Tech Bulletin | December 2017

Updates to Sample Tracking for OOS

DYNALABS has made additional tracking features for samples that result Out of Specification (OOS) on the Sample Tracking page. Within Sample Tracking, DYNALABS clients can now see where their OOS samples are within the OOS process by hovering over the icon located next to each test.

The OOS stage icons available on sample tracking will be abbreviated and include the following:

Laboratory Investigation In Process (LIIP): The preliminary result has been posted and a detailed laboratory investigation is in process.

Customer Response Pending (CRP): The preliminary investigation has been completed and the customer has been emailed their result. DYNALABS is awaiting a response from the customer to determine how to proceed with the investigation.

Retests in Process (RIP): Either DYNALABS attributes an internal error as the cause for the OOS result and is retesting or DYNALABS is working with the client to execute investigational testing as discussed between the client and DYNALABS.

Technical Review (TR): Retesting has been completed and the Investigation Team is working on assigning a root cause to conclude the investigation.

Compliance Review (CR): The IR has been submitted to quality for review and approval.

DYNALABS has updated our API list for Potency testing to include the following:

  • Bromfenac Sodium – Tier 2
  • Choline Chloride – Special
  • Doxycycline Hyclate – Tier 2
  • Gatifloxacin – Tier 2
  • Inositol – Special
  • Methionine – Special
  • Oseltamivir Phosphate – Tier 2
  • Phosphatidylcholine – Special
  • Phytonadione (aka vitamin K) – Tier 2
  • Prednisolone Acetate – Tier 2
  • Sodium Deoxycholate – Special
  • Vasopressin – Coming Soon!

An updated, comprehensive list can be found by clicking this link Any active that is dictated with “Special” in the tier column requires a quote/pre-approval before proceeding with testing. If you wish to test something not on this list, please contact DYNALABS for Method Feasibility and Method Development.

Testing Procedure for Solid Units

Starting January 1, 2018 DYNALABS will not be pooling units together to perform Potency testing on troches, suppositories, tablets and pellets.

DYNALABS will only perform potency testing on 1 unit to obtain the concentration of the sample. The amount requirements for submitting these samples to DYNALABS will remain the same to account for additional testing if it is required. If you would like help with validating your process to ensure Uniformity of Dosage Units, please reach out to your Regional Business Manager

December 25th – Christmas Day
Our office will be closed December 25th. Please make shipment arrangements to have the samples arrive before December 24th. Normal hours resume Tuesday, December 26th.
January 1st – New Year’s Day
Our office will be closed January 1st. Please make shipment arrangements to have the samples arrive before December 31st. Normal hours resume Tuesday, January 2nd.

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