Promoting a Validation Mindset: Subject Matter Experts

Subject matter experts (SMEs) are considered to be those individual stakeholders in a computer system who contribute their technical expertise to the system validation effort.  Among the SMEs are system software developers, infrastructure support providers, process engineers, process owners and others who share in the responsibility for design and configuration of the system. Our first […]

Read More

Pillars of Success for 503Bs

What makes for a successful 503B Outsourcing Facility? While undoubtedly there may be more elements that contribute to the overall success of the organization the three pillars described above are critical based on my experience in review of multiple Form 483s, Warning Letters, and discussions with pharmacy industry professionals.

Read 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FDA’s published draft guidance on data integrity, to clarify the role of data integrity in current good manufacturing practice (cGMPs) with both electronic and paper based records.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. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate […]

Read More

Level of Quality

Friedman (2011) USFDA presented at the Pharmaceutical Quality System (ICH Q10) Conference October/November 2011.  On slide 21, Chowdhury (2001) as cited by Friedman provides a comparison of common day events when operating at 3.8 Sigma meaning that you are getting it right 99% of the time.  This sounds really good—BUT  Chowdhury (2001) identified that getting […]

Read More

Intended Use

Among the observations cited in FDA Form 483 reports over the last ten years there are numerous documented findings were where software used as part of the production and/or quality system was not adequately validated for its intended use according to an established protocol. The ‘FDA’s General Principles of Software Validation – Final Guidance for […]

Read More

After the Inspection

At the conclusion of the inspection, the FDA inspector will give the owner a FDA Form 483 which lists the firm, the dates of the inspection, and the observations made by the inspector(s). FDA will then provide an initial classification of the inspection based on the observations noted in the inspection, the investigator’s report, and […]

Read More

Insanitary Conditions

FDA has released final approved guidance addressing Insanitary Conditions at Compounding Facilities.  The guidance is available at this FDA link. This guidance provides specific examples of insanitary conditions identified during FDA inspections of 503A and 503B facilities in section IIIA for both sterile and non-sterile compounding. Some examples in the guidance include: In section IIIB the […]

Read More

What are Insanitary Conditions?

As described in the Food Drug and Cosmetic Act (501(a)(2)(A)), a drug is deemed to be adulterated “if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.”It is important to note that the drug does not […]

Read More

How do you do Risk Management?

ICH Q9 provides a simple process flow of a typical risk management process.  This process includes risk assessment (risk identification, risk analysis, and risk evaluation) which leads to risk control (risk reduction and risk acceptance). Figure 1 below, extracted from ICH Q9 illustrates this process flow. Figure 1. Adapted from ICH Q9, Quality Risk Management, Nov […]

Read More

Governance, Risk, and Compliance (GRC) Basic Concepts

Governance, risk, and compliance or GRC is a term one in the pharma or biotech world might not hear all that often. It is a concept most often employed in financial, legal, and information technology divisions. “Governance” refers to the processes/procedures/activities used to manage the organization – such as management processes. This includes the GRC […]

Read More