April 2018 (week of 4/23/18) three cGMP warning letters were posted by FDA. The most interesting warning letter was to a Chinese API manufacturer for an inspection from October 2017 and provides some interesting lessons learned. This API manufacturer promised FDA to improve controls over laboratory computerized systems to prevent unauthorized access or changes to data (data integrity) based on a 2015 inspection. … more
Do you have metered dose inhaler (MDI) or dry powder inhaler (DPI) products in your prodcut offerings? Are you considering adding these product types? FDA draft guidance on MDI and DPI products has been distributed for comment.
Comments and suggestions regarding this FDA draft guidance document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.… more
Do you do API’s? Have questions? If yes, you should check out – FDA’s Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients – Question and Answers.
FDA’s published draft guidance on data integrity, to clarify the role of data integrity in current good manufacturing practice (cGMPs) with both electronic and paper based records.
Data integrity is defined as “refers to the completeness, consistency, and accuracy of data.… more
Five things a Pharmacist should understand prior to writing that check for registration fees to the FDA for their brand new 503B outsourcing facility.
During 2017, Performance Validation executed 31 projects that included a temperature mapping component of project work. These projects were completed with multiple clients, across both Pharmaceutical and Medical Device life science industries. These projects included mapping studies using PV’s own inventory of Vaisala Veriteq data loggers measuring temperature only, or temperature and humidity, or using the Kaye Validator 2000 for projects involving extreme cold or heat. … more
As reported by Zachary Brennan (Feb 14, 2018), FDA Commissionner Gottlieb outlined FDA plans for FY 2019. Of specific interest to the Compounding world: FDA is proposing to create, as it did for oncology, a “Center of Excellence on Compounding for Outsourcing Facilities,” with expanded FDA engagement with outsourcing facilities and states to help the pharmacy outsourcing industry grow to meet its intended function and adhere to higher quality standards to protect patient health.… more
USFDA inspected Phillips Medical Systems 7-17 to 8-18, 2017 and on completion of the inspection issued Phillips Medical Systems an 18 page 483 with 9 observations.
If I were a patient and had to get re-scanned/re-injected because of a known equipment failure (page 3, b1) , I would be a bit upset.… more
A leading pharmaceutical packaging company planned to migrate their outdated Building Management System hardware which controlled and monitored their freezers, coolers and packaging suites to their existing BMS system. The monitored temperature controlled spaces contained product during the migration. … more
PDA Midwest March 2018 Dinner Meeting
(Indianapolis, Indiana, February 2018) Performance Validation will be attending and exhibiting at the PDA Midwest March 2018 Dinner Meeting. At this meeting there will be a networking opportunity for the attendees and vendors. Stephanie Ranck will be presenting Comparability Protocols, and Linda Biava will be presenting Regulatory Submissions and Changes.… more