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Presentation on Good Manufacturing Practice

Presentation on Good Manufacturing Practice. Good Manufacturing Practice.

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Presentation on Good Manufacturing Practice

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  1. Presentation onGood Manufacturing Practice www.AssignmentPoint.com

  2. Good Manufacturing Practice • A good manufacturing practice (GMP) is a production and testing practice that helps to ensure a quality product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines. www.AssignmentPoint.com

  3. Why is GMP required? • To minimize human error. • To prevent the contamination of pharmaceuticals and deterioration of quality. • To ensure high quality of product. www.AssignmentPoint.com

  4. GMP Guidelines for Microbiology Laboratory: • Personnel : All personal must be wear apron,gloves. • Environment: Control air, ventilation,temparature & humidity. • Equipment: Must be cleaned up & stored. • Validation: To ensure consistency & complience. • Sampling: Random sampling must be associated by any testing procedure in microbiology lab. www.AssignmentPoint.com

  5. GMP Guidelines for Microbiology Laboratory: • Good procedure: Clear, concise & logical. • Reagents and culture media: Adjacent main lab is used for storage of culture media. • Contamination: Avoid accidental contamination. • Testing procedure: Are designed to reveal the presence of MO. • Test record: Record all necessary info. immediately after complitation of task. www.AssignmentPoint.com

  6. Other good practices: • GLP : Good laboratory practice for laboratories conducting non-clinical studies (toxicology and pharmacology studies in animals). • GCP : Good clinical practice for hospitals and clinicians conducting clinical studies on new drugs in humans. • GRP: Good regulatory practice for the management of regulatory commitments, procedures and documentation. • GDP : Good Distribution Practice deals with the guidelines for the proper distribution of medicinal products for human use. • GTP : Good Transportation Practice (GTP) deals with the guidelines for the proper domestic and international transportation of medicinal products for human use. www.AssignmentPoint.com

  7. Organization/Authorize : • WHO : The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over one hundred countries worldwide, primarily in the developing world. • WHO is expanding its guidance library to focus specifically on GMP expectations for microbiology labs and is adjusting its existing guidelines on drafting site master files, on water used in pharmaceutical manufacturing and heating, ventilation, and air-conditioning (HVAC) systems www.AssignmentPoint.com

  8. cGMP: cGMP are the Current Good Manufacturing Practices followed by the pharmaceutical and biotech firms to ensure that the products produced meet specific requirements for identity, strength, quality, and purity cGMP in a microbiological laboratory : • It begins by introducing the different types of microorganisms that can contaminate medicinal products. • It then goes on to introduce GMP and explain its importance in a microbiology laboratory and the rules and guidelines for handling infectious material. www.AssignmentPoint.com

  9. Some Organizations are : • FDA : The Food and Drug Administration, Department of Health and Human Services (FDA) of the United States of America exchange information & documents on the observation facilities for adherence to Current Good Manufacturing Practices (CGMPs) . • TGA: The Therapeutic Goods Administration (TGA) is the part of the Australian Government Department of Health and Ageing, and is responsible for regulating therapeutic goods including medicines, medical devices, blood and blood products. www.AssignmentPoint.com

  10. Organization: EU-GMP: The European Union's GMP (EU-GMP) enforces similar requirements to WHO GMP, as does the Food and Drug Administration's version in the US. The Orange Guide: In the United Kingdom, the Medicines Act (1968) covers most aspects of GMP in what is commonly referred to as "The Orange Guide", which is named so because of the color of its cover; it is officially known as Rules and Guidance for Pharmaceutical Manufacturers and Distributors. www.AssignmentPoint.com

  11. Thank you all……. www.AssignmentPoint.com

  12. Any Question ??? www.AssignmentPoint.com

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