Good Manufacturing Practice (GMP) Lecture PDF
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Dr. Amira Motawea
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Summary
This lecture provides an overview of Good Manufacturing Practices (GMP) in the pharmaceutical industry. It covers various aspects of GMP, including quality assurance, quality control, and the objectives of these practices. The lecture also discusses the importance of GMP for the safety and efficacy of pharmaceutical products.
Full Transcript
Good Manufacturing Practice (PT-5110) By: Dr. Amira Motawea Good Manufacturing Practice and Quality Assurance Introduction about Quality Assurance & Good Manufacturing Practice Quality Quality The total features and ch...
Good Manufacturing Practice (PT-5110) By: Dr. Amira Motawea Good Manufacturing Practice and Quality Assurance Introduction about Quality Assurance & Good Manufacturing Practice Quality Quality The total features and characteristics of a medicinal product and its ability to satisfy stated and/or implied needs. Quality management Quality management It is defined as the aspect of management that determines and implements the “quality policy” that is formally expressed and authorized by top management. The basic elements are: “Quality system” that includes the organizational structure, procedures, and resources. “Quality assurance (QA) Quality assurance (QA) Quality assurance (QA) It is the arrangements made to ensure that pharmaceutical products are of the quality required for their intended use. Requirements: Competent personnel Suitable & sufficient buildings, equipment & facilities Objectives of quality assurance (QA): quality assurance should ensure that: Pharmaceutical products are designed and developed according to the requirements of GMP Production and control (evaluation) operations are specified in a written form Management responsibilities are clearly specified in job descriptions. Arrangements are made for the manufacture, supply and use of the starting and packaging materials. Objectives of quality assurance (QA): quality assurance should ensure that: All necessary controls on starting materials, intermediate products, bulk products, calibrations, and validations are carried out. The finished product is correctly processed and checked Pharmaceutical products are not sold before the authorized persons have certified that each batch has been produced and controlled in accordance with the requirements. Objectives of quality assurance (QA): – Quality assurance should ensure that: There is a procedure for self-inspection Regular evaluation of the quality of pharmaceutical products Good manufacturing practice (GMP) Definition: GMP is that part of quality assurance which ensures that products are produced and controlled according to the quality standards suitable to their intended use. GMP ensures that quality is built into the organization & processes involved in manufacture. Good manufacturing practice (GMP) GMP covers all aspects of manufacture including Collection, Transportation, Processing, Storage, QC Delivery of the finished product Good manufacturing practice (GMP) GMP violations consequences Product is “adulterated” Shutdown of manufacturing facility Seizure of product Recall product Competitive disadvantage Quality control (QC) It is that part of GMP concerned with sampling, specification & testing, documentation & release procedures which ensure that the necessary & tests are performed and the product is released for use only after ascertaining its quality. Quality control (QC) Quality Management Quality Assurance GMP Quality Control Differences between quality control and quality assurance QC is a part of GMP that is concerned with materials testing but QA is concerned with processes testing Objectives of GMP: To ensure that: All manufacturing processes are clearly defined and systematically reviewed. Qualification and validation are performed. All necessary resources are provided, including: (i) Appropriately qualified and trained personnel. (ii) Adequate building and space. (iii) Suitable equipment and services. Objectives of GMP: All necessary resources are provided, including: (contd) (iv) Appropriate materials, containers and labels. (v) Approved procedures and instructions. (vi) Suitable storage and transport. (vii) Adequate personnel, laboratories and equipment. Instructions and procedures are written in clear language Operators are trained to carry out procedures correctly. Objectives of GMP: Records are made manually and/or by recording instruments. Records covering manufacture and distribution, which enable the reproduction of a batch are provided. The proper storage and distribution of the products without affecting their quality. Complaints about marketed products are examined; the causes of quality defects are investigated, and appropriate measures are taken to prevent recurrence. Ten Principles of GMP Design & construct the facilities & equipment properly Follow written procedures & Instructions Documentation Validation Conduct planned & periodic audits monitoring facilities & equipment Write step by step operating procedures & work on instructions Ten Principles of GMP Design, develop & demonstrate job competence. Protect against contamination. Control components & product related processes. Conduct planned & periodic audits. Industrial benefits of GMP/QA Good plant lay out. Smooth work flows. Efficient documentation systems. Well-controlled processes. Good stores lay outs and stores records. Avoidance of cost of quality failure (cost of waste, of rework, of recall, of consumer compensation and of loss of company reputation. Industrial benefits of GMP/QA A poor quality medicine may contain toxic substances that have been unintentionally added. It prevents mislabeling and adulteration It prevents/controls contamination and cross- contamination The clinical benefits of GMP Ensures that products are safe for use by humans. Minimizes variations in potency of the drug. Ensures reproducible physiological activity. Prevent side effects and toxicity due to variations in drug content and potency. Good manufacturing practice