What is process validation for drug / pharmaceutical products?

 

What is Process Validation?

The FDA defines process validation as, “the collection and evaluation of data, from the process design stage through marketable product, which establishes scientific substantiation that a process is able of constantly delivering quality product”.

A foundational tenet of this FDA guidance document is the lifecycle conception. The lifecycle approach is concerned not only with the original drug development processes; but also, the establishment of marketable manufacturing and routine marketable product until discontinuation of the product.

Process Validation is conducted to ensure consistent delivery of quality products meeting its predetermined specifications/requirements and quality characteristics. This enables to ensure the complete safety & efficacy of medical device.


IZiel works with your team to assist you to complete all the following process validation activities for your medical devices.

  • ·         Process Validation Master Plan (PVMP)
  • ·         Process Characterization
  • ·         Equipment Installation and Qualification (IQ)
  • ·         Operational Qualification (OQ) – 
  • ·         Performance Qualification (PQ)
  • ·         Test Method Development (TMD) & Validation (TMV)



Comments

Post a Comment

Popular posts from this blog

Clinical Evaluation Report for Medical Devices

A Clinical Evaluation Report (CER) for medical devices is a comprehensive document that assesses the safety and performance of a medical device through the review and analysis of clinical data. The purpose of a CER is to demonstrate the device's conformity with relevant regulations, standards, and requirements, such as the Medical Device Regulation (MDR). A well-prepared CER plays a crucial role in gaining regulatory approval and ensuring the device's ongoing compliance throughout its lifecycle. Here's an outline of the key components typically included in a Clinical Evaluation Report : 1. Device Description and Intended Use :    - Provide a detailed description of the medical device, including its specifications, intended use, and indications for use.    - Clearly define the device's intended purpose, patient population, and the medical condition it is intended to address 2. Clinical Literature Review :    - Conduct a systematic and thorough r...
Read more

Navigating the Maze: Understanding Clinical Evaluation Reports for Medical Devices

In the realm of medical devices, ensuring their safety and effectiveness is paramount to safeguarding patient health. Clinical Evaluation Reports (CERs) play a pivotal role in this process, providing a comprehensive assessment of a medical device's clinical performance. This blog aims to demystify the world of Clinical Evaluation Reports, shedding light on their significance, components, and the intricate process involved in their creation.   What is a Clinical Evaluation Report (CER) ?   A Clinical Evaluation Report is a systematic and critical analysis of clinical data pertaining to a medical device. It is a crucial component of the regulatory submission process, providing evidence that supports the device's safety and performance throughout its lifecycle. The goal is to ensure that the benefits of the medical device outweigh any potential risks.   Key Components of a CER:   1. Device Description:    - Begin with a detailed description ...
Read more

The Significance of Clinical Evaluation Reports in Medical Device Assurance

 As the medical device industry advances, the focus on patient safety and efficacy becomes increasingly paramount. The Clinical Evaluation Report (CER) is central to ensuring medical device performance and safety. This comprehensive document plays a pivotal role in providing a systematic and objective assessment of a medical device's clinical performance, confirming its conformity with regulatory requirements, and ultimately contributing to improved patient outcomes.   Understanding the Clinical Evaluation Report :   A Clinical Evaluation Report (CER) is a thorough analysis and appraisal of clinical data related to a medical device. This process involves the systematic collection, appraisal, and analysis of clinical evidence pertaining to the safety, performance, and intended use of the device. Key components of a CER include:   1. Clinical Data Collection:    - Gathering clinical data from various sources, including clinical investigations, p...
Read more