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Serialization and Track-and-Trace Compliance in Contract Manufacturing: Ensuring Product Integrity and Security

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Pharmaceutical Contract Manufacturer in India adopts a structured and focused approach that remain rationalized and aligned with the current demand of their customers. Their approach is centralized to efficiently take up the tasks of manufacturing. 

Introduction

Systematic planning and effective execution are the routines of pharmaceutical contract manufacturing. They keep on exploring different possibilities to make it happen and thus remain research oriented to look for newness in their endeavours. Compliance too is dealt with intense seriousness to maintain consistency in quality and effectiveness.

Serialization and track-and-trace are one of those important aspects of Pharmaceutical Contract Manufacturers in India and around the pharmaceutical sector. They are considered to confirm product integrity, safety, and security throughout the process. Let’s explore these areas of contract manufacturing:

Serialization: This refers to the process of assigning a unique identifier or serial number to an individual entity which is further encoded in a barcode or data matrix along with other relevant details. This serial number helps to track the movement of product from production to distribution and further to distribute it to patients.

Track and Trace: It is a comprehensive record of the product and its journey throughout the manufacturing process which involves collection of data at various points like facilities, distribution pharmacies, etc which gets shared with stakeholders throughout the supply chain.

Both these processes help maintain regulatory compliance and get an edge in checking the individuality of the product. Pharmaceutical Contract Manufacturing stays updated with the latest serialization and track-and-trace regulations to get the approval of products as the finished ones. They try to make every possible effort like specialized software and equipment to encode and verify these serial numbers. They maintain data integrity to ensure that data is accurate, secure, and cannot be tampered with. They maintain flawless integration and collaboration with supply chain partners to exchange the serialized data seamlessly.

Benefits of both processes

  • Improved product safety by avoiding fabricating and alteration.
  • Enhanced patient security by decreasing the risk of getting deficient medications.
  • Improved supply chain perceptibility, allowing for more effective recalls and improved inventory management.
  • Governing compliance, avoiding drawbacks, and preserving market access.

Akums Drugs and Pharmaceutical Ltd.

Akums Drugs and Pharmaceutical Ltd. is a recognized Pharmaceutical Contract Manufacturer in India that believes in the best manufacturing processes and tries to go hand in hand with the latest updates. They make things and processes evident as per the latest updates and maintain a strict record of the same.

FAQ

Q1. Why do serialization and track-and-trace compliance are essential for contract manufacturers?

Serialization and track-and-trace compliance are important for contract manufacturers to ensure product integrity and security in the pharmaceutical supply chain. By obeying regulatory requirements, capitalizing on suitable technology, and nurturing partnerships with supply chain partners, contract manufacturers can sustain the maximum standards of product safety and security.

Q2. What is serialization in pharmaceutical contract manufacturing?

 Serialisation refers to the process of assigning a unique identifier or serial number to an individual entity which is further encoded in a barcode or data matrix along with other relevant details.

 Q3. What is Track and trace compliance in pharmaceutical contract manufacturing?

It is a comprehensive record of the product and its journey throughout the manufacturing process which involves the collection of data at various points like facilities, distribution pharmacies, etc.

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