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.more

Compounding Labeling

On Sept 27, 2018 FDA shared recent case reports of dosing errors and confusion with the labeled strength expression for certain compounded unjectable products.  Both MedWatch reports attributed the medication error to the labeling of the drug (IV/Syringe) packaging. See Differences in strength expression on product lables of compounders and contentional manufacturers may lead to dosing errors.… more

Promoting a Validation Mindset: Overview

Among our cadre of validation engineers and specialists we offer an experienced and knowledgeable team of personnel whose area of expertise is focused on the delivery of validation services for computerized systems. With decades of combined experience in the computerized systems validation field, our team has gained an informed point of view of what constitutes a successful validation project and the organizational practices the make it successful.… more

Summary of the 2018 Q3 FDA Observations

FDA has posted 17 Form 483s, to 503B facilities, thus far in the third quarter of 2018.  FDA has identified 68 observations of potentially objectionable issues within these 17 facilities.  A summary of the 2018 Q3 FDA Observations follows:

Table 1 – 68 observations categorized by topic

Category of Observation Frequency of occurance
Disinfection 14
Aseptic Technique 11
Containment 7
Poor Facility Design 7
Enviornmental Monitoring 5
Maintenance 4
Critical Air Flow 3
Production Processes 3
Media Fills 3
Cleaning 2
Equipment 2
Finished product testing 2
Improper Materials 2
Adverse Event Reporting 1
Lab Methods 1
Quality Review 1

As we can see from the above table, the two largest groupings of observations fall into the disinfection and aseptic techique. … more

ISO 9001:2015

Performance Validation’s quality management system is based on ISO 9001:2008, Quality management system – Requirements.  As you are aware, ISO 9001:2008 was revised to ISO 9001:2015.  A three year period was provided to allow companies to review and revise their quality systems to the new standard. … more

503B cGMP Inspection

Are you really ready for your initial or follow up 503B cGMP Inspection?

Most 503B outsourcing facilities would assume they are ready for inspection, but often this is not the case.  Thus far in 2018 – FDA has issued 62 Form 483’s to 503B Outsourcing Facilities at the conclusion of the 503B cGMP inspection.… more

Data Integrity Warning Letter Summary – August 2018

The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter to a Japanese bio-chemical manufacturing company.  The Warning Letter summarized significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API).  The letter cited non-compliance with section 501(a)(2)(B) of the 21 U.S.C.more


Normal flu vaccines are prepared each year and target a specific flu strain.  If however the flu strain mutates or is not the strain anticipated than often the vaccine provides limited protection.  It takes many months to develop the doses needed to protect the general population.… more

Out of Specification Results

What happens when a firm obtains out of specification results?

21 CFR 211.192 states:

All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.… more

Lack of Sterility Assurance – Ranier’s Pharmacy

On July 10, 2018 FDA issued a health care alert for products compounded by Ranier’s Pharmacy do to a lack of sterility assurance. Rainer’s inspection history includes:

  • A 6-page form 483 issued April 22, 2016
  • A warning letter issue March 28, 2017 (for the inspection April 18-22, 2016)
  • A 5-page form 483 issued May 22, 2018 (following an inspection from May 14-22, 2018)

In the warning letter, the FDA recommended:

FDA strongly recommends that your management first undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, materials, and systems for the production of human and animal drugs. more