Lec. 2 GMP PDF

GMP Lec. 2 Prof. Hesham M. Tawfeek Last Lecture?? Special Product Quality Management Tree QA, QC, GMP Definitions 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek Quality Management 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek ❑Quality management' i...

GMP Lec. 2 Prof. Hesham M. Tawfeek Last Lecture?? Special Product Quality Management Tree QA, QC, GMP Definitions 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek Quality Management 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek ❑Quality management' it is the management functions that determines and implements the quality policy. ❑ It is defined as 'a combined team effort to develop1, produce2, control3, market4 and distribute5 products that are safe and effective during the time they remain in the market place. 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek  Quality Management System: It is the formalized system for: Documents, Processes, Procedures and responsibilities to achieve the quality policies and objectives 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek  The primary goal of quality management within the workplace is to strive for continuous improvement. As such, both corrective and preventive actions play an important role in providing the employees and management with improved performance. The preventive actions; actions taken to eliminate the cause of potential nonconformities in order to prevent their occurrence The corrective actions; taken to eliminate causes of nonconformities in order you prevent the reoccurrence. 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek  Head of Quality Management Job?? Establishes quality and reliability standard by studying product and consumer requirements with other members of management and with production operators, technicians, etc., Maintain the quality assurance staff by recruiting, selecting, orienting, and training employs. 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek There are two basic elements to the function of quality management. I-Quality System Infrastructure There must be an infrastructure in place dedicated to making the products correctly. This sets up the procedures and processes that need to be carried out, and ensures that appropriate resources are available to carry out those procedures and processes. 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek 2- Systematic Actions ‫اإلجراءات النظامية‬ Once the infrastructure is in place, carrying out a set of systematic actions, which bring the quality policy to life. It is these actions that make up the function of QA. An important part of the systematic actions is the availability of a complete system of standard operating procedures. \ ‫إجراءات التشغيل القياسية‬ They describe all the actions that need to be taken in a standardized way. 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek Quality Assurance daman el gawda 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek  Is the sum total of the organized arrangements made with the object of ensuring: A- Products will be of the quality required by their intended use. (fit its use) B- Meets the required specifications. ‫مطابق للمواصفات المطلوبة‬ QA = GMP + other factors affecting the product quality like product design and development 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek ❑The achievement of QA is not the duty of this single organizational unit alone, but is the responsibility of all staff members and production units who can influence product quality in any way. ❑QA will have the final authority for product acceptance (release) or rejection. ❑Therefore, the QA must be independent of the economic issues associated with manufacturing and distribution of the product. 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek  What they are doing? Ideally, they should do report directly to the president of the company. (in case of rejection and or acceptance) This means that, they are considered to be the key decisions on product quality and there is no interference from manufacturing staff. 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek Responsibilities of OA; 1-Product design and development It is important to ensure that products are formulated and developed in accordance with QA principles and quality management policy and with the required specifications. 2- Specification for production and control (preparation of SOPs): The SOPs are written specifications for all aspects of manufacturing and supply 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek ❖These specifications should state what must be achieved and how to achieve. ❖They will cover all: ❖Starting materials, ❖Intermediates, ❖ Finished products, together with process specifications and analytical methodology to achieve QA in the rest of manufacturing. 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek SOP again: They describe all the actions that need to be taken in a standardized way. This means that everyone involved in pharmaceutical manufacturing has a book of procedures, which guides them in the way that they should do their job. 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek 3-Managerial responsibilities: There need to be a defined organizational structure and clear job descriptions for all personnel, particularly those in managerial positions. This is required to ensure that there are sufficient qualified and experienced people available who have the correct training to carry out their responsibilities. 4- Control of starting and packaging materials: This relates to management of purchasing, receipt. Sampling and testing of raw materials and packaging materials to ensure they comply with the required standards and specifications. 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek 5- Control of intermediate materials: There is a requirement to ensure that all intermediate materials be appropriate and for all in-process checks to be set up and carried out. 6- Control of finished products: Similarly, there is a requirement to ensure that all the necessary measures are in place for testing of finished products. 7- Batch release: Batch release can only be authorized by the qualified person after all the checks have been done to ensure that the product has been produced and controlled in accordance with the established specifications 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek 8- Control of storage and distribution conditions During product development, stability testing will have been done. The result from the stability testing is a set of specified conditions under which the product should be stored and distributed. This will be a specification relating to temperature, humidity, exposure to light and/or other parameters. 9- Self-inspection program morag3a w fa7s ▪ A key part of the management of the manufacturing operation is the auditing of the operation for its compliance to all quality requirements. ▪ The auditing is done at several levels within the company. ▪ Self-inspection is the internal audit function existing within the departments. 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek 10- Documentation ▪ The QA is responsible for assembling and reviewing all documentation related to the processing, packaging and testing of each batch of the finished products before authorizing release for sale. ▪ All documents should be clear, precise, unambiguous and written in a language the user can understand. 11- Control of Records 2024 ،‫ تشرين الثاني‬09 ،‫السبت‬ Dr. Hesham M. Tawfeek Quality Control  The Pharmaceutical quality control refers to; The sum of all procedures undertaken to ensure the Identity, Purity, Compliance of a particular pharmaceutical product with the predetermined specifications. Such procedure may range from performing single chemical experiment to more complicated requirements of pharmacopeia monographs.  It is considered a part of Good Manufacturing Practice which is concerned with sampling and testing. The quality of the product may deviate from the standard required, so carrying on analysis is important in order to determine its quality. And to insure the standard level required Testing of pharmaceutical products involves; Chemical, Physical and sometimes Microbial evaluation test. Counterfeit Medicine: not similar to whats written on label A product that with intent an illegally mislabelled with respect to its identity and/or resource Counterfeit medicine is a criminal offense which may endanger patient life  Counterfeit Medicine may: Contain no active ingredient Contain wrong AI e.g., low quality or sheep antibiotic instead of highly grade and expensive one Contain incorrect quantity of active ingredients Be in low quality packaging Be manufactured under low quality active ingredients and or excipients Be manufactured under low standards of GMP compliance  Counterfeit products could be detected by carrying out appropriate identification and quantities tests. This is the major role of Q.C. department towards different materials e.g., starting and packaging materials Requirements for QC ??? 1- Adequate resources: The QC department must have adequate resources to carry out its responsibilities.  These resources are; A- Adequate laboratory facilities. E.g., equipment B- Appropriately qualified, trained and experienced personnel. C- Approved documented procedures covering all the operational duties of the departments e.g., Sampling; Analytical testing; Inspecting and monitoring of all materials and environmental conditions in the factory.  mix up: replace material by material Quality Control Laboratories: The laboratories should be:- a5lt material b material together by mistake (I) Large enough to suit the level of production being monitored and to prevent cross-contamination between samples, orderly placement of equipment. (2) Adequately staffed and fully equipped for performing all quality control tests and analyses required during and after manufacture. (3) Located close to, but physically separated from, production areas. 2- Validated or verified test methods: All test methods used within the laboratories and in-process control areas should be validated or verified. For a method that is taken from e.g., national pharmacopoeia, it is considered satisfactory. However. if an analytical method has been developed in- house, it must be fully validated.  The validation of test methods includes consideration of accuracy, precision, linearity, repeatability, robustness and specificity. This means that the test methods should demonstrate that they are able to give an accurate result on a repeatable basis. Quality Control must ensure:- A- Active ingredients and correctly labelled containers QC must ensure that all the finished products contain active ingredients that comply with the qualitative and quantitative composition of the finished product described in the product registration file (dossier).  Labelling of finished product is very important. How? Mixing up the printed components during printing or labelling and text errors in the printing should be identified before the product is released. B- Raw materials It is most important that the materials used in manufacture comply with the required specifications which dose not affect the quality of the final product. Maintaining a consistent specification for excipients is important for the quality of the final product. lazm test every time i get materials