Compliant Qualification and use of Reference Standards in Quality Control

Overview:

Reference standards are an essential part of many analytical procedures in pharmaceutical analysis, and their integrity is pivotal for the accuracy of results. The suitability for their use should never be underrated, in particular if quantitative, as reference standards are often used for a long time, and many released batches of API or drug products may be affected in case of problems. Therefore, a thorough characterization, in particular the content assignment (if relevant), a complete documentation, an appropriate storage and monitoring of their stability is of utmost importance.

Compendia do not only provide official reference standards within the scope of their monographs and general chapters, but establish also comprehensive information, discussion, and requirements with respect to their characterization, maintenance, and use. This can also be taken as orientation for internal reference standards, in order to prepare for regulatory submissions, as well as for inspections and audits.

Why you should Attend:

Participants will gain an overview on GMP and compendial requirements with respect to reference standards, as well as practical orientation and recommendations concerning appropriate characterization, use and maintenance, as well as establishment of a retest period. Due to its impact, the content assignment is discussed in detail, including the corresponding uncertainty implications with respect to the mass balance approach and (collaborative) assay design. 

Areas Covered in the Session:

• Regulatory requirements to pharmaceutical reference standards
• Compendial standards (USP, Ph.Eur., JP)
• Characterization (Guidelines FDA, ICH, WHO)
• Content assignment with uncertainty (mass balance approach, assay)
• Retest period, stability, re-qualification, replacement
• Sources of reference standards and responsibilities of the user
• Appropriate use of reference standards in GMP testing

Who Will Benefit:

• Analysts 
• Lab Supervisors and Managers in Quality Control and Analytical Development
• Quality Assurance
• Regulatory Affairs, and inspection functions interested to gain an overview on GMP and compendial requirements with respect to reference standards, as well as practical orientation and recommendations concerning appropriate characterization, use and maintenance in dependence on the type of reference standards.