DYNALABS will be sending out technical updates like this one, once a month starting December 2017. These updates are strictly informational and require no response from your end. We aim to further increase communication between DYNALABS and the clients with these updates.
As always, if you do have questions, please do not hesitate to reach out to your Regional Business Manager or contact us at sales@dynalabs.us
November 2018
- Case Study 4: The Mystery of the Disappearing Fentanyl
- FDA Guidance on Container Closure Systems (CCS) and Out of Specification Investigations (OOS)
- Container Closure System (CCS) Suitability Services
- Updates; OOS, Password Security
- DYNALABS is happy to announce:
- Notable Dates; Holiday schedules
- DYNALABS Named One of the Nation’s Fastest-Growing Inner City Businesses
September 2018
- How are Potency Specifications Established?
- FDA to Remove APIs from Interim list
- CQI Partner Program – Newly Revised and Expanded
- 21 CFR Part 11, Exceeding Standards
- Show Dates
- Welcoming New Staff
Tech Bulletin Archive:
June 2018
- New Method Transfers
- Validation Extensions Updates
- Hazardous Drugs per NIOSH
- Re: Docket No. FDA-2018-D-1067
- and… USP Notes, Sample Storage Fees, API List Update
May 2018
- FDA Docket ID: FDA-2018-D-1067-0002 until May 25, 2018.
- Particulate USP <788> and USP <789> dilution changes Method 1
- Methods Moving to New UHPLC
- Investigation Reports; Now available for download
- DYNALABS will be closed 05/28/18 in observance of Memorial Day
April 2018
- Non-stability Indicating Methods and How to Establish a BUD
- Container Closure Integrity Testing (CCIT)
- Make sure your browser and operating systems are up to date!
- Certificate of Analysis (COA) – Upcoming Changes
March 2018
- Stability Program and Annual Stability
- Water Activity per USP <51> and USP <1112>
- API List Updates
- Changes/Updates to Testing
February 2018
- USP test updates
- Cleanroom News
- Security Additions
- Published Articles on 503 A and B
January 2018
- Validation Notes
- Stability Study / Drug Shortages
- API List Updates
December 2017
- Updates to Sample Tracking for OOS
- Testing procedure for solid units
- API List Updates