MES for Pharmaceutical Manufacturing | Cloud-based MES for Pharma | Electronic Batch Manufacturing Record

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MES for Pharmaceutical Manufacturing
Cloud-based MES for Pharma Electronic Batch
Manufacturing Record
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• Pharmaceutical manufacturers are under continuous
  pressure to remain competitive while meeting the
  stringent regulatory manufacturing requirements.
  These manufacturing requirements range from
  simple electronic record keeping to complex data
  assuring consistently the reliability of the
  manufacturing processes, equipment and peoples
  training, raw material quality, sampling plans,
  root-cause-analysis, products deviations, etc.
  Atachi Systems experience in deploying MES for
  pharmaceutical manufacturing companies for
  several years in a row is a testimonial on its
  own. Put simply, Atachi Systems understands the
  importance of deploying an MES system that is
  strategic to its core manufacturing requirements,
  yet cost effective to maintain and run for years
  to come! Our clients call it the Atachi Advantage.

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• NGIMES is the premiere MES for pharmaceutical
  manufacturing companies that uses SAP ERP. It
  helps comply with 21CFR Part 11 electronic
  signatures, FDA audits, validation and confirms
  to US FDA cGMP requirements. Furthermore,
  pharmaceutical companies can take advantage of
  the cloud based MES (NGIMES) to contain costs
  while delivering accelerated performance with its
  in-memory computing platform. Below image covers
  all the MES functionalities detailed in ISA-95
  model that Atachi NGIMES brings.

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• NGIMES

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• Atachi Systems has the experience and knowledge
  to deliver on every aspect of regulated
  pharmaceutical manufacturing with various MES
  solutions including NGIMES, a cloud-based MES
  solution that is run on the SAP HANA platform.
  Our hands-on experience working with other MES
  systems in the marketplace is unmatched because
  we understand the criticality of data migration
  to and from these systems to ensure total client
  satisfaction.
• Young and fast growing Indian pharmaceutical
  companies have shown a keen interest in migrating
  to NGIMES because of its solid performance on SAP
  HANA and its unique industry specific pricing
  structure. This combined with SAP worldwide
  support and training makes NGIMES the obvious
  choice for those leading edge companies who want
  to stand head and shoulders above their peers.

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• Below is a list of the most common issues and
  solutions that NGMIES can deliver to any
  pharmaceutical or medical device company. Please
  note that this list is updated on a regular basis
  as we continuously configure NGIMES to better
  serve our client needs and requirements.

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Problem Solutions
Drugs adulteration within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FDC Act), 21 U.S.C. 351(a)(2)(B), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP Manufacturing Execution Systems (MES) enforcing the strict conformity to the cGMP requirements to ensure that right procedures are used and enforced at every step of the manufacturing process along with the equipment cleared for the production lines.
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Investigation of out-of-specification (OOS) laboratory test results failed to identify a root cause or provide adequate corrective actions. Continuous improvement of the manufacturing process Reliability of the manufacturing equipment used in the process The whole Batch Manufacturing Record (BMR) or electronic Ba tch Manufacturing Record (eBMR) data needs to be captured without compromising for the data integrity to analyze and understand the root causes of the out-of-specification products manufacturing Corrective and Preventive actions need to be identified, documented and implemented
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Failure to establish and follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product. Failure to maintain an adequate written record for each investigation conducted pursuant to 21 CFR 211.192 that included the findings of the investigation and follow-up (21 CFR 211.198(a) and (b)(2)). Line clearance checks need to be strictly enforced with all the relevant information and signatures holding the accountability of the individuals. Corrective and Preventive actions need to be identified, documented and implemented.
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Mixed up drugs caused by inadequate cleaning procedures, personnel flow, equipment suitability, material flow, line segregation, inappropriate line-clearance documentation, etc. Failure to establish appropriate controls over computers and related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel (21 CFR 211. 68(b)). Manufacturing Execution Systems enforcing the personnel certifications for the processes, capturing the Line clearance checks and ensure that the materials are dispensed with proper sampling activities are completed MES, CAPA and any other shop floor systems security needs to be properly ensured so that only authorized individuals have access to the data
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Adequate documentation to prove that the processes are designed to manufacture the product safely, documented and operators have been trained and systems are ensuring that these processes are followed. 21 CFR 211.113(b)) Lack of appropriate documentation for rejecting the semi-finished/finished/packaging products, etc. Ensure that Standard Operating Procedures are backed by adequate design documentation, training and process control documentation Documentation of scrap/product rejection reasons. Documentation of the processes performed, equipment used along with Line clearance checks and personnel certified and ensure that e-signatures are captured. Any deviations need to be captured and shall generate the triggers
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Reliability of the processes, equipment used, personnel worked on the batches Failure to establish and document the accuracy, sensitivity, specificity and reproducibility of test methods employed by the firm (21 C.F.R. 211.165(e)) Ensure that the processes are closely monitored by Manufacturing Execution Systems
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Failure to routinely calibrate, inspect, or check according to a written program designed to assure proper performance and to maintain adequate written records of calibration checks and inspections of automatic, mechanical, or electronic equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product (21 C.F.R 211.68(a)). Ensure that the Equipment are closely monitored by Manufacturing Execution Systems
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• API stability for Active Pharmaceutical
  Ingredient Manufacturers
• Lately few API (Active Pharmaceutical
  Ingredients) manufacturers have been getting the
  FDA warning letters for not being able to prove
  that their API is stable through the stability
  period. Lot of times the manufacturers face the
  critical challenges in providing the required
  documentation that doesnt tie well into the data
  integrity of the API stability. There could be
  various reasons how an API stability got affected
  and which could have been easily prevented and
  saved lot of product recalls and avoided the drug
  shortages into the market. Our below slide gives
  a simplistic process that could avoid the API
  stability issues and reduces the FDA audit
  response times to as low as an hour provided the
  appropriate system structure is implemented.

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• API Stability

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• Data Integrity for Pharmaceutical Manufacturing
  companies
• Data integrity has been a serious issue across
  all the pharmaceutical industries lately. These
  issues simply putting the pharmaceutical
  manufacturers out of the US consumer market. Put
  simply the impact is a growth killer for the
  pharma manufacturer and drug shortage for the
  consumer.

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• It has been too expensive for small and mid-size
  pharma industries to own and maintain an MES
  systems due to the nature of the MES systems
  available in the market. MES systems have been
  built by different software companies over a
  period of the last 20 years. Some of these
  companies have derived their roots from
  delivering (a) the shop floor automation
  solutions like PLC, DCS, SCADA integration (b)
  LIMS (Laboratory Information Management Systems)
  (c) others have come from the ERP background (d)
  organic MES systems providers. We have come
  across several worlds leading pharmaceutical
  manufacturers taking an MES road-map for a
  decade.
• With the latest technologies the above rules are
  re-written with our NGIMES.

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• Whatever may be the dynamics of MES software
  market, the customers have been facing the
  problems with MES
• Too expensive to own and maintain1
• Too difficult to hire and retain the talent to
  manage the MES2
• Too difficult to put the MES projects on right
  track and realize the ROI
• Too difficult to do the seamless integration of
  data across all the other systems on the
  shop-floor and present a holistic actionable
  intelligence to the manufacturing management.
• Data integrity for pharma industries issue can be
  well addressed with the FDA 21 CFR part 11
  compliance by considering the below screen shot.

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