Tech Bulletin | February 2018

DYNALABS has updated our quoting process to include 3 lots for antimicrobial effectiveness testing. This is referencing FDA guidelines which will provide more thorough results and meet new regulations being integrated for stability studies.

OOS Changes:

• Through our continuous quality improvement initiative, DYNALABS has reformatted some of the OOS investigation report questions. The updated questions allow for our team to share more about our internal investigation process and allows for a more robust report.
• The DYNALABS Quality and OOS Investigation teams have worked together to revise and create several OOS SOPs that will be effective soon. If you would like more information, please reach out to your Regional Business Manager to schedule a meeting with the Director of Quality and the OOS/Quality Manager to discuss the changes.

• Risk-Based Approach to Manufacturing Standards for Outsourcing Facilities
• Restricting Compounding of Drugs that are Essentially Copies of FDA-Approved Drugs
• Regulating Compounding from Bulk Drug Substances
• Finalization of Biological Products Guidance and Clarifying Other Policies on Activities that Compounders Undertake.
• Solidifying FDA’s Partnership with State Regulatory Authorities Refer to FDA announcement FDA 2018 Guidance Plan

• This chapter pertains to a large variety of samples for injections to be tested based on USP limits provided for light obscuration test or microscopic particle count test.

• Opthalmic testing has stricter limits due to the sensitivity of the eye and how it is administered. This can be tested through light obscuration test or microscopic particle count test.

• This chapter clarifies on specific caveats depending on application as topical, intraocular injections, and extraocular injection. Intraocular and topical administration of the drug, USP recommends the sample to be tested with USP <789> limits due to the local and systemic issues that can occur. Extraocular injections are suggested in USP to follow <788> limits since the injectables are similar in nature and have less of an effect to the area of administration.

DYNALABS LLC, has invested $1.2 million to expand its microbiology lab and office space. The renovation, nearing completion, will double capacity and improve workflow, among other administrative benefits.

Gray Design Group was tapped for the project, along with PortaFab of Chesterfield, Liberty Electric of O’Fallon, Missouri, and American Mechanical of Eureka.

This couples with the $1.5 million chemistry department expansion finished last year. Since then, DYNALABS has nearly doubled its workforce to 95 employees.