag name of status indicators.
c) Event recording.
d) Alarm recording
e) Report generation
f) Audit trail.
3.8 Operational Features.
Alarm Management.
a) Action.
b) Priority.
c) Reporting.
d) Acknowledgment.
e) Power failure.
Security
a) Levels
b) Means of access.
c) Parameter modification.
d) Program access.
Safety
a) Physical Interlocks.
b) Software interlocks.
c) Emergency shutdown and recovery.
System Failure.
a) Failure Modes
b) Default state

c) Recovery modes.
Analog data update Time
a) control inputs
b) alarms
c) Displays.
d) Reports.
e) Archived data.
f) Transmission to other system.
Discrete data update time
a) Control outputs.
b) Alarms.
c) Displays.
d) Reports.
e) Archived data
f) Transmission to other systems.
Response to operator inputs.
a) Analog.
b) Discrete
c) Alarm.
3.9 Physical Requirements
System Structure.
a) Layout of components.
b) Relation to facilities and other systems.
Size Restrictions.
Materials.
a) Type.
b) Finishes.
Utilities.
a) Electrical.
b) Water.
c) System
d) Air.
Environmental.
a) Temperature.
b) Vibration.
c) Electrical interference.
d) Humidity.
6.0 Vendors Communication
Attach the copy of communication received from the Vendor)
Specify the Reference Documents required e.g.
Compelete Details and Specifications on hardware, software and Peripherals used in the system
Installation Manual-
Software User manual
Line Diagram of the System
Calibration and maintenance manual
Utilities Requirements
Working Environment details
IQ, OQ and PQ details for the system
Validation Checks Performed before Supply
Test Report on the system and on individual components
Operators Qualification and Experience Details
FAQ on Handling the System
Contact details
Security System employed and its operational details
7.0 Vendor Qualifications

7.1 Company Information
7.2 Human and Financial resources.
7.3 Knowledge of GMP requirements
7.4 Organization
a) Structure
b) Responsibilities.
7.5 Customer Support
a) Installation and service.
b) Technical support
c) User training.
7.2 Quality System –General.
a) Management’s stated policy and commitments.
b) Quality group’s responsibility and authority.
c) Written Company quality plan.
d) Management Review of quality system.
7.3 Quality System –Software Development.
Development Plan
a) Functional Requirements.
b) Software design specifications.
c) Programming standards and procedures.
d) Programming tools.
e) Review procedures.
Test Plan
a) Types of Tests.
b) Test tools and methods.
c) Error correction and re-test.
d) Test review.
e) Acceptance criteria.
f) Test reports.
Configuration Management.
a) Organization and responsibilities.
b) Identification and traceability.
c) Configuration tools.
d) Change control procedures.
e) Version identification control policy.
f) Release approval procedures.
g) Configuration history and status report.
Program Documentation
a) Source code.
b) Logic diagrams.
c) List of all inputs and outputs.
d) List of all modifiable parameters.
e) List of all operator inputs.
f) Description of interfaces to other systems.
g) Description of alarms and interlocks.
h) Description of error detection and recovery.
i) Description of all data displays.
j) Description of all reports.
Document Control
a) Documents to be controlled.
b) Approval of issue procedures.
c) Change control procedures.
d) Retention and security procedures.
Personnel Qualification
a) Formal education.
b) Internal training.
c) Experience in software development.
d) Experience with specific programs used.
e) Experience with application.
7.4 Product Information
7.5 Validation Features.
a) Security.

b) Self documentation.
c) Automatic program change audit trail.
d) Simulation capability.
e) Program compare.
f) Revision documentation detail.
7.6 History of Use
a) Customers of all version.
b) Customers of present version.
c) Configuration history and status report.
7.7 Expected Life
a) Present version
b) Revised products.
7.8 Revision Policy
a) Notification of problems.
b) Change required to fix problems.
c) Change to add or modify features.
d) Notification of revisions.
e) Support old versions.

PQ FOR NEW SOFTWARES CHECKLIST

1.0 Structural Codes
Check if the Source Codes confirm to predefined Design Specifications.
2.0 Functionability
a. Develop Test Data Sets with known Inputs and Outputs. The test data shall represent as much as possible Upper and Lower limit of intended use. However it shall also include Unusual Data (wrong case).
b. Define the Test Environment i.e. place computer system to be used for testing.
c. Define the Persons responsible for Testing (Number, Names, Qualifications, and Experience).
d. Define the Errors and their Classification and Documentation.
e. Define Release /Acceptance criteria before the test.
f. Define the Testing Program as per follows.

3.0 Perform the test in predefined environment using predefined test persons. Only predefined test cases simulating as much as possible the real life environment shall be used.

Record the results as per follows for each operation.
Operator Name :
Verslam Test :

 4.0 Check the User Manual for

a. If it describes Program’s Functionability and Formulae used for Calculations.
b. If it provides Detailed Instructions for Operating the Software.
c. If it describes all Security Features and their Implementations.
d. If it specifies Program Operator / User Qualification and Experience.
e. If it covers Help Features during Use.
f. If it describes Method for Archiving the Results, Migration of Data to other programs as needed.
5.0 Validation Report
a. Describes who has prepared the Protocols and who has finally approved them.
b. Describe all the Tests Performed.
c. Describe the defects observed during Testing.
6.0 Comment
If the software is OK.
If the changes are required. If Yes, who is authorized to control the same, what are the documents for the same, which tests to be carried out.
What shall be the version number after implementing changes.

VALIDATION DURING SOFTWARE DEVELOPMENT

Validation of softwares during development is performed in three distinct stages:

1.      Validation of Design Inputs

2.      Validation of the Implementation stage

3.      Validation of Alpha and Beta Testing

1.0       VALIDATION OF DESIGN INPUTS

1.1       Design Specifications

Prepared By                :           ________________

Approved By              :           ________________

Design Checked By    :           ________________

1.2       Validation Report

This shall include

a.       Internal Design Document.

b.      Report on Design Inspection in above format.

c.       Comments e.g. whether Design Specifications are complete, correct, and consistent with the defined requirements.

2.0       VALIDATION OF IMPLEMENTATION PHASE

2.1       Validation Report

This shall include

a.       Description on Source Code and Internal Documents used.

b.      Report on Functionability and reliability of individual and group programming.

3.0       ALPHA TESTING

3.1       Inputs

3.1.1    Test cases Prepared By         :           QA Person.

3.1.2    No. of Test  Persons              :           10 - 20

3.1.3    Type of the information

provided to the Persons        :           Detailed Test Description and Expected Results.

 3.2       ALPHA TEST SUMMARY SHEET

The test results are evaluated Graphically. The defect Discovery Rate plotted versus the Total number of Defects Discovered. A regression linear fit curve is calculated and plotted together with maximum and minimum fits, which by definition have a confidence interval of 5%. This helps in calculation the number of remaining defects. This information is useful to forecast the number test cycles that are still necessary and a possible release date.

The number of critical defects after the last test cycle must be zero for the software to pass the release criteria.

4.0              Beta (b) Testing

Once software defects and usability discrepancies reported during alpha testing have been corrected, the software may be tested at selected customers’ sites (the so-called b- test). The key feature of b-testing is that it is conducted in a customer environment and supervised by a person not involved in the development process. One of the objectives of b -testing is to test the HP Product delivery and support channel. A trained HP applications engineer (AE) assists the customer with installation and checks the software installation procedure.

4.1       Validation Report include:

Test plans with acceptance criteria and test cases

Test results

Validation documents

Defects density report.

User Training Material

System status bulletin (SSB)

VALIDATION OF LAN SYSTEM - PERFORMANCE QUALIFICATION

1.1 Data Access
Prepare Test cases with slightly distrtal combination of Login ID and password and attempt access.
Designated ID

1.2 Audit Trail
1.2.1 File to be checked :
1.2.2 Persons having access :
1..2.3 Data

1.3 Communication with Peripheral

1.3.1 Peripheral to be checked -Printer :
1.3.2 File to be checked :
1.3.3 File Size :

2.4 Data Integrity

VALIDATION OF LAN SYSTEM - DESIGN PARAMETERS

1.0 DESIGN PARAMETERS
1.1 Define the Lan Model
The Open System Interconnection (OSI)
Others
1.2 Define the various protocols used
The Physical Layer
Transmits raw data bits over a communication channel (mostly mechanical and electrical issues)
The Data Link Layer
Guarantees to the network layer that there are no transmission errors by breaking the input data stream up into frames and sending back acknowledgement frames
The Network Layer
Controls the operation of the involved subnet; main issues are routing (determine a way from source to destination) and dealing with problems of heterogeneous networks, e. g. different size requirements of transmitted data blocks
The Transport Layer
Splits up data from the session layer if necessary (segmentation) and ensures that the pieces arrive correctly
The Session Layer
Allows users on different computer systems to establish a session between them, i. e. they are able to transfer files or log into a remote system; the conditions of communication are laid down, for example full-duplex or half-duplex
The Presentation Layer
Unlike the layers before it is concerned with the syntax and semantics of the transmitted information; it is concerned with all aspects of information representation such as data encoding, data compression and encryption
The Application Layer
Contains a variety of commonly needed protocols like handling with different terminal types and file systems; a label to identify the communication process, its origin and destination application is added to the transmitted information
Define true end-to-end layers, i. e. the layer on the source system carries on a communication process with the same layer on the destination system.
Define the other layers i.e. the lower layers wherein the protocols are between a system and its immediate neighbor
1.3 Define Medium Access Control (MAC) sublayer, which determines how the devices are attached to the network.
1.4 Define the intended speed of computer networks. The speed is measured in terms of the amount of information units (bits) that can be transmitted per second. Often, to transmit one character of a text, eight bits are necessary. Thus, if a network would have a speed of 8 bits per second (bps), one character per second could be transmitted. The speed of real networks is much higher. Usually Kilo, Mega, and Giga bits per second are common measures (Kbps, Mbps, Gbps), which mean thousands, millions or billions of transmitted bits per second.
1.5 Define the intended speed for running individual application softwares
1.6 The topology of a network (representation of how the devices in this network interact)
- Bus topology
- Ring topology
1.7 Define the transmission media used
Twisted pair
Two insulated copper wires twisted together in a regular spiral pattern; one pair establishes one communication link; it transmits electromagnetic signals. Twisted pairs are distinguished between shielded and unshielded twisted pairs according to their protection against electromagnetic fields
Coaxial cable
A single insulated inner wire is surrounded by a cylindrical conductor which is covered with a shield; it transmits electromagnetic signals. Coaxial cable is classified into two categories: base band (uses digital signals) and broadband (uses analog signals) coaxial cable
Optical fiber
Consists of three concentric sections, the core (a fiber conducting optical rays), the cladding (reflecting optical rays) and the jacket (surrounding one or many fibers to protect them); transmits optical signals, which must be transformed to electromagnetic signals
1.8 Defining Objectives
Define what the system is supposed to do. This should be as quantitative as possible and related to the creation, storage, transfer, and processing of information. The goals must be based on the present situation, which can certainly be improved. The whole environment of the planned system should be looked at; there should be no restrictions at that point of the process. This leads to some key product goals from which more specific system requirements can be derived.
1.9 Determine Communication Needs
Explain how information has to be moved what the network has to do. Network requirements have two major points: compatibility (the possibility to connect the devices) and capacity (maximum performance of the net). Thus, the selection of a network should take into account interconnection with other networks and future growth of the network.
1.10 Define other objectives
The network has to meet the established requirements and to provide the needed services
- Network must be expandable with only incremental costs
- Network is reliable (total network failures are prevented)
- Network can handle equipment supplied by several vendors
- Ease of installation, maintenance, reconfiguration, interconnection
- Software availability
- Limited Access capability
- Biometrics
- Data Migration and Archiving from one computer to the other
- Software access from multi-user versions of the software
- Audit trail
- Read Only/Read and Edit features
- Electronic Time
1.11 Correct storage retrieval Meta data
1.12 Communication with Printer,
- Scanner and other peripheral
- Devices for all points
1.13 Correct Function of special Application Software for all USERS

VALIDATION FOR COMPUTER SYSTEM

1.0              What is Computer Validation?

The Food and Drug Administration of the USA defines Validation as

“Establishing documented evidence that provides a high degree of assurance that a specific (computerized) process will consistently produce a product meeting its predetermined specifications and quality characteristics”.

To simply put it: Identifying and documenting that the computer system does what it is supposed to do consistently, repeatedly, and accurately.

2.0              What comprise the Computer System?

A device made up from electronics that can store and run a software-coded program. This includes all microprocessor based controllers, PLC, SCADA Systems, DCS, ERP, LIMS etc.

3.0              Why is Computer System Validation required?

RISK

Risk associated with the patient’s life being one of the most critical followed by Risk associated with the product quality. Risk associated to Goodwill and thus Risk associated with the business.

4.0              What are Regulatory Norms?

It is required to validate the Computer System especially by the regulatory bodies of Europe and USA. Even the MCC, TGA, Japanese regulatory bodies have recommended computer system validations. Any exports to the countries in these jurisdictions will want the computer systems validated.

5.0              What are Advantages of Computer Validation?

Helps in keeping track of the performance of the computer system implemented in the organization. It also helps in perfecting the system and making it devoid of any bugs or errors.

6.0              Difference between Equipment Validation and Computer System Validations?

The major difference between the Equipment Validation and Computer System Validation is that the computer system validation begins at the beginning of the system design. It begins and goes through a complete SDLC (System Design Life Cycle). The computer system validation begins with freezing the URS (User Requirement Specifications) and ends with the Performance testing of the system and further plans on decommissioning.

1.0              How to perform Computer System Validations?

New Systems Validation (Module I) 

7. On conceptualization of a computer system it is very important to create a URS in a very simple language and is conveyed by the actual user. Each URS should be unique and clearly defined and testable and unambiguous. No conflicting requirements should be asked for. Many a times it may so happen that the end user is qualified enough to describe the functional requirements of the system as well. Based on the URS the technical team creates a functional requirement specifications (FS) detailing the functional aspects of the system. On the basis of URS and FS the detailed Design Specifications (DS) are made. Design Specifications equivalent to Design Qualification. On completion and approval of DS the inquiry is floated to all the listed vendors who can fulfill the requirements and separate Vendor Audits Performed. It is very necessary to conduct this audit with the view of after sales support, support in validation of System, vendors past record, infrastructure, willingness to create a Escrow account and many such factors. Evaluate the vendor for the quality Management System with him. The commercial contract should be signed only after Vendor management and qualification is approved.

A whole lot of documentation should be called for before placements of Commercial order, which are ultimately required for the Validation of Computer systems.

Third party agencies  (like Vaiktron) re available to undertake Vendor Qualifications or the Computer System Validations.

            Legacy System Validation (Module II)

           

The approach and methodology is just the same as mentioned above. But a lot of documentation, which is now not available, will have to be created. A retrospective qualification of vendor will be essential. Though it is tough job the requirements are clearly defined.

SOPs required are Computer Systems Validation Master Plan, Design Specification (DQ), Vendor Management, Installation/ Operational Qualification (IQ/OQ), Document Archival & Retrieval, Change Control, Disaster Recovery & Contingency, Operator and Maintenance Training, Access Management to System, Performance Qualification (PQ) etc.

PQ: DATA MIGRATION

1.0              Define the inventory of Old Data

-          Computer system where the data is located.

-          Format of data.( Text, Graphics).

-          Data Volume (MB, GB).

-          Identify the Raw Data Formats used.

-          Identify the different files and their contents.

2.0              Define the Importance of Data

-          Archiving is compulsory under regulatory requirements.

-          Data will need reanalysis / Recomputing in future.

-          Data is required very often by many users.

3.0              Define the Old and New Computer System involved in Data Migration.

-          Hard Disc Capacity.

-          A/D Device Used.

-          Operating System Used.

-          Associated Softwares, their vendor and versions.

-          RAM

4.0              Experimental

Select the critical files from the old computer and migrate the same to new computer system and check the result.

VALIDATION REPORT

The entire data was identified by its File Number, format, and Volume. The critical text and values were underlined.

After migration, all documents were checked for correctness by designated persons. There were no change in formatting and Volume. The critical values, graphs were not affected by any means. The transfer was complete in respect of raw data, meta data, and processed data. The data can be accurately archived and processed on new system and the results are within the limits as specified during the original computation.

DQ,OQ PQ FOR COMPUTER SYSTEM

1.0 Define the System

1.1 Describe the purpose.

- Analytical Use.

- Inventory / Store.

- Archives / Records.

- Management Information.

1.2 List of all Hardware.

1.1 List all Softwares.

1.4 List all Operational Parameters.

1.5 Define Requirements to Operator.

1.6 Define Security Requirements.
- Hardware Lock
- Password Access.
- Biometric.
- Hardware Lock + Password Access.
1.7 Check following parameters concerning to DQ
- Purchase Order.
- Certificates and specifications for Vendor.
- Communications between internal users and Vendors.
- Users Manual.
- Maintenance, Calibration, and testing guidelines.
- All Drawings.
- List of Spares Supplied.
1.8 Check following parameters concerning OQ.
- Date of Installation.
- Installation Report.
- Place of Installation.
- Power Supply.
- Safety aspects.
- Calibration Details.
- Functionability of all switches and ancillary devices such as Printer, Modem, LAN, FDD, ZDD.
1.9 Verify following matter concerning PQ
- Security System.
- Operator Qualification.
- Functioning of each module and functioning of the total system over anticipated operating range.

VALIDATION REPORT
Prepare Validation Report stating Acceptance Criteria and Observations.

CONCLUSIONS
- System was valid during its past use.
- System was not valid during its past use and performance may have errors.
- System was not valid and needs improvement.
- System has become outdated and may be dissolved.