Speaker 1: Hello and welcome to this InnoPharma course on GMP and Pharmaceutical Quality Systems. This course is designed to give you an overview of good manufacturing practice or GMP and the quality system used in the manufacture of medicinal products.

Speaker 2: A firm understanding of the importance of quality and good manufacturing practice or GMP is essential for any career in the pharmaceutical industry. This course gives a brief history of the regulatory roadmap which has led to the regulations and quality systems that are in place today. The course begins by defining quality with respect to pharmaceutical products. The product should contain the correct ingredients in the correct quantities, free from contamination and be correctly labelled. It should be properly sealed in its container and protected from damage and contamination. Next you'll learn about good manufacturing practice or GMP. GMP is a set of principles and procedures which when followed by manufacturers help to ensure that the products will have the required quality. This includes the people working in the plant and the design and management of the premises, equipment and utilities. The processes we use are well defined and controlled, while the procedures in place clearly document how each task is to be performed. The product itself needs to be traceable from start to finish. Moving on, the concept of quality system element or QSE is introduced. This is a business process which forms part of the pharmaceutical quality system. We've broken it into 15 quality system elements in this course. An overview of each of these is provided. First quality assurance. Next premises and equipment. This is followed by calibration. The next QSE is technology transfer. This involves transferring processes from development to production or from one manufacturing site to another while ensuring the product quality is maintained. For training, all personnel need to adequately perform their assigned roles. Personnel are trained during induction, when roles are changed or whenever changes are made to how a task is performed. Training is therefore an ongoing exercise in any manufacturing facility. The QSE of good documentation is a huge part of GMP and working in the pharmaceutical industry. This course teaches you all about the hierarchy of documentation. You'll learn about typical GMP documents like the batch manufacturing record or BMR. You'll also cover how to make corrections to entries in GMP documents, which is standard practice in the industry. For the QSE supplier qualification, careful selection and management of our suppliers is key to ensuring consistent quality of finished products. Next QC testing and stability. The QC lab tests raw materials, products in the process of being manufactured as well as finished product and environmental samples. The QC lab also manage the stability program which supports the shelf life of our products. To cover the QSE validation, the course provides an overview of validation documentation as well as equipment qualification, process validation and cleaning validation. The next QSE is change control. This is a mechanism for managing the implementation of change and ensuring product quality is not impacted.

Speaker 3: Change control is a mechanism whereby when we want to make change to a system, we put through a formal request. We provide the details behind that request. We provide the implications for the equipment and details of the level of testing that we're going to do following the change. And typically a cross-functional committee at senior level will determine whether or not we have gone far enough in our change control with our explanations that we put enough detail around the change and provided enough information with respect to the change and that we're going far enough with regard to verifying that the change has no negative impact on the process that is already being validated. And through that mechanism, we get the green light to make changes, to qualify changes and the ultimate goal is maintaining the validated state so that we at no time put the end user which is the patient relying on the medication, that at no time we put them at risk through making uncontrolled or improper changes to a validated process.

Speaker 2: This is followed by covering the QSE investigation and CAPA.

Speaker 4: Of any issue in manufacturing or in the labs or within a business, it's important to do a proper root cause analysis or investigation into that issue to ensure that you've found exactly what caused the issue so you can address that issue and put in the proper and corrective actions or preventative actions if you've found something may happen again in the future.

Speaker 2: Audits may be internal or external. It highlights any potential weaknesses in our system and facilitates continuous improvement. For the QSE of customer complaints, these are taken very seriously by the industry and need to be investigated thoroughly. The next QSE is recalls. There are times when a company needs to remove batches of product from the marketplace. There's a process for performing a recall and the relevant regulatory authority needs to be informed. The final QSE is annual product review. This is a systematic review of a product's performance over a calendar year. This can be reviewed at the learner's own pace with knowledge checks throughout the course to verify their understanding and an assessment to test their knowledge at the very end. This course assumes no prior knowledge and all topics are broken down piece by piece to make them accessible and enjoyable to learn. To find out more, contact InnoPharma by phone at plus 353-1485-3346. You can also email us at elearning at innopharmalabs.com and you'll find plenty of information on our website at innopharmalabs.com.