production management and batch Record maintenance.pptx

Production management and batch record maintenance

1. PRODUCTION MANAGEMENT

2. 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”.

3. Batch Manufacturing Record (BMR) 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

4. Batch Manufacturing Record (BMR) 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.

5. Batch Manufacturing Record (BMR) 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: The batch, lot, or control number: Of the finished batch of dietary supplement; and That you assign in accordance with 111.415 (f) for the following: Each lot of packaged and labeled dietary supplement from the finished batch of dietary supplement; Each lot of dietary supplement, from the finished batch of dietary supplement, that you distribute to another person for packaging or labeling; The identity of equipment and processing lines used in producing the batch;

6. Batch Manufacturing Record (BMR) 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; 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; The identity and weight or measure of each component used; A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing; The actual results obtained during any monitoring operation; The results of any testing or examination performed during the batch production, or a cross-reference to such results; Documentation that the finished dietary supplement meets specifications established in accordance with 111.70 (e) and (g);

7. Batch Manufacturing Record (BMR) Documentation, at the time of performance, of the manufacture of the batch, including: The date on which each step of the master manufacturing record was performed; and The initials of the persons performing each step, including: The initials of the person responsible for weighing or measuring each component used in the batch; The initials of the person responsible for verifying the weight or measure of each component used in the batch; The initials of the person responsible for adding the component to the batch; and he initials of the person responsible for verifying the addition of components to the batch; Documentation, at the time of performance, of packaging and labeling operations, including: 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;

8. Batch Manufacturing Record (BMR) 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 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; Documentation at the time of performance that quality control personnel: Reviewed the batch production record, including: Review of any monitoring operation required under subpart E of this part; and 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;

9. Batch Manufacturing Record (BMR) Approved or rejected any reprocessing or repackaging; and Approved and released, or rejected, the batch for distribution, including any reprocessed batch; and Approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement. Documentation at the time of performance of any required material review and disposition decision. Documentation at the time of performance of any reprocessing.

10. 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.

11. Importance of Production Management The importance of production management to the business firm: 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. 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. 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.

12. Importance of Production Management 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. 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.

13. Importance of Production Management 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. 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. 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.

14. Importance of Production Management The importance of production management to customers and society: 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. 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. 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.

15. Importance of Production Management 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. 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. 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.

16. 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

17. Production Management Software Solutions 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.

18. Production Management Software Solutions 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.

19. Production Management Software Solutions 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.

20. Production Management Software Solutions 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

21. Production Management Software Solutions 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.

22. Production Management Software Solutions 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.