As a part of international regulatory standards of GMP, pharmaceutical
industries are required to maintain documentation of the entire
manufacturing process and batch execution process.
Pharmaceutical
companies have been traditionally using paper to maintain Batch Records
(BR) like Batch Manufacturing Records (BMR), BPR, process and equipment
templates etc. in order to comply with the requirements of regulatory
standards like FDA, MHRA, etc. In this current process, the Batch
Records documentation is a manual process, with scores of papers to fill
and this is tedious, time-consuming, laborious, monotonous and highly
error-prone. A large number of documents are generated and there is a
high stipulated retention time for such documents which is posing a
great challenge to the industry to manage a highly secured space for
storing the documents. A paper-based forms process like Batch Records
can be plagued with inefficiency and issues such as wrong issuance,
incomplete information, errors and reworks. A study reveals that Batch
Record issuance has huge manual and tedious component of work, often
turns out to be source of errors and reworks.
For these manual
Batch Records, the information has to be collected correctly and
completely. With paper forms, the onus lies with the QA team for error-
free templates and on the operator to input accurate and complete
information. Though manually collected information helps pharma
companies meet regulatory requirements, it is very labour-intensive to
collect, review and retrieve the information quickly for compliance and
production decision making purposes.
In today's knowledge -based
world, information is the greatest asset and quick use of information
for improvement is the key to business success. Manual systems don't
connect forms-based processes like audit findings, corrective action,
etc. making continuous improvement almost impossible. It is also nearly
impossible to analyse and correlate significant volumes of information
necessary to improve production processes. Globally, the pharma industry
has the need for timely and accurate manufacturing information that can
be collected, stored, retrieved, analysed and reported more readily.
The only option for efficiently managing these Batch Records is to
automate the process.
Challenges faced in manual Batch Record management system
? Laborious and repetitive documentation due to similar data appearing at many places.
? Integrity and version management of the templates
? Prone to human errors making compliance with cGMP difficult.
? Substantial time spent on approval and review process.
? Reconciliation of errors leads to wastage of time, paper and valuable resources.
? Report configuration, retrieval of records is time consuming.
? Maintaining audit trails of various processes is tedious.
21CFR
Part 11 guidelines and automation of Batch Records With the advent of
21 CFR Part 11, the FDA has begun to accept electronic Batch Records.
Since then, more and more manufacturers have recognized the advantages
of automating the process of controlling Electronic Batch Records (EBR).
Under
cGMP regulations found in 21 CFR Parts 210 and 211, the Electronic
Batch Record (EBR) must demonstrate the accomplishment of every
significant step in the production, packing, and holding of each batch
of a drug product. cGMP requires extensive Batch Record documentation,
including batch dates, identity of major equipment/lines used,
components / materials used and their weights, in-process and laboratory
control results, complete labelling control records, sampling, and
identification of personnel supervising or checking each step.
In
addition to what cGMP requires, manufacturers that automate their Batch
Records must do so in accordance with 21 CFR Part 11 requirements.
Benefits of automation of Batch Records:
?
Better organisation and control: Automation facilitates organizing and
controlling the individual template of processes, equipment operating
procedures. All individual templates have to be controlled for access to
the authorized personnel so as to maintain the template integrity. More
than 20 per cent of mistakes happen because of uncontrolled formats in a
manual process and this can be avoided by automation.
? Controlled
creation of the Master Batch Records: Automation facilitates controlled
creation of the Master Batch Record templates and holding of the
documents in secured electronic repositories.
? Issuance of the
Batch Records: Issuance of the Batch Records can be done through a
controlled process, which improves compliance and reduces errors that
are a feature in repeated manual written information.
?
Simplification: Automation simplifies the compliance environment by
enforcing the procedures related to each process while enabling the
decision making abilities of qualified personnel.
? Accurate data
capture: A batch record management software gives the user a list of
forms with form fields for data to be entered and also offers data
options that can be easily entered into a form with a mere click of a
mouse. Fields can also be set up to calculate data using simple or
complex math operations.
? Continuous compliance: Automation helps
companies attain continuous compliance to FDA and cGMP guidelines by
simplifying and optimizing workflows, enforcing procedures and lowering
overall compliance cost. Batch Record Management software provides
time-stamped audit trail, reporting, and electronic signature
capabilities that will fully satisfy FDA's 21 CFR Part 11 requirements.
Security features should include dual passwords for document approval;
password expiration, encryption, and certification. Unauthorized users
can be stopped from gaining system access.
? Flexibility in workflow
design: Process designers can configure all aspects of a workflow like,
including the assigned users, what users can do with the task (such as
rejecting or approving it), the number of approvers required to move to
the next step, which pages are viewable or editable, which users are
allowed to change user assignments to the step, and when the task
escalates to another set of users.
? Streamlined performer/witness
signoff: Automation helps a process step to be configured to allow two
people to sign off from a single screen. This is useful for tasks that
require a witness during completion (e.g. Electronic Batch Records) and
eliminates the need for one user to log out and another to log back in
so the second signature can be committed.
? Connected system :
Automation connects processes to each other as well as to centralized
data repositories or third-party databases eliminating duplicate
repositories.
? Analytics and reporting: Pre-configured reports for
a process can be created in the system, allowing for advanced data
analysis. The reports can include any user-entered data as well as
metadata on the process task. Reports can also include pie charts, bar
charts, trend charts with drill-down capabilities, and are easily
modified by end users. Chart dashboards can provide a quick overview of
current activity and scheduled reporting assists in regular reviews of
key data.
? Integration with other applications: The software can
offer integration with applications like ERP, LIMS, accounting, and
human resources applications to connect different departments and
operations within an enterprise. This integration would enable an
integrated seamless process there by reducing errors and latency between
the processes.
? Access to centralized data: Processes can display
and let the user select data from central repositories, whether they are
stored in a third party application or administered internally in a
data structure. EBR data structures are fully configurable and can
accommodate anything from a simple pick list to a full blown table of
records.
For the above reasons, pharma manufacturers can migrate
from their current manual / paper-based procedures for capturing the BR
towards an automated compliance system to cost effectively achieve and
maintain compliance with regulatory mandates and prove compliance to
internal and external auditors. The end result is sustainable risk
reduction, cost reduction, and regulatory compliance. An automated
approach for an EBR will reduce the time and effort required by
operators to complete manual paperwork, eliminate paperwork error and
reduce the time required by supervisors and production investigators to
follow-up with responsible person(s) to obtain resolution to anomalies.
EBR can save more than 40 per cent of time in preparation, review and
approval process, can reduce errors by more than 95% and save costs.
There
are software solutions like CaliberBRM available to e-manage your Batch
Records in the most efficient and effective manner. CaliberBRM is a
very valuable information technology tool for organizing, automating and
controlling of BRs in an industry like pharmaceuticals, where Batch
Manufacturing takes place and meticulous records are to be maintained,
under strict compliance to regulations. It provides an innovative
automation solution right from systematic and structured organization of
documents to fully automated on-line product documentation.
It
organizes repositories for master templates, master BRs, issued BRs,
executed BRs, and compiles batch summaries. The master templates,
headers, footers, indexes etc are reusable. The document repositories
and the workflows are configurable. Execution of BMR may be on-line or
off-line. The records can also have scanned signatures to authenticate,
along with electronic signatures. CaliberBRM is a complete platform for
Batch Records automation and control, with Good Documentation Practice.
It
is a DSS for batch yield and quality parameters. It can be integrated
with ERP / SAP - for Batch Information, with equipment / SOP Masters -
for template preparation, with CAPA / DMS - for Management of Deviations
in Quality / Yield Parameters, and with Process Analytics - to capture
Batch Analytics.
Implementing Batch Record Management softwares
like CaliberBRM in pharma labs would result in big savings in voluminous
paperwork, time and effort, and reworks due to human errors. What's
more, this would contribute to the environment too!
(The writer is a Director of Caliber Technologies Private Ltd)