Electronic Batch Records Market: Global Industry Analysis and Opportunity Assessment 2016-2026

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SOURCE: http://www.futuremarketinsights.com/reports/electronic-batch-records-market

The introduction of Electronic batch records will optimize the work by reducing the production life cycles, improve accuracy and consistency. Electronic batch record is a compilation of information, data and document into a single record. It provides history of the batch, quality information, operator interactions etc. Automation of batch records can also bring down the cost as it offers paperless solutions by replacing paper batch records and also keeping track of the automated batch history is easier through the online environment. Manual maintained of records can impact the whole production quality and slight changes in production sequence can even detent product from quarantine till the review was completed. Since only one copy or master copy of manual records exist coordination between different departments become difficult. The advantages offered by Electronic batch records are manifold like automated calculations, electronic signatures, save time, online access, easier audit trails etc.

Generally pharmaceutical companies prefer in using Electronic batch records (EBR) but now many of the industries started using the electronic batch records as it reduce cost, risk and possibility of human errors.

Market drivers & challenges:

Many industries are planning to shift to automation thereby reducing the overall human resource cost which is a major driver for the market. The need to improve workflow and efficiency of industries was also a major driver for electronic batch records market. With the evolution of information technology and adoption of ERPs along with EBR was also a major driver for electronic batch records market. Challenges of electronic batch record market are fraud detection and need for adequate testing to be done before implementing. Compliance with established government standards and regulations is another major challenge.  Another major challenge was handling multiple manufacturing styles as every industry has own characteristic data models.

Market Segmentation:

Global electronic batch records market is classified into end-user and region. On the basis of the end user, the global electronics batch record market is segmented into pharmaceuticals, Life sciences, automobile and others.

On basis of region global electronics batch records market is segmented into North America, Latin America, Eastern Europe, Western Europe, Asia Pacific Excluding Japan (APEJ), Japan and the Middle East and Africa (MEA).

Key Market Players:

The major players active in electronic batch records market are Rockwell Automation, Honeywell international, Emerson Electric Co, ABB, Schneider Electric SE, Siemens AG, Accelyrs, SAP SE, etc.

The report covers exhaustive analysis on:

  • Global Electronic Batch Records market segments
  • Global Electronic Batch Records market dynamics
  • Historical Actual Market Size, 2014 – 2015
  • Global Electronic Batch Records market size & forecast 2016 to 2026
  • Ecosystem analysis
  • Global Electronic Batch Records market current trends/issues/challenges
  • Competition & Companies involved technology
  • Value Chain
  • Global Electronic Batch Records market drivers and restraints

 

The report is a compilation of first-hand information, qualitative and quantitative assessment by industry analysts, inputs from industry experts and industry participants across the value chain. The report provides in-depth analysis of parent market trends, macro-economic indicators and governing factors along with market attractiveness as per segments. The report also maps the qualitative impact of various market factors on market segments and geographies.

Report Highlights:

  • Detailed overview of parent market
  • Changing market dynamics of the industry
  • In-depth market segmentation
  • Historical, current and projected market size in terms of value
  • Recent industry trends and developments
  • Competitive landscape
  • Strategies of key players and product offerings
  • Potential and niche segments/regions exhibiting promising growth
  • A neutral perspective towards market performance
  • Must-have information for market players to sustain and enhance their market footprint.

Electronic Batch Record System

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SOURCE: http://www.pharmacim.fr/Electronic-Batch-Record-System.html

Time decrease for batch liberation
According to the master sheet, PHARMACIM® DLE software centralyses data collected during the manufacturing process of the medicine. The electronic batch record system collects and gives information for control and validation from the launching of the manufacturing order to the end of the inspection storage year.

 

 

Modeling

PHARMACIM® BPM has a process parameterizing graphic tool for an easy customization.
Accessible to users without any computing competences, the graphic creation allows a modeling of all manufacturing unit processes.
Each step of the process is built with elements that can have access to information system components of the production unit :

  • M.E.S. (Manufacturing Execution System)
  • L.I.M.S. (Laboratory Information Management System)
  • E.R.P. (Enterprise Resource Planning)
  • Monitoring systems
  • automated systems
  • Supervisors

 

Data adquisition and collection



PHARMACIM® enables you to recover all the information coming from miscellaneous applications (MES, ERP…) or manufacturing systems (automation, measuring instruments…).
Strengthened by a 30-year-old expertise in pharmaceutical production systems, COURBON, has the required skills to implement material and software solutions so as to collect data. Our teams have already set up :

  • interfaces with ERP systems : SAP/R3, Protean, Qualiac, MS Dynamics, Prodig, Minos, …
  • applications with industrial systems : Siemens, Rockwell, Emerson, Schneider, Intellution,…

Implementation and monitoring

Pharmacim® pilotes all processes, from the launching of the manufacturing order to the final validation and recording.
For each step of a process, the software collects, distributes, exchanges and storages data with other information system components.
Pharmacim® has all required tools to control the whole process and/or a specific step of a process.

Dynamic Piloting

Through a dynamic screen, each user has, a real time list of the operations for which an action is expected for the process continuation.
The user has also an access to the documentation without waiting for its final constitution.

Optimisation of validation channels
If the process is stopped too much time, PHARMACIM is able to orientate the action to an other user

Variation management

Every critical step generates a real time analysis of its managed data, and a variation management with respect to the target. The software creates warnings and pilotes dedicated validation channels.

Marking & serialization



Facing notably counterfeiting, laboratories are asked by authorities to take measures.
Manufacturers have to implement traceability systems with the aim to enable product certification in easiest and quickest conditions possible. The aim is to ensure full traceability of products to dispensaries.

Standards



Several norms will soon be effective such as :

  • in 2009 : the Turkish regulation imposes a serialization, Datamatric identification and a full filiation,
  • in 2011 : the French regulation imposes a Datamatrix identification according to ISO/CEI 16022 norms and EAN.UCC 128 syntaxis,
  • in 2011 : the Californian regulation imposes a serialization, Datamatrix identification and a full filiation,
  • in 2012 : the Canadian regulation impozes a Datamatrix identification.

 

 

 

 

 

 

 

 

 

 

 

Electronic Batch Record System (EBR)

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SOURCE: https://software.rescop.com/electronic-batch-records/

Objective of the Electronic Batch Record System (RC-EBR)

Time and costs as well as errors and deviations can be reduced with the Electronic Batch Record System. Manual systems can be replaced by an Electronic Batch Record System to maintain your batch records in an automatic and controlled manner.

The Rescop Electronic Batch Record System stores, manages, processes and publishes batch record documentation, in accordance with GMP regulations.

Main functionalities of the Electronic Batch Record System (RC-EBR)

  • Creation and maintenance of document content and generation of .pdf versions
  • Content creation by either uploading of documents with common file types or based on templates, forms and protocols
  • Storage, review and approval of documentation
  • Publish and search for documentation
  • Configure document (sub)types and corresponding execution, verification, review and approval workflows
  • Configurable roles and rights
  • User interface depending on roles and rights
  • Version Management
  • Schedule, trigger and register manufacturing execution
  • Possibility to print authentic copies
  • Management Reporting

Benefits of the Electronic Batch Record System (RC-EBR)

The batch record handling is GMP compliant. The Rescop Electronic Batch Record System provides a standardized and efficient document workflow and documentation is centrally and readily retrievable.
The manual system can be replaced by paperless manufacturing execution and compliance. The Rescop Electronic Batch Record System works on personal computers, laptops, tablets and smart phones.
Electronic Batch Record System

Electronic Batch Record System workflow

 

GMP Standard Operating Procedures

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indexelement269

Part 1 – GMP Standard Operating Procedures
 
1.1 – Validation Procedures SOPs
  1.1.1 – Process/Cleaning/Method Validation Procedures
Here you can download samples of the procedures, click on title
 
This procedure describes general validation concepts and practices, the way processes and systems must be qualified/validated and the confirmatory documentation required. Here you will find the philosophy of validation, responsibilities, validation approaches of design qualification, installation qualification, operational qualification, performance qualification, cleaning validation, method validation, computer validation, general and specific criteria of validation, validation documentation and change control, validation reporting, guidelines of validation acceptance criteria.
 
This procedure contains step by step instruction on initiation of revalidation categories, changes that warrant revalidation programs, basic steps of revalidation procedure, revalidation activities and specific responsibilities, revalidation protocols, revalidation timing, equipment checklist, revalidation discrepancy procedure, release of revalidated equipment, preparation of the revalidation reporting file.
 
This procedure provides a guideline for a validation Technician on the characteristics that must be considered during the validation of an analytical testing procedure. The procedures set out in this SOP apply to qualitative and quantitative analytical methods which are used to test finished goods, in-process material, excipients and raw materials in support of registration documentation and cleaning validations and management responsibilities towards completing those method validation tasks.
 
This SOP describes the types of cleaning process and cleaning agents of process equipments and their validation, complete instruction on cleaning validation procedure, calculation of acceptance limits for rinse and swab samples, calculation of acceptance limits for swabs, analytical method validation for cleaning, cleaning validation test protocols and change control for revalidation.
 
This procedure describes the validation practices for laboratory instrument/equipment to be validated or calibrated and the confirmatory documentation required showing that the instrument/equipment is capable and operating effectively for its intended purpose. This procedure has practical instruction on Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) to be performed by the qualified equipment service technician in the presence of the laboratory staff with reference to the instrument/equipment manual.
 
This procedure describes in detail the procedures for the procurement of equipment, incorporating standardized demand specifications and Installation Qualification documentation, to ensure that equipment procured complies with in-house requirements and standards and conform to Good Engineering Practice, to detail the general procedure to be followed regarding the reporting of Factory and Site Acceptance Tests, to detail the manner by which the equipment Installation Qualification is documented.
 
The purpose of this SOP is to define common procedures to follow when organizing Trials/Evaluation Studies for the purpose of process improvement, equipment capability and validation studies.  It defines the responsibilities within the trial process and documents that need to be considered when preparing the Trial documentation to ensure that the trial meets GMP and where applicable validation requirements. This SOP defines the procedures for conducting in house stand-alone trials on systems, processes and equipment. There can be an overlap between a trial and validation in that Trial documentation may form part of a latter process validation, (i.e. concurrent and prospective validation) and qualifications (OQ, PQ).
 
This SOP defines the procedure for cleaning, passivating and derouging the purified water system at a GMP site. The procedure may be performed after construction, following invasive repair or following maintenance.  The various parts of this procedure are to be performed as necessary.  Parts of this procedure may not always be executed at the same time (e.g., The storage tank for the purified water may be cleaned and passivated without cleaning and passivating the ringmain).
 
The scope of this procedure includes the validation of 1. Sampling methods used to determine residues after cleaning of manufacturing and packaging equipment used for the production of commercial product. 2. Analytical methods to detect residue after cleaning of manufacturing and packaging equipment used for the production of commercial product.
 
The objective of this Standard Operating Procedure is to describe the actions required to handle deviations encountered during validation studies.
 
The Validation Master Plan is designed to provide a planned and systematic framework within which all validation activities will occur.  This document will also ensure that the manufacturing facilities comply with the local applicable GMP regulations and site requirements for validation.
 
This policy applies to all production process used for manufacture of commercial drug products or in-process materials for commercial drug products. Excluded form this scope is filling of tablets and capsules and labelling and secondary packaging of all drug products.
 
This validation guideline describes the approach and methods which will be used for the qualification of equipment at a GMP manufacturing site.  The aim of this validation guideline is to provide a clear statement of the scope, validation approach and testing requirements for the validation of the equipment that is involved, directly or indirectly, in the manufacturing and testing processes.  The plan pertains to the qualification of processes and laboratory equipment.
 
The aim of this validation guideline is to provide a clear statement of the scope, validation approach and testing required for the validation of the facilities and utilities that are involved, directly or indirectly, in the manufacturing processes at a GMP site.
 
This procedure is applicable to validation sampling and testing for all new product introductions, and when changes to manufacturing procedures, manufacturing equipment, or raw materials warrant process validation.  Each situation will be assessed on an individual basis, and the appropriate sections of this document shall be applied.
 
The purpose of this Standard Operating Procedure is to describe the evaluation process for a new, or a change of, source raw material used to manufacture Drug Products at the GMP manufacturing facility. The procedure will provide a documented means of assuring that the changes are identified, documented, authorised and implemented taking due account of quality, regulatory and validation factors as well as environmental and safety issues.
 
To outline the requirements for preparation, review, approval and execution of process validation protocols and preparation, review and approval of process validation reports for semi solid and solid dose products manufactured at a GMP Manufacturing Site.
 
The purpose of cleaning validation is to provide documented evidence that the cleaning process is effective in removing residues of a product, cleaning agent or microbial contamination to below a predetermined level. The objective of this guideline is to describe the approach and methods, which will be used to validate cleaning and sanitation procedures involved in GMP processes employed in GMP Site Manufacturing facilities.
 
The purpose of the VPP is to, 1. Establish a plan for the overall validation effort and validation lifecycle to describe the extent of the validation effort required to meet Site and regulatory requirements. 2. Define Validation Deliverables for the computer system. 3. Provide a standardized format for Validation Project Plans.
 
This procedure serves as a guideline for the development of a User Requirement Specification (URS) document and Functional Requirement Specification (FRS) document for a computer system at a GMP manufacturing facility.
 
This SOP is to provide guidelines to ensure that materials that are brought into the manufacturing plant for trial purposes and not recorded into Material database are still accompanied by documentation so that their usage is recorded and reconciled and equipment that they contact is also recorded.
 
This SOP covers the validated Direct Impact Systems (including the facilities, utilities, equipment, process control systems, computer / automation systems) and Processes in production, storage and distribution of drug products in a GMP site.
 
The purpose of this SOP is to define common procedures to be followed when organising Trials, including allocation of responsibility to coordinate the Trial and suggestion of what needs to be considered when preparing the Trial documentation.

Electronic Batch Records: A Story of Workflow Improvement

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SOURCE: http://www.automationworld.com/batch-manufacturing/electronic-batch-records-story-workflow-improvement

The story of electronic batch records began as a way to streamline regulatory compliance. Now these records can also help users produce higher-quality batches and ensure optimal workflow.

Once upon a time, electronic batch records (EBRs) were simply a means for helping pharmaceutical companies automate away the mountains of paperwork required for maintaining production batch records. But the story didn’t end there.

Consider, for example, Baxter S.A. The diversified healthcare company is among a growing group of global manufacturers that are also using the technology to develop, implement and even enforce optimal workflows.

This new narrative began to take shape in industry in the ‘90s when the U.S. Food and Drug Administration (FDA) issued new 21 CFR Part 11 compliance standards. The regulation’s promotion of good manufacturing practices (GMPs) permitted production facilities to use EBRs to document each step in the production, packaging and handling of every batch of their products. Since then, automation vendors have shown users how automating batch records can also help them improve their workflows and efficiencies.

A case in point is Baxter’s production facility in Lessines, Belgium, where the company makes intravenously administered nutriments for patients in healthcare facilities. A new automated line there prepares solutions of glucose and amino acids and puts them into storage bags with help from Wonderware software from Schneider Electric. Not only does the software help the line conform to governmental compliance regulations in the U.S. and Europe, but it also helped Baxter double production, streamline operations and manage costs.

“EBRs are traditionally generated by MES [manufacturing execution system] or batch-management applications,” explains Michael Schwarz, product marketing manager for MES, EMI, workflow and batch software at Schneider Electric. Not only do MES and batch-management software help in managing process execution, but they also capture event execution and data records through automated means, by enforcing manual data entry, or both.

“In doing so, these software systems have significantly reduced the manual activities required to capture batch data or generate electronic reports and production documents,” says Schwarz.

At Lessines, these benefits came through Schneider Electric’s Wonderware InBatch software, which oversees batch execution, maintains equipment histories and material genealogies, and generates the necessary reports. Besides complying with the FDA’s 21 CFR Part 11 regulations, the software also conforms to the S88 batch process control standard developed by the International Society of Automation (ISA). In addition, the software relies on the World Batch Forum’s batch markup language standards to create XML (extensible markup language) documents for recipe-version histories and comparisons.

Because InBatch runs on the Wonderware System Platform, it has access to a process historian that archives production histories, compresses data, and auto-configures historical archives. Once configured, the Wonderware Historian and the vendor’s eSignature management applications ensure that the new automated line complies with the FDA’s regulations and adheres to the company’s optimal workflows. The data also gives decision-makers the historical information that they need for continuous-improvement initiatives.

Another outcome of running InBatch on the object-oriented System Platform is that Baxter was able to design a custom set of ISA S88-compliant objects representing such things as valves, sensors, weigh scales and variable-speed drives. Stored in the system’s library, these objects can be maintained from a central location and reused for future projects. Any change to an object can be linked to all instances within the system and applied only to those instances specified by the engineering staff. This ability to apply changes selectively permits the staff to validate modifications before making a global deployment.

Looking beyond the process

Documenting batch production fully, however, often requires actions beyond process automation itself. Examples include tracking quality-conformance data, compiling these records into product certificates, and documenting sign-off procedures.

“Coordinating the timely execution of quality-related activities at the end of a batch, assembling the data for documentation, and getting sign-offsare beyond the scope of the production or quality system domain,” notes Schwarz. “They still rely heavily on human collaboration.”

To oversee these interactions, automation vendors have established links to business-process and workflow-management software. “This helps to coordinate and document the activities and data flows between people and systems used in production, quality, asset management and business domains,” says Schwarz.

Schneider Electric, for example, has integrated Wonderware Skelta BPM workflow software with its Wonderware System Platform to automate human-centric workflows, as well as the processes with links to applications like enterprise resource planning (ERP) systems and SharePoint collaboration tools.

“An end-of-batch event, for example, could automatically present a sequence of quality-related activities as workflow notifications or work tasks, which in turn could initiate the required data flows or sign-off processes,” says Schwarz.

He adds that the software can replace paperwork with electronic work instructions and records even in semi-automated production environments that are still run in an operator-centric fashion. “This enables similar collaboration with quality or business functions as well as the automation of product, quality and document sign-off and approval processes,” he says.

Just by reducing manual activities in these instances, electronic workflow management can expedite the execution of EBR processes, while improving their definitions, documentation and consistency in execution.

Incorporation into ERP

Such uses of EBRs evolved alongside information technology. As capabilities multiplied and costs fell, EBRs moved well beyond the initial practice of simply scanning batch production records and storing them in an electronic repository.

Meanwhile, “as ERP-system adoption became more prevalent, EBR capabilities started to appear in stand-alone systems and in pharma-specific ERP systems,” recounts Reddy Beeram, director of product development at Edgewater Fullscope, an ERP consulting firm and Microsoft Dynamics partner. “A more recent evolution of EBR involves capturing batch production record information at the source and as the batch production progresses, from release to completion.”

Besides automating the collection and documentation of process workflows as they happen, the latest ERP systems have extended EBR capability to MESs and other classes of applications that affect batch records: product lifecycle management (PLM), laboratory information management systems (LIMS), and corrective actions and preventive actions (CAPA) software.

These developments have not been without their problems, however. Neither conventional “administrative” ERP systems nor complex niche MESs were dealing with EBRs in an efficient manner, observes Colin Masson, global industry director for manufacturing at Microsoft Business Solutions. “Many MES architectures are inflexible and don’t scale for multi-site rollouts, which is a must in today’s global, connected industry,” he says. Likewise, administrative ERP systems are not really designed for the demands imposed by the realities of manufacturing and need a fair measure of customization.

“Especially when customized, these traditional ERP and MES architectures could not cope with the constant reconfiguration and requirements to support Lean and Six Sigma initiatives,” adds Masson. They also have difficulty handling multiple manufacturing styles that have their own characteristic data models. “For example, EBRs often need to feed and provide traceability from batches through to discrete manufacturing ‘pill and pack’ operations. This is a challenge for traditional systems.”

Meeting these challenges is usually expensive and requires engineering skills that are in short supply. Because it exceeds the automation threshold that keeps many batch manufacturers from using them, they continue using manual processes based upon paper records.

To overcome the threshold for conventional MES applications and administrative ERP systems, some software vendors are offering what they call “operations ERP.” An example is Microsoft Dynamics AX 2012. “Its architecture is built to support high-fidelity, quality, compliant manufacturing,” says Masson. It is extensible and supports open web services to promote integration with mobile devices and automated data-collection devices.

The power of connectivity

This movement to make EBRs available to ERP systems and other business applications is really a manifestation of a more widespread trend—the trend everywhere toward greater connectivity. In the batch industries, the result is that more users are asking for the ability to access recipe and other information from a variety of places, reports Eric Heavin, advanced solutions and services sales consultant at Yokogawa Corp. of America.

“These users want links to workflows,” Heavin says, “so that, if they receive an order that needs to be filled by a particular day, it is sent to the DCS [distributed control system], scheduled, executed and recorded in an historical database; and results post back to the ERP system.”

Users have a raft of reasons for wanting this ability. One is to transfer data accurately throughout the organization in real time. “There is a lot of potential for error in the manual recording and transfer of data,” notes Heavin. Another reason is traceability. “Some users might keep track of it for liability reasons. They may even have to keep data for a certain number of years for their customers.”

Others simply want the ability to mine the vast amounts of historical data that is now cost-effective to collect and store for long periods of time. An example of this can be seen in a job Yokogawa did recently to help a company in the oil and gas industry improve the tracking of its products after manufacturing.

“Engineers there were trying to track the different grades going to various locations and produce a monthly reconciliation report,” recalls Heavin. “They did it by taking the pertinent data from each historical production or transaction record.”

Through an analysis, they were able to determine where the mislabeling of a product occurred and to reconcile actual product movements and transactions against the inventories in their accounting system.

In this case, the historical records were taken from a structured query language (SQL) database that had been populated over time with data collected automatically from the process. Access to a uniform set of highly granular data makes it possible for the company’s engineers to conduct various kinds of studies. Not only did they have the flexibility to track the movement of products throughout the supply and delivery chains, but they also could look at what a particular tank, for example, was doing on any day in the past.

Although the evolution of information technology has made keeping vast amounts of data for these purposes cheap and practical, Heavin warns users to store only the necessary information to avoid being overwhelmed with superfluous data. “That’s critical for presenting only pertinent data to personnel, so they can make decisions about whether a procedure or formula needs adjusting to generate improvements,” he says.

Batch documentation – Pharmaceutical Manufacturing

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SOURCE: http://www.gmpua.com/World/Manu/15/c.htm

Here you will find answers to the following questions:

  • What must the manufacturing instructions/batch processing record contain?
  • Example: Manufacturing instructions/record
  • What must the packaging instructions/batch packaging record contain?
  • What does the expression “Electronic Batch Recording System” mean?
  • What must a testing procedure contain and how must it be organised?
  • What does a test protocol contain? How must raw data be handled?
  • What is a BRR and what is its purpose?
  • How can the BRR be documented?

All tasks relevant to the manufacturing, packaging and checking of medicinal products can be traced via the batch documentation. This is particularly important if quality problems occur that did not exist or were unknown at the time the medicinal product was approved for sale. In terms of product liability, a properly compiled batch documentation is often the only means at the disposal of the pharmaceutical manufacturer for providing evidence (see chapter 1 Quality Management). This not only underscores the importance of compiling GMP conforming documentation, but also emphasises the necessity for appropriate subsequent handling.

Example of a batch record:

15-c-515-c-5aea15-c-5aeb15-c-5aec15-c-5aed15-c-5aee15-c-5aef15-c-5aeg15-c-5aeh15-c-5aei15-c-5aej15-c-5aek15-c-5ael15-c-5aem15-c-5aen15-c-5aeo15-c-5aep15-c-5aeq15-c-5aer

 

 

 

 

What is 21 CFR Part 11?

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SOURCE: https://www.instantgmp.com/compliance/21-cfr-part-11

What is 21 CFR Part 11?

These days, manufacturers are talking about the FDA’s 21 CFR Part 11 requirements for electronic documentation but what does that mean? This primer will give you an understanding of the FDA’s requirements.

In the 21 CFR Part 11 documentation, the FDA states:

“FDA has concluded that regulations are necessary to establish uniform, enforceable, baseline standards for accepting electronic signatures and records.”

Part 11 regulations cover issues such as:
•Security
•Audit trails
•Electronic signatures
•Copies for inspection
Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following:

(a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

(b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records.

(c) Protection of records to enable their accurate and ready retrieval throughout the records retention period.

(d) Limiting system access to authorized individuals.

(e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.

(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.

(g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.

(h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.

(i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.

(j) The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification.

(k) Use of appropriate controls over systems documentation including:

(1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.

(2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.

Master Electronic Batch Records – InstantGMP™

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SOURCE: https://www.instantgmp.com/feat/mpr

With InstantGMP™, you can see all your Master Batch Records anytime from anywhere.mpr1-2

Good Manufacturing Practices require that you have a Master Batch Record or Master Manufacturing Formula for each unique formulation and each unique batch size. This ensures that all proper ingredients are added, that each process step is completed according to an established procedure and that essential points in the process are controlled.

InstantGMP™ provides electronic master batch record workflows that enforce collections of information and data that contain all the information required by GMPs:

  • A complete list of components to be used
  • An accurate statement of the weight or measure of each component to be used
  • The identity and weight or measure of each dietary ingredient/pharmaceutical/e-liquid
  • A statement of theoretical yield at each step of the manufacturing process where control is needed to ensure the quality of the dietary supplement/pharmaceutical/e-liquid is completed
  • The expected yield when you finished manufacturing the dietary supplement/pharmaceutical/e-liquid
  • Written instructions, including specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement/pharmaceutical/e-liquid
  • Procedures for sampling
  • Written instructions for manual operations, for example, one person to add and another person to verify the addition of the components and materials
  • MPRs can be hidden, printed, edited, viewed, and searched
  • Approvers are assigned the responsibility of approving or rejecting an MPR. They must sign in order for it to be issued and for the ability to create Batch Records
  • After one approver has signed, the MPR is locked
  • An MPR can be unlocked to make edits. The first approver must sign the MPR again to approve
  • Each MPR can have multiple versions
  • Attachments are read only once uploaded

Master Production Records With Version Control:

  • A new version of an MPR can be created
  • A copy can be generated, but one or more of the fields project title, product name, client, author, formulation ID or Theoretical Batch yield must be edited to ensure that a copy is needed and not a version
  • MPRs have the ability to scale up or down a recipe the “Actions” for inventory steps will auto-populate with new material amounts
  • These records cannot be deleted but can be hidden (sorting for hidden items allows access to these records and the ability to “unhide”)

One-Click Copy:

  • Select multiple materials and/or manufacturing instruction steps to transfer to a new MPR
  • Materials and manufacturing instruction steps appear as a centralized list

The following MPR examples are available as PDF downloads.

View Master Production Record Examples:

InstantGMP™ MES Master Production Record Example

InstantGMP™ PRO Master Production Record Example

InstantGMP™ Vape Master Production Record Example

CAPA is not a difficult concept, so why do many companies have difficulty managing it?

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SOURCE: http://www.propharmagroup.com/blog/capa-not-difficult-concept-so-why-do-many-companies-have-difficulty-managing-it

If keeping up with CAPA is a challenge for your company’s cGMP quality system, I hope that this article provides you with a new understanding of CAPA and leaves you armed with a few tricks that I have seen work well with sustained management.

From discussions with other ProPharma Group colleagues, I have noticed a recurring theme in the pharmaceutical industry regarding the difficulty in managing CAPA, and I would like to share some of my firsthand experience on how to effectively manage CAPA, without allowing it to manage you.

What Is CAPA? 

Simply put, CAPA is an acronym for Corrective Action / Preventive Action.  Per the FDA’s “Guidance for Industry: Quality System Approach to Pharmaceutical cGMP Regulations,” it is a concept that focuses on investigating, understanding, and correcting discrepancies, while preventing a recurrence of undesired issues.

Corrective Action: The immediate implementation of a solution(s) resulting in the reduction or elimination of an identified problem or quality system failure. Corrective actions are the first steps that are implemented, immediate reactions, and are usually isolated to that single situation.

  • For example, equipment repair, document amendment, process inspection, and/or product rejection.

Preventive Action: The measures taken to prevent the recurrence of the incident. These are the long-term fixes. Preventative actions should be broad enough to prevent failures similar in nature that have not yet occurred.

  • For example, training, equipment modification, procedural creation/revisions, and/or process modifications.

How Is CAPA Generated?

Part of understanding CAPA is understanding how it is derived. In the cGMP world, CAPA typically originates as an outcome from an unforeseen event, documentation oversight, or incidents of failure. Typically, CAPA is initiated in response to correct or prevent an error. Figure 1 illustrates a simple process flow for how CAPA can be generated.

CAPA Generation Flow

For example, CAPA can be initiated as a response to the following situations:

  • Deviation investigation
  • OOS investigation
  • Audit observation (internal audit, customer audit, regulatory inspection)
  • Process improvement need
  • Customer complaint investigation
  • Adverse drug event
  • Ineffective CAPA previously assigned

The majority of CAPAs that I encounter are those that result from occurrences of simple errors:

  • Documentation errors
  • Personnel errors in following procedures

Why Do Errors Occur?

This simple optical illusion (Figure 2) provides a good visualization of how many errors occur. It emphasizes how there can be more than one way to perceive the same thing.

Optical Illusion

When creating your quality documents, instructions, directives, etc., ensure that they are clear and concise. For instance, use complete sentences that are non-ambiguous when writing a work instruction to avoid confusion or misinterpretation.

  • For example, the Hood filter to be changed bi-monthly—is that twice a month? Every two months?

Understanding how CAPA is generated is crucial in understating how to prevent the cause of one in the first place.

Importance of CAPA:

Another key factor in managing CAPA is understanding its necessity. The following are some of the reasons highlighting the importance of CAPA:

  • 21 CFR regulatory requirement
  • An expected platform for maintaining GMP compliance
  • Effective CAPA can lead to system and process improvements
  • Can help prevent a systemic problem from evolving
  • Improves the overall awareness of a quality system, which leads to better adherence to procedures and regulations
  • Effective CAPA can reduce operating costs from lost time and product as a result of errors

Appreciating the importance of CAPA may promote better systems upstream, thus preventing unnecessary CAPA downstream.

How to Get Unburied:

Hopefully by now you have an improved understanding and appreciation in the important role that CAPA plays. So what do you do if you are already bogged down in overdue CAPA? I like to begin with a review of the data trends to determine if any patterns emerge. Does anything stand out? Is there a particular system, procedure, or piece of equipment frequently involved? This activity can lead to a starting point.

In many cases, I find that the department(s) that do stand out as primary sources of open CAPAs do so not because the department personnel are lazy, quite the opposite, but because in most cases the department personnel are too busy working on the day-to-day priorities and can’t devote quality time upfront to addressing a problem fully.

In this fast paced environment, I like to implement a four-part approach that has proven successful in managing CAPA. That approach is summarized by the following:

Awareness:
Create and present CAPA metrics at the beginning of routine management or operation meetings.

Management Support:
Emphasize the importance from the top down. Lack of CAPA compliance is a pack leader of cited FDA 483 observations. Avoiding an observation is an easy concept for management to understand, and preventing issues can save the company time and money.

Consolidate:
Are there multiple CAPAs that are similar in nature? Can any of these be closed together with a common fix?

Suspend/Inactivate:
Are there documents that can be inactivated to close out the CAPA? Perhaps documents that are obsolete or seldom used? This can have immediate reduction results. With the document out of service, the problem cannot be repeated. This can eliminate “wasted effort” on revising documents that may never be utilized again. This forces correction prior to use, preventing an accidental reoccurrence.

Performing these four steps can yield immediate and noticeable results in CAPA management and number reduction.

How to Sustain CAPA Management:

Once your CAPA numbers are reduced, you will want to maintain the momentum gained by your efforts. The following are some things that I have seen work well in sustaining a manageable and compliant level of CAPA:

  • Incorporate CAPA into employee goals, e.g., your facility maintains an average of fewer than five overdue CAPA.
  • Make CAPA management someone’s responsibility; assign someone as a CAPA coordinator.
  • Assign “smart” CAPAs to begin with, i.e., don’t assign a CAPA to re-train an employee, just train them at the time.
  • Use the email “cc” function and keep open CAPAs visible to department supervisors. This will help entice an individual to close a CAPA and stay below radar.
  • Keep up the routine reporting of open and past due CAPAs at management meetings.
  • Apply real fixes; take the time to rewrite a confusing SOP for clarity.
  • Take the time to find address all root causes.

Summary:

CAPA is an integral part of a healthy cGMP quality management system; it is used to help drive improvements and prevent future failures. CAPA management requires constant attention—don’t let it become overlooked; it can get away from you quickly.

Once your company embraces the management of a Corrective Action and Preventative Action program, CAPA numbers will be reduced, the management of it will become easier, and continual improvement of quality will be promoted.

In conclusion, the title of this article asks the question:

Q:   CAPA is not a difficult concept, so why do many companies have difficulty managing it?

A:   I believe it is because the GMP industry is fast paced, lean, and focused on releasing products on schedule, which makes it easy to become wrapped-up in only fixing the immediate problem as fast as possible. Not taking time to slow down or taking a step back to think really causes a CAPA program to get out of control quickly.
James Meckstroth
Sr. Compliance Consultant

Process Validation of Product

Manostaxx

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SOURCE: https://qualityassuranceinpharma.blogspot.com.tr/2014/03/process-validation-of-product.html

1.0              OBJECTIVE:

To provide general guideline for conducting process validation of the products.

  • 0 SCOPE:

This procedure is applicable to Manufacturing section at company location.

  • 0 RESPONSIBILITY:
    • 1. QA Manager/ QA Executive shall be responsible to prepare a protocol for process validation and sampling plan.
    • 2. QA Officer shall be responsible of sampling and fill on line process validation report as per protocol.
    • 3. QC Officer shall be responsible for analysis of the process validation samples.
    • 4. Production Officer shall be responsible to operate the machine / procedure as defined in the process validation protocol.
    • 5. QC Manager, Production Manager and QA Manager shall be accountable for review and approval of process validation protocol and report.
  • 0 PROCEDURE:
    • 1. Definitions :
      • 1.1. It is a high degree of assurance in the performance of the manufacturing process such that it will consistently produce finished products meeting those attributes relating to strength, quality, purity, and potency.
      • 1.2. Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
      • 1.3. It is a study to ensure that the manufacturing process is capable to give consistency results to meet the quality (safety, efficacy & purity) of the product during routine manufacturing processes.
    • 2. Re-validation Criteria :
      • 2.1. If any change in the process formula.
      • 2.2. Change in approved vendor.
      • 2.3. Change in manufacturing location.
      • 2.4. Change in equipment / facility.
      • 2.5. External Agency / Regulatory requirement.
      • 2.6. Any quality impact on the product monitor during annual product review.
    • 3. When any new product / formulation to be manufactured, it must be prior to validate the process.
    • 4. Each critical process steps, hold time study must be identified and validate.
    • 5. In the protocol product details, formula details, sampling plant, critical process steps, deviations must be reported.
    • 6. Process validation protocol shall be contain at least following contents :
      • 6.1. Protocol Approval:

In this content give details of authorized personnel who will prepared, checked, review and approved the protocol.

  • 6.2. Table of Content :

Give table contents with title and page number.

  • 6.3. Objective :

Give brief objective of the validation.

  • 6.4. Scope :

Mention the scope for which product and location the process validation should be conducted.

  • 6.5. Responsibility :

Mention the responsibilities of validation team.

  • 6.6. Process Validation Requirement :

Described general precautions before starting the validation activities.

  • 6.7. Product Description and Batch Details :

Give the details of the product which shall be going for validation.

  • 6.8. Bill of Raw Material :

Describe the raw materials (active and / or inactive) containing in the product for each stage.

  • 6.9. Bill of  Primary Packing Material :

Describe the packing materials which are to be used for packing of product.

  • 6.10. List of Critical Equipment/Accessories :

List down the equipments/accessories which are to be used to manufactured the product.

  • 6.11. Summary of Critical Process Parameters to be Validated :

List down critical process parameters / stage with monitoring of quality attributes.

  • 6.12. Manufacturing Process Steps and Critical Parameters :

Draw the process steps in brief.

  • 6.13. Packing Process Parameters :

Collect the samples from frequently during packing process and check quality attributes of the product.

  • 6.14. Summary Observations and Results :

Give the summary and conclusion of the various process steps.

  • 6.15. Certification Report :

Give final conclusion on the basis of report review.

  • 6.16. Report Approval :

In this content give details of authorized personnel who will conducting, checked, review and approval of the Report.

  • 6.17. List of Annexes :

List down the annexes if any and attach with report.

  • 6.18. Revision History :

Give history of the revision with justification.

  • 0 ANNEXURE:

NIL

  • 0 REFERENCES:

NIL

  • 0 ABBREVIATION:

Abbreviation used       Full form of abbreviation used

QA                              Quality Assurance

QC                              Quality Control

QAD                           Quality Assurance Department

  • 0 DISTIBUTED TO:

Quality Assurance

Manufacturing & Capsule

Quality Control & Microbiology

  • 0 REVISION HISTORY:
Revision No. Change Control No. Reason for the Modifications

Posted by Karamshi Chaudhar