1. Establishing a base line of
Compliance within a GLP Lab.
It is said the journey of thousand miles begins with a
single step.
To establish a baseline of compliance in QC the Design
and implementation of Quality Control Management
System (QCMS) would be the first and foremost step.
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2. Establishing a base line of
Compliance within a GLP Lab.
For a new organization the QCMS has to be designed
and implemented as per the regulatory requirements
which are applicable like USFDA / MHRA etc.
For an existing organization GAP analysis needs to be
done between the existing facility and the QCMS
desired.
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3. Establishing a base line of
Compliance within a GLP Lab.
Compliance: Conformance to the specification or
predefined standards. Following the standardized
procedures and documenting accurately and
concurrently what is done.
Do what is written / described, write / report what is
done.
Compliance is a very broad term which applies for
each and every activity in QC. But how it is to be
implemented is very specific for each section.
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4. Establishing a base line of
Compliance within a GLP Lab.
Quality Control Laboratory generally has the following
sections:
Raw Material
In process
Finished Product
Stability
Validation
Good Laboratory Practices (GLP) / Analytical Assurance
Microbiology
Documentation
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5. Establishing a base line of
Compliance within a GLP Lab.
Compliance for RM, PM & FP section is:
Receiving the GRN / TRN, logging in the A.R.No. log, sampling for RM
and FP sample receipt from IPQA.
Sample allocation and worksheet issuance by the section head to the
respective chemist.
Testing as per the Protocol of Analysis.
Documentation as per the worksheet.
Review of raw data and related entries by the section in charge.
Approval / Rejection (Disposition) by QC Manager.
Retention / Control sample storage.
Archival of the reports.
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6. Establishing a base line of
Compliance within a GLP Lab.
Compliance for Validation Section is:
Method Validation: Analytical / Microbial Method Validation to be
carried out as per the pre-approved protocol as per ICH guidelines
(ICH Q2).
Cleaning Validation: Swab, rinse, CIP, sampling and testing as per the
approved protocol.
Process Validation: Prospective, concurrent and retrospective
validation samples to be tested as per validation protocol.
Instrument Validation: Analytical Instrument Qualification-
DQ,IQ,OQ&PQ.
Analyst validation / Qualification: New comer & periodic.
Computer System Validation.
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7. Establishing a base line of
Compliance within a GLP Lab.
Compliance for GLP Section is:
Calibrations as per Calibration Schedule.
Preventive Maintenance as per PM Schedule.
Training as per the training needs matrix.
Working standards and reference standards management.
User administration (21 CFR Compliance).
Data back up and restoration (Disaster mitigation).
Chromatographic column management (HPLC / GC)
Chemical / reagents receipt, storage and consumption.
Issuance- Log books, Worksheets, calibration formats.
OOS, change management and deviation handling.
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8. Establishing a base line of
Compliance within a GLP Lab.
Non compliance in QC may be due to the following
commonly known reasons:
Measurement System Variation.
Instrument breakdowns
Lack of training
Improper standardization
Calibration failures
Lack of precision
Improper reagent quality
Utility failure
Sampling error
Testing error
conti…….
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9. Establishing a base line of
Compliance within a GLP Lab.
Improper storage
Visual error
Washing problems and carryovers
Improper column maintenance
Power failures
Software related problems
Sterility failures
Documentation errors.
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10. Establishing a base line of
Compliance within a GLP Lab.
The baseline of compliance can be established by:
Recruiting the right people (appropriate technical qualification and
experience) to perform the task.
Describing the job to be done by each one (job description)
Identifying the training needs and training the personnel for the specific
task.
Providing adequate resources like instruments, standards, reagents etc for
testing.
Establishing Written Procedures (SOPs and General Procedures) for every
task.
Ensuring that the testing has been conducted by well trained qualified
chemists as per the approved protocol and validated method with proper
documentation using calibrated instruments and valid standards &
reagents. Conti……….
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11. Establishing a base line of
Compliance within a GLP Lab.
Quality Control Management System (QCMS) can be effectively
implemented by assigning the project to the core team.
The Project Manager should assign the core team the schedule and
deadline for GAP analysis and QCMS implementation.
The core team should perform the GAP analysis, prepare a project
report and discuss the mitigation plan.
The management should provide the resources required for
establishing the baseline for compliance.
Compliance should be done and QCMS should be in place and in use
thus making the site ready for regulatory audits.
Compliance is a continuous process and should be maintained and
continuously improved for long term / throughout product life cycle
assurance of quality.
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