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This document serves as a guide for vaccine manufacturers regarding validation studies required by Good Manufacturing Practices (GMP) as set forth by the World Health Organization (WHO). It outlines
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How to fill out whovsq9702 - whqlibdoc who
How to fill out WHO/VSQ/97.02
01
Obtain a copy of the WHO/VSQ/97.02 form from the appropriate source.
02
Read through the instructions carefully to understand the requirements.
03
Begin filling out the form by entering the relevant personal or organizational information in the designated sections.
04
Provide detailed answers to any questions or sections that require specific data.
05
Double-check all entries for accuracy and completeness before submission.
06
Submit the form as instructed, either electronically or in paper format, based on the guidelines.
Who needs WHO/VSQ/97.02?
01
Healthcare professionals working with vaccines.
02
Managers in vaccine supply chains.
03
Regulatory authorities overseeing vaccine distribution and safety.
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People Also Ask about
What are the 5 keys of GMP?
By paying attention to the 5 P's of GMP – Products, Processes, Procedures, Premises and People, we can ensure the creation of products that meet and exceed the standards of quality and safety that our consumers expect and deserve.
What are the 5 main components of good manufacturing practice?
GMP programs are typically broken down into five main components: People, Products, Procedures, Processes and Premises.
What are the 5 factors of GMP?
5 Main Components of Good Manufacturing Practice (GMP) People. At the heart of the 5 main components of good manufacturing practice are people. Premises. Premises refer to your facilities where manufacturing takes place. Products. Processes. Procedures.
What are the 5 basic GMP concepts?
Good Manufacturing Practices (GMP) is a comprehensive manufacturing system that ensures product consistency and quality by addressing 5 key components: products, people, processes, procedures, and premises.
WHO guidelines for batch manufacturing record?
The WHO guidelines for BMRs outline a comprehensive set of requirements that must be met to ensure the integrity and traceability of pharmaceutical products. These key elements include: Identification: Each BMR must be uniquely identified with a clear and traceable batch number.
WHO basic training modules on GMP?
Professional Certification in Professional in WHO-GMP Certified Study Resources. Module 1: Basic Principles of Pharmaceutical Good Manufacturing Practices. Module 2: WHO-GMP. Module 3: Certificate of Pharmaceutical Product (CoPP) Module 4: Computer System Validation (WHO Perspective)
What are the 5 P's of Good Manufacturing Practices?
GMP programs are typically broken down into five main components: People, Products, Procedures, Processes and Premises.
What are the GMP requirements of factory premises?
It covers factors to consider for location, design, construction, sanitation, maintenance, utilities, and environmental control of premises to prevent contamination. The premises must have defined areas for receiving, sampling, storage, production, packaging, and quality control.
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What is WHO/VSQ/97.02?
WHO/VSQ/97.02 is a form used to collect and report data related to the safety and efficacy of vaccines, as established by the World Health Organization.
Who is required to file WHO/VSQ/97.02?
Entities involved in vaccine development, production, and distribution, including manufacturers and regulatory authorities, are required to file WHO/VSQ/97.02.
How to fill out WHO/VSQ/97.02?
To fill out WHO/VSQ/97.02, users must follow the guidelines provided by WHO, ensuring all sections are completed accurately, including specific data about the vaccine, its clinical trials, and post-marketing surveillance.
What is the purpose of WHO/VSQ/97.02?
The purpose of WHO/VSQ/97.02 is to facilitate the monitoring of vaccine safety and efficacy, helping to ensure public health and safety.
What information must be reported on WHO/VSQ/97.02?
Information that must be reported includes vaccine details, manufacturing notes, clinical trial results, adverse event reports, and any additional data relevant to the vaccine's safety and efficacy.
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