#batch records

In the intricate kingdom of pharmaceutical manufacturing, careful documentation is imperative at every stage. However, the reliance on paper records can be both time-consuming and susceptible to human errors. The pharmaceutical industry has included Electronic Batch Record (EBR) systems to streamline workflows and enhance accuracy. This article delves into how the innovative Process-XE system is transforming document creation across the pharmaceutical sector, from bulk processing to packaging.

Understanding Electronic Batch Records

Pharmaceutical companies opting for production solutions prioritize not only the digitization of forms but also seek to expedite form filling by automating data collection directly from machines. The comprehensive EBR solution covers a spectrum of processes, including product weighing, mixing, granulation, tableting, coating, packaging, and quality control. The system gathers data from various equipment such as scales and meters, minimizing the chances of errors and allowing real-time tracking of deviations from the norm during production. ProcessXE ensures compliance with Good Manufacturing Practice (GMP) standards.

The implementation of ProcessXE goes beyond digitizing documentation; it guides operators through the entire production process, including changeovers, quality control, logistics, and maintenance processes.

ProcessXE: An Advantage for Pharma

ProcessXE offers a complete system encompassing machine data acquisition, hardware, ERP integration, and infrastructure. Especially, it includes Master Batch Record (MBR) template creation, allowing clients to configure activities in the right sequence with defined roles and responsibilities. Each activity is customizable with reporting data types, such as numbers, text, and data read from automation, validated against preset quality limits.

Fields in the forms cover a range of parameters, including task completion status, production values, task duration, electronic signatures, and remarks by responsible personnel. The system equips every work center with an operator panel, facilitating actions like selecting production orders, confirming actions, electronic signatures, step-by-step instructions, documentation display, production progress monitoring, traceability, and Overall Equipment Effectiveness (OEE) analysis.

Integration with SAP is seamlessly achieved through web services, and additional production process details can be configured in the ProcessXE Master Data module.

The Paperless Pharma Process

A paperless approach involves digitally guiding operators through production stages, displaying activity to-do lists, changeover information, and dedicated documentation for each step. ProcessXE Forms automates the filling of sheets, tables, and reports with real-time shift data, issuing timely task completion notifications and monitoring changes and deviations with an audit trail.

Mobile barcode scanners ensure validation and traceability of materials, with the system supporting label printing for boxes or containers. During sample testing, the system prompts the creation of new samples, generates labels for scanning in the laboratory, and automatically compares test results against set quality tolerances.

The batch approval process in ProcessXE mandates electronic signatures at each step, providing a transparent workflow. Notifications alert relevant roles, enabling personnel with the right permissions to monitor progress and KPIs for batch releases.

Benefits for Pharma Businesses

Implementing EBR with ProcessXE brings substantial benefits to pharmaceutical businesses. A 35% reduction in batch release time is achieved through workflow optimization and automated data gathering. Material validation, periodic quality checks, and digital instructions contribute to a 15% reduction in errors and waste. Additionally, On-Time-In-Full performance sees a 7% improvement.

EBR implementation fosters faster communication between departments, eliminates paper from production processes, and provides continuous monitoring of batch release statuses. ProcessXE emerges as a solution that not only enhances operational efficiency but also aligns with environmental sustainability goals.

The requirement for simplified procedures and strong regulatory compliance has never been more crucial in the ever-changing environment of the manufacturing and pharmaceutical sectors. Electronic Batch Records (EBRs) arise as a game changer, revolutionizing how enterprises manage and document their manufacturing operations. In this blog, learning about what they are, how they work, and how they're changing the future of manufacturing. Development of Batch Records

Batch records were traditionally paper-based documentation that documented the phases of a manufacturing process. These records were not only difficult to handle, but they were also disposed to to mistakes, inefficiencies, and compliance problems. It was a difficult undertaking to keep these records up to date, retrieve past data, and ensure compliance with changing regulations. Electronic Batch Records: A Switchover

Introduction of Electronic Batch Records signaled a revolution in how industry managed their production operations. EBRs replace stacks of paper with digital records, which has various advantages.

EBRs remove the risk of human mistakes associated with manual data entry, resulting in increased accuracy and efficiency. Data gathering and validation methods that are automated ensure that information is correct and up to date. This results in fewer manufacturing mistakes, less waste, and more efficiency.

With EBRs, you can monitor manufacturing processes in real time. This not only allows for speedier decision-making but also gives significant insights into the manufacturing workflow. Managers can quickly identify bottlenecks and inefficiencies and implement remedial actions.

Compliance with industrial rules is of the utmost importance. EBRs make compliance easier by automatically recording each stage of the manufacturing process, ensuring that all necessary data is gathered and securely preserved. This makes audits and regulatory inspections easier.

EBRs make it simple to retrieve past data. This is extremely useful for tracking product quality, investigating issues, and continuously improving. It also makes it easier to generate batch-related reports.

Collaboration across teams in various places is frequent in today's globalized environment. EBRs provide remote access and collaboration, allowing teams to collaborate effortlessly regardless of their geographical location.

Implementing Electronic Batch Records

EBR implementation necessitates careful planning and technological investment. The following are important goals in the implementation process:

Choosing the Right Software: Select EBR software that meets the demands and regulatory standards of your sector. Scalability should be considered to support future expansion.

Training: Provide training to your workers to guarantee they can utilize the EBR system properly. This involves knowing how to enter data, monitor operations, and fix problems.

Transferring data from paper-based records is referred to as data migration.

Process XE is web based, flexible and user-friendly software solutions for Business process automation.

Batch Records Software

Process XE batch records software workflows are 100% configurable. No coding required.

What is a Batch Record?

A batch record is a record of the history of a manufactured product. It comprises processing instructions to assure its safety, quality, and GMP compliance.

As a result, pharmaceutical businesses choose to use Electronic Batch Record (EBR) in order to streamline production and reduce the potential of mistakes seeping in. This article demonstrates how the system facilitates document generation in the pharmaceutical industry, from bulk to packaging processes.

What is Electronic Batch Records all about?

The pharmaceutical business that wishes to apply innovative solutions in manufacturing is concerned with more than just the digitization of forms. The EBR system is also designed to reduce the time necessary to fill out form fields and eventually lead to automatic form completion by gathering data directly from machines. Data collection directly from equipment such as scales, pH meters, and conductivity meters is frequently required as well. Furthermore, the organization wishes to avoid mistakes and track deviations from the standard that occur during the manufacturing process.

The deployment of the Process XE system results in more than just efficient documentation digitalization. Operators are directed through the manufacturing process, which includes changeovers, quality, logistics, and maintenance. Process XE is being compiled using GMP by the system.

This greatly simplified the process of creating or changing forms. However, this still necessitates the use of authorized individuals; only those with the necessary access may make modifications to the forms. All of this is done to avoid mistakes or inappropriate processing.

What does the Process XE solution offer for Pharma?

Process XE provides an all-inclusive solution that includes machine data collecting, hardware, ERP integration, and infrastructure. This method also allows you to create MBR templates. Clients can develop Master Batch Record (MBR) templates by arranging all actions in the system in the correct sequence and assigning responsibility for each role. Each activity may be customized with several reporting data kinds such as numbers, text, and data retrieved from automation, among others. These results can subsequently be checked against the system's quality limitations.

Fields in forms that have been implemented include whether or not an action has been done. A production value column and information about when a given activity was begun or stopped, as well as a computation of the time spent on it, are also among the modifications. There is also an electronic signature placed on the form and comments or remarks made by the responsible person among the implementations.

What does a paperless procedure in the pharmaceutical sector look like?

The paperless process includes digitally directing the operator through particular portions of production, beginning with the activity display - the production to-do list. It also contains changeover information and documentation for each production phase (picture, text, and video). Using Forms, all paper documentation from production are digitized.

All sheets, tables, and reports are immediately fielded with data from current shifts thanks to Process XE. The system monitors and alerts the operator when the task must be finished. Any modifications or deviations are tracked using an audit trail.

To be released, each batch must go through the Process XE system's approval procedure. This relates to the workflow aspect. The persons who notify certain positions in the organization must sign each step with an electronic signature. If the current step in the workflow is allocated to a certain role, notifications are issued. People with the necessary rights may observe where the batch release process has halted and track KPIs for the time it takes to finish each step.

Digital Records Management with Electronic Batch Records

EBR works because of all of the criteria mentioned above. This provides digital documentation management throughout the manufacturing process. The system ensures that the essential data is entered into the stages. EBR generation yields a PDF file with finished reports and signatures.

What are the benefits of this for the pharmaceutical business?

To begin, the system reduces batch release time by 35% owing to workflow and automatic data collection. Material validation, frequent quality inspections, and step-by-step digital teaching also result in 15% reduced mistakes and waste. It also delivers a 7% boost to OTIF.

The use of EBR also facilitates speedier communication between business divisions, contributes to the removal of paper from the manufacturing process, and allows for round-the-clock monitoring of current batch release statuses.

Process XE provides the solutions your pharmaceutical company need to improve workflow efficiency and environmental friendliness. Please contact a member of the team for more personalized help.

Process XE is web based, flexible and user-friendly software solutions for Business process automation.

This Digital, Smart Manufacturing process automation is principally developed for Pharmaceutical, Life science and Healthcare industries to simplify their manufacturing execution system of various processes such as data capture, batch information exchange, batch production management, data security maintenance, data integrity and report production, ensuring compliance to cGMP requirements.

A batch manufacturing records serves as a comprehensive document, capturing the entire manufacturing history of a product batch. This terminology finds widespread application in the Pharmaceutical & Chemical industries and is a key reference in various pharmaceutical and food regulatory agency guidelines. According to the US Food and Drug Administration's definition, a batch represents a specific quantity of a drug or material, intended to possess consistent characteristics and quality, adhering to defined limits. It is manufactured in a single production order during the same manufacturing cycle.

Batch Manufacturing Records

Batch Manufacturing Records play a crucial role in ensuring the attainment of quality standards and meeting regulatory requirements. These essential documents typically encompass information pertaining to various aspects of product batch manufacturing, including:

Commencement and completion dates of the manufacturing process.

A comprehensive list of all materials used, along with their respective quantities.

Inventory of packaging materials utilized in the process.

Detailed description of each step in the manufacturing process, including the corresponding completion times.

Identification of the responsible person's initials at each stage.

Documentation of all in-process checks, along with their outcomes.

Reference to any equipment used during the manufacturing.

Batch yield and reconciliation data.

Any deviations or variations encountered during the process.

Information related to Quality Control measures and assessments.

The Electronic Batch Manufacturing Records are often presented in an instructional format, allowing operators to input processing details as needed. It is of utmost significance to furnish the required information in the designated sections of these records.

During vital procedures like raw material weighing, an additional individual is required to verify calculations, confirm material identities, and endorse the Batch Manufacturing Records.

Furthermore, a unique batch number is assigned to each production batch and is clearly indicated on the corresponding Batch Manufacturing Record.

The Batch Manufacturing Records are required to adhere to the following guidelines:

Readable

Enduring

Precise

Authentic

Signed

Every correction and deviation must be documented and approved within the Batch Manufacturing Records.

Mandates the inclusion of specific information in a Batch Manufacturing Record. The details that must be documented are as follows:

The identity of the dietary supplement or dietary ingredient used in the manufacturing process.

The quantity of each component used.

A statement of the actual income and percentage of theoretical income.

A description of the packaging and labeling process used.

Documentation of any product specifications established to ensure the quality of the finished product.

Written procedures for the calibration of instruments, if applicable.

Written procedures for the manufacturing process and control of each batch.

Documentation of the reevaluation of any manufacturing process that is not controlled by the specifications.

Documentation of the review and approval of any deviation from the batch record, including the reason for the deviation and the signature of the individual responsible for the decision.

Documentation of the date and time of the signature of the person responsible for the manufacturing operation and the quality control unit.

Ensuring that these specific pieces of information are included in the Batch Manufacturing Record is crucial for compliance with FDA regulations and maintaining product quality and safety.

Process XE is web based, flexible and user-friendly software solutions for Business process automation.

This Digital, Smart Manufacturing process automation is principally developed for Pharmaceutical, Life science and Healthcare industries to simplify their manufacturing execution system of various processes such as data capture, batch information exchange, batch production management, data security maintenance, data integrity and report production, ensuring compliance to cGMP requirements.

When it comes to pharmaceutical manufacturing, ensuring quality and safety is of utmost importance. Adhering to current Good Manufacturing Practices (cGMP) is mandatory as they form the foundation for producing high-quality products. In most countries, meeting cGMP requirements is a prerequisite for selling pharmaceutical products in their respective jurisdictions.

Given the high impact of the pharmaceutical industry on public health and safety, it is mandatory to meet specific regulatory demands. However, cGMP standards go beyond mere compliance. They enable pharmaceutical manufacturers to establish robust systems that facilitate informed decisions, meticulous monitoring, and effective control of processes, materials, and facilities involved in drug production. These standards can be applied throughout the entire global supply chain.

Deviation from standard operating procedures (SOP’s) can have severe consequences, potentially leading to the release of contaminated medications or worse. An entire batch of product may be compromised, resulting in potential drug shortages and financial losses to the organization.

To prevent such situations, adhering to cGMP guidelines and maintaining thorough and accurate records throughout the manufacturing process is crucial. This is where batch records play a pivotal role. They are among the most critical types of records in the pharmaceutical manufacturing industry and investing time in perfecting them is worth the effort.

Batch Records in Pharmaceutical Manufacturing

The Batch Manufacturing Record (BMR) is a crucial document that provides detailed instructions on production of medication. It contains essential information such as the product name, precise weight and quantities of each component in the medication, a comprehensive list of processes and procedures to be followed, and the expected yield of each batch. Essentially, the BMR serves as the blueprint for drug manufacturing, requiring strict adherence with precision and care.

Having an efficient BMR in place offers several advantages. Firstly, it can significantly reduce medication shortages caused by production delays or issues with quality control, which are responsible for up to 66% of medicine shortages. Additionally, it plays a crucial role in preventing contamination or other potential problems that could arise during the manufacturing process.

In order to ensure that medication is produced in accordance with current Good Manufacturing Practices (cGMP), a batch production record is employed to cross-check the details specified in the BMR. This helps to guarantee that each batch of medication meets the required quality standards and regulatory guidelines, ultimately ensuring the safety and efficacy of the final product.

What is a Batch Production Record?

In contrast to the Batch Manufacturing Records (BMR), which outlines the overall manufacturing process, the Batch Production Record (BPR) offers a comprehensive history of every stage involved in the pharmaceutical manufacturing process for each specific lot or batch of medication produced. Essentially, it serves as a detailed checklist, ensuring that all instructions mentioned in the BMR are meticulously followed by all personnel engaged in the manufacturing process.

The Structure of a Perfect Batch Manufacturing Record

A perfect batch records is a comprehensive and detailed document that serves as a critical tool for ensuring the consistent and quality production of goods in various industries, particularly in pharmaceutical, food, and chemical manufacturing. It provides a step-by-step account of the entire production process, from raw material procurement to the final product's release, and serves as an essential reference for regulatory compliance, quality control, and traceability. Here are the key components that constitute a perfect batch record:

Batch Information: The document begins with essential identification details, such as the batch number, manufacturing date, and expiration date, allowing for easy tracking and reference.

Ingredients and Materials: A complete list of all raw materials and their sources, including their batch numbers and quantities used, is recorded to ensure consistency and traceability.

Equipment and Instrumentation: This section outlines the equipment used in the manufacturing process, including its unique identification, calibration status, and maintenance records, to ensure that production occurs under appropriate conditions.

Standard Operating Procedures (SOPs): The batch record includes detailed SOPs for each manufacturing step, outlining the exact procedures to be followed, ensuring consistency and minimizing the risk of errors.

Process Parameters: Critical process parameters, such as temperature, pressure, and time, are documented to ensure that the process is carried out within specified limits, ensuring product quality and reproducibility.

In-Process Controls: This section details the checks and tests performed during the manufacturing process, ensuring that quality standards are met at each stage.

Sampling and Testing Protocols: The batch record describes the sampling plan and analytical testing methods used to assess the product's quality and compliance with specifications.

Environmental Conditions: For industries sensitive to environmental factors, such as pharmaceuticals, environmental conditions like humidity and cleanliness are documented to maintain product integrity.

Personnel and Training Records: The batch record includes the names and signatures of personnel involved in each step, as well as records of their training and qualifications, ensuring accountability and compliance.

Deviations and Corrective Actions: Any deviations from the standard procedures are documented, along with the corresponding corrective actions taken to rectify the issue and prevent its recurrence.

Review and Approval: The batch record requires a final review and approval by authorized personnel, certifying that the production process meets all the required standards and complies with regulatory guidelines.

Packaging and Labeling Details: If applicable, the record includes information on the packaging materials used and the labeling specifications, ensuring proper identification and traceability of the final product.

Documentation Archiving: A process for secure storage and retention of batch records is outlined to meet regulatory requirements and facilitate future audits.

By incorporating these elements, a perfect batch record not only ensures the quality and consistency of the manufactured products but also plays a vital role in regulatory compliance, providing a reliable and transparent account of the production process for inspection by relevant authorities.

Process XE is web based, flexible and user-friendly software solutions for Business process automation.

This Digital, Smart Manufacturing process automation is principally developed for Pharmaceutical, Life science and Healthcare industries to simplify their manufacturing execution system of various processes such as data capture, batch information exchange, batch production management, data security maintenance, data integrity and report production, ensuring compliance to cGMP requirements.

Manufacturing batch records are documents that provide a detailed record of the production data for a specific batch of products. These records are typically maintained by manufacturers in industries such as pharmaceuticals sectors where quality control is essential. Here’s all you must to know about them.

The pharmaceutical manufacturing business intends to comply with current good manufacturing practice (cGMP) rules and under these regulations, documentation is essential. Batch manufacturing records (BMRs) are a critical component of the entire documentation process.

However, without electronic systems in place, keeping comprehensive and accurate BMRs might be difficult. We'll guide you through different sorts of documents to maintain, why they're necessary, and what each of these include.

What is a Batch?

A batch refers to a specific quantity or group of items or products that are produced or processed together as one unit. In Pharmaceutical manufacturing, a batch is a defined quantity of a product that is produced under similar conditions and within a specific time frame.

For example, a company that is making 10,00,000 pills of a certain medicine would consider the entire 10,00,000-pill run to be single batch. Each pill is probable to be identical to the others in terms of the active element, strength, and other stipulations.

What is a Batch Records?

A batch record is a complete set of documents that outlines all aspects of the manufacturing process for a specific batch. It includes details about ingredients and supplies used, equipment settings, personnel involved, test results, and many more details pertaining to that specific batch of production.

There are several types of batch records and other documents that are typically generated during the manufacturing process in various industries. Here are some common types of batch records:

Batch Production Record (BPR): The BPR is a comprehensive document that provides a detailed account of the manufacturing process for a specific batch. It includes information on raw materials, equipment, procedures, in-process controls, and other relevant details. The BPR serves as a step-by-step guide for operators and ensures consistency and traceability throughout production.

Master Batch Record (MBR): The MBR is a master document that contains all the standardized procedures (SOP’s), work instructions, protocols and specifications for a specific product or formulation. It serves as a reference document for creating batch-specific records. The MBR includes information on raw materials, equipment setup, manufacturing steps, and quality control requirements.

Equipment Logbooks: Equipment logbooks are used to record equipment usage, maintenance activities, calibrations, and cleaning procedures. These records document the history and maintenance of equipment, ensuring that it is properly maintained and functioning optimally.

Raw Material and Component Records: These records provide details about the receipt, testing, usage, and disposal of raw materials and components used in the manufacturing process. They include information on supplier details, batch or lot numbers, quantities received, testing results, and storage conditions.

In-Process Testing and Control Records: These records document the results of in-process testing and quality control checks performed during manufacturing. They include information on tests conducted, acceptance criteria, test results, and any deviations or corrective actions taken. In-process testing ensures that the product meets quality standards and specifications.

Packaging and Labeling Records: Packaging and labeling records capture information about the packaging and labeling processes for each batch. They include details such as packaging materials used, labeling specifications, inspection results, and any deviations or rejections encountered during packaging.

Cleaning Records: Cleaning records document the cleaning procedures performed on equipment and manufacturing areas. They provide evidence that proper cleaning practices were followed to prevent cross-contamination and ensure product safety and quality.

Deviation and Corrective Action Reports: Deviation reports document any deviations from standard procedures or specifications encountered during the manufacturing process. They outline the nature of the deviation, its impact on the product, and the corrective actions taken to address it. These reports ensure that deviations are investigated, documented, and resolved appropriately.

Why are Batch Records Important?

Batch records are important for several reasons in manufacturing industries. Here are the key reasons why batch records hold significance:

It acts as evidence that the manufacturing process complies with cGMP rules. This is essential in showing to regulatory authorities that a firm is functioning, legal and generating safe and effective products.

The production process must be traceable and transparent. This ensures that any faults may be rapidly discovered and fixed before new batches with the same flaws are generated.

These records are used to improve operations by providing information on how long each step takes or which components produce the best outcomes. This data may then be utilized to make modifications as needed.

They also act as a reference for future production, instructing on how to achieve the same results.

What is Included in a Batch Manufacturing Record?

Each Batch Manufacturing Record (BMR), when correctly organized, should include the following sections:

Critical dates

Bill of materials

Manufacturing process

Signatures

Potential hazards

Equipment

Quality control

Maintenance

Electronic batch manufacturing records (EBMRs) are digital versions of paper-based batch records used in the manufacturing industry. They serve as comprehensive documentation of the manufacturing process, capturing crucial information such as batch details, materials used, equipment specifications, manufacturing steps, quality control tests, and operator activities. EBMRs are stored electronically within software solutions, enabling easy access, retrieval, and analysis of batch records.

 To prepare EBMRs using software solutions, follow these steps:

Select the right software solution: Choose electronic batch manufacturing record software that aligns with your organization's needs and regulatory requirements. Consider factors such as functionality, user-friendliness, scalability, regulatory compliance features, and integration capabilities with other systems.

Configure the software: Work with the software vendor like Sarjen Systems  to configure the software according to your specific requirements. This includes setting up data fields, sections, and workflows that mirror your manufacturing processes. Configure the software to capture all necessary information and ensure data integrity. Customize templates and forms: Customize templates and forms within the software to match your organization's specific requirements. Define the structure, layout, and data fields within each section of the EBMR. Incorporate dropdown menus, checkboxes, and data validation rules to facilitate accurate data entry. Establish user roles and permissions: Define user roles and permissions within the software solution. Determine who can access, create, edit, and approve EBMRs. Assign appropriate roles and permissions to ensure data security and compliance. Implement data entry mechanisms: Utilize data entry mechanisms within the software to facilitate accurate and efficient data input. This may include auto-populating fields, barcode scanning, or integrating with other systems to pull relevant data automatically. Implement data validation rules to prevent errors and ensure data accuracy. Enable electronic signatures and approvals: Implement electronic signature and approval functionalities within the software. Authorized personnel can electronically sign off on each section or step of the EBMR, ensuring accountability and compliance. Implement appropriate workflows and approval processes to maintain control and traceability. Conduct user training: Provide comprehensive training to operators and personnel on using the software solution for preparing EBMRs. Train them in system navigation, data entry procedures, validation requirements, and workflows specific to the software. Regularly update the training to incorporate any software updates or changes.