Pharmaceutical Guidance Complete Pharma Solution

  • QA
    • Quality Assurance
  • QC
    • Quality Control
  • Microbiology
    • Microbiology
  • Production
    • Production
  • Engineering
    • Engineering
  • Warehouse
  • Validation
    • Validation & Qualification
    • Audit and Guideline
  • JOBS
  • USFDA 483
    • USFDA 483 USFDA 483 Warning Letter
  • Question and Answer
    • Question and Answer
Breaking News
  • Microbiological Efficacy of the Cycle
  • Microbiological Monitoring of the Environment
  • TOOLS FOR QUALITY IMPROVEMENT PART – I
  • Human Errors
  • What are the different types of Quality Management systems (QMS)?
  • What is future mapping?
  • OUT OF SPECIFICATIONS (OOS)
  • SOP for Quality Assurance Policy
  • ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION
  • RISK MANAGEMENT METHODOLOGY – ICH Q9

USFDA 483 Warning Letter

  • USFDA 483 Warning Letter Dated MAY 23, 2022

    USFDA 483 Warning Letter Dated MAY 23, 2022 This warning letter summarizes significant violations of …

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  • USFDA 483 Warning Letter Dated JUNE 14, 2022

  • USFDA 483 Warning Letter Dated JUNE 10, 2022

  • USFDA 483 Warning Letter Dated JUNE 22, 2022

  • USFDA 483 Observations – Top 5 Common Observations

Quality Assurance

  • TOOLS FOR QUALITY

    TOOLS FOR QUALITY IMPROVEMENT PART – I

    TOOLS FOR QUALITY IMPROVEMENT PART – I teams of people working together on projects in …

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  • Human Errors

  • What are the different types of Quality Management systems (QMS)?

  • What is future mapping?

  • OUT OF SPECIFICATIONS (OOS)

  • SOP for Quality Assurance Policy

  • ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION

  • RISK MANAGEMENT METHODOLOGY – ICH Q9

  • TABLE OF CONTENTS – QUALITY RISK MANAGEMENT -ICH Q9

Microbiology

  • Microbiological Efficacy of the Cycle

    Microbiological Efficacy of the Cycle Validation studies that demonstrate the efficacy (lethality) of the production …

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  • Microbiological Monitoring of the Environment

  • Operation, cleaning and maintenance of Static Pass Box.

  • STERILITY ASSURANCE

  • Functioning, cleaning and maintenance of Dynamic Pass Box

Production

  • VIAL WASHING MACHINE

    VIAL WASHING MACHINE An automatic rotary vial washing machine with an integral washing tank for …

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  • Sterilization and depyrogenation tunnel

  • ASEPTIC PROCESSES VALIDATION AS PER PIC/S

  • Tablet Defects and Remedial action in Pharma

  • Batch Manufacturing Record(BMR)

Quality Control

  • SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA

    SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA AS PER ICH Q6 A GUIDELINE Question – 1: …

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  • Quality Risk Management in Analytical Laboratory

  • IMPURITIES IN NEW DRUG SUBSTANCES

  • HPLC (Questions & answers)

  • Dissolution (Question & Answer)




Recent Jobs

Jobs in Akums Haridwar-  opening for QA Validation & IPQA of injectable

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Aurobindo Pharma – Urgent Openings for Production / Process Development / Technology Transfer – Apply Now

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Jobs in Mankind Pharma Limited- Openings for Multiple Positions in QA/ QC/ Microbiology/ Production/ Engineering Dept. -Apply Now

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Jobs in Encube Ethicals Pvt. Ltd. Hiring for Officer/Sr. Officer – Production & Jr. Engineer – Production Department

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Jobs in JB Chemicals & Pharmaceuticals Ltd. Hiring for Officer/Executive – ADL department

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