Technical Discussions

Question : How does the USFDA define a facility?  If I register as a 503B outsourcing facility – can I also compound under 503A within the same facility? This has been a common question to FDA from outsourcing facilities and other stakeholders.  To answer this question the FDA issued the Draft Guidance: Facility Definition Under Section […]

Do you understand the sources of variation in your manufacturing processes?As described the FDA Process Validation: General Principles and Practices, the manufacturer should use the product and process knowledge as a basis for establishing an approach to control that is appropriate for the manufacturing process. This includes: • understanding the sources of variation• detecting the […]

User Requirements User requirements are just what the name implies.  They are requirements set by the end user.  These requirements express how a facility, equipment or process should perform in terms of the product to be manufactured, required throughput, and conditions in which product should be made.  User requirements provide information that serves as the […]

The final rule for implementation of a unique device identifier or UDI has been released and will be posted on the following FDA page on 9-24-13.  Additionally, the FDA has posted the Global Unique Device Identification Database (GUDID) draft guidance available here. The FDA has provided a summary of compliance dates for the UDI final rule. 1 year […]

Most regulated organizations are well aware of the need to deliver the core suite of planning, user requirement, functional and design specification, testing protocol, and summary report documentation required to complete a successful validation of their computerized system.  And they are very conscientious to adhere to the requirements found the first eight paragraphs of 21 CFR, Part […]

SISPQ Safety, Identity, strength, purity and quality.  Anyone working in the business knows that the firm must meet SISPQ as an expectation of quality and that meeting the current Good Manufacturing Practices (cGMPs) are a requirement to demonstrate SISPQ.  However, where is this requirement stated? As codified in 21 CFR 210.1(a): The regulations set forth in […]

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.  […]

In the January 2016 Intergovernmental meeting on Compounding the FDA provided a response to the Nov 2015 meeting item concerning communication from FDA to the states when compounders resume operation.  The response to this item is provided from the USFDA site: FDA intends to provide the following information to states regarding the Agency’s recommendations to compounders to […]

Why are we concerned with Quality Risk Management (QRM) when planning, developing, and executing commissioning, qualification, and validation work?   The simple answer is time and money.  Pharmaceutical companies are under pressure to bring new therapies to market quicker and to do so at less cost, while still meeting the mandates of cGMPs which ensure […]

On July 28, 2015 the FDA posted the draft guidance on Request for Quality Metrics for public comment.  Industry has 60 days from the publication date in the federal register to submit comments.  The public comment period will end on September 28, which means there are approximately 3 weeks remaining to review the draft and provide your comments. […]