QALT Mock Audit

A QALT mock FDA audit is a simulated inspection or review conducted to assess company or organization readiness for an actual FDA audit. Instead of being carried out by FDA inspectors, a mock audit is led by QALT auditors who have expertise in FDA

QALT Compliance Evaluation

Evaluate the company's adherence to FDA regulations, encompassing Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and other pertinent standards.

QALT Identify Discrepancies

Pinpoint any deficiencies or areas of non-compliance that necessitate rectification before an impending FDA inspection.

QALT Assess Procedures

Scrutinize the efficacy of internal protocols, documentation systems, and quality assurance mechanisms to ensure alignment with regulatory standards.

QALT Staff Training

Offer training sessions for personnel engaged in regulatory compliance to enhance their understanding of roles and responsibilities in preparation for an FDA inspection.

QALT Enhances Preparedness

Assist the company in enhancing its preparedness and response capabilities for managing an FDA audit effectively, thereby mitigating compliance risks and regulatory repercussions.

QALT Training and Qualification of Personnel

Providing training and verifying the proficiency of laboratory staff engaged in testing procedures is imperative. This encompasses instruction on pertinent protocols, techniques, and equipment usage, along with continual competency evaluations.

QALT Laboratory Facilities and EnvironmenT

Maintaining appropriate laboratory facilities and environmental conditions is crucial for enabling accurate and reliable testing. This includes controlling temperature, humidity, cleanliness, and implementing protocols to mitigate the risk of contamination.

QALT Investigation of Out-of-Specification (OOS) Results

Establishing protocols to investigate and document out-of-specification test outcomes to determine their underlying causes and avert future instances. This process may entail conducting root cause analyses and enacting corrective and preventive actions (CAPAs).

QALT Investigation of Out-of-Specification (OOS) Results

Preparing for regulatory inspections and internal audits involves maintaining meticulous documentation, adhering to standard operating procedures (SOPs), and ensuring compliance with regulatory mandates.

QALT MethodS ASSESSment

Verifying the appropriateness of analytical methods utilized in the laboratory for their designated purpose entails ensuring their accuracy, precision, specificity, and robustness. Also supports for comparison and lifecycle management of methods

QALT Instrument Management

Supports documentation from qualification to retirement of instruments. Regular calibration and maintenance of laboratory instruments are imperative to guarantee the accuracy and reliability of test results. This process encompasses sophisticated analytical instruments like HPLC, LC-MS, GC, ICP and many more...

QALT Quality Control MANAgement

Analysis of quality control samples is essential for monitoring the long-term performance of analytical methods and instruments. These samples are usually maintained and stored at required conditions to meet regulated reconciliation requirements.

QALT Data Integrity ASSESSMENT

Ensuring data integrity and reliability in laboratory settings necessitates meticulous documentation practices. This includes utilizing electronic data systems equipped with robust controls to uphold data security and traceability.

qALT Identification of Issues

The process commences by identifying deviations, discrepancies, or issues within pharmaceutical manufacturing or quality control processes. This can be achieved through audits, inspections, customer feedback, or internal quality control protocols.

QALT Root Cause Analysis (RCA)

Upon identifying an issue, the subsequent step involves conducting a comprehensive root cause analysis to ascertain the reasons behind its occurrence. Commonly utilized RCA techniques such as fishbone diagrams, the 5 Whys method, or fault tree analysis are instrumental in uncovering the underlying causes.

QALT Corrective Actions

Upon conducting a thorough root cause analysis, corrective actions are being implemented to address the immediate issue and prevent its recurrence. These actions may encompass adjustments to processes, retraining of personnel, recalibration of equipment, or updates to standard operating procedures.

QALT Preventive Actions

In addition to resolving the current concern, it is essential to establish preventive measures to avert the recurrence of similar issues. This entails introducing modifications to processes, protocols, or systems to preemptively manage risks.

QALT Documentation and Reporting

All Corrective and Preventive Action (CAPA) activities necessitate comprehensive documentation, encompassing specifics of the problem, root cause analysis, implemented corrective and preventive measures, assigned personnel, and designated timelines for execution. This meticulous documentation is crucial for regulatory adherence and the facilitation of continuous enhancement initiatives.

QALT Review and Verification

Corrective and Preventive Action (CAPA) activities necessitate regular reviews to guarantee their efficacy and adherence to regulatory standards. This process may encompass subsequent audits, inspections, or internal assessments to confirm that the corrective and preventive measures have been executed as planned and are yielding the intended outcomes.

QALT Continuous Improvement

Pharmaceutical Corrective and Preventive Action (CAPA) management constitutes an iterative process designed for ongoing enhancement. Insights gained from CAPA initiatives should be leveraged to refine and fortify quality management systems, processes, and protocols with the objective of averting future complications and elevating standards of quality and compliance.

qALT Identification of Deviation

The initial step entails promptly identifying and documenting any deviation once it is observed or detected. Such deviations may encompass deviations from standard operating procedures (SOPs), specifications, batch records, or any pertinent documentation.

QALT Evaluation of Impact

Upon identification, the impact of the deviation on product quality, safety, efficacy, and regulatory compliance is evaluated. This assessment includes gauging the severity and potential ramifications of the deviation.

QALT Immediate Corrective Action

In situations demanding swift action to avert further divergence or potential harm, prompt corrective actions are implemented. These measures may include halting production, isolating affected products, or introducing temporary strategies to alleviate risks.

QALT Root Cause Analysis (RCA)

The root cause of the deviation is meticulously examined to identify the fundamental factors that led to it. Various tools and methodologies, such as the 5 Whys, fishbone diagrams, fault tree analysis, or failure mode and effects analysis (FMEA), are commonly employed in this investigative process to unveil the root cause.

QALT Corrective and Preventive Actions (CAPA)

Upon completion of the root cause analysis, corrective and preventive actions (CAPAs) are formulated and executed to rectify the underlying issue and forestall its reappearance. Such measures encompass enhancements to processes, adjustments to procedures, training initiatives, equipment upgrades, or any necessary corrective actions.

QALT Documentation and Reporting

A thorough report on the deviation investigation is compiled, encompassing all facets of the deviation, investigation outcomes, as well as corrective and preventive action (CAPA) plans and their execution. This documentation is vital for regulatory adherence, internal quality assurance, and ongoing enhancement endeavors.

QALT Review and Approval

The deviation investigation report undergoes review and approval by pertinent stakeholders, such as quality assurance, regulatory affairs, production, and any other relevant departments.