Laboratory Internal Audit Preparation Steps

    Pharmaceutical quality control laboratory quality auditing is a crucial activity for those undertaking due diligence or monitoring a subcontractor's performance.

    Throughout the drug production process and its shelf life, testing is done to ensure that the drug product meets acceptance standards.

    Laboratory Inspection and Auditing

    Laboratory data is utilized to make strategic decisions for a wide range of initiatives such as investigation, remediation, compliance, etc. To minimize costly resampling and expense overruns the data must be of the greatest quality. A laboratory audit verifies that the lab has quality procedures in place, follows acceptable laboratory practices, and produces data that is both accurate and reliable.

    The audit's effectiveness is determined by proper planning, accurate execution, well-documented and insightful reporting, and effective follow-up. Here are the internal audit preparation steps.

    Define the objectives and goals of the Internal Audit:

    These could include the following and more:

    • To evaluate overall compliance with internal policy or regulatory requirements.
    • To prepare for an external audit
    • To undertake a follow-up internal audit in response to a complaint, a poor external inspection, or a nonconforming incident
    • To confirm that a new method meets regulatory criteria
    • To reassure management that the management system is being implemented correctly.
    • To learn the requirements of certification bodies (standards) for training reasons
    • To improve processes
    • To ensure that the quality management system's requirements, such as analytical methods, SOPs, the quality manual, ethics policies, data integrity, internal laboratory policies are met.
    • To assemble the relevant paperwork, which will include:
      • Auditor reviews of remedial activities
      • Auditee/section response if necessary
      • Management review of the final report
      • Follow-up if necessary

    Define the Internal audit's scope

    Laboratory management should be included in the planning process to help define the audit's scope and intended outcome. Here's where you define the limits or boundaries of the laboratory quality audit. Will it be a corporate/organization-wide project, a central laboratory project, or a satellite laboratory project? Will all analytical methodologies be covered, or just a subset of them? How will the audit's scope affect laboratory employees and operations?

    These will help in:

    • Ensuring that proper test processes, equipment, controls, and calibration methods are established.
    • Ensuring that appropriate laboratory tests are ordered
    • Obtaining test samples in a timely and efficient manner
    • Producing reliable laboratory test results
    • Disseminating laboratory test information to clients and providers promptly
    • Utilizing qualified laboratory staff

    Determine the audit team resources to be utilized.

    Determine which team members' particular skills/knowledge are required to handle the audit scope efficiently and effectively. Here's where you determine the general qualifications, responsibilities, training and continuing education of the auditors

    Determine who is in the authority of the audit.

    The audit is authorized by the company/quality organization's assurance manual, the contract for analytical services, or the third-party audit request.

    Determine the performance standards to be applied.

    The audit team must compare the auditee's quality system to a set of guidelines. This does not imply that all laboratory quality control systems are or should be equal. The task is to ensure that, regardless of how the auditee's quality system is titled and described, all of the required functions are covered and implemented. For coverage equivalency, the audit team will compare the auditee's system to the auditor's system.

    Acquire a technical grasp of processes to be audited.

    If the audit team has a thorough understanding of the laboratory's quality system, it will be more effective and efficient. Before arriving at the laboratory, review the Quality Manual and implementing procedures, as well as historical data from previous audits (where available), to focus on the "mission important" issues and design better checklists.

    Make contact with those who will be audited.

    The auditee is notified of the audit using the appropriate channel for the situation. The Lead Auditor must either ensure that it is completed or complete it, depending on the situation. This initial contact allows you to get to know the auditee, figure out the practicalities of the audit, and, if necessary, obtain documents for preparation. Following approval, the formal audit plan is sent to the auditee.

    Conduct a preliminary assessment of lower-tier documents with higher-level requirements.

    This procedure is part of the audit team's instruction. The procedure also serves as a focal point for the actual on-site data collection initiatives.

    Make a list of the data requirements in writing.

    The construction of the checklists reflects the focus established in the prior section. Some sections of the checklists are general when the audit program is utilized to cover multiple comparable laboratories. The precise concerns to be examined are specified because the checklist's principal purpose is to collect data. The audit question must also be directly related to the requirement stated by the standard.