QUALITY CONTROL (QC ) DEPARTMENT

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QUALITY CONTROL (QC ) DEPTMENT – SYLLABUS :

 

  • 1. Good Manufacturing Practice (GMP) , D & C Act – Schedule M.
  • Good Laboratory Practice (GLP) , D & C Act – Schedule L1.
  • Role of QC in Pharmaceutical Organizations.
  • A. Sampling of RM /PM / In-process / FP samples, Affixing of Under
  • Test / Approved / Rejection labels on RM/PM/FP containers /

          shippers.                                                                                                           

  1. Preparation of Working Standards & Maintenance Vs Reference

          Standards.                                                                                                         

  1. Preparation of Reagents & Chemical agents, Buffers etc. & labelling

          of Preparatory date & their Validity.                                                                                                                                     

  1. Approval, Rejection, Reporting-Generation of Certificate of Analysis

          (COA) .

  • Good Documentation Practices (GDP)
  • Standard Operating Procedures (SOPs) -QC (05).
  • A. List of all QC Instruments & their uses.
  1. Instrumental Analysis: HPLC operation
  • Water System Validation.
  • Role of Public Testing Laboratories.
  • Control samples Management.
  • Stability samples Management.
  • How to face the interviews in Pharmaceutical organizations

      Confidently & Successfully.

  • QC Interview likely questions.
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What Will You Learn?

  • QUALITY CONTROL (QC ) DEPTMENT - SYLLABUS :
  • • 1. Good Manufacturing Practice (GMP) , D & C Act – Schedule M.
  • • 2. Good Laboratory Practice (GLP) , D & C Act – Schedule L1.
  • • 3. Role of QC in Pharmaceutical Organizations.
  • • 4.A. Sampling of RM /PM / In-process / FP samples, Affixing of Under
  • • Test / Approved / Rejection labels on RM/PM/FP containers /
  • shippers.
  • B. Preparation of Working Standards & Maintenance Vs Reference
  • Standards.
  • C. Preparation of Reagents & Chemical agents, Buffers etc. & labelling
  • of Preparatory date & their Validity.
  • D. Approval, Rejection, Reporting-Generation of Certificate of Analysis
  • (COA) .
  • • 5. Good Documentation Practices (GDP)
  • • 6. Standard Operating Procedures (SOPs) -QC (05).
  • • 7. A. List of all QC Instruments & their uses.
  • B. Instrumental Analysis: HPLC operation
  • • 8. Water System Validation.
  • • 9. Role of Public Testing Laboratories.
  • • 10. Control samples Management.
  • • 11. Stability samples Management.
  • • 12. How to face the interviews in Pharmaceutical organizations
  • Confidently & Successfully.
  • • 13. QC Interview likely questions.

Course Content

QUALITY CONTROL (QC ) DEPTMENT
QUALITY CONTROL (QC ) DEPTMENT - SYLLABUS : • 1. Good Manufacturing Practice (GMP) , D & C Act – Schedule M. • 2. Good Laboratory Practice (GLP) , D & C Act – Schedule L1. • 3. Role of QC in Pharmaceutical Organizations. • 4.A. Sampling of RM /PM / In-process / FP samples, Affixing of Under • Test / Approved / Rejection labels on RM/PM/FP containers / shippers. B. Preparation of Working Standards & Maintenance Vs Reference Standards. C. Preparation of Reagents & Chemical agents, Buffers etc. & labelling of Preparatory date & their Validity. D. Approval, Rejection, Reporting-Generation of Certificate of Analysis (COA) . • 5. Good Documentation Practices (GDP) • 6. Standard Operating Procedures (SOPs) -QC (05). • 7. A. List of all QC Instruments & their uses. B. Instrumental Analysis: HPLC operation • 8. Water System Validation. • 9. Role of Public Testing Laboratories. • 10. Control samples Management. • 11. Stability samples Management. • 12. How to face the interviews in Pharmaceutical organizations Confidently & Successfully. • 13. QC Interview likely questions.

  • 1. Good Manufacturing Practice (GMP) , D & C Act – Schedule M.
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