10+ Regulatory Affairs Manager 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

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

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

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

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

To apply FSSAI labelling regulations to develop artwork, one must understand the specific requirements and guidelines set by FSSAI and incorporate them into the design.

• Study and familiarize yourself with the FSSAI labelling regulations

• Identify the mandatory information that needs to be included on the label, such as FSSAI license number, nutritional information, allergen declaration, etc.

• Ensure compliance with font size, placement, and visibility requirements specified by FSS...read more

The licensing procedure to apply for FSSAI license involves several steps and documentation.

• Determine the type of FSSAI license required based on the nature and scale of the food business.

• Complete the application form with accurate information and submit it online or offline.

• Attach the necessary documents such as identity proof, address proof, food safety management plan, etc.

• Pay the applicable fees based on the category and duration of the license.

• After submission, the appli...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

Nitrosamine impurities are a group of chemical compounds that can be found in certain medications and other products.

• Nitrosamines are formed when amines react with nitrites or other nitrogen-containing compounds.

• They are classified as probable human carcinogens and can pose a risk to human health.

• Nitrosamine impurities have gained attention in the pharmaceutical industry due to their presence in some medications, such as ranitidine (Zantac).

• Regulatory agencies, such as the FD...read more

GMP stands for Good Manufacturing Practice and refers to the guidelines for ensuring quality and safety of pharmaceutical products. Data integrity is the maintenance of accuracy, completeness, and consistency of data throughout its lifecycle.

• GMP is a set of regulations that ensure pharmaceutical products are consistently produced and controlled according to quality standards

• It covers all aspects of production from raw materials to finished products

• Data integrity is essential ...read more

Regulatory affairs involve ensuring compliance with laws and regulations related to products and services.

• Regulatory affairs involve interpreting and implementing regulations set by government agencies.

• They ensure products meet safety and quality standards before being marketed.

• Regulatory affairs professionals work to obtain and maintain product approvals and registrations.

• They also monitor and report any changes in regulations that may impact the company's operations.

• Example...read more

Types of clinical trials include randomized controlled trials, observational studies, and expanded access trials.

• Randomized controlled trials: Participants are randomly assigned to different treatment groups to compare outcomes.

• Observational studies: Researchers observe participants in their usual environment without intervention.

• Expanded access trials: Provide investigational drugs to patients who do not qualify for ongoing clinical trials but have serious conditions.

• Adaptiv...read more