ASTM E55 Fall 2021 Newsletter

E55_Newsletter_Issue12_Q4_2021 is available for your review, take a look to see what the committee has been up to!

As you may be aware, Committee E55, developed consensus standards for the Manufacture of Pharmaceutical and Biopharmaceutical Products.  The committee has a number of subcommittees that develop standards, the sub-committees are:

  • E55.01 Process Understanding and PAT System Management, Implementation and Practice for: Process Analytical Technology,
  • E55.03 General Pharmaceutical Standards,
  • E55.04 General Biopharmaceutical Standards,
  • E55.05 Lyophilization, and
  • E55.06 Microbial/Sterility Assurance for Pharmaceutical and Biopharmaceutical Products

Be a part of the solution! … more

Performance Validation Announces Martin Long as President and Chief Executive Officer

INDIANAPOLISDec. 7, 2021 /PRNewswire/ — Performance Validation, Inc., a leading national provider of commissioning, qualification, and validation services, today announced that Martin Long has been named as President and Chief Executive Officer effective Jan 1, 2022. Dr. … more

Certificate of Analysis

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

Role of the Quality Unit

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

Adverse Event Reporting

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

UDI Final FDA Guidance

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

Trends in FDA Inspection Observations

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

Pharmaceutical Manufacturing – Autoclave Steam Sterilization

Pharmaceutical Manufacturing – Autoclave Steam Sterilization:

The Challenge

A pharmaceutical manufacturing company recently had several autoclave sterilization cycles that were very long in duration, resulting in premature failure of stopper and seal RTP bags. The cycles had been developed and validated years ago and the company did not have much in-house autoclave/sterilization expertise.… more

Why do we Validate?

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

Quality Upset

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