Regulatory Affairs Flashcards

Front

What sections are required for unregulated drug substances when applying for a variation?

Back

General Information, Manufacturer Details, Specification of API, Batch Analysis, Certificate of Analysis from API manufacturer, Certificate of Analysis from finished product manufacturer, Justification of Specification, Certificates of Suitability (CEP), Drug Master File (DMF), Certificate of GMP for API Manufacturer, Other Supporting Documents.

Front

What regulations are involved in Regulatory Affairs?

Back

GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GMP (Good Manufacturing Practice).

Front

What is Good Laboratory Practice (GLP)?

Back

GLP are regulations applied in non-clinical health and safety studies of pharmaceutical products, pesticides, cosmetics, veterinary drugs, food additives, feed additives, and industrial chemicals.

Front

What does GLP define?

Back

GLP defines the quality processes and working environment under which studies are planned, performed, monitored, recorded, archived, and reported.

Front

What is Good Clinical Practice (GCP)?

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An international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human subjects.

Front

What is the purpose of Good Clinical Practice (GCP)?

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To ensure the rights, safety, and wellbeing of trial subjects are protected.

Front

What is Good Manufacturing Practice (GMP)?

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The aspect of quality assurance that ensures medicinal products are consistently produced and controlled to quality standards appropriate to their intended use.

Front

What does Good Distribution Practice (GDP) describe?

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The minimum standards that a wholesale distributor must meet to ensure the quality and integrity of medicines throughout the supply chain.

Front

What is the trigger and frequency for GMP inspections?

Back

Every 1-3 years based on risk or if there's a safety issue.

Front

What is the typical duration of a GMP inspection?

Back

2-5 days.