Lec 3a- FDA Sterile Drug Inspections

Which dosage form is considered a variety that is tested during an FDA sterile drug inspection?

What is a key focus of FDA inspections regarding drug manufacturing?

What is one of the FDA's procedures during an inspection?

Which of the following is a primary concern during FDA sterile drug inspections?

Which of the following is an element of sterility controls?

During a facility tour, what should inspectors look for?

What documentation are manufacturers required to maintain and investigate?

What is an area reviewed as part of trended data by the FDA?

What is considered during general coverage of FDA sterile drug inspections?

What is an example of equipment that is commonly inspected?

What aspect of 'materials' is typically assessed during an FDA inspection?

What is a factor evaluated during the 'production' portion of a sterile drug inspection?

What aspect of packaging and labeling is evaluated during inspections?

Which area does laboratory analysis cover during an FDA inspection?

What is observed during an FDA inspection?

During interviews, what is a type of question asked?

What type of records are reviewed?

What is an example of evidence collected during an inspection?

Who directs the inspection process?

What should justifications be supported by?

What must data support when validating moist heat sterilization?

For processes, what requires proof?

What requirements must the significant violations follow for an FDA-483?

What is a possible outcome after an FDA inspection?

An FDA sterile drug inspection may include a review of:

The FDA conducts sterile drug inspections to assess a company's compliance with:

The purpose of an FDA sterile drug inspection is to:

One reason the FDA would visit a manufacturing location is to:

Common issues of concern during FDA sterile drug inspections include:

To control for sterility concerns, companies should implement:

During a facility tour, FDA inspectors are trained to:

Manufacturers are required to document and investigate:

When reviewing environmental monitoring data, inspectors look for:

The 'General Coverage' portion of FDA sterile drug inspections often focuses on:

Common equipment inspected as part of FDA sterile drug inspections includes:

In the "Materials" section, FDA inspections focus on:

Critical parameters under process validation include:

The "packaging and labeling" review assesses:

Reference standards and controls are reviewed during inspections of a:

Which dosage form is considered a variety?

What is the main focus of FDA inspections?

Which of the following is a reason that would cause the FDA to visit a manufacturing location?

What is looked into when learning about systems, processes, and procedures?

Under the FD&C Act, what is one of the ways a drug can be deemed illegal?

What is the primary focus of FDA inspections, as highlighted in the presentation?

What is generally the first step the FDA takes when conducting an inspection?

Besides sterility, what is another major concern during FDA sterile drug inspections?

During a facility tour, what subtle aspects do FDA inspectors pay attention to?

What types of documentation are manufacturers required to maintain and investigate, according to the presentation?

When reviewing trended data, which of the following areas is commonly assessed by the FDA?

What is the focus of the 'Facilities and Equipment' aspect of 'General Coverage' during FDA sterile drug inspections?

Which of the following pieces of equipment is commonly inspected during FDA sterile drug inspections?

What is a critical factor evaluated during the 'production' portion of a sterile drug inspection?

During observations, what is assessed by FDA inspectors?

What type of records are typically reviewed during an FDA inspection?

Who directs the inspection process during an FDA sterile drug inspection?

Why must justifications be supported by evidence?

What type of data must support the validation of moist heat sterilization?

For processes like filter sterilization and aseptic filling, what is required?

What is a key criterion for significant violations listed on an FDA-483 form?

What is a potential outcome after an FDA inspection where significant violations are found?

What might the FDA do if they find significant violations during an inspection?

What is the purpose of an FDA sterile drug inspection?

What is one of the reasons the FDA would need to visit a manufacturing location?

Which route of administration is considered part of injectable dosage?

A critical aspect of aseptic filling is:

One variety of dosage includes:

Why do FDA inspections focus on "CGMPs"?

During what process do inspectors look for critical control points?

What is one of the lists required during a problems and trends review?

What might cause a failure during the problems and trends review process?

What factor is reviewed as a part of the water system?

What is one of the five systems the FDA focuses on?

What is considered in materials during general coverage by the FDA?

What is the first step to produce?

When packaging and labeling, what steps are important to review?

During laboratory coverage, what aspect should be reviewed?

During interviews, the FDA wants to speak with whom?

Considering the FDA's focus during sterile drug inspections, which of the following scenarios would MOST likely lead to a drug being deemed illegal under the Federal Food, Drug, and Cosmetic (FD&C) Act?

During an FDA inspection of a sterile drug manufacturing facility, the inspectors notice an accumulation of dust on the surfaces of equipment used in the production area. While this observation alone may not be conclusive, what broader concern related to CGMP could this indicate?

Aseptic processing requires multiple controls to ensure product sterility. How do environmental controls contribute to assuring sterility during aseptic processing:

Aseptic technique and cleanroom behavior are critical in sterile pharmaceutical manufacturing. Considering this, which activity would be of GREATEST concern to an FDA inspector during a facility tour?

To adhere to CGMP regulations, manufacturers must justify their processes and procedures. What action would BEST demonstrate a company's commitment to validating a moist heat sterilization?

Which of the following scenarios relating to aseptic processing would raise the MOST significant concern during an FDA sterile drug inspection, potentially leading to an FDA-483 observation?

Why might an FDA investigator choose to examine a firm's historical data related to filter sterilization validation during a sterile drug inspection?

A manufacturing firm is developing a novel sterile drug product using a blow-fill-seal process. What documentation would be MOST critical to have readily available during an FDA inspection to demonstrate adequate process control and CGMP compliance?

During which phase of an FDA sterile drug inspection would an investigator MOST likely scrutinize the calibration records of temperature probes used in autoclaves for moist heat sterilization?

How does the FDA use trended data related to personnel monitoring in sterile manufacturing facilities to assess compliance with Current Good Manufacturing Practice (CGMP) regulations?

A sterile drug manufacturing facility has received an FDA-483 observation citing inadequate justification for the cleaning and disinfection procedures in its ISO 5 aseptic filling area. Which remediation strategy would MOST comprehensively address the FDA's concern?

Given that packaging and labeling issues account for a significant percentage of drug recalls, what proactive measure would be deemed MOST effective during an FDA sterile drug inspection to mitigate risks in this area?

During an FDA inspection of a sterile drug manufacturing facility, the investigator identifies a pattern of unexplained deviations in batch records that were not thoroughly investigated. What is the MOST likely consequence of this finding regarding CGMP compliance?

In an FDA sterile drug inspection, what is the primary importance of reviewing the 'state of affairs' within a manufacturing facility, specifically environmental monitoring and complaint trending?

An FDA investigator, while reviewing quality control laboratory records, discovers that certain reference standards used in drug product testing have not been properly qualified according to USP guidelines. What is the MOST immediate concern?

An FDA investigator observes an operator in an aseptic filling suite repeatedly making adjustments to a piece of equipment without following proper procedures. What is the PRIMARY concern?

During a tour of a sterile drug manufacturing facility, an FDA inspector notices that the facility's diagram does not accurately reflect the current layout of the production area. How could this discrepancy MOST significantly affect the inspection?

A sterile drug product manufacturer uses contract testing laboratories for endotoxin testing of raw materials. What aspect of this arrangement would the FDA likely scrutinize MOST closely during an inspection?

A sterile drug manufacturing company has implemented a new computerized system for monitoring environmental conditions in its cleanrooms. During an FDA inspection, what evidence would be MOST persuasive in demonstrating the system's reliability?

During an inspection of a sterile drug manufacturing facility, the investigator requests to speak with both high-level management and line operators. What is the purpose of these interviews?

What is the MOST critical reason for an FDA investigator to meticulously document and photograph observations during a sterile drug inspection?

The FDA observes that a sterile drug manufacturer is using single-use disposable filters for product sterilization. What aspect is MOST critical for FDA inspectors to verify?

A company is preparing for an FDA inspection. They have identified several deviations related to temperature excursions during the storage of a temperature-sensitive drug. Considering FDA's focus on thorough investigations, what approach would be MOST effective?

During an FDA inspection, an investigator discovers that several pieces of equipment used in the production of a sterile drug product have not been properly maintained or calibrated. What is the MOST likely outcome?

The FDA's primary goal in conducting sterile drug inspections is to ascertain whether a manufacturing facility:

During a tour of a sterile drug manufacturing facility, an FDA inspector observes multiple instances of operators touching surfaces and then immediately manipulating sterile equipment without proper sanitization. What interpretation should be made?

In the context of FDA sterile drug inspections, what does the term "Prove It!" MOST directly emphasize for pharmaceutical manufacturers?

Why is the review of batch records a pivotal component of an FDA sterile drug inspection?

A sterile drug manufacturer is planning to implement a new rapid microbial method for in-process bioburden testing. During an FDA inspection, what evidence would be MOST compelling to demonstrate the suitability of this method?

An FDA inspector is reviewing the water system validation data for a sterile drug manufacturing facility. What area of control would be MOST concerning if found lacking or inconsistent?

Aseptic processing requires multiple controls that will ensure product sterility. How do environmental controls help in assuring sterility during aseptic processing?

During a facility tour, FDA inspectors will look for:

In trended environmental monitoring, which is reviewed by the FDA?

What items are common to inspect by the FDA?

For significant violations listed on an FDA-483 during inspections, what must the violations follow?

What are some options presented by the FDA after an inspection?

An FDA sterile drug inspection will review

During an FDA inspection, what would an investigator expect when reviewing a company's validation data for a moist heat sterilization cycle, especially regarding the data's integrity?

If a sterile drug product manufacturer is performing filter sterilization, aseptic filling, stoppering/capping, packaging, and labeling, what must they provide?

If an FDA inspection finds significant violations of CGMP related to sterile manufacturing, which immediate action might the FDA take to protect consumers?

During an FDA inspection, what implication does an inadequately justified process have on CGMP compliance?

Aseptic processing is a critical area during sterile drug inspections. Suppose a company uses an isolator for aseptic filling. Which finding would be MOST concerning to an FDA inspector?

A sterile drug product requires a validated moist heat sterilization cycle. If a sterilizer load is insufficiently heated due to a loading error, what action must be taken?

A company manufactures an ophthalmic solution using aseptic processing. The company validation data shows multiple batches that failed sterility testing, but were reprocessed, passed sterility, then released as good product. Based on this scenario, what is the MOST likely enforcement action the FDA might take?

During an FDA inspection of a sterile drug manufacturing facility, an investigator notes that trended data from environmental monitoring consistently shows higher microbial counts in certain locations within the cleanroom. The manufacturing facility claims that this is most likely due to lab error and should not be investigated. According to CGMP regulations, which course of action by the investigator should be taken?