Instrumental Methods Of Analysis Questions And Answers

[Ortiz Ullery]

Reliableanalytical results help in making informed decisions about the quality and safety of the products in the pharmaceutical industry. Also, such analytical data are essential to support the drug product registrations. Learning how to execute document development, how to demonstrate FDA and EU compliance to auditors and inspectors, how to explain company's strategy for method validation, verification, transfer and equivalency testing and the best practices will be invaluable to your firm.

This article provides answers questions about Analytical Method Validation, Verification and Transfer and guides you to the next steps. Scientists who are directly or indirectly involved with the drug development, analysis, stability studies or regulatory/compendial submissions will find the information in this article useful. Among others who will benefit from this article are Analytical Chemists, supervisors and managers of Analytical Chemists, those responsible for hosting FDA inspections, responding to 483s and warning letters, regulatory affairs or those preparing for NDA's and ANDAs, QA managers, Quality control staff, validation specialists, consultants, formulation chemists, lab supervisors, Compendial Liaisons, and chemistry, pharmaceutical, pharmacy senior or graduate students.

Analytical data are required for regulatory submissions in support of the drug product registrations. The Regulatory bodies require proof of safety and quality of products. Companies are required to have reliable test methods. The reliability of test methods is substantiated by performing validation which is then documented.

The Code of Federal Regulations (CFR) 311.165c explicitly states that the "Accuracy, Sensitivity, Specificity, and Reproducibility of test methods employed by the firm shall be established and documented.

It is also important to use certified reference material in analytical laboratories to meet the FDA and international requirements for selection, purchasing, testing, storage, and use of (certified) reference material.

System suitability and acceptance criteria are integral parts of analytical validation. During each method/procedure, it should be ensured that all analytical operations, electronics and equipment are working properly at the time of analysis. Relevant system suitability, and its criteria should be defined including

The Analytical procedures in the current USP are legally recognized under section 501(b) of the Federal Food, Drug and Cosmetic Act as the regulatory analytical procedures for the compendial items. The suitability of these procedures must be verified under the actual conditions of use.

USP 'The transfer of analytical procedures (TAP), also referred to as method transfer, is the documented process that qualifies a laboratory (the receiving unit) to use an analytical test procedure that originated in another laboratory (the transferring unit), thus ensuring that the receiving unit has the procedural knowledge and ability to perform the transferred analytical procedure as intended."

A drug's characterization, quality control, and manufacturing batch records are supported by validated analytical records. Analytical method validation provides documented proof that the test procedure is suitable for its intended. It provides evidence of the method's performance and the quality and reliability of results. Analytical methods provide data that is important to ensure consumer health and safety. Hence their validation is highly inspected.

A drug's characterization, quality control and manufacturing batch records are supported by validated analytical records. To show that the test procedure is suitable for its intended analytical test method is documented, thus providing proof of the method's performance and quality and reliability of results.

Attend the seminar Analytical Method Validation, Verification and Transfer to understand how to determine the analytical characteristics for different types of validation procedures for the analysis of both the drug substance and drug product. The factors to consider for verification of the compendial procedures will also be discussed in the seminar. In addition, different approaches for the transfer of analytical procedure from one lab (transferring) to other lab(s) (receiving) under different circumstances will be covered. Other related topics for obtaining reliable data will also be discussed. These topics include analytical instrument qualification as well as how to set, handle and monitor specifications.

The course Director Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

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