production management and batch Record maintenance.pptx

Batch Manufacturing Record (BMR)
As a part of international regulatory standards of Good Manufacturing Practice (GMP),
pharmaceutical industries are required to maintain documentation of the entire
manufacturing process and batch execution process.
A batch manufacturing record is a document designed to provide a complete record of the
manufacturing history of a batch of product.
The terminology is widely applied within the Pharmaceutical & Chemical industries and is
referenced in many of the pharmaceutical and food regulatory agency requirements.
The US Food and Drug Administration (FDA) defines a batch as “a specific quantity of a drug
or other material that is intended to have uniform character and quality, within specified
limits, and is produced according to a single manufacturing order during the same cycle of
manufacture”.

Batch Manufacturing Records are critical documents for ensuring quality and regulatory
requirements are achieved.
They normally contain information that relates to the following aspects of the manufacture of a
batch of product:
• Dates of start and finish of manufacture
• Lists all materials used and amounts of each used
• Lists of packaging materials used
• Details of the steps completed in the manufacturing process and times of completion
• Initials of the person responsible at every stage
• Details and results of all in-process checks
• Reference to any equipment used
• Batch yield and reconciliation
• Any deviations
• Quality control information

In many cases, the Batch Manufacturing Records are written in an instructional format with areas
for the operator to enter processing information.
It is very important to provide the information in the Batch Manufacturing Record where requested.
For certain critical operations, e.g., weighing of raw materials, a second person must check
calculations and identity of materials and sign off on the Batch Manufacturing Record.
Each batch has an individual number, written on the Batch Manufacturing Record.
Batch Manufacturing Record must be:
• Legible
• Permanent
• Accurate
• Original
• Signed
All corrections and deviations must be recorded and signed off in the Batch Manufacturing Record.

The following are the specific information to be detailed within a Batch Manufacturing
Record as defined by the US FDA, under the CFR (Code of Federal Regulations) Title 21, Sec.
111.260.
“What must the batch record include?”
The batch production record must include the following:
a) The batch, lot, or control number:
1) Of the finished batch of dietary supplement; and
2) That you assign in accordance with 111.415 (f) for the following:
i. Each lot of packaged and labeled dietary supplement from the finished batch of dietary supplement;
ii. Each lot of dietary supplement, from the finished batch of dietary supplement, that you distribute to
another person for packaging or labeling;
b) The identity of equipment and processing lines used in producing the batch;

c) The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing
lines used in producing the batch, or a cross-reference to records, such as individual equipment
logs, where this information is retained;
d) The unique identifier that you assigned to each component (or, when applicable, to a product that
you receive from a supplier for packaging or labeling as a dietary supplement), packaging, and label
used;
e) The identity and weight or measure of each component used;
f) A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate
phases of processing;
g) The actual results obtained during any monitoring operation;
h) The results of any testing or examination performed during the batch production, or a cross-
reference to such results;
i) Documentation that the finished dietary supplement meets specifications established in accordance
with 111.70 (e) and (g);

j) Documentation, at the time of performance, of the manufacture of the batch, including:
1) The date on which each step of the master manufacturing record was performed; and
2) The initials of the persons performing each step, including:
i. The initials of the person responsible for weighing or measuring each component used in the batch;
ii. The initials of the person responsible for verifying the weight or measure of each component used in
the batch;
iii. The initials of the person responsible for adding the component to the batch; and
iv. he initials of the person responsible for verifying the addition of components to the batch;
k) Documentation, at the time of performance, of packaging and labeling operations, including:
1) The unique identifier that you assigned to packaging and labels used, the quantity of the
packaging and labels used, and, when label reconciliation is required, reconciliation of any
discrepancies between issuance and use of labels;

2) An actual or representative label, or a cross-reference to the physical location of the actual or
representative label specified in the master manufacturing record; and
3) The results of any tests or examinations conducted on packaged and labeled dietary
supplements (including repackaged or relabeled dietary supplements), or a cross-reference to
the physical location of such results;
l) Documentation at the time of performance that quality control personnel:
1) Reviewed the batch production record, including:
i. Review of any monitoring operation required under subpart E of this part; and
ii. Review of the results of any tests and examinations, including tests and examinations conducted
on components, in-process materials, finished batches of dietary supplements, and packaged
and labeled dietary supplements;

2) Approved or rejected any reprocessing or repackaging; and
3) Approved and released, or rejected, the batch for distribution, including any reprocessed batch;
and
4) Approved and released, or rejected, the packaged and labeled dietary supplement, including
any repackaged or relabeled dietary supplement.
m) Documentation at the time of performance of any required material review and disposition
decision.
n) Documentation at the time of performance of any reprocessing.

Importance of Production Management
The importance of production management in a business is that it will spearhead the
process which will ultimately bring in profit to the business.
There are several responsibilities and tasks that a production management team is
responsible for and it is a very stressful job.
It is also stated that it is very important for the management to form good relations with the
various teams within the organization as well.

The importance of production management to the business firm:
1. Accomplishment of firm's objectives: Production management helps the business firm
to achieve all its objectives. It produces products, which satisfy the customers' needs
and wants. So, the firm will increase its sales. This will help it to achieve its objectives.
2. Reputation, Goodwill and Image: Production management helps the firm to satisfy its
customers. This increases the firm’s reputation, goodwill and image. A good image helps
the firm to expand and grow.
3. Helps to introduce new products: Production management helps to introduce new
products in the market. It conducts Research and development (R&D). This helps the
firm to develop newer and better-quality products. These products are successful in the
market because they give full satisfaction to the customers.

4. Supports other functional areas: Production management supports other functional
areas in an organization, such as marketing, finance, and personnel. The marketing
department will find it easier to sell good-quality products, and the finance department
will get more funds due to increase in sales. It will also get more loans and share capital
for expansion and modernization. The personnel department will be able to manage the
human resources effectively due to the better performance of the production
department.
5. Helps to face competition: Production management helps the firm to face competition
in the market. This is because production management produces products of right
quantity, right quality, right price and at the right time. These products are delivered to
the customers as per their requirements.

6. Optimum utilization of resources: Production management facilitates optimum
utilization of resources such as manpower, machines, etc. So, the firm can meet its
capacity utilization objective. This will bring higher returns to the organization.
7. Minimizes cost of production: Production management helps to minimize the cost of
production. It tries to maximize the output and minimize the inputs. This helps the firm
to achieve its cost reduction and efficiency objective.
8. Expansion of the firm: The Production management helps the firm to expand and grow.
This is because it tries to improve quality and reduce costs. This helps the firm to earn
higher profits. These profits help the firm to expand and grow.

The importance of production management to customers and society:
1. Higher standard of living: Production management conducts continuous research and
development (R&D). So, they produce new and better varieties of products. People use
these products and enjoy a higher standard of living.
2. Generates employment: Production activities create many different job opportunities in
the country, either directly or indirectly. Direct employment is generated in the
production area, and indirect employment is generated in the supporting areas such as
marketing, finance, customer support, etc.
3. Improves quality and reduces cost: Production management improves the quality of
the products because of research and development. Because of large-scale production,
there are economies of large scale. This brings down the cost of production. So,
consumer prices also reduce.

4. Spread effect: Because of production, other sectors also expand. Companies making
spare parts will expand. The service sector such as banking, transport, communication,
insurance, BPO, etc. also expand. This spread effect offers more job opportunities and
boosts economy.
5. Creates utility: Production creates form utility. Consumers can get form utility in the
shape, size and designs of the product. Production also creates time utility, because
goods are available whenever consumers need it.
6. Boosts economy: Production management ensures optimum utilization of resources
and effective production of goods and services. This leads to speedy economic growth
and well-being of the nation.

Production Management Software Solutions
While the concept of systemized production management is not new, with the arrival of the
digital age companies have tools available to them that were not possible before.
Production management software can take the system described above to the next level,
further homing in to improve all areas through the identification of deeper levels of data
that can be turned into improvements.
It also automates many functions reducing both time and human error.
Here are some of the benefits that production management software can deliver:
• Cloud-Based
• Intuitive and User Friendly
• Analytics
• Interoperability
• Customizable

Cloud-Based: Most available software solutions today are cloud-based. This means that
manufacturers using these platforms do not need to have a heavy infrastructure or IT
presence to deploy.
This is especially important for small and medium-sized businesses (SMB) who may not
have in-house skillsets for IT and may not be able to afford a traditional enterprise-level
system.
It also means that companies always have access to the most updated version of the
software, eliminating the need for costly and time-consuming periodic upgrades.

Intuitive and User Friendly: Software is also more user friendly using intuitive dashboards,
drop-downs, and drag-and-drop features to simplify tasks.
This may be in the form of drag-and-drop scheduling or perhaps in the automation of the
purchasing process.
In cases like these, rules-based logic can automate these and other tasks to eliminate the
need for manual monitoring.
And because the data being analyzed is real-time, it means that these functional areas are
optimized.
Finally, intuitive and user-friendly platforms reduce training time and the cost associated
with steep learning curves.

Analytics: Today’s production management software uses deep analytics to automate and
produce more accurate views of the workflow and of the entire production operation.
This includes shop floor reporting, workforce, and labor utilization, equipment loading, and
more.
It aligns Bills of Material (BOM) with manufacturing routing and uses real-time production
performance data to maintain adherence to standards and to allow managers to make
decisions in real-time with accurate data.

Interoperability: One traditional barrier to better production management was the
existence of siloed data.
With each respective department and support area maintaining their own system and
software for managing data, information was not real-time and had to be reconciled before
it could be acted upon at higher levels.
Today, production management software can integrate through APIs with other third-party
applications.
This allows it to become part of an end-to-end ecosystem for managing business practices.
Its real-time flow and integration of data from production can be tied to finance systems,
billing systems, quality management, and others to offer seamless integration and a more
holistic visualization of manufacturing and its total imp

Customizable: Agility and flexibility are important in today’s hyper-competitive markets.
And production management software is customizable to allow companies to leverage
flexibility to only use the functionality they need.
This allows manufacturers to only use the needed functionality, reducing clutter in the user
experience, and improving efficiency.
It can be utilized specifically for production but is flexible and agile to incorporate modules
for CRM, inventory control, supply chain management, and procurement.
This is highly valuable for SMBs whose staff often performs tasks and duties across several
departments or functional areas and who need a comprehensive production management
system tied to a larger suite of functions.

For manufacturing, production management is the systemized deployment of techniques
and methods that allow managers to control production and deliver the lowest cost, highest
quality finished goods in pursuit of business objectives.
It can be implemented in any size factory and enhanced through the use of production
management software.

production management and batch Record maintenance.pptx

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