Lessons Learned from FDA Warning Letters

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

FDA Draft Guidance

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  FDA draft guidance on MDI and DPI products has been distributed for comment.

Comments and suggestions regarding this FDA draft guidance document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.… more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?

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.

Per the intro section –
Since the ICH Q7 Guidance was finalized, experience with implementing the guidance worldwide has given rise to requests for clarification of uncertainties due to the interpretation of certain sections.… more

Paper Based Data Integrity

FDA’s published draft guidance on data integrity, to clarify the role of data integrity in current good manufacturing practice (cGMPs) with both electronic and paper based records.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

Five things a Pharmacist should understand prior to writing that check for registration fees to the FDA for their brand new 503B outsourcing facility.

  1. These facilities are inspected by USFDA following the applicable FDA Compliance Policy Guide 7356.002 Drug Manufacturing Inspections and 7356.002A Sterile Drug Process Inspections. 

2017 Temp Mapping Summary

2017 Temp Mapping Summary

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

Center of Excellence on Compounding

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

Phillips Medical Systems

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

Building Management System

The Challenge

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

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