Software as a Medical Device (SaMD): Clinical Evaluation and Validation

Your doctor is probably not using the data from your wearable (e.g. fitbit) to make decisions about your health. However, this is the kind of question we begin to ask when considering Software as a Medical Device (SaMD). By definition, these are applications (software) intended for medical use without the use of hardware (International Medical Device Regulators Forum (IMDRF) guidance).more

Come on Man

Come On Man…

if you watch ESPN Sports Center you have probably heard the announcers do their Come on Man bit.  Well perhaps we should have something similar for the pharmaceutical industry when they do something just plain dumb….

How about a CMO in North Carolina that recently received a FDA warning letter


Certificate of Analysis

Question: Can I use my vendor’s Certificate of Analysis when making a pharmaceutical product or compounding a product as a 503B outsourcing facility?  Yes – BUT in accordance with 21 CFR 211.84(d)(1) and (2):

(d) Samples shall be examined and tested as follows:

(1) At least one test shall be conducted to verify the identity of each component of a drug product.… more

503B Electronic Record Data Integrity

For compounding pharmacies regulated under section 503B, electronic record data integrity concerns are increasing in regulatory and customer visibility. The concepts of good data integrity practices is not new. Yet an organization can inadvertently open itself up to serious problems with their electronic record integrity if proper operating and computer system validation procedures are not followed.more

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FDA Draft Guidance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  FDA draft guidance on MDI and DPI products has been distributed for comment.

Comments and suggestions regarding this FDA draft guidance document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.… more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

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