Q. As a manufacturer can I rely on a Certificate of Analysis (CofA) from my supplier?
A. Yes – But… as noted by USFDA in a recent warning letter:
You can rely on vendor CoA for quality attributes, provided you conduct at least one test to verify the identity of each component lot before use in the drug product manufacturing.… more
Under the cGMPs the role/responsibilities of the quality unit are described in Subpart B Organization and Personnel, specifically 21 CFR 211.22.
However, these roles/responsibilities are not always implemented or effective by pharmaceutical manufacturers. As described in a recently posted FDA Warning Letter, the FDA cited a manufacturer of OTC products with significant failures of the Quality Unit. … more
In a recently posted FDA Warning Letter to a registered outsourcing facility the FDA cited the registration and reporting requirements of 503B(b) the requirement to submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations)”
I believe this is the first warning letter to an outsourcing facility that has referenced or cited adverse event reporting. … more
FDA Final Guidance on Unique Device Identifier (UDI) posted July 7, 2021, a PDF copy of the guidance is available at the following Link: UDI Final Guidance
Specifically, this guidance describes the requirements for and FDA’s recommendations regarding the form and content of the UDI to help ensure that the UDIs developed under systems for the issuance of UDIs meet the objectives of the Unique Device Identification System Final Rule, 78 FR 58786 (September 24, 2013).… more
What are the top 5 citations from FDA inspections for the past 3-years (2018-2020)?
For each of the past 3-years 21 CFR 211.22(D) has been the most frequent observations in FDA inspections. The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed. … more
In a recently posted warning letter, FDA cited a drug manufacturer for failing to validate the manufacturing process for tablets. FDA collected three samples during the inspection and laboratory results identified that all three were sub-potent for the active ingredient and one of the samples failed for content uniformity.… more
Are you a 503B or Pharmaceutical Manufacturer regulated by USFDA or a 503A regulated by your State?
What do you do if/ when your API supplier is inspected by FDA, receives a 483, and warning letter?
Do you have a quality agreement in place that specifies notification of inspection results?… more
In a recently posted warning letter, a drug manufacturer was cited for receipt and delivery of adulterated drugs. As cited in the warning letter:
We note that an inspection of records at your facility and a review of FDA import data demonstrated that FDA has, in the past, taken regulatory action against at least 23 of your other API suppliers [bold added] for the manufacture of adulterated drugs under section 501 of the FD&C Act by either listing their drugs on import alert and/or issuing them warning letters.… more
INDIANAPOLIS, Jan. 27, 2021 /PRNewswire/ — Performance Validation, Inc., an Indiana based company providing Commissioning, Qualification, and Validation Services to the Life Science Industries, has acquired 100% of the interests of the Welsh Commissioning Group, Inc. (WCG) headquartered in Auburn, Washington. … more
In the world of commissioning, qualification, and validation for life science companies our world its pretty simple – you make a regulated product, you qualify the facility, the equipment, you validate the manufacturing process, and do change controls as necessary for equipment, facility, or process changes with updates to FDA depending on the magnitude of the change.… more