Starting Materials

Starting Materials for Drug Products:

Analysis of 108 FDA Form 483’s issued to Compounding pharmacies in 2018 was performed. A textual analysis for the term non-pharmaceutical identified approximately 11% of the facilities (12) received an observation associated with the use of non-pharmaceutical products as an ingredient (starting materials) and 1 case where a non-pharmaceutical cleaning solution was used for washing glassware.… more


503B Data Integrity Concerns

For compounding pharmacies regulated under section 503B, electronic record data integrity concerns are increasing in regulatory and customer visibility. The concepts of good data integrity practices is not new. Yet an organization can inadvertently open itself up to serious problems with their electronic record integrity if proper operating and computer system validation procedures are not followed.more


Critical Airflow in Compounding Pharmacies

Analysis of 108 FDA Form 483’s issued to Compounding Pharmacies in 2018 was performed. A textual analysis for the term SMOKE identified approximately 1/3 of the facilities (34) received an observation associated with Critical Airflow Visualization or as commonly referred to as Smoke Studies.
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Audit Trail Review for Data Integrity

In December 2018 the FDA finalized its guidance titled “Data Integrity and Compliance with cGMP, Guidance for Industry.”  Among the topics covered in the guidance was ‘audit trails’. The answers to these two questions “How often should audit trails be reviewed?” and “Who should review audit trails?” may represent a significant update to the FDA’s interpretation and enforcement of predicate rules regarding the use of audit trails.more


CDRH – Recognized Standards

As posted in the Federal Register today (March 14, 2019) closes the comment period on CDRH – Recognized Standards.  Once finalized, this document will list all the CDRH – Recognized Standards as FDA recognized consensus standards and will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.… more


FDA Funding

On March 11 FDA Commissioner Scott Gottlieb provided a statement in the request for new FDA Funding. The full FDA statement is available here. Below is the excerpt concerning funding requested to Strengthen the FDA’s oversight of compounded drugs to help secure patient safety:

The practice of compounding medicine can provide important public health opportunities.… more


21 CFR 211.42 – Buildings and Facilities

A review of FDA citations for 21 CFR 211.42 Subpart C Buildings and Facilities over the past 5 years (2018-2014) from the FDA Turbo data was conducted by Performance Validation. Our analysis identified that the highest frequency of citations within the buildings and facilities subpart were consistently attributed to two code sections:

  • 21 CFR 211.42(c)(iv) A system for monitoring environmental conditions;
  • 21 CFR 211.42(c)(v) A system for cleaning and disinfecting the room and equipment to produce aseptic conditions;

The citations to these two sections are illustated below for the past 5-years.… more


Consensus Standards

The Center for Drug Evaluation and Research (CDER) releases the CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Guidance for Industry draft guidance for comment.

This proposed guidance will address how CDER will informally recognize volunatry consensus standards.… more


New CRF4 Fogger

Performance Validation’s Critical Airflow Visualization Services Group has purchased an Applied Physics CRF4 cleanroom fogger. As noted in the above video [downloaded from Applied Physics USA], the CRF4 is a portable cleanroom fogger that can use deionized (DI) water or water for injection (WFI water) to generate 1.25 cubic meters of pure fog per minute at 170 ml fog density per minute to provide from 10 to 15 feet visible fog distance.… more


Process Validation

In a recentlyposted warning letter to a Chinese drug manufacturer the FDA identified a specific violation citing the Jan 2011 FDA Guidance to process validation.

Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).more