Definitions Related to Qualification of Contract Test Laboratory

Definitions Related to Qualification of Contract Test Laboratory in Pharma:

Audit: Systematic, independent, and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.

Auditee: Members representing the vendors manufacturing/suppliers site to be audited.

Auditors: Qualified persons who conduct an audit. The audit team may represent one or more persons conducting an audit supported if needed by technical experts.

Audit Criteria: Set of requirements used as a reference against which objective evidence is completed.

Audit Conclusion: Outcome of an audit after consideration of the audit objectives and all audit findings.

Audit Findings: Results of the evaluation of the collected audit evidence against audit criteria.

Audit Scope: Extent and boundaries of an audit.

Audit Plan: Description of the activities and arrangements for an audit

Cause Audit: An audit performed in case of conditions like Regulatory Action, Investigation, against assessment outcome of any major/significant change notification from the CTL, etc. These are unscheduled audits.

Contract Testing Laboratory: Any laboratory that is approved and authorized for the analysis of samples.

Critical Observation: A non-conformance that may have a significant impact on product safety, identity, strength or purity and is likely to have serious and/or harmful effects on the patient. Also, a combination of major non-conformances, which indicates serious system failure, may be classified as critical observation.

Follow-up Audit: An additional audit performed to evaluate the compliance of any critical or more than 5 major observation(s) reported during the first-time audit or periodic audit. These are unscheduled audits.

Major Observation: A non-conformance, other than critical, that is likely to have a significant impact on product quality resulting in failure or reduction in the suitability of use of product for its intended purpose.

Onsite Audit: The physical audit, which is performed at the site of the Contract Testing Laboratory.

Other Observation: A deficiency that may not have any impact on product quality but indicates a deviation from written procedure.

Periodic Audit: An audit performed at the CTL facility at a predefined frequency/ schedule for the periodic evaluation of established controls and systems as per the applicable cGMP guidelines.

Provisional Approval: Conditional approval of a CTL for a particular time period or situation following a risk-based approach, to continue utilization of the CTL under exceptions.

Qualification of Contract Testing Laboratory: The process by which the Contract Testing Laboratory is evaluated to determine the services provided by the laboratory is per the requirements specified in this SOP and has the appropriate accreditations, practices, and approvals from respective Regulatory agencies.

Quality Agreement: It is an agreement made between Lupin and the Contract Testing Laboratory to have predefined terms and conditions and clearly establish each party’s responsibilities.

Quality Unit: The quality Unit is comprised of Quality Assurance / DQA and Quality Control.

Recommendation: Recommendations are suggested practices to improve quality systems. However, recommendations are non-binding, and the laboratory has no obligatory implementation responsibility. Recommendations are not non-conformance to any quality system.

Remote (Virtual) Audit: Audit conducted remotely (virtually in place of onsite audit) by using multi-media and web-based applications like Skype, Microsoft Teams, and any other online/real-time electronic methods for audio and visuals and to exchange information and data. Such audits can be considered as an alternative tool for physical on-site audits, where on-site audits are not possible due to valid and justified reasons.

Requalification of Contract Testing Laboratory: Requalification of Contract Testing Laboratory could be a periodic requalification activity or change in status from disqualified to re-qualified.

Risk-based Approach: An approach following a risk review consideration in the management of CTL’s selection, audits, and management of the CTL life cycle.

Risk-based Assessment (RBA): A systematic assessment, to review the frequency of the CTL audit based on (but not limited to) the CTL’s performance, type of material tested, audit compliance and regulatory actions, etc.

Third-Party Audit: A Third-party audit is performed by a competent audit organization independent of the customer-supplier relationship and is free of any conflict of interest. Audit reports can also be procured from certified/recognized and/or qualified third-party audit agencies and organizations.

Definitions Related to Qualification of Contract Test Laboratory

Definitions Related to Qualification of Contract Test Laboratory

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