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FDA Draft Guidance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  FDA draft guidance on MDI and DPI products has been distributed for comment.

Comments and suggestions regarding this FDA draft guidance document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.… more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FDA’s published draft guidance on data integrity, to clarify the role of data integrity in current good manufacturing practice (cGMPs) with both electronic and paper based records.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. 
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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


PDA Midwest Dinner Meeting

Performance Validation sponsored and exhibited at the PDA Midwest Dinner Meeting. In attendance from PV were Mike Stires and Gerry Achoki.

The speaker for this event was Tony Cundell, Ph.D. who presented on Current Activities of the USP General Chapters – Microbiology Expert Committee.… more


503A Pharmacies

503A pharmacies were mentioned 31 times in FDA Commissioner Scott Gottlieb’s testimony before U.S. House of Representatives Subcommittee on Health, Jan 30, 2018

Commissioner Gottlieb states (Examining implementation, 2018, p. 5):

For example, during our initial inspections, we have seen vermin, such as cockroaches, in the area where employees prepare for sterile processing; employees processing sterile drugs with exposed skin that sheds particles and bacteria; contamination, including bacteria and mold, in the environment where sterile drugs are produced; and much more.… more


Design Review

A Design Review (DR) is a systematic process used to review the design of facilities, utilities, and equipment against specifications. It is best to complete a Design Review early in a project so that design or specification issues can be brought to the forefront before changes become damaging to the project budget and timeline.… more