Lecture 1. D. amira motawea.pdf

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