establishing a base line of compliance within a glp lab

8/3/2019 Establishing a Base Line of Compliance Within a GLP Lab

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Establishing a base line of

Compliance within a GLP Lab.

It is said the journey of thousand miles begins with asingle step.

To establish a baseline of compliance in QC the Designand implementation of Quality Control Management

System (QCMS) would be the first and foremost step.

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Establishing a base line ofCompliance within a GLP Lab.

For a new organization the QCMS has to be designed

and implemented as per the regulatory requirementswhich are applicable like USFDA / MHRA etc.

For an existing organization GAP analysis needs to bedone between the existing facility and the QCMS

desired.

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Establishing a base line ofCompliance within a GLP Lab.Compliance: Conformance to the specification or

predefined standards. Following the standardized

procedures and documenting accurately andconcurrently what is done.

Do what is written / described, write / report what isdone.

Compliance is a very broad term which applies foreach and every activity in QC. But how it is to beimplemented is very specific for each section.

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Establishing a base line ofCompliance within a GLP Lab.Quality Control Laboratory generally has the following

sections:

Raw MaterialIn process

Finished Product

Stability

Validation

Good Laboratory Practices (GLP) / Analytical AssuranceMicrobiology

Documentation

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Establishing a base line ofCompliance 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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Establishing a base line ofCompliance 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 retrospectivevalidation 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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Establishing a base line ofCompliance 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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Establishing a base line ofCompliance within a GLP Lab.Non compliance in QC may be due to the following

commonly known reasons:Measurement System Variation.

Instrument breakdownsLack of training

Improper standardization

Calibration failures

Lack of precision

Improper reagent qualityUtility failure

Sampling error

Testing error

conti.

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Establishing a base line ofCompliance within a GLP Lab.Improper storage

Visual error

Washing problems and carryoversImproper column maintenance

Power failures

Software related problems

Sterility failures

Documentation errors.

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Establishing a base line ofCompliance 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 fortesting.

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 properdocumentation using calibrated instruments and valid standards &reagents. Conti.

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Establishing a base line ofCompliance 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 forestablishing the baseline for compliance.

Compliance should be done and QCMS should be in place and in usethus making the site ready for regulatory audits.

Compliance is a continuous process and should be maintained andcontinuously improved for long term / throughout product life cycleassurance of quality.

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establishing a base line of compliance within a glp lab

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