Paper batch records are replaced by an electronic batch recording software. The application provides a complete solution with electronic signatures and audit trails. The electronic batch recording software, includes text, graphics, data, audio, pictorial or other information represented in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system.

The master production record is often referred to as the master batch record. This is the documented and approved set of instructions used to describe how to manufacture a specific product. The required elements of the master batch record are outlined in CFR Title 21 Part 211.186.

The master batch record consists of the recipe, which includes the material requirements, equipment, resource requirements, processing instructions, sampling requirements and various notes regarding batch processing. It is the template that is used repeatedly to manufacture a consistent product. Batch record is a journal that documents all events in the batch lifecycle.

The intent of these records is to assure product uniformity from batch to batch. The master production and control records for each product include written procedures for batch formulation that must be followed on the shop floor, and a complete batch control record to document that each significant step in the manufacture, processing, packing, or holding of the batch is done. These records must be signed and dated by at least one individual, and independently checked, dated, and signed by a second person.

The Master Batch Record (MBR) provides detailed recipe-specific information. It is a complete specification for manufacturing a specific batch size in a specific plant at a specific time. The MBR must provide:

• Name and strength of the product with its description
• Name and weight or measure of each active ingredient
• Complete list of components designated by names or codes sufficiently specific to indicate any special quality characteristics
• Accurate statements of the weight or measure of each component, using the same weight system
• Statement concerning any calculated component excesses
• Statement of theoretical weight or measure at appropriate phases of production processing
• Description of product containers, closures, and packaging materials, including a specimen or copy of each label and all other labeling signed and dated by the individuals responsible for label approval
• Complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations, and precautions to be followed

The MBR contains all the key information in the product recipe, including a complete specification to manufacture the product in a given plant, batch size, and date range. The MBR contains the recipe header information, validity rule data, formula details, routing details, instructions, and material dispensing setup information with the corresponding instructions. It is available for viewing and printing after the recipe validity rule is approved for general use.

Batch control records provide a complete information set related to the production and control of each individual batch. The Control Batch Record (CBR) is updated with actual data as the batch proceeds through its lifecycle. Material usage, dispensing activities, and component weights and measure records provide batch traceability. Product output quantities, lot details, manufacturing nonconformance’s, and quality sampling and test results all add to this batch history. The CBR must provide:

• An accurate reproduction of the appropriate MBR checked for accuracy, dated, and signed
• Documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished, including:

o Start date, stop date, and time stamps for each step
o Identity of specific major equipment and production lines used
o Identification of each batch of component or in-process material used
o Weights and measures of components used in processing
o In-process and laboratory control results
o Inspection of the packaging and labeling area before and after use
o Complete labeling control records, including specimens or copies of all labeling used
o Description of product containers and closure systems
o Quality sampling performed
o Identification of the individuals who performed each task
o Identification of individuals who supervised or checked each significant step in the operation
o Documentation of any investigations for nonconformance
o Results of examinations made for compliance

The electronic CBR is created when the production batch is created. It is updated with actual data as the batch progresses though its life cycle. The CBR contains information such as actual material usages, product output quantities and lot details, manufacturing nonconformance, quality samples and results, label images, instructions, material dispensing setup information with the corresponding instructions, changes in batch and batch step status, operator comments, and all electronic signatures captured during the processing of the batch.

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Pharmaceutical companies are often on the cutting edge in terms of research, but when it comes to manufacturing they are, in many ways “tied up with paper”. Regulatory reporting burdens have transformed historically driven complex procedures and paperwork into electronic batch recording software in order to ensure compliance.

A significant problem with historic paper-based systems is that managing the paperwork takes a great deal of time and effort, and has substantial financial implications on pharmaceutical manufacturing operations. What is needed is a way to eliminate the paperwork and optimize the paperwork process: converting to electronic batch recording software. They will electronically capture and improve workflow activity, replace paper logbooks, keep track of everything that has affected a batch, manage the approval process, and more. Improving workflow management and information flow can dramatically improve quality, throughout and reduce manufacturing costs while satisfying regulatory requirements.

Today’s integrated electronic batch recording software can be applied from one end of the plant floor to the other, including the facility design and day-to-day maintenance. A dynamic electronic batch recording software includes components for the following:

• A security and audit component that addresses 21 CFR Part 11 concerns for electronic records and signatures, and provides audit trail services of all production and operations activities for all modules in the system.

• A content repository that provides controlled access to manufacturing documentation, and gives the company full control of all documents and version information.

• A training and development function that manages training courses and comprehensive training records, including the tracking of GMP training courses, scheduling of personnel, and real-time status confirmation of operator qualifications.

• An equipment tracking function that tracks definable equipment events like usage, cleaning, and maintenance in any manufacturing environment. It should provide paperless calibration records and equipment logbooks with real-time updating.

• A materials management module that provides both work in progress and centralized material management capabilities with container level tracking, material genealogy, and quality controls.

• Configurable electronic workflow that manages and sequences batch records, collects and consolidates all batch data and generates facility performance metrics, graphs and charts.

• An electronic batch recording software provides routing, review and approval of paperless manufacturing records for current good manufacturing practices (cGMP) facilities with complete product and activity genealogy.

• Easy integration to all existing plant floor systems and connectivity to high level applications such as Enterprise Resource Planning.

The opportunities are real and significant. Taking advantage of changes in regulations and leveraging new technology such as electronic batch recording software are making pharmaceutical manufacturing more competitive.

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In a paper-based environment, creating and maintaining master batch records (MBRs) involves huge effort. During production, manual entry is subject to human error, information can be duplicated because of multiple systems, and it takes a lot of time to gather and input all relevant data. The review and reconciliation of this information is also time-consuming.Standardization in the definition of the different manufacturing processes is even more difficult because information is not always centralized. Analysis of the key performance indicators of executed batch records is possible only after the labor-intensive re-entry of data from disparate systems.Electronic batch recording software is a web based solution which automate the process of preparing, releasing and controlling various pharmaceutical manufacturing documents (PMD).

Electronic batch recording software (EBRS) provide you the ability to create standardized processes or sub processes and facilitate their maintenance and validation. These systems provide a readymade templates with automatic versioning for data collection during production. Then the required production parameters are distributed to the relevant systems for execution.

This approach provides error reduction and prevention as well as data centralization for further analysis. Step by step, the solution follows the lifecycle of the batch record, taking advantage of the wide range of out-of-the-box MES functionalities, such as order management, tracking and tracing of materials, and equipment management. Dynamic electronic batch recording software further allow you to record the batch recipes. The recipe information is available with ease and designing MBR’s is greatly simplified.

The biggest USP of our solution is its interoperability with any legacy ERP, training management system (TMS), quality management, LIMS and many more. Its ability to integrate with other systems like legacy ERP systems, quality management system, training management system and document management system allow you to get real time production floor informations like inventory status, deviation, most current SOP’s and many more. With electronic batch recording software organizations can now reduce project complexity, lowering infrastructure maintenance costs, reaching time to benefits much faster, and lowering deployment risks significantly.

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Pharmaceutical, Life science and Health Care are few of the industries need to operate under continuous pressure to remain competitive while meeting the stringent regulatory manufacturing requirements. These manufacturing requirements include simple electronic record keeping to complex data assuring consistently the reliability of the manufacturing processes, equipment testing, peoples training, raw material quality, sampling plans, root cause-analysis, products deviations etc. The continuous up gradation of Manufacturing Execution System (MES) in Pharma industry in a row is a testimonial on its own.

MSE helps Pharma companies comply with 21CFR Part 11 electronic signatures, FDA audits, validation and confirms to US FDA cGMP requirements. Manufacturing Execution System (MES) enable the Pharmaceutical industry to reduce production cost and increase compliance with regulatory requirements significantly. This is due to the capability of an MES to optimize business processes in the production supply chain, improve product quality and ensure the safety of manufacturing processes.

A Manufacturing Execution System is an electronic interface between personnel, equipment automation, orders, logistics, equipment and processing instructions (batch records). The MES mediates between business administration (covering core functions such as sales and production planning or controlling) and the automation of the production process.

However, despite the importance of such a structured approach it cannot be denied that the decision for or against the benefits of an MES system frequently involve factors that are not measurable in economic terms.

Goals to be achieved by the implementation of an MES system are:

• Best suitable for controlling workflows, improving process safety, reliability and recognition of deviations at an early stage
• Reduction of operating costs due to a high level of integration and thus prevention of isolated solutions
• Rapid access to current data: management based on up-to-the-minute information for all critical business cases
• Visibility and transparency throughout the entire production process
• Reduction of administrative work for maintaining manufacturing documents
• Immediate documentation of process steps
• Reduction of storage costs due to reduced lead times (WIP)
• Creating and approving master batch records
• Reducing the number of lost batches
• Complete 21 CFR Part 11 compliance

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Pharmaceutical and Life science are few of the early adopters of information technology for quality compliance, process optimization, reducing errors, involving the supply chain and increasing profit.

According to a report published by Gartner in 2010, there is a huge need of integrated IT manufacturing technologies, supported by the fact that the increase in corporate IT budgets from 19 % in 2007 to 25% in 2015. The Pharmaceutical industry has adopted this strategic initiative of integrating manufacturing IT and is benefiting through improved quality and production efficiencies. The key to a successful MES implementation is applying the right level of IT to maximize Return on Investment (ROI).

Role of information technology (IT) in manufacturing

IT is playing a major role to streamline, automate and expedite various process involves at all levels of manufacturing operations. Technologies like manufacturing execution system (MES) has enabled IT in manufacturing to shift from being data centric to process centric. By not restricting technology at the manufacturing operations management level, activities such as Electronic Batch Records (EBR), real-time reporting, Enterprise Resource Planning (ERP) and equipment integration all have allowed pharmaceutical companies to maximize return on IT investment, improve quality, provide a platform for continuous improvement and ultimately increase profits.

Role of manufacturing execution system (MES) in Pharma

Manufacturing Execution System (MES) as a technology has been successfully deployed within the pharmaceutical industry since the Food and Drug Administration (FDA) declared the final 21 Part 11 regulations on 21 March 1997. According to this electronic records and electronic signatures are equivalent to handwritten records and signature. In these 16 years technologies associated with Manufacturing Execution System (MES) has upgraded lot and became best practice in Pharma industry.

The amount of IT included to an MES project is dependent on the customers’ business need. The basic version of Manufacturing Execution System (MES) should include replacement of paper batch records with an EBR, automated material weigh & dispense and integration with legacy ERP system to achieve optimization in inventory and production. Manufacturing Execution System (MES) can also be integrated at the factory level, for gaining complete control over the entire enterprise. This level of control helps ensure ‘right-first-time’ manufacturing and total enterprise visibility. The MES acts as a central system with effective integrations with other manufacturing systems and departments such as operations, quality, maintenance and inventory control. The MES not only facilitates regulatory compliance, but also supports drug makers to ensure high quality in their manufacturing processes.p>

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Every phase of research and development, manufacturing and quality control and product distribution must be thoroughly documented and reviewed at every phase. Maintenance of these records is vital to the day-to-day operation of every pharmaceutical company manufacturing and marketing drugs and is necessary for establishing a detailed audit trial for every lot of product manufactured. Pharmaceutical companies have traditionally used paper to maintain batch records also known as Master Production Control Records (MPCR). Many companies have realized that the burden of paperwork can be lessened with the use of Electronic Batch Recording Software.

Accountability is an important component of quality management and FDA compliance for Pharmaceutical companies. Electronic Batch Recording Software enhance transparency, productivity, control and accountability by providing proof of  proper handling for every step in the production of each batch of a drug product. In addition, manufacturers that execute and document batch records electronically must comply with 21 CFR Part 11 requirements.

Benefits comes with Electronic Batch Recording Software:

  • Reduce time, cost and effort
  • Bring end-to-end transparency
  • Enhance accuracy and consistency of batch records
  • Speed up product changes and new product introduction
  • Speed up information distribution and collaboration
  • Help to identify loopholes, mistakes and errors
  • Reducing the no. of lost batches
  • Minimize reworks and investigation
  • Access trending, productivity and metrics instantly
  • Reduce warehouse inventories

This transition from paper based batch records to electronic batch records can be challenging.  Employee pushback, system validation and incomplete and inadequate identification of requirements can put your systems and processes at a higher risk of failure. But the competitive advantages and benefits offered by the use of Electronic Batch Records in modern time is real, significant and too compelling to ignore. When properly implemented and integrated with ERP system, electronic batch recording software can help you to upgrade the profitability and maintain a competitive advantage.

 

 

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Pharmaceutical industry is one of the industry needs to comply with stringent regulatory and quality guidelines to reassure the superior quality of medicines they are delivering for the wellbeing of human health. Effective management of batch recording documents like Master Production Control Record (MPCR) and Batch Production Control Record (BPCR) is very important part of Good Manufacturing Practices (GMP). But slowly and steadily the Pharmaceutical industry is shifting its focus towards process automation to reduce time, cost and effort required in traditional methods. Hence following Good Automated Manufacturing Practices (GAMP) to streamline, integrate and automate the various processes like management of batch records, training management, document management, quality management, audit management, CAPA management and many more. Hence the demand for Electronic Batch Recording Software is very high.

Electronic Batch Recoding Software reduce scrap, batch paperwork errors and redundant checks and bring flexibility to model and change the complex processes based on master batch records and the real-time feedback needed to quickly identify and resolve batch record issues that inhibit process and product improvement.

Modern Electronic Batch Recording Software organize, automate, control your batch manufacturing records which includes processes and equipment used, quality data, test results, non-conformances, materials consumed, process yield, operator signatures, and dates and times and fully 21 CFR Part 11 compliant.

Electronic Batch Recoding Software salient features:

  • Web based platform
  • Step control with step-based work instructions
  • Qualification checks on all equipment and materials used
  • Automated data capture from equipment and devices
  • Automated calculations
  • Forced authentication
  • Forced sequencing
  • Electronic signatures
  • Compliance flags indicating non-conforming data values
  • Audit trails with operator identification and date/time stamp
  • Trending reports and batch certificates
  • Smooth integration with any external systems such as DMS, TMS and ERP

Pharmaceutical, Life Science and medical device manufactures are challenged daily to secure and sustain a profitable, growing business despite rigorous regulations and oversight, global competition and demand for customized products. With Electronic Batch Recording Software they can reduce their operating and compliance cost, improve quality and consistency and shorten time-to-volume product cycles.

 

 

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As a Pharmaceutical company, your proof of success is found in the document records that you keep. Documentation is your proof that your product and services are produced in compliance with cGMP regulations and your company’s operating procedure and standards. That’s why it’s said that any Pharmaceutical organization is producing two things drugs and paper.

Hence developing paper free environment is in demand. According to FDA’s cGMP (Current Good Manufacturing Practices) Electronic Batch Recording Software demonstrate accountability by providing proof of proper handling for every step in the production of each batch of a drug product. In addition, manufacturers that execute and document batch records electronically must comply with 21 CFR Part 11 requirements.

Complexities associated in manually managing the batch records:

  • Slow, cumbersome and error prone
  • Taking more time to prepare and review
  • Incorrect data entry
  • Failure to recognize out-of-specification entries
  • Missing signatures
  • Filling out incorrect forms
  • Sending forms to the wrong recipient
  • Forms left incomplete
  • Increase instance of lost batches

In today’s cut-throat competitive world, success depend on just in time (JIT)delivery and these above mentioned complexities are creating obstacles to achieve JIT. Hence Pharmaceutical industry have realized the importance of having a dynamic Electronic Batch Recording Software.

Web based Electronic Batch Recording Software is an easy to deploy solution for mid and small size Pharma manufacturers because of quick hassle free implementation and the low cost of ownership. Electronic Batch Recording Software (EBR) capabilities:

  • On-screen access to current batch record
  • Step control with step-based work instructions
  • Qualification checks on all equipment and materials used
  • Automated data capture from equipment and devices
  • Real-time limit checking
  • Automated calculations
  • Forced authentication
  • Forced sequencing
  • Electronic signatures
  • Data review dashboard for “review by exception”
  • Compliance flags indicating non-conforming data values
  • Audit trails with operator identification and date/time stamp
  • Trending reports and batch certificates
  • Export data to external systems such as MES and ERP

How Electronic Batch Recording Software help manufacturing operators and managers as well as QA data reviewers:

  • Standardize and efficient document flow
  • Centrally and readily retrievable documents
  • Save time with right first time data collection
  • Minimize reworks and investigations
  • Reduce overall cycle times to release products
  • Reduce warehouse inventories
  • Maintain consistency with use of most current version of Batch Records throughout organization

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This transition journey of Pharmaceutical industry towards electronic processes like- electronic batch recording software (EBR), supply chain management software, quality management software, distribution software and many more, would be incomplete without first mentioning the International Conference on Harmonization (ICH). ICH was formed in 1989 to bring uniformity and standardization in the formats called Common Technical Document(CTD) required for new drug applications in US, Europe and Japan because at that time the majority of new medicines were developed by these countries. ICH not only defined the fix format for CTD, but in 1994, started developing the Electronic Standards for the Transfer of Regulatory Information(ESTRI) to meet the requirements of both, Pharmaceutical companies and regulatory agencies.

This planted the seed of the FDA’s effort to encourage pharmaceutical companies to abandon their manual, paper-based processes in favor of modern technology.

Any Pharmaceutical organization is producing two things paper and drugs. To mitigate enormous paper work, in August 2002, the FDA launched a 2-year initiative, titled Pharmaceutical cGMP for the 21st Century: A risk-based approach (also known Pharmaceutical cGMP initiative). The very first objective among the various objectives put forward, was “to encourage the adoption of new technological advances by the Pharmaceutical Industry.

In these few years the market dynamics has changed a lot due to increased competition, globalization and digitization, arrival of new entrants, shortening patent cycle, merger and acquitions. This triggers the Pharmaceutical industry to bring process automation to streamline, integrate and simplify various processes like electronic batch recording (EBR), ERP, SCM, SFA, CRM and many more.

Advantages to Pharmaceutical Companies of Automated Processes

Process automation drastically reduce errors and shorten the time required to develop new products, as well as product submissions. For pharmaceutical companies, accountability is an important component of quality management and FDA compliance. Electronic batch recording software(EBR), required by FDA’s Current Good Manufacturing Practice (CGMP) regulations, demonstrate accountability by providing proof of proper handling for every step in the production of each batch of a drug product.

In fact, with a web-based delivery system, automated systems can route data from clinical trials directly to the appropriate files, allowing the submission to be developed as the data come in. This provides companies more time at the end of the clinical trial to ensure that the submission is clear, concise and correct as per the FDA guidelines. This plays a significant role in submissions timely approval.

The other benefits are:

  • Enhanced transparency, security, accessibility and redundancy.
  • Reduce time, cost and effort
  • Improved workflows, tighter accountability, and better management of resources
  • Enhanced cross-functional team communication and collaboration
  • Easy to store data, copy, revise and retrieve
  • Easy to conduct regular internal quality audits to ensure compliance
  • External team members, such as principal investigators, contracted providers, hospitals, vendors, service providers and partners can promptly communicate problems
  • Providing instant access to the most current data and information available
  • With web-based system, management— even when traveling—can access and follow the development of products, as well as participate in the approval and sign off process
  • Real time insights of all company activities and developments, 24-hours a day, to keep management well informed

These are the triggering points responsible for this transition of Pharmaceutical industry towards electronic processes.

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According to good manufacturing practices (GMP) your each process should be documented properly to establish evidence that your process, operated within pre-established parameters to prove that the produced drug and dietary product meeting its pre-determined specifications and quality attributes.   Before establishing the importance of creating and maintaining batch manufacturing records, let’s understand what batch manufacturing records are:

Batch manufacturing record is a written document of the batch, prepared during pharmaceutical manufacturing process. It contains actual data and step by step process for manufacturing each batch.

Batch manufacturing record is like a proof that batches were properly made and checked by quality control personnel. This ensures that proper ingredients are added and each processing step is completed according to the SOP and also ensures uniformity in finished product in each batch.

A good batch manufacturing record format should include following parts:

1.Batch records

Batch records include master production and control records (MPCR) and batch production and control records (BPCR). MPCR includes name of the product, name and codes of API, batch formula, batch or code no., identification of equipment, line and location used, start and finishing date with processing and packaging.

BPCR is the replica of MPCR carries factual information like material usage, dispensing activities, component weights , product output quantities, lot details, manufacturing nonconformance’s, and quality sampling and test results all add to this batch history.

  2. Bill of Material

Complete list of raw materials needed for manufacturing the finished product with required quantity and weight.

3.General instruction for manufacturing

Clear instructions related to safety and health of operators, should be followed during the manufacturing process.

4.Equipment cleaning record

Checklist for the cleaning of all equipments used in the manufacturing of the batch with the previous product, batch and date of cleaning.

  5.Yield

Yield of the batch should be calculated at the end of every stage to calculate the process loss. Final yield should be calculated at the end of the manufacturing that should not be less than 99.00%.

6.Abbreviations

List of the abbreviations used in the batch manufacturing records (BMR)  should be made to understand easily.

7.History of Chances

At the last, list of all the changes occurred including the revision number and the date of change.

Batch manufacturing record is like a back bone in the current good manufacturing practices (cGMP), and very essential to stay compliance.

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