Are You Smarter Than An Ora Inspector? Test Your Knowledge Of Aseptic Cgmps

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The phrase "whether or not the batch has already been distributed" means that the investigation or evaluation process applies to the lot regardless of whether it has been already distributed or not. Both options A and B suggest that the lot at hand will undergo extensive investigation or evaluation, indicating that the meaning of the phrase is encompassed by both options.

The correct answer is 21 CFR Part 211.192. This regulation states that a "release of batches before the last successful media fill had been performed" represents an observation related to the production and process control system. It indicates that batches were released without completing the necessary quality control measures, specifically the media fill test, which is used to validate the aseptic manufacturing process. This observation highlights a potential non-compliance with good manufacturing practices and the need for corrective actions to ensure product safety and quality.

The given correct answer, 21 CFR Part 211.113(b), represents an observation that the media fill program does not adequately demonstrate the state of process control in the aseptic process. This means that the program does not include all the major contamination risk factors, which could potentially compromise the integrity and safety of the process. Therefore, it is necessary to address this observation and make improvements to ensure proper control and minimize contamination risks.

21 CFR Part 211, which stands for Code of Federal Regulations Title 21 Part 211, is a set of regulations established by the U.S. Food and Drug Administration (FDA) that specifically pertains to Current Good Manufacturing Practice (cGMP) for finished pharmaceutical products. These regulations outline the requirements for the manufacturing, processing, packaging, and holding of drug products. However, it is important to note that there may be instances where certain provisions of 21 CFR Part 211 do not apply to all drug products, such as investigational drugs or certain exemptions provided by the FDA. Therefore, the statement "21 CFR Part 211 only relates to finished drug products" is correct, but it is not applicable in all cases.

The correct answer is 21 CFR Part 211.192. This regulation states that failure to conduct adequate investigations of media fill failures in the aseptic filling line represents a major observation. The investigator would likely write a report detailing the failure to conduct proper investigations and recommend corrective actions to address the issue.

The given correct answer, 21 CFR Part 211.113(b), represents a specific observation related to the failure to perform adequate unidirectional airflow pattern studies for the aseptic filling line used for the production of (b) (4) injections. This observation indicates a violation of the regulation that requires the performance of such studies to ensure the proper functioning of the aseptic filling line and maintain the sterility of the injections.

The reason why there is a 21 CFR 211.113(a) and a 21 CFR 211.113(b) is because they address different aspects of contamination in pharmaceutical products. 21 CFR 211.113(a) refers to the contamination of products that are not required to be sterile, while 21 CFR 211.113(b) refers to the contamination of products that are required to be sterile. Therefore, the correct answer is both A and B, as both types of contamination are addressed separately in the regulations.