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Category: Uncategorized

Personnel – Good Practices for Pharmaceutical Quality Control Laboratories

July 30, 2020 Admin Leave a comment

The laboratory should have sufficient personnel with the necessary education, training, technical knowledge and experience for their assigned functions. The…

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Posted in: Uncategorized Filed under: Personnel, Quality Control

Data Processing of Quality Control Lab Equipment

July 28, 2020 Admin Leave a comment

Data Processing of Quality Control Lab Equipment. Detailed recommendations are provided in Appendix 5 to Annex 4 of the Fortieth…

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Control of documentation

July 24, 2020 Admin Leave a comment

Documentation is an essential part of the quality management system. The laboratory should establish and maintain procedures to control and…

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Specific Requirements For Manufacture of Oral Solid Dosage Forms

April 5, 2019 Admin Leave a comment

SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL SOLID DOSAGE FORMS (TABLETS AND CAPSULES) The processing of dry materials and products creates…

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SOP For Corrective Action and Preventive Actions

April 2, 2019 Admin Leave a comment

SOP For Corrective Action and Preventive Actions   OBJECTIVE: Lay down the procedure for corrective and preventive action programme in…

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Performance Qualification (PQ) Protocol & Report Format In Pharmaceuticals.

Admin 2 Comments

Performance Qualification In Pharmaceutical Industry. Systems and equipment should consistently perform in accordance with design specifications. The performance should be…

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Temperature And Relative Humidity Monitoring In Pharmaceutical Industry

March 11, 2019 Admin Leave a comment

Temperature and Relative Humidity Monitoring In Pharmaceutical Industry   The environment inside a pharmacy and pharmaceutical storage areas must be…

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GMP Requirements for Certificates of Analysis (CoA)

February 25, 2019 Admin Leave a comment

GMP Requirements for Certificates of Analysis (CoA) At times of outsourcing and globalisation, the significance of Certificates of Analysis (CoA) is…

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General Safety Rules for  Quality Control Laboratory. 

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General Safety Rules for  Quality Control Laboratory. General Safety Rules For Quality Control Laboratory. General and specific safety instructions reflecting…

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Quality Control Testing of Raw Materials, APIs, and Finished Products.

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Quality Control Testing of Raw Materials, APIs, and Finished Products. The Quality Control Testing  of Raw Materials, APIs, and Finished…

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  • SOP List For Pharmaceutical Quality Assurance
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  • WHO

Pages

  • Analytical Method Validation
  • Blog
  • cGMP
  • Contact Us
  • Drug Regulatory Affairs
  • EDQM
  • Home
  • ICH
  • List of ICH Quality Guidelines for Pharmaceutical Industry
  • Maintenance
  • Microbiology
  • Privacy Policy
  • Process Validation
  • Production
  • Quality Assurance
  • Quality Control
  • SOP Format
  • SOP List For Pharmaceutical Quality Assurance
  • SOP on Change control
  • SOP on Handling of Incidents and Deviations
  • SOP on Training of Employees
  • WHO

Tags

Analyst Qualification Audit Preparation Calibration CAPA Change Management System Cleaning Validation Compression Machine Computerized System EU Audit Requirements FDA Warning Letter HPLC Calibration ICH Guideline ICH Q10 laboratory guideline MHRA Microbial Testing Microbiology Microbiology SOP Microbiology Techniques OOS Operation Out of Specification Out of Trend Pharmaceutical Production Pharmaceutical Quality System Phase-I Phase-II Phase Ia Phase Ib production Production SOP QMS Qualifications Protocol Qualification  Steps Quality Assurance Quality Control Quality Control Laboratory Quality Control SOP Quality Management System SOP SOP for Qualification of Quality Control analyst Stability Study Sterile Pharmaceutical products Sterility Testing USFDA
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  • SOP Format
  • Quality Control
  • Production
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  • Maintenance
  • EDQM
  • Analytical Method Validation
  • Process Validation
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  • ICH
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