PowerPoint Presentation

[Virtual Presenter] This training session on Good Manufacturing Practices aims to provide a comprehensive overview of the fundamental concepts and principles of GMP, which are crucial for guaranteeing the quality of our products. We will embark on this educational journey together, exploring the key aspects of GMP that are vital for ensuring the reliability and consistency of our products..

[Audio] GMP is the basic control measures and procedures that have to be carried out to produce a product which meets specifications and is safe to consume. It is not a single event or task, but a set of ongoing control measures and procedures that must be carried out consistently to ensure the end product meets all specifications and is safe for consumption. This is in accordance with the guidelines provided by the World Health Organization (WHO). GMP is an integral part of quality management and applies to all aspects of production and quality control. It ensures that products are consistently produced and controlled according to the quality standards required for their intended use and in line with the regulations set by the relevant authorities. GMP is not a static concept, but rather an ever-evolving one, continuously improving and adapting to new regulations and technologies..

[Audio] GMP is a set of guidelines and standards designed to minimize the risks involved in any pharmaceutical production process. It is not only applicable to the final production of medicines but also covers all stages of the life-cycle, from manufacturing investigational medicinal products to technology transfer and commercial manufacturing, all the way to product discontinuation. The main goal of GMP is to manage and minimize the risks inherent in pharmaceutical manufacturing. By following these guidelines, we can ensure that our products are of the highest quality, safety, and efficacy for the benefit of the patients who rely on them. Quality is the responsibility of everyone involved in the production process..

[Audio] Regulations are enforced by law, making them mandatory to follow. Standards, on the other hand, are typically set by private organizations and provide specific requirements tailored to an organization's needs. These standards serve as a framework for ensuring quality products. Guidelines offer recommendations rather than strict requirements, providing general guidance on how to accomplish tasks. Procedures outline the exact steps needed to complete a process, while standards represent the foundation upon which procedures are built. Policies are high-level statements that apply uniformly throughout an organization. Finally, international regulations must be adhered to when exporting products..

[Audio] Key personnel play a crucial role in ensuring the smooth operation of our manufacturing process. The head of production oversees the actual production of our products, while the head of quality unit ensures that all materials, procedures, and specifications meet the required standards. An authorized person has the authority to approve or reject these materials, procedures, and specifications. It is essential that these key personnel operate independently of each other to maintain the integrity of our quality system. This independence prevents conflicts of interest and ensures that decisions are made based solely on scientific evidence and technical considerations..

[Audio] The manufacturer should have an organization chart outlining the roles and responsibilities of each staff member. This chart should clearly show who reports to whom and the lines of authority within the organization. Responsible staff members should have their specific duties recorded in written descriptions ensuring that everyone understands their role and what is expected of them. These staff members should have adequate authority to carry out their responsibilities allowing them to make decisions and take actions without needing approval from others. The organization should have an adequate number of personnel with the necessary qualifications and practical experience. Everyone should have sufficient training knowledge and experience to perform their job effectively reducing the risk of errors and ensuring high-quality products. The responsibilities placed on any one individual should not be so extensive as to present any risk to quality..

[Audio] All personnel should undergo health examinations prior to and during employment. This is a crucial aspect of personal hygiene. Furthermore, it's essential that employees report any conditions that might impact product quality to their supervisors..

[Audio] It is essential to avoid direct contact between operators' hands and starting materials, primary packaging materials, and intermediate or bulk products, as such contact can potentially compromise the quality of the final product. According to the World Health Organization's Technical Report Series 986, Annex 2, Point 11, this practice is crucial to maintain the integrity of the manufacturing process. Additionally, personnel who appear to be ill or have open lesions, wounds, or infections that could impact the quality of the product should not work in close proximity to these materials. This precaution ensures that the risk of contamination is minimized, thereby guaranteeing the safety and efficacy of the final product. By adhering to this principle, we can ensure that our products meet the highest standards of quality and purity, ultimately benefiting patients and consumers alike..

[Audio] All personnel should practice good personal hygiene habits at all times. Wearing clean clothes, cleaning and combing hair, trimming and keeping nails neat, regular bathing, brushing teeth, and washing hands frequently are essential parts of this habit..

[Audio] Hand washing is an essential part of good manufacturing practices. It is crucial to remove germs and avoid getting sick. Proper hand washing requires good techniques, which include scrubbing our hands for at least 20 seconds to remove harmful germs and chemicals. This helps prevent the spread of germs to others..

[Audio] Wet your hands with clean running water. Apply soap and rub your hands together to create a lather. Ensure that all surfaces are covered, including the backs of your hands, between your fingers, and under your nails. Scrub your hands for at least 20 seconds, singing the happy birthday song twice if necessary. Rinse your hands thoroughly under clean running water, then dry them using a clean towel, electric hand dryer, or air dryer. This proper hand washing technique helps eliminate germs and chemicals from your hands..

[Audio] Everyone must practice good personal hygiene. This includes washing their hands at various times such as before eating, after eating, after using the toilet, before starting work, and after completing work. This is essential to maintain a clean environment and prevent contamination..

[Audio] Buildings and facilities must be well-maintained to guarantee the quality of products. Premises should be meticulously cared for to prevent any risks to product quality during repair and maintenance operations. Written protocols should be followed when cleaning and disinfecting. Additionally, pest control programs should aim to deny entry, food, and shelter to pests, insects, rodents, and birds. As such, buildings must be kept clean, easily cleanable, and pest-free. Schedules with approved cleaning agents should also be established..

[Audio] Waste material should not be allowed to accumulate. Instead, it should be collected in suitable receptacles for removal. This practice ensures a clean and hygienic environment, preventing contamination of the product..

[Audio] Storage areas should be designed to ensure the safe storage of materials and products. Electrical supply, lighting, temperature, humidity, and ventilation should be suitable. The area should be large enough to store different types of materials and products in a way that maintains order and prevents contamination. Rejected materials and products should be clearly labeled and stored separately in restricted areas. This ensures that they cannot be confused with other products and minimizes the risk of contamination..

[Audio] When checking containers, we need to ensure that they are intact and sealed properly to maintain the integrity of our products. We also need to verify that the information on the container matches the order, delivery note, and supplier's labels. Additionally, when storing materials, we must keep them away from walls and stacked above the floor, ensuring that the stacking height does not exceed the safety load and that there is no deformation of the stock units. Furthermore, it is essential to apply continuous temperature monitoring devices in critical storage areas such as cold storage, cool storage, stability chambers, and sample retention rooms..

[Audio] Equipment must be designed, constructed, and maintained to suit the operations to be carried out. This includes the location of the equipment within the facility. The design and construction of the equipment must ensure that it can operate safely and effectively. Maintenance is also crucial to prevent equipment failure and ensure consistent performance. Furthermore, all instruments attached to the equipment must be calibrated regularly to guarantee accurate results..

[Audio] Pneumatics is a branch of engineering that uses gas or pressurized air. In industry, pneumatic systems are often powered by compressed air or compressed inert gases. It is essential to ensure that there are no loose live electrical cables in the process. Any loose parts, including nuts and bolts, should be fixed immediately. Equipment and instruments should be properly tagged and labeled. Defective equipment should be removed and labeled. Furthermore, a supply of clean, oil-free air is required to operate pneumatic equipment..

[Audio] The production equipment used in manufacturing processes must be designed and constructed to ensure that they do not contaminate the product. Materials used to build the equipment must not react with, add to, or absorb the product in a way that affects its quality. A complete list of equipment and instruments, each identified by a unique ID number, is maintained. Additionally, equipment is ensured not to pose any hazards to the products being manufactured. Current drawings of critical equipment and support systems are kept, enabling identification of potential issues and taking corrective actions when necessary..

[Audio] Documentation is an essential part of the Quality Assurance system and should exist for all aspects of Good Manufacturing Practice. This principle emphasizes the importance of documenting every aspect of our work, from preparation to completion. The Data Integrity ALCOA+ principles provide guidelines for maintaining accurate and reliable records. These principles include attributes such as attributable, legible, contemporaneous, original, accurate, available, enduring, complete, and consistent. Following these guidelines ensures that our documentation meets the required standards. All mistakes should be corrected by crossing them out, leaving the original text or figures visible, and initialing and dating the correction. We must also avoid using scrap paper, blanco, or whitewash, as this can compromise the integrity of our records. Finally, we sign only what we have performed or verified, ensuring accountability and transparency in our work..

[Audio] Documents should be carefully designed, prepared, reviewed, and distributed. They should be regularly updated and kept current. Superseded documents should be retained for a specified period, ensuring they remain accessible during this time..

[Audio] Documentation is an essential part of the Quality Assurance system. Approved documents or written procedures are crucial for various activities within the organization. These include master formulae, specifications, batch records, testing methods, standard operating procedures, records, trainings, maintenance, qualification and calibration, labeling, and cleaning and sanitation. In essence, if something is not documented, it did not occur. This principle ensures that all activities are properly recorded and tracked, allowing for easy retrieval and review of information..

Thank You..