Lithion Power 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

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

CTD stands for Common Technical Document as per ICH guidelines.

• CTD is a set of specifications for the registration of medicines and designed to be used across different regulatory agencies.

• It includes modules on quality, safety, and efficacy of the drug product.

• CTD format helps streamline the submission process for regulatory approval.

• Examples of CTD modules include Module 1 (Administrative information), Module 2 (Summaries), Module 3 (Quality), Module 4 (Nonclinical study re...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