United Financial Services Interview Questions and Answers

The additional requirements for DMF submission purpose include providing detailed information on the manufacturing process, quality control procedures, and stability data.

• DMF (Drug Master File) submission is a regulatory requirement for pharmaceutical companies to provide confidential information about the manufacturing, processing, and packaging of a drug product.

• In addition to the general requirements for DMF submission, there are specific additional requirements depending ...read more

Limits for nitrosamine impurities in regulatory affairs

• Consider the acceptable daily intake (ADI) for nitrosamines

• Refer to regulatory guidelines and requirements for specific limits

• Evaluate the potential risk and toxicity of nitrosamines

• Take into account the route of administration and dosage form

• Consider the level of nitrosamine impurities in raw materials and finished products

• Monitor and analyze data from stability studies and batch testing

• Collaborate with toxicologists and...read more

TTC for a drug substance can be calculated using a formula based on NOAEL and safety factors.

• TTC stands for Threshold of Toxicological Concern

• Calculate TTC by dividing NOAEL by safety factors

• Safety factors are determined based on the quality of data available

• Formula: TTC = NOAEL / safety factors

• TTC is used to assess the safety of impurities in drug substances

The DMF specification for China will depend on the batches and specifications required.

• The DMF (Drug Master File) specification for China will vary depending on the specific drug or product being registered.

• Different batches of the same drug may have different specifications based on factors such as manufacturing processes or raw material sources.

• The specifications outlined in the DMF will typically include information on the drug's composition, quality control tests, and man...read more

Explanation of the calculation used per ICHM7 for option 1

• The calculation is used to determine the acceptable level of impurities in a drug substance or product

• The formula is 1.5 divided by the maximum daily dose in milligrams

• The result is compared to the qualification threshold for impurities

• Option 1 is used when the drug is administered for less than 30 days

• Example: If the maximum daily dose is 100mg, the calculation would be 1.5/100 = 0.015

Changes submission process in US and EU for regulatory affairs

• Changes in US require submission of a supplement to the original application

• Changes in EU require submission of a variation to the original application

• Both US and EU require assessment of the impact of changes on safety, efficacy and quality

• US FDA has specific timelines for review of changes, while EU timelines vary based on type of variation

• Both US and EU require communication with regulatory authorities throughou...read more

A purging study is a research study conducted to evaluate the effectiveness of a purging process in removing impurities or contaminants.

• A purging study is typically conducted in industries such as pharmaceuticals, food processing, and manufacturing.

• The study involves testing the efficiency of a purging process in eliminating unwanted substances.

• It may include analyzing samples before and after the purging process to measure the reduction in impurities.

• Purging studies are impo...read more

China has implemented new regulations for pharmaceutical products.

• China has recently introduced new regulations for the registration and approval of pharmaceutical products.

• The new regulations aim to enhance drug safety and improve the efficiency of the regulatory process.

• One significant change is the requirement for all pharmaceutical companies to conduct clinical trials in China before seeking approval.

• The regulations also emphasize the importance of post-marketing surveill...read more