10+ Senior Executive Regulatory Affairs Interview Questions and Answers

WHO annex 2 provides guidelines for stability testing of active pharmaceutical ingredients and finished pharmaceutical products.

• WHO annex 2 outlines the requirements for stability testing of pharmaceutical products.

• It includes guidelines on the design of stability studies, storage conditions, and testing frequency.

• The annex also covers the evaluation of stability data and the establishment of shelf life.

• Compliance with WHO annex 2 is important for ensuring the quality and eff...read more

Yes, dietary fiber provides energy but it is not absorbed by the body.

• Dietary fiber is a type of carbohydrate that cannot be digested by the body.

• It passes through the digestive system mostly intact.

• Although it does not provide calories, it can help regulate blood sugar levels and promote satiety.

• The recommended daily intake of fiber is 25-30 grams for adults.

• Good sources of fiber include fruits, vegetables, whole grains, and legumes.

Difficulties for export include regulatory compliance, market access barriers, cultural differences, and logistical challenges.

• Regulatory compliance requirements vary by country and can be complex to navigate.

• Market access barriers such as tariffs, quotas, and trade restrictions can hinder export efforts.

• Cultural differences in business practices, communication styles, and consumer preferences may require adaptation.

• Logistical challenges like transportation, packaging, and di...read more

Carbs, protein & fat are macronutrients that provide energy to the body.

• Carbs are the primary source of energy for the body.

• Protein can also be used for energy, but it is primarily used for building and repairing tissues.

• Fat is a secondary source of energy and is used when carb stores are depleted.

• The body converts carbs into glucose, which is used for energy.

• Protein is broken down into amino acids, which can be converted into glucose or used for energy.

• Fat is broken down int...read more

Labeling regulations are crucial for compliance with FSSAI and Legal Metrology requirements.

• FSSAI mandates specific labeling requirements for food products, including information on ingredients, nutritional value, and allergens.

• Legal Metrology regulations govern the labeling of packaged goods, including mandatory declarations of net quantity, MRP, and consumer care information.

• Non-compliance with labeling regulations can result in penalties, product recalls, and damage to bra...read more

Validation is required to ensure that a product or process meets the specified requirements and is fit for its intended use.

• Validation helps to confirm that the product or process will consistently perform as intended.

• It ensures that the product meets regulatory requirements and standards.

• Validation helps to identify and mitigate risks associated with the product or process.

• It provides evidence that the product is safe, effective, and reliable.

• Validation is essential in indus...read more

A dossier is a collection of documents or information compiled for a specific purpose or project.

• A dossier typically includes reports, data, analysis, and other relevant documents.

• In regulatory affairs, a dossier may refer to a collection of documents submitted to regulatory authorities for approval of a new drug or medical device.

• Dossiers are often organized in a specific format to meet regulatory requirements and standards.

• Maintaining accurate and up-to-date dossiers is cru...read more

FSSAI has issued various notifications, advisories and orders related to food safety and standards.

• FSSAI has issued an advisory on the use of potassium bromate and potassium iodate in bread making.

• FSSAI has issued an order to ban the use of 28 pesticides in food items.

• FSSAI has issued a notification on the labeling requirements for packaged food products.

• FSSAI has issued an advisory on the use of antibiotics in animal feed.

• FSSAI has issued an order to recall Maggi noodles due...read more

Module 3 is a part of the Common Technical Document (CTD) that contains information on quality aspects of the drug product.

• Module 3 includes detailed information on drug substance, drug product, manufacturing process, packaging, and stability data.

• It also includes information on specifications, analytical methods, and validation studies.

• Examples of documents in Module 3 include batch records, certificates of analysis, and stability reports.

Safety parameters for food products include microbiological, chemical, and physical hazards.

• Microbiological hazards include bacteria, viruses, and parasites that can cause foodborne illnesses.

• Chemical hazards include toxins, pesticides, and additives that can be harmful if consumed in large quantities.

• Physical hazards include foreign objects such as glass or metal that can cause injury if ingested.

• Food safety regulations and guidelines are in place to ensure that food product...read more