ACTIVITIES INVOLVED IN THE PLANT:

Activities involved in the production of active pharmaceutical ingredients

There are six activities involved in the production of active pharmaceutical ingredients.
These activities are: resource management, definition management, detailed scheduling,
dispatching, execution management, data collection, tracking, and analysis. Each of these
activities ensures that the production, quality, maintenance and inventory of the plants in in the
good state.
For the resource management, this involves the employees and the process equipment
in the plant. This manages the training of the employees and the planning of their shifts and
holidays. The definition management deals with the controlling of the equipment and the
employees by implementing work instructions and safety instructions. For the detailed
scheduling, this determines the resources and time for carrying out operations. This interfaces to
enterprise resource planning system, which is a software that allows an organization to use a
system of integrated applications to manage the business and automate many back offices
functions related to technology, services and human resources. This also includes the unit
assignment proposal, connection proposal and selection based on the recipe needed and the
availability of the unit at the expected time it will run. This compare the target production to the
actual production of the plant. In dispatching, this controls the flow of production by scheduling
the batches in a batch control system. This includes the order assignment for campaign setup,
weighing of ingredient containers, processing of the individual batches, test orders for the
laboratories, immediate cleaning and for the final cleanup. In execution management, it includes
the management of the products in line with the schedules and in comply with the standards for
the products. It also includes the recipe control for the medicine production. This also manages
the transfer of one process to another process in the production of the medicine. For the data
collection, this concerns the data which are used in the production of the medicine like the data
inputted on the sensors for the processes. This also includes the storage of data according to US
legal requirements: 21 Code of Federal Regulation Part 11: Electronic Records; Electronic
Signatures. For tracking, this includes the evaluation of data related to the resources utilized in
the production of medicines. It includes automatic tracking of changes in state of campaigns,
batches, work and transport orders. It also tracks the feedback of material consumption and
manufactured products to enterprise resource planning. And lastly for the analysis, this includes
activities which are related to the evaluation and reporting of data to business systems. This also
generate electronic batch records of the time progress, quality-relevant discrepancies, and
historic trend plots of quality-relevant measurements. It also overviews which ingredients were
used in a batch of medicines and which batch these ingredients were used. It also has statistical
analyses for the key performance indicator.
To ensure quality product, employees were properly trained and these employees are
qualified to do the right job. The equipment is maintained properly and are always available when
it is needed to be used. Current good manufacturing practice are required to conform to the
guidelines recommended by agencies that control the authorization and licensing of the
 manufacture and sale of pharmaceutical products. Tests are required for good receipt, in-process
control and product releases. The target production is compared to the actual production. Test
orders and test procedures are available online. The test results are also documented. Tracking of
completed test orders and warning if analysis values outside tolerance is automated.

The maintenance of the process involves:

- Training of the personnel
- Maintenance and calibration of the equipment used
- Availability of spare parts and operating materials
- Creation, quantification, release and control of maintenance plans, test procedures,
and calibration cycles
- Planning of status inspection and maintenance
- Assigning of the maintenance orders
- Control and monitoring of maintenance orders
- Electronic data recording of failure time, damage, necessary working times, spare
parts needed, maintenance order costs, and resulting costs of production losses
- Collection of completed maintenance orders
- Statistical analysis of the technical plant availability, reliability of parts and
optimization of maintenance plans

Inventory for each activity

1. Resource management
a. Personnel training and availability
b. Types, quantity and status of material
c. Capacity and allocation of storage
d. Packaging of material
2. Definition management
a. Handling of dangerous materials
b. Specification of permitted packaging
3. Planning
a. The material stock level
b. Weighing of the necessary containers
c. Required transport operations
4. Dispatching
a. Sampling of received goods
5. Execution management
a. Checking of the correct weight of material
b. Checking of the transportation of materials
c. Checking of the quarantine of materials and products
6. Data Collection
a. Material Data
b. Data recording of stock levels and location
c. Data of the use and status of mobile containers
d. Data of the execution of transport orders
7. Tracking
a. Collection of completed goods received
b. Collection of completed shipped goods
c. Collection of completed weighing of materials
d. Collection of completed transport orders
8. Analysis
a. Supplier Evaluations

Robotics
-making use of robotics to automate specific processes in drug development, including drug
screening, anti-counterfeiting and manufacturing tasks
Internet of Things
- facilitate connectivity and easy exchange of data in real-time in the factory
Big Data Analytics
- useful in predictive manufacturing to provide early warning for anomalies and system failures
and to predict product quality
AI Technology
- analyze patient data to identify treatment options predicting a patient’s response to possible
drug treatments