To establish a baseline of compliance in QC the Design and implementation of Quality Control Management System (QCMS)

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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