FDA Trends and Remediation Efforts | Author: Kim Lim
Introduction
There are several different cases of microbial contamination in manufacturing settings cited by FDA warning letters in 2022. These cases cross several different manufacturers, from medical devices to over-the-counter (OTC) to compounding pharmacies to positron emission tomography (PET) for parenteral administration. The cause of the contamination may be overtly due to violation of aseptic processing but there are many factors that contribute to these conditions. The common thread to all the case studies described below is that microbial contamination is a result of inadequate quality control (QC) and systematic process and procedural issues. The Experts at MEDVACON can assess your processes and operations and assist in reducing microbial contamination.
In the Age of COVID-19
A surge in sanitizer manufacturing occurred in response to the COVID-19 epidemic. Even though there were emergency and expedited approvals of vaccines, there were ancillary products, such as, hand sanitizers, hand soaps and anti-bacterial products that flooded the manufacturing space trying to keep up with demand. These products eventually undergo FDA examination and auditing. Some of the most common issues found and issued through warning letters were:
- Inadequate chemical and microbial quality control specifications to test and lot release product.
- Inadequate chemical and microbial quality control specifications to test and lot release major product components, e.g. USP Purified Water.
- Inadequate process validation and process performance qualifications.
- Lack of cleaning validation and equipment cleaning.
- Lack of sanitization.
- Failure to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable organisms.
- Inadequate root-cause investigation of microbial limit excursions.
- Inadequate method validation.
The FDA suggested the following remediation tasks:
- Assessment of drug product process to ensure data-driven and scientifically sound program that identifies and controls all sources of variability such that the production processes consistently meet established specifications.
- Detailed summary of validation program for ensuring a state of control throughout the product lifecycle along with associated procedures.
- Detailed program for designing, validation, maintaining, controlling and monitoring manufacturing processes including vigilant monitoring of intra-batch and inter-batch variation to ensure an on-going state of control.
- Comprehensive assessment of cleaning effectiveness to evaluate cope of cross-contamination hazards.
- Ensure total microbial count limit for cleaning water is appropriate, controlled and consistently tested.
- Generate an action plane to conduct full chemical and microbial testing of retain samples to determine quality of all batches of drug product already distributed.
The Experts at MEDVACON can assist you and your company with implementation of these FDA suggestions as well as MEDVACON’s suggestions to reduce microbial contamination.
