Conducting and Documenting Robust Investigation for OOS Results

Description:

The United States Pharmacopeia monographs establish standards for identity, strength, quality, and purity of medicines. Monographs list tests and acceptance criteria (usually expressed in percentage ranges or limits). Drug substances and products should meet the acceptance criteria to be considered acceptable for its intended use. An Out of Specification (OOS) occurs when a test fails to meet acceptance criteria. An OOS Investigation follows an OOS test result and is performed to determine if there is a root cause. Understanding the factors that contributed to the potency failure allows the pharmacist and laboratory to define a strategic approach in eliminating future failures. The more specific the findings, the easier it is to properly address the cause.

This training will instruct analysts and supervisors as to their responsibilities. It will explain what the FDA is looking for in terms of documenting and investigating possible contamination, human error in sampling, processing of samples and in implementing CAPAs to prevent out of specification results. This training will describe what a full investigation looks like and when it should be triggered. It will also instruct participants on the frequency of retesting and resampling.

Why Should You Attend:

Failing to properly investigate and document out of specification results can lead to several significant risks including;

1. Regulatory non-compliance – Regulatory agencies like the FDA expect thorough investigations and documentation of OOS results to ensure product quality and patient safety. The cost of noncompliance results in warning letters and 483s as well as batch rejection and recall.
2. Compromised product quality -OOS results can indicate that a product is not meeting its intended quality standards, potentially leading to degradation and instability.
3. Potential patient harm – inadequately performing and documenting OOS results can lead to the drug not containing the correct concentration of active ingredients and potentially leading to ineffective treatment or an adverse drug reaction.
4. Damage to a company's reputation - Product recalls, batch rejections, and regulatory fines can result in significant financial losses for a company. Failing to address OOS results can damage a company's reputation and erode patient trust. Repeated quality issues can lead to customers losing confidence in a company's products and services, resulting in reduced market share

Areas Covered in the Webinar:

• Responsibilities of Analysts and Supervisors
• Explain what the FDA looks for in terms of sampling and processing errors
• Describe when a Full Investigation should be triggered and how it should be documented.
• Describe Re?testing and Re?sampling frequencies
• Implement the corrective and preventive action plans (CAPA)

Who Will Benefit:

This webinar is for professionals responsible for generating or evaluating test results in a regulated environment.

• Lab Analysts
• Supervisors and Managers in Pharmaceutical or Biological Laboratories
• Quality Control and Quality Assurance Analysts

Joy McElroy
Principle Consultant, Maynard Consulting Company

Joy McElroy has 10 years of experience as a consultant and over 30 years of total experience in the pharmaceutical and biotech industries. Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, and equipment qualification. She worked in Quality Control and Quality Assurance for several years before moving into validation and qualification. She has written and executed equipment qualification and validation protocols for numerous companies.

Ms. McElroy specializes in manufacturing equipment qualification, sterilization, cleaning validation, analytical instrument qualification, computer system validation and GMP compliance auditing. In 2019, Ms. McElroy started her own company, McElroy Training and Consultancy. She currently works with Actalent Services, LLC.

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