Auditing Laboratories Conducting Assays Supporting Biologics

Overview:

Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.

Careful consideration of the work that will be performed at the laboratory provides a working framework for the content of the audit. The first steps in preparing for the audit involves determining necessary personnel required for the site visit (quality assurance and subject matter experts), understanding the purpose of the audit, and triaging the documents necessary for review.

The initial steps are best handled by advance planning, even for routine audits. Routine audits can have templates created to assist with performance of the audit, but care should be taken to identify and incorporate examination of any new processes performed by the laboratory. Templates may cover basic audit procedures and requests, such as in prequalification of vendors.

Audits for cause focus on specific issues and require additional planning to uncover the root cause of the quality issue. This webinar will address key points to assess during the preparation and performance of GMP/GLP laboratory audits for laboratories conducting assays supporting biologics.

The range of assays required to test for biologic product safety and stability creates the necessary inclusion of subject matter experts during the audit. Quality assurance personnel may adequately review general standard operating procedures.

However, subject matter experts in cell culture, cell-based procedures, or ligand-binding methods should be included in the audit team to review procedures for clarity and consistency with accepted laboratory practices. Included in this presentation are suggestions for specific items to review. Those items include identifying personnel involved in performance of the method, reviewing training files, observing key procedures, and examining raw data files.

Standard operating procedures (SOPs) for all components necessary for performance of the methods should be reviewed against actual procedures in the laboratory. Also discussed are points to consider when negotiating changes to procedures if variances are observed. Key procedures are not limited to the laboratory method but include auxiliary functions required to bring the samples or reagents from receipt to storage to testing. Training files provide details on the background, experience, and on-the-job training for all personnel involved with a sponsor’s work at the laboratory.

Pairing training files with SOPs helps clarify if all personnel involved with the work are sufficiently trained and knowledgeable regarding the requirements of functions in a GMP/GLP laboratory. SOPs should also fit with current practices as expected by regulatory agencies. Processes that are not consistent should be identified and observations discussed during the site audit.

This webinar will address practices for reviewing SOPs against laboratory procedures. Also discussed is the specific scope of auditing laboratories that conduct cell-based methods. Cell-based methods have additional requirements for SOPs to govern the work.

Auditors should conduct a careful review to determine that practices are aligned with expectations. Finally, findings in the audit must be communicated. This webinar will conclude with addressing best practices for communicating findings and negotiating agreements to either clarify the findings or to address the issue and reach a resolution.

The quality or laboratory professionals that attend this webinar will gain knowledge useful in addressing maintaining a quality method through careful auditing of key processes.

Why you should Attend:

Auditing vendors is an essential function for quality and scientific personnel. Training and clarification of the process necessary for good audits is important for Sponsors gathering the necessary information to qualify a vendor laboratory or to document that procedures are following standard expectations of GMP and GLP.

Both Quality Assurance personnel and Subject Matter Experts will benefit from training in conducting audits. With the overwhelming number of documents and data a detailed, specific plan based on good training makes audits more beneficial for uncovering and addressing issues as well as having confidence that no issues exist.

Quality of the pharmaceutical or biopharmaceutical product is the key parameter that must be maintained through careful implementation of practices consistent with good quality systems.

Maintaining quality requires strict adherence to procedures designed to provide verification of quality attributes of pharmaceutical products. Sponsors are the final responsible party when quality of a marketed product or a product in development is questioned.

Serious issues may arise if careful attention is not given to details of processes that have an impact on quality. Both quality assurance personnel and scientific subject matter experts, working together, monitor processes and laboratories performing methods to assure that high quality is maintained.

Quality Assurance (QA) personnel understand and monitor adherence to standard practices as outlined in Standard Operating Procedures (SOPs), Quality Agreements, and other documents governing handling, testing, and reporting of product quality attributes.

Laboratories not following good quality practices put the product and the sponsor at risk. Sponsors not preparing in advance and reviewing which procedures or processes to audit often miss critical issues that if not corrected have a negative impact on quality of the product.

Audits can be developed based on the Quality Agreement if Quality Agreements outline in detail specific expectations for testing, delivery of data, auditing, and access to documentation.

In addition, the Quality Agreement is a legally binding document used by the Sponsor and the laboratory to provide details of interactions and expectations for following GMP and GLP practices.

Lack of a good Quality Agreement is an unfortunate oversight that may cause significant problems when quality issues arise. The Sponsor’s QA personnel should be aware of current practices and regulatory documents to include those expectations in the Quality Agreement.

Standard Operating Procedures (SOPs) typically follow GMP and GLP guidances and are included as documents for audit in the Quality Agreement. Subject matter experts bring valuable scientific and process information to the audit as defined by the Quality Agreement.

Areas Covered in the Session:

• Regulatory agency expectations
• Quality Agreements
• Identifying additional audit/inspection topics specific for cell-based laboratories
• Establishing and communicating the audit plan
• Identifying the audit team
• Assessments during the walk-through
• Setting the timing
• Identifying potential quality issues
• Presenting findings
• Negotiating responses

Who Will Benefit:

• Pharmaceutical regulatory affairs
• Biopharmaceutical regulatory affairs
• Pharmacists
• Consultants
• Pharmaceuticals
• Biopharmaceuticals
• Botanicals
• Natural products