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

Pharma Admin Office Building Commissioning


A Greenfield construction project of a new administrative office for an Indiana Pharmaceutical Manufacturer required building commissioning of all utility systems, including HVAC, chilled water, plant steam, heating hot water, compressed air, electrical/lighting, and sanitary and storm sewer systems.

The Solution
The pharmaceutical Manufacturer retained Performance Validation (PV) to perform the building commissioning.… more

Neil Enlow Receives Commissioning Professional Certification

For Immediate Release (Indianapolis, Indiana June 28, 2018). Neil EnlowPerformance Validation (PV) is pleased to recognize Mr. Neil Enlow’s certification as a Certified Commissioning Professional (CCP) by the Building Commissioning Certification Board for demonstrating a high level of competence and experience for the building commissioning process by successfully completing an examination, documenting professional and education achievements and fulfilling prescribed standards of performance and conduct required for CCP.… more

Qualification of Continuous Manufacturing Suite

Continuous Manufacturing Process Train Qualification

The Challenge

A Pharmaceutical Manufacturer in Indiana requested help from Performance Validation (PV) with the commissioning and qualification of a continuous manufacturing process train. The process train was the first commercial continuous manufacturing suite for the company.… more

Critical Airflow – Manufacturing Area Upgrade

The Challenge:

A large Fortune 500 company required  Critical Airflow Visualization testing (Smoke Studies)  after an upgrade to a high-volume filling line with new RABS barriers.  Additionally, there were multiple changes to the layout of the line and room were completed in conjunction with the upgrade.more


One of the more interesting and novel cancer therapies is the genetic engineering of the patients T-cells, where the cells are modified to target a specific protein expression on the cancer cell. However, this is a paradigm shift in manufacturing moving from a centralized manufacturing (what we see today at large pharmaceutical companies, or 503B Outsourcing Facilities) to a patient point-of-care or decentralized manufacturing model.  … more

503B Consent Decree

One of the tools FDA has to enforce laws and regulations are injunctions which may leed to a consent decree.  These tools are goverened by FDA Policy. Injunctions are managed through the Office of the Chief Counsel (OCC) per FDA policy. … more

Enviornmental Data Integrity

As identified in a recently posted FDA warning letter during the inspection, the FDA investigator requested the firm to provide all deviations from environmental monitoring limits.  The firm reported that they had no results outside limits for over a year prior to the inspection date…

However, during the inspection the FDA investigator found containers storing environmental and personnel monitoring microbiological samples, dated August 30 and 31, 2017.… more


Did you know that 503B Outsourcing Facilities are tracked under CDER Strategic Area 2 – Drug Quality and Compliance on the CDER Dashboard.

Section III identifies Inspections and Enforcement of Compounders.  This CDER Dashboard identifies by fiscal year the number of compounds that recalled products, the number of warning letters issued, the number of state referral letters, the number of injuctions/consent decrees, and the total number of regestered outsoursing facilities. … more