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Good manufacturing practices himanshu

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Good manufacturing practices, GMP, pharmaceutical quality assurance, 6th sem , b pharam
Introduction
Why GMP?
Evolution of GMP
Main risks without GMP
Principles of GMP
Design and construct the facilities and equipment properly
Follow written procedures and Instructions
Document work
Validate work
Monitor facilities and equipment
Write step by step operating procedures and work on instructions
Design ,develop and demonstrate job competence
Protect against contamination
Control components and product related processes
Conduct planned and periodic audits

GMP categories

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Good manufacturing practices himanshu

  1. 1. Good Manufacturing Practices Himanshu Assistant professor
  2. 2. CONTENTS  Introduction  Why GMP?  Evolution of GMP  Main risks without GMP  Principles of GMP  GMP categories
  3. 3. Good Manufacturing Practices (GMP) Performance standards that WHO and many national governments established for a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods for example, personnel, facilities, packaging, and quality control INTRODUCTION
  4. 4. Why GMP?  Final testing of the product cannot ensure the Quality efficiency and safety.  Final testing may always not detect contamination, error, etc.  Conformance to the predetermined specification.  To minimize contamination eg:- microbial contamination.  To eliminate error.  To produce product of consistent quality.  Government requirement.  Ensure quality product.  Reduce rejects, recalls.  Satisfied customers.  Company image and reputation.
  5. 5. EVOLUITON OF GMP 1963: - first GMP publication –USA 1971: -first revision 1978: - Major revision Current regulation of GMP appear in part 210 (title 21) of code of federal regulations published by USFDA
  6. 6. MAIN RISKS WITHOUT GMP:  Unexpected contamination of products, causing damage to health or even death.  Incorrect labels on containers, which could mean that patients receive the wrong medicine.  Insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.
  7. 7. WHY GMP IS IMPORTANT?  Government requirement  Ensure quality product  Reduce rejects, recalls  Satisfied customers  Maintain manufacturing consistency  Company image and reputation
  8. 8. PRINCIPLES OF GMP:  Design and construct the facilities and equipment properly  Follow written procedures and Instructions  Document work  Validate work  Monitor facilities and equipment  Write step by step operating procedures and work on instructions  Design ,develop and demonstrate job competence  Protect against contamination  Control components and product related processes  Conduct planned and periodic audits
  9. 9. GMP Categories  Sale  Premises  Equipment  Personnel  Sanitation  Raw Material Testing  Manufacturing Control  Packaging Material Testing  Finished Product Testing  Quality Control Department  Records  Samples  Stability  Sterile Products
  10. 10. Sale No distributor … and no importer shall sell a drug unless it has been fabricated, packaged/labeled, tested, and stored . Premises & Equipment Permits effective cleaning Prevents contamination Orderly conditions Good state of repair Personnel Appropriate education, training and experience Sufficient number of people Receive GMP training Sanitation Sanitation Program to prevent contamination Limit the sources and types of contamination Cleaning procedures for facilities & equipment Pest control Environmental monitoring
  11. 11. Raw Material, Packaging Material and Finished Product Testing each lot or batch of raw material is tested • confirm the identity of the raw materials • provide assurance that quality of the drug in dosage Samples of incoming materials are collected and tested before use Approved test methods and specifications are used Results must conform to specifications for release for use or sale Transportation and storage records Manufacturing Control Written procedures are established and followed Master formulae, manufacturing order and packaging order Critical processes are validated 2nd person verification of activities Self-Inspection Programmed
  12. 12. Quality Control Department Quality Control Responsibilities Testing of bulk components prior to use by production Testing of finished product prior to release for sale Stability program Review batch records, labels Release product, based on QC test results Training, auditing Customer complaints Records Document all GMP activities Use Good Documentation Practices (GDP) Records must be readily available Good Documentation Practices Documentation must be: permanent (black or blue ink) legible, clear, concise accurate Timely, complete
  13. 13. Samples Retain samples of each lot of raw material and finished product for specified period of time Stability Establish the length of time in which the product meets all specifications Monitor the drug for this period of time Sterile Products Packaged in separate enclosed area by trained personnel using method to ensure sterility
  14. 14. THANK YOU

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