This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry. -Standard Operating Procedures. -Documentation in GALP. -Logs and Related Forms.

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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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