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Master Batch Record vs. Electronic Batch Record: A Comparative Analysis

Qualityze
21 Nov 2023
master-batch-record-vs-electronic-batch-record-a-comparative-analysis

Introduction

Precision, cost-effectiveness, and efficiency are the most important factors in the pharmaceutical and manufacturing industries. The two most essential elements to achieving these objectives, i.e., precision, cost-effectiveness, and efficiency, are Master Batch Records and Electronic Batch Records. These two elements play a crucial role in ensuring uninterrupted manufacturing processes. This master batch record vs electronic batch record blog post talks you through the ins and outs of MBRs and EBRs. We also discuss their differences and what you must adopt to make your business more effective and efficient.

Why You Must Maintain Records?

Have you ever wondered what role records play in our lives? If you observe closely, you will find that records are everywhere, from government to private. Maintaining records ensures proper documentation. Document Management Software makes making decisions easy, thanks to actionable reports and data availability. In the absence of records, you won't have a reference point; you will not know what you did in the past and what results your actions produced. An organization must document its processes to ensure compliance with regulatory bodies and maintain actionable data and many other things. 

There is no room for mistakes lest a company wants to attract heavy penalties or cancellation of license. Pharmaceutical companies must be more vigilant as the cost of error can be human lives. In the last few years, two pharmaceutical companies – one from India and the other from Indonesia -- have faced punitive actions because of their substandard cough syrup, which claimed lives and left many others paralyzed. The regulatory requirements for pharmaceutical companies worldwide are extremely tight, and any company deviating from the set standards faces the music of government and international regulatory bodies such as the World Health Organization.

The manufacturing companies, too, must be mindful of regulatory requirements in their countries and around the world. Missing the standards set by government and regulatory bodies results in product recall, leading to a higher cost of production. Adherence to rules and regulations is not limited to pharmaceutical, manufacturing, or other product-driven companies. Service providers, too, must operate within the regulatory requirements set by their industries. Indonesian Airline operator Lion Airlines faced regulatory backlash because of its non-compliance with industry regulations. The many fatal crashes the airline suffered, claiming the lives of 214 people, not only attracted penalties and grounding of its airplanes but also caused loss of its face among the public. The biggest loss for a business is loss of reputation. If an organization cannot inspire consumer confidence, it isn't easy to remain profitable. 

 Master Batch Records: An Introduction

The life sciences industry must maintain standards set by regulatory bodies in manufacturing products. Compliance with standards in the life science industry ensures products are free of risks to lives and effective for consumers. Manufacturers must strictly document every stage of their operations to ensure compliance with industry standards. Everything must be thoroughly documented, from personnel involved to materials used to processes adopted for production.

U.S. Food and Drug Administration demands documentation for each drug formulation and batch produced. The documentation is necessary for two things: (1) It enables the internal quality management team to enforce quality standards; (2) it also allows external regulators to verify production processes and find out if there were any deviations from the manufacturer's plan and laid down guidelines in production. Master Batch record is one of the most crucial documents that ensure compliance and consistency in production in the pharmaceutical industry. 

The Whats and Whys of the Master Batch Record

Think of an Olympic relay race. Everyone in the relay race plays a crucial role in ensuring team success. The passing of the baton from one person to another requires cohesiveness in the team. The team member needs a thorough plan and strategy to achieve their objectives. The team management ensures every team player thoroughly understands each other and produces reports that can be read and used. Master Batch Record in manufacturing processes is also like an Olympic relay race. MBRs offer a thoroughly written document identifying procedures and guidelines to manufacture a specific product batch.

The MBRs are written documents that act as a blueprint for the production team. The documents contain information on raw materials, manufacturing instructions, quality control measures, etc. They also identify issues in manufacturing and offer a comprehensive solution, enabling continuous production without compromising quality and quantity. The biggest advantage of MBRs is that they allow the manufacturing processes to be in sync with pre-established standards. MBRs play a vital role in maintaining consistency in production and meeting regulatory requirements, lowering business risks. 

What makes MBRs Unique? 

The most unique feature of MBRs is its human approach to documentation. In a world dominated by software and digital interfaces, MBRs rely on physical documentation in manufacturing processes. Teams involved in manufacturing sift through the physical document, making notes and taking down instructions. MBRs are responsible for humanizing the production process.

Some Other Unique Features of MBRs

Each Batch size has its own unique MBR. Giving unique MBR to different batch sizes ensures easy identification of one batch from the other, reducing time spent on identification and correction. 

The Master Batch Records are comprehensive documents containing all relevant information about a product. It stores products' names, counts of components needed for a batch's manufacturing, sampling, testing procedures to ensure there is no error, specific instructions for different stages in the manufacturing process, instructions, guidelines for manual operations, etc. 

MBRs ensure each step in the manufacturing process is documented and completed in compliance with the standard operating procedures. The department responsible for manufacturing products writes MBRs, while the quality team(s) approve them. 

MBRs must be signed by two people in accordance with 21 CFR 211.186. In drug manufacturing, MBRs require a written declaration of any use of excess components.  

Master Batch Records: Challenges and Shortcomings

The biggest challenge of Master Batch Records is human error. MBR is an old-style pen and paper documentation, leading to the accumulation of a vast amount of paperwork. Going back to previous records can be a daunting task. Additionally, paper-based records are at risk of delays due to manual processes, misplacement, storage difficulty, and wear and tear. Digitalization and workflow automation ensure hassle-free documentation without the risk associated with paper-based documentation. Good Manufacturing Practices are intolerant to deviation from set standards. MBRs can lead to some discrepancies, inviting penalties for the users. 

Some Other Shortcomings of MBRs.

  1. They are time-consuming and expensive to create, lowering the cost-effectiveness and efficiency of an organization.
  2. They are susceptible to such errors as miscalculation, illegible handwriting, missing signatures, etc.
  3. It is a cumbersome process to update and revise them.
  4. Paper-based documentation demands standardization and harmonization across different sites, departments, and systems. 
  5. They are at risk of being stolen or destroyed.
  6. They are ineffective and inefficient in capturing real-time data, insights, feedback, and deviation from set standards. 

The Way Forward:

Electronic Batch Record – known as EBR in short – is the answer to the shortcomings of MBR. The world we live in is moving towards digitalization and automation. The industries are evolving fast to optimize the benefits offered by the digital world. Electronic Batch record is disrupting the traditional popularity of Master Batch Records and enabling a new way of documentation sans the challenges of MBR.

EBR: An Introduction

The pharmaceutical industry's history can be divided into the pre- and post-pandemic eras. The post-pandemic period has disrupted the pharmaceutical industry. The regulatory requirements are changing fast and becoming stricter. EBRs – Electronic Batch records – ensure the pharmaceutical industry complies effectively and efficiently with regulatory requirements.

EBRs are digital tools tracking and monitoring batch production at every stage of their manufacturing process. EBRs store SOPs digitally and are easy to access, eliminating human error common in MBRs. The biggest advantage of EBRs is that they capture real-time data and offer continuous feedback, enabling verifiable results in compliance with regulatory requirements. EBRs are efficient as they eliminate wastage of resources, time-consuming data maintenance and retrieval, and optimize production. 

EBR: A Digital Solution to Record-Keeping 

EBR – Electronic Batch Records – are more cost-effective and efficient vis-à-vis MBR -- Master Batch Records. Pharmaceutical companies globally are facing the challenges of escalating operational costs and increasingly stringent regulatory and safety recommendations. Pharmaceutical companies also witness diverse product portfolios, necessitating up-to-date and flawless documentation to avoid deviation from set regulatory requirements and standards. 

Qualityze Offers time-tested and result-oriented EBR solutions, enabling paperless manufacturing without regulatory deviations. 

Why EBR?

The biggest reason for choosing EBR is that it speeds up documentation and reports. EBR ensures thorough recording of process data, captures real-time data and insights, offers uninterrupted feedback on errors and deviation, etc. Qualityze, a leading name in EBR solutions, helps you go paperless and ensures comprehensive, error-free processes. Our EBR solution eliminates deviation, making your manufacturing process more cost-effective and efficient. 

EBR and Quality Assurance

Quality is a word everyone swears by in the pharmaceutical and manufacturing industries. Deviation from expected quality can be catastrophic. MBRs count on unwavering attention and the unblinking eyes of quality control personnel to review every step required by regulatory bodies. Such an approach is prone to errors. Electronic Batch records eliminate errors by incorporating automated quality checks into its digital framework. 

Unique Features of EBRs:

  • It breaks down geographical barriers, enabling teams in different parts of the world to collaborate.
  • It offers a comprehensive audit trail, simplifying manufacturing processes.
  • Creates a log for every action taken and every change made, creating traceable records.
  • It is very safe as it requires authentication, authorization, and other backup mechanisms.
  • It automates workflows, helping companies to meet regulatory requirements of CGMP, 21 CFR Part 11, FDA, etc. 

Benefits of EBR

The benefits of EBRs are obvious. They help you eliminate the time and effort involved with entering data, revision, maintenance, storage, etc. Paper documentation is a labor-intensive work prone to human errors. EBRs eliminate paperwork and do away with errors associated with manual work.

The benefits of Using Qualityze EBR

Compliance is the buzzword in pharmaceutical and other manufacturing industries. Deviation from compliance requirements can not only invite steep penalties but also may see a company being barred from operating. Keeping an eye on ever-evolving and continuously changing regulatory needs can take time and effort. The most significant advantage of using Qualityze's EBR management is that it is fully compliant with FDA, CGMP, GMP, and CFR. Simply put, Qualityze EBR meets all current standards for pharmaceutical manufacturing in the USA and the world. 

Other benefits of using Qualityze EBR:

  • It optimizes batch manufacturing processes.
  • It simplifies and optimally organizes resource and equipment allocation for better results.
  • It simplifies access to Standard Operating Procedures, eliminating human errors.
  • It is flexible to cater to the unique needs of manufacturing companies with diverse product portfolios. 

Quick read: How to Build an Effective Competency Matrix or Skills Matrix

Parting shot:

We will state the obvious if we say EBRs have a distinct advantage over their counterpart, MBRs. EBR is reimagining the execution and monitoring of manufacturing processes, turning companies nimbler and more efficient.

EBRs have brought hitherto unimaginable efficiency into the manufacturing processes. The digital format of EBRs ensures real-time data entry, eliminating the discrepancy associated with MBRs. The easy and real-time accessibility of data and critical information enables swift decision-making, anticipation and mitigation of future challenges, and acceleration of manufacturing processes, besides a host of other benefits. 

One of the biggest challenges of paper-based documentation is the geographical barrier. Sharing physical documents is not only cumbersome and fraught with danger – think of loss, theft, etc., -- but also expensive. EBRs remove geographical barriers. Qualityze cloud-based, AI-powered EBRs ensure seamless storage and uninterrupted accessibility to critical documents globally, enabling teams in different locations to collaborate on a single platform. Improved communication among various teams increases efficiency and ensures consistency throughout the manufacturing processes, eliminating deviation from regulatory requirements.

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