The document outlines Good Automated Laboratory Practices (GALP), focusing on the importance of Standard Operating Procedures (SOPs) and documentation for ensuring data integrity in laboratory operations. It includes specific topics such as security, raw data management, data entry, and error handling, as well as the necessity for training and maintaining logs. Overall, GALP provides essential guidelines for the efficient and compliant management of automated laboratories.

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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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Definition
Aim of SOP’s
SOP’s Concerned with GALP.

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GALP SOP’s
General Criteria for Standard Operating Procedures
Criteria is as follows:
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Accessibility Currency
Practice
Comprehensiveness Credibility

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GALP SOP’s
 The minimum SOP topics are –
Security
Raw Data
Data Entry
DataVerification
Error Codes
Data Change Control
Data Archiving
Backup and Recovery
Hardware Maintenance
Electronic Reporting Specifics
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 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.
 DataVerification –
– 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 SoftwareTesting 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

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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.No
131-150
 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&printse
c=frontcover&source=gbs_ge_summary_r&cad=0#v=onepage&q
&f=false (Accessed on 25th October 2017)
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