good automated laboratory practices

www.ngsmips.nitte.edu.in

GOOD AUTOMATED LABORATORY PRACTICES

Good Regulatory Practices

Department of Regulatory Affairs

NGSMIPS, Nitte University

Mangalore

- Swapnil Dylan Fernandes

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Contents

Standard Operating Procedures.

Documentation in GALP.

Logs and Related Forms.

Training

Conclusion

References

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STANDARD OPERATING PROCEDURES

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DefinitionAim of SOP’sSOP’s Concerned with GALP.


GALP SOP’s

General Criteria for Standard Operating Procedures

Criteria is as follows:

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Accessibility Currency

Practice

Comprehensiveness Credibility


GALP SOP’s The minimum SOP topics are –

Security

Raw Data

Data Entry

Data Verification

Error Codes

Data Change Control

Data Archiving

Backup and Recovery

Hardware Maintenance

Electronic Reporting Specifics5


Security –

– 2 types : System access security and Physical Security

– Focus: • Primarily on the computer room.

• Any related workstations.

– Physical Security

– System Access Security

Raw Data –

– Raw data is also known as primary data.

– Working definition used within the laboratory.

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Data Entry –

– Procedures related to data entry is the identification of

the person/personnel entering the system.

Data Verification –

– Verification of the Input Data.

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Error Codes –

– Interpretation of any error messages.

Data Change Control –

– Include –

• Documentation of how the authorised changes are carried out.

• Proof that the changes do not represent changes that could lead to the loss or corruption of data.

• Cost, scheduling and impact statements.

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Data Archiving –

– Define the procedures to ensure that the data is stored in a clear, logical, repeatable manner.

Backup and Recovery –

– Primary aim is to ensure the integrity and availability of the stored data in the event of serious breach of security or a system wide failure.

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Hardware Maintenance –

– SOP’s pertaining to efficient functioning of Hardware.

Electronic Reporting Specifics –

– Standards, protocols and the procedures used in the collection of data and analysis.

Additional Standard Operating Procedures Requirements

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DOCUMENTATION IN GALP

The purpose of GALP is to provide a vehicle for demonstrating system control. Documentation is an important cog in the wheel when it comes to GALP.

In general, six categories of documents are specified and required for compliance with GALP guidelines. They are as follows –

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Personnel:

– Personnel records help support the competence of various employees assigned to the system responsibilities.

Equipment:

– A hardware description log records

– A record of acceptance testing

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Operations:

– A security risk document identifies the likely and possible risks to the security of computer-resident data.

Facilities:

– A written environmental specifications guard against data loss or corruption from various environmental threats.

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Software:

– Documents for ensuring the continual functioning of the software.

Operational Logs:

– Backup and recovery logs and drills help guard against data loss or corruption.

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LOGS AND RELATED FORMS

Logs are used to document regular, incremental or complete backups or changes or performance data of the systems as well as other elements in the laboratory.

To safeguard existing data against the risk of future loss of data in the event of system failure or application failure.

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Types of Logs –

– System Backup Log –

• Documents, regularly, complete or incremental system backups.

– Routine Software Testing Log –

• Records the changes made to the system software.

– User Problem Log-

• Records user related problems with the systems or related softwares.

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– System maintenance Log –• Records the preventative maintenance completed on particular

hardware.

– Training Log –• Documents all the user training related information.

– Security Log –• Used to track and identify visitors, consultants, contractors and

other nonemployees who are currently in the premises.

– Data Change Log-• Used to record all changes made to the data in the system.

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TRAINING

Training documents are helpful in the training of new users.

Orientation training for individuals or groups of users of new systems or new version of existing systems.

Training programs should be comprehensive.

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CONCLUSION

Before the introduction of GALP

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After the introduction of GALP


CONCLUSION

GALP provides important guidance for the management of automated regulated laboratory.

GALP’s serve as important interpretive material in applying the content and principles of the GLP’s to the realities of the modern laboratory.

GALP’s have provided the much needed impetus to the modernisation of laboratory work and have ensured that work can be carried out in an efficient manner within relatively shorter time.

Streamlining of processes to has been one of the major successes of the GALP’s.

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REFERENCES Sandy Weinberg, Good Laboratory Practice Regulations,

Informa Healthcare, 52 Vanderbilt Avenue New York, P.No131-150

2185 good Automated Laboratory Practices Principles And Guidance to Regulations for Ensuring Data Integrity in Automated Laboratory Operations with Implementation Guidance 1995 Edition.

url:https://nepis.epa.gov/Exe/ZyPDF.cgi/2000AOGI.PDF?Dockey=2000AOGLPDF (accessed on 25 October 2017)

GALP Regulatory Handbook, Sandy Weinberg, Lewis Publishers e-book

url:https://books.google.co.in/books?id=RfzlISKm581EC&printsec=frontcover&source=gbs_ge_summary_r&cad=0#v=onepage&q&f=false (Accessed on 25th October 2017)

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https://nepis.epa.gov/Exe/ZyPDF.cgi/2000AOGI.PDF?Dockey=2000AOGLPDF

https://books.google.co.in/books?id=RfzlISKm581EC&printsec=frontcover&source=gbs_ge_summary_r&cad=0#v=onepage&q&f=false