What is a Facility – Updated

September 2016, I blogged about the draft FDA Guidance Facility Definition Under Section 503B of the FD&C act.  In May 2018, the draft guiance was approved and published in the Federal Register and is available here.

Industry Questions:

FDA has been asked whether an outsourcing facility can create a separate area within its facility for compounding according to patient specific prescriptions under section 503A, and not follow CGMP requirements in that area.… more

OTC Manufacturer Warning Letter

Recently a manufacturer of an OTC product was inspected by FDA (Nov 2017) and the resultant warning letter was posted on the FDA website May 2018.  This firm received 3 citations which are summarized below:

Observation 1 – the firm elected to manufacture the OTC product with raw material that had not been tested and released by the quality unit. … more

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