BMR entries can be made in pencil if the document is reviewed by QA

In pharmaceutical terminology, “SOP” is an abbreviation for:

Transcriptions should be clearly labeled and verified against the original

During the research and development (R&D) stage of a new medicine, preclinical testing is performed to:

Which position involves laboratory testing of raw materials, in-process samples, and finished pharmaceutical products to ensure they meet quality specifications?

Which muckraking book published in 1906 exposed unsanitary conditions in the food industry and helped lead to the Pure Food and Drug Act?

A 0.22 µm filter is typically used to sterilize air entering a bioreactor.

In the term cGMP, the word "current" reminds manufacturers that they:

A Master Batch Record is completed during production to capture batch-specific details

Who is responsible for managing and organizing controlled documents such as Standard Operating Procedures (SOPs) and batch records in a pharmaceutical company?

The regulatory term “IND” denotes:

A Batch Manufacturing Record (BMR) is best described as:

Which activity is part of the distribution step for a medicine?

A missing QA signature on an in-process check is considered a data integrity issue.

All packing operations do not require a separate line clearance.

Capsules are best described as medications:

Thermal paper must be photocopied for record retention

Tablets are one of the most common dosage forms mainly because they are

An FDA Form 483 is issued to a manufacturing facility to

Which of the following is NOT one of the ALCOA+ principles of data integrity in documentation?

The FDA was officially established as a consumer protection agency after the passage of the 1906 Pure Food and Drugs Act.

The BMR must be completed only after the batch has been manufactured.

FDA inspects only finished product manufacturers and not API producers.

Load cells are used to monitor weight or volume in formulation vessels

Biopharmaceuticals can be more effective for certain diseases (e.g., cancer or autoimmune disorders) because they:

cGMP requires that all critical manufacturing processes are:

Autoclaves sterilize materials using dry heat only.

A key raw material or Key Starting Material (KSM) is not structurally related to the final API.

Obsolete technologies can still be used in manufacturing if they were once approved.

Which of the following is a semi-solid dosage form?

Who is often called the "Father of the FDA" for his role in advocating food and drug safety (including organizing the "Poison Squad" experiments)?

Stoppering is performed before the vial is filled in the filling line.

To ensure completeness of records, what should you do if a section of a form or batch record is not applicable?

Total batch reconciliation includes compressed, rejected, and sampled tablets.

Pre-signing a document is acceptable as long as you perform the task later.

FDA offers training, webinars, and guidance documents to help new companies comply with CGMP

Department heads are responsible for the creation and management of their own documentation.

Gel pens and pencils are acceptable for recording GxP data entries

Jacketed vessels allow for heating or cooling of the formulation.

Aseptic technique refers to methods used to ensure chemical purity.

Which phrase best underscores the importance of documentation in pharma manufacturing?

Which of the following represents the correct order of stages in the lifecycle of a medicine from discovery to patient use?

Pharmacovigilance,” in the context of the medicine lifecycle, refers to:

Which of the following is an example of a traditional small-molecule pharmaceutical (not a biologic)?

Which of the following actions is a violation of Good Documentation Practices?

All filters used in sterile filtration are reusable after SIP (Sterilization in Place)

“White-Out” is a permitted correction tool for paper-based entries

Biopharmaceuticals (biologics) are typically produced by:

If a change is made to a established manufacturing process or formula, cGMP regulations mandate

Phase I clinical trials primarily assess a new drug’s ______ using a small group of healthy volunteers.

Injectables (such as IV injections or infusions) are considered

Which Title of the Code of Federal Regulations (CFR) contains the FDA’s regulations for food and drugs?

CGMP regulations do not apply to manufacturing drugs for clinical trials.

Regulatory expectations for cleaning validation are outlined in 21 CFR 211.67.

Which job role assists in the production of biopharmaceuticals by operating equipment and performing routine manufacturing tasks?

All compression machines used must be labeled “Cleaned” before use

Compared to traditional small-molecule drugs, biopharmaceutical products are generally:

Consultants performing GxP activities must follow the GDP SOP.

Clinical trials involve only one phase before regulatory approval is granted.

Logbooks must be bound and controlled to ensure traceability.

Filling machines used for injectables operate under aseptic (Grade A) conditions.

Which of the following is NOT a key skill or practice for a pharmaceutical manufacturing technician?

“Aseptic technique” refers to

Rounding of time entries is permitted if the deviation is minimal

Audit trails are handwritten records maintained by the quality unit

The “current” in CGMP means manufacturers can continue using outdated equipment and processes

"Available” under ALCOA+ refers to the accessibility of records when needed

What event prompted the passage of the Biologics Control Act of 1902 (the first U.S. law to regulate biological drugs)?

The digit 0.00369000 has seven significant figures

The QA department is responsible for dispensing raw materials.

Integrity testing of sterilizing-grade filters is optional.

What is the proper way to correct a minor error in a paper GMP document?

What is the effect of an FDA Import Alert?

The average tablet weight is an important in-process parameter during compression.

The FDA’s "Fast Track" program is intended to:

A Class I recall (the most serious type of FDA recall) indicates that a drug or product:

The 1937 Elixir Sulfanilamide disaster, in which over 100 people died, led directly to the passage of which landmark law requiring proof of drug safety before marketing?

Good Documentation Practices (GDP) ensure the integrity and traceability of records.

The acronym “cGMP” stands for:

According to cGMP, manufacturing facilities should be designed and maintained to:

Sterile filtration is used to remove microbial contamination from a solution.

In a GMP manufacturing environment, a “deviation” is:

If any deviation occurs during manufacturing, it must be documented and reported.

When seeking approval to market a new biologic (such as a vaccine or antibody therapy) in the U.S., a company must submit a ____ to the FDA.

The FDA issues Form 483 when a facility is found non-compliant during an inspection.

A Quality Manual provides detailed step-by-step instructions on performing manufacturing operations.

Drug products do not require stability studies if the API is stable.

Employees may wear personal jewelry in cleanrooms as long as it’s covered.

One may cross out incorrect entries with a single line and provide initials and date.

Before a new drug can be marketed, the manufacturer must submit a formal request for approval to regulatory agencies. For example, this submission to the USFDA is called a:

Overprinting of batch numbers on cartons should be verified before packing starts.

The modern FDA as a consumer protection agency is largely traced back to the passage of which law?

Under cGMP, raw materials and ingredients used in manufacturing must:

Quality Assurance (QA) in a pharmaceutical company is primarily responsible for:

Tablets and capsules are examples of which category of medicine dosage form?

Phase III clinical trials involve:

Which situation is an example of a cGMP violation during production?

Which writing instrument is appropriate for making entries in official GMP documentation?

ALCOA+ principles include attributes such as Attributable, Accurate, and Consistent

Autoclaves are used to sterilize both liquids and solid materials.