Title: MES for Pharmaceutical Manufacturing | Cloud-based MES for Pharma | Electronic Batch Manufacturing Record
1MES for Pharmaceutical Manufacturing
Cloud-based MES for Pharma Electronic Batch
Manufacturing Record
2- 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.
3- 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.
4 5- 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.
6- 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.
7Problem 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.
8Investigation 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
9Failure 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.
10Mixed 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
11Adequate 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
12Reliability 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
13Failure 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
14- 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.
15 16- 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.
17- 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.
18- 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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