Lecture 11 Batch Manu R and Batch PR.pptx

BPR

1. COMMUNICATION IN INDUSTRY Sarder Arifuzzaman Sr. Lecturer Department of pharmacy World university of Bangladesh

2. Pharmaceutical Industry In the pharmaceutical industry, there are various departments or functions that work together to research, develop, manufacture, and market pharmaceutical products. Some of the key departments in the pharmaceutical industry include: Research and Development (R&D): This department is responsible for discovering and developing new drugs and therapies. It includes medicinal chemists, pharmacologists, and other scientists who conduct research to find potential drug candidates. Regulatory Affairs: Regulatory affairs professionals ensure that pharmaceutical products comply with all applicable regulations and guidelines set by health authorities. They prepare and submit documents for drug approvals and maintain compliance throughout the product lifecycle.

3. Manufacturing and Production: This department is involved in the large-scale production of pharmaceutical products. It includes pharmaceutical engineers, quality control specialists, and production operators who ensure the efficient and safe manufacturing of drugs. Quality Control and Assurance: Quality control and assurance teams monitor the quality of pharmaceutical products at every stage of production. They ensure that products meet established quality standards and are safe for use. Sales and Marketing: Sales and marketing departments are responsible for promoting pharmaceutical products to healthcare professionals, pharmacies, and the general public. They develop marketing strategies and sales plans to maximize product reach and profitability. Pharmaceutical Industry

4. Pharmaceutical Industry Clinical Research: Clinical research professionals conduct clinical trials to test the safety and efficacy of pharmaceutical products in human subjects. This department plays a crucial role in obtaining regulatory approvals for new drugs. Supply Chain and Logistics: Supply chain professionals manage the distribution of pharmaceutical products to wholesalers, pharmacies, and healthcare facilities. They ensure timely and efficient delivery while maintaining product integrity. Medical Affairs: Medical affairs teams provide scientific and medical support for pharmaceutical products. They engage with healthcare professionals, respond to medical inquiries, and provide medical information about products.

5. Pharmaceutical Industry Legal and Compliance: The legal and compliance department ensures that pharmaceutical companies adhere to laws and regulations governing the industry. They handle legal matters, intellectual property, and compliance issues. Finance and Administration: Finance and administrative departments manage the financial aspects of pharmaceutical companies, including budgeting, financial planning, and administrative functions. These departments work collaboratively to bring pharmaceutical products from the research stage to the market while ensuring safety, efficacy, and compliance with regulatory requirements. Each department plays a vital role in the success of pharmaceutical companies.

6. Examples for pharmaceutical communications Internal communications team:  sending general news and updates, policies, procedures and various employee engagement-related emails. Human resources:  sending reminders and invitations about training, policies, payroll, health and wellbeing, employee entitlements and benefits, performance management, job opportunities and development initiatives. IT team : sending outage notifications, planned maintenance advice, cybersecurity reminders and alerts, training, updates about new software or hardware projects, hints and tips. Admin team:  sending generic reminders about dates, deadlines, events and other routine communications. Compliance team : sending reminders about policies, procedures, regulations and legal obligations, deadlines, how to report non-compliance and other issues. Customer service:  can send alerts advising all employees about any emerging issues and trends that have been identified.   Sales and marketing : sending employees updates about sales and marketing campaigns, sales targets, KPIs and branding guidelines. Operations team:  can send alerts about production issues, maintenance, outages, quality control issues, logistics and transport.

7. CHALLENGES IN THE PHARMACEUTICAL INDUSTRY TO ADDRESS WITH EFFECTIVE INTERNAL COMMUNICATION The pharmaceutical industry has its own unique set of challenges that can both be an obstacle to effective internal communication and be improved by effective internal communication. 1. EMPLOYEE ENGAGEMENT AND RETENTION IN THE PHARMA INDUSTRY One of the major HR challenges in the pharma industry is keeping employees motivated and engaged, as well as retaining talent. Across the industry, there is a skills shortage that is driving salaries up as people pursue opportunities with higher monetary benefits. When employees move on to a new company, they take their experience and corporate knowledge with them, and in the current environment, it can be difficult to replace them. Disengaged employees are more likely to leave their company to pursue opportunities elsewhere. 

8. CHALLENGES…… 2. PHARMACEUTICAL INDUSTRY COMPLIANCE COMMUNICATIONS Compliance in the pharma industry is one of the sector’s top priorities. There are a range of regulatory standards that pharmaceutical companies must abide by, and not doing them or cutting corners has the potential to damage the company and its reputation catastrophically. Every single employee needs to understand the rules and regulations that they have to follow, and why it is important. Implementing a  corporate compliance program  can help you to keep track of all your various regulatory requirements. As part of this program, you should develop a targeted internal communications strategy that is used to remind employees of their obligations and reminders around things like due dates and deadlines. Compliance training – including refresher training – should also form a part of this.

9. CHALLENGES…… 3. CONTINUOUS MANUFACTURING AND REMOTE COMMUNICATIONS IN PHARMA As pharmaceutical companies roll out continuous, 24/7 manufacturing to keep up with demand, this means that employees are in the workplace around the clock, working across a number of shifts each day. Shift-to-shift communications are important to ensure that if there are any issues, the next shift knows about them so they can be productive. Added to this, different plants may be located in different locations, even in different countries and continents. Other parts of the company might be based in corporate offices, warehouses or be on the road working in transport and logistics or sales roles.  This means that some traditional internal communication strategies where everyone in the company works in the same office building, 9-5 Monday to Friday, are outdated and irrelevant. Pharmaceutical companies should consider investing in tools that will help them reach employees regardless of when and where they work to ensure that everyone has access to the same information and nobody is overlooked. Internal communications software  can help to overhaul company communications. Consider targeted deliveries to reach the specific groups of people you need to reach, sending messages that you can schedule ahead of time for different time zones and employee apps or SMS messages to reach people who aren’t in an environment with computer access.

10. CHALLENGES…… 4. QUALITY CONTROL ISSUES Quality control issues have the ability to affect the company’s outputs and can also lead to major issues if unchecked, such as product recalls or patient deaths and lawsuits. Having an effective internal communications system in place to notify staff about any issues that are detected is paramount. It is also critical that companies have robust systems where employees can communicate quickly and easily with management when they identify a problem. Sending  pop-up alerts  and notifications to employees is a great way to keep them informed about any quality control concerns. These can also be aligned with existing systems that you use within your company to notify about any issues.

11. CHALLENGES…… 5. CYBERSECURITY IN THE PHARMA INDUSTRY AND IT COMMUNICATIONS Cyber attacks are becoming more and more prevalent each year, and the pharmaceutical industry is not immune from this. Phishing, ransomware, denial of service attacks and hacking attempts are just some of the cybersecurity threats that the pharma industry is exposed to.  Intellectual property theft is one of the biggest risks for pharmaceutical companies if they do find their systems compromised.  Cybersecurity risks in the pharma industry include losing complete access to systems, extended periods of downtime and disruption, financial losses and potential legal consequences. Every employee in your organization has a role to play in keeping your systems and data safe. It’s important to regularly communicate cybersecurity issues to them, including what to look out for and what steps they need to take. Emerging threats should also be communicated as quickly as possible to mitigate risk. Use tools like corporate screensavers and digital signage to remind staff about cybersecurity issues and send hints and tips. Pop-up alerts and  scrolling desktop tickers  are also useful for sending reminders or alerts to let people know about new threats. You can also test your employees’ knowledge by sending them quizzes.

12. CHALLENGES…… 6. EMERGENCIES AND LOCKDOWNS Emergency situations can happen at any time, with little to no warning. Whether it’s a fire, a natural disaster, a chemical leak, a shooter or some other calamity, it’s important that you have systems in place to inform your employees in as little time as possible: after all, every single second counts. Sometimes you may need to lock down an entire plant or facility if there is a dangerous situation nearby. Other times you may need employees to evacuate or shelter in place: providing clear and timely instructions can help to save lives and reduce injuries. An  emergency alert system  that reaches employees, whether they are on-site or off, is one of the best tools you can have in your internal communications arsenal.

13. What is a Batch? A batch in pharma manufacturing is a specific quantity of a drug product intended to have uniform character and quality within specified limits. It can be produced according to single or multiple production orders during the same cycle of manufacture and is intended to be available as a homogenous product. A batch has a unique identification number that is clearly identified and recorded during production.

14. What are Batch Manufacturing Records? Batch Manufacturing Records are documents used to track production batches throughout the  manufacturing  process. These records typically include detailed instructions on how to manufacture a product, quality control procedures, test results, and other relevant data. This data is used to ensure that the product meets the required specifications and safety standards set by the regulatory bodies. However, before the BMR can be created, chemical and process manufacturers must first establish another document: the master formula record (MFR).

15. What Precisely is a Master Formula Record (MFR)? The MFR is a collection of instructions that teaches you how to make a product batch. It differs from a BMR as a BMR is a record of what you made. Consider this method to be similar to the process of making a loaf of bread. The MFR is your recipe; it tells you how much flour to use and how many eggs to use. It also instructs you about the duration and temperature of cooking. It also documents the most critical test for a baker or a manufacturer, which is  quality control . The BMR is a record of how that bread turned out, including how much dough was wasted along the way.

16. Importance of Batch Manufacturing Records Batch manufacturing records are essential for ensuring that products are produced safely and consistently. They provide a detailed and organized record of all the steps in the manufacturing process. This includes raw materials and packaging, as well as any intermediate processes such as blending, mixing, and packaging. Batch records also provide a valuable audit trail to ensure that the product meets all regulatory requirements and standards. They enable manufacturers to track the production process and enable them to make necessary adjustments for future batches. Batch manufacturing records are also essential for getting FDA approval for new products.

17. Importance of Batch Manufacturing Records Here’s how we can summarize the importance of batch records: Establishes a Product’s Quality Standards : Batch manufacturing records document the step-by-step processes used to manufacture a product. This information can then be used to set quality standards that must be met during production. Provides Traceability and Reproducibility : Batch manufacturing records provide an audit trail of each product that is produced. This allows the manufacturer to trace the product back to its original raw materials and reproduce the product if needed. Enhances Product Safety : When manufacturers have detailed batch records, they can quickly identify and recall products that may have been contaminated or have otherwise become unsafe for consumption. Ensures Regulatory Compliance : Regulatory agencies often use batch manufacturing records to ensure that quality standards and safety protocols are being followed. Improves Efficiency : By having detailed batch records, manufacturers can streamline their production process and reduce the amount of time it takes to produce a product. Facilitates Communication : Batch records often serve as a way for different departments, such as quality control and production, to communicate with each other. This ensures that everyone is on the same page and that the product being produced meets the required standards.

18. Types of Batch Manufacturing Records There are various types of batch records. Let’s learn about each of them. Master Batch Records : These records provide the product's overall description and detailed manufacturing and testing instructions. Production Batch Records : These records provide detailed instructions for each step in the process and are used to record data such as temperature, pressure, and time for each step. Quality Control Batch Records : These records provide instructions for testing the product and recording the results of the tests. Packaging Batch Records : These records provide instructions for packaging the product and recording the results of the packaging process. Validation Batch Records : These records provide instructions for validating the product and recording the results of the validation process.

19. What is included in a Batch Manufacturing Record? A batch manufacturing record typically includes a batch number, product name, date, operator name, ingredients, and quantities used. It may also include the manufacturing instructions, batch yield, in-process testing results, packaging details, storage conditions, and expiration date.

20. What is included in a Batch Manufacturing Record? When properly structured, every BMR should comprise the following sections: Bill of Materials The bill of materials (BOM) should include all raw materials utilized in the batch, including ingredients and packaging components. This is done to confirm that each component complies with cGMP batch record criteria and is safe to use. Crucial Dates This section should provide the batch's start and finish dates and any additional milestone dates. These are necessary to track the batch's progress and ensure it is completed on schedule. Manufacturing Process This is a summary of the actions taken to complete the batch, beginning with mixing and blending ingredients and finishing with packaging and labeling. Any changes from the normal method should be documented in this section. Hazards Medical products may comprise potential hazards that must be introduced to the user. If there are any hazards, those must be notified in this space.

21. What is included in a Batch Manufacturing Record? Quality Control This section describes all of the tests that will be done on the product. It should include guidelines and recommendations for how the test should be carried out and what equipment is required. Once completed, the findings will be posted here, with any noteworthy anomalies indicated. Equipment All of the equipment utilized in the process should be listed. This guarantees that all machinery and tools are up to date and correctly calibrated to achieve the best results. Maintenance Guidelines Any maintenance chores performed during the batch process, as well as any unforeseen maintenance concerns, should be recorded here. Dates, persons, and other pertinent information should be mentioned. Batch Details This part should provide the batch's name, identification number, and amount. This helps to guarantee that each batch is traceable and that any issues are detected and remedied as soon as possible. Compliance Record This part should include any documents relating to batch records GMP compliance. Signatures of approval and materials from third-party testing should be added.

22. Requirements of Batch Manufacturing Records Generally, batch records must include information about the raw materials used, process steps followed, and tests performed to verify quality during the batch manufacturing process. Additionally, these records must be kept up to date, securely stored, and readily available to regulatory authorities or auditors. Regulatory Requirements Regulatory requirements of batch manufacturing records dictate that all relevant information related to the production of a product must be documented and tracked in a batch record. These records must include the raw materials and ingredients used, the production process, the completed product, and all other quality control measures. Also, a quality assurance representative must verify and sign all batch records to ensure accuracy and compliance with regulatory standards. Furthermore, all records must be stored and maintained in a secure location for a minimum of five years.

23. Requirements of Batch Manufacturing Records Auditing Requirements Auditing batch manufacturing records is the process of reviewing and verifying the accuracy and completeness of the logs associated with the production of a single batch of a product. This includes reviewing records of raw materials and ingredients, equipment, batch production processes, finished product specifications, and test results. Auditing is important to ensure compliance with applicable regulations and standards, product quality and safety, and the records accurately reflect the production process. Auditing requirements will vary by industry but generally include the following: Review of all raw materials and ingredients used in the production process, including associated test results and certificates of analysis.

24. Requirements of Batch Manufacturing Records Review of all production processes, including process parameters, instrument readings, equipment settings, and operator documentation. Review of all finished product specifications, including test results. Review of all records associated with the release of the finished product, including certificates of analysis, release records, and sterility testing. Review of any changes to the batch production process, including any changes to the raw materials or ingredients used. Verify the accuracy and completeness of the batch records by comparing them to the production process.

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