SOP for Good Laboratory Practices (GLP) in Microbiology, Good Laboratory Practices (GLP) for the Bacterial Endotoxin Test (BET) and Sterility / Bio Burden test

SOP for Good Laboratory Practices (GLP) in Microbiology, Good Laboratory Practices (GLP) for the Bacterial Endotoxin Test (BET) and Sterility / Bio Burden test This SOP is applicable for the microbiology laboratory to achieve accuracy in the microbiological results. Mainly Bacterial Endotoxin Test (BET) and sterility / Bio Burden tests are performed into the microbiology … Read more

SOP on Supplier Qualification / Vendor Qualification / Vendor Management / Vendor Approval Procedure / Approved vendor list template

  SOP on Supplier Qualification / Vendor Qualification / Vendor Management / Vendor Approval Procedure / Approved vendor list template All pharmaceutical industries are following the vendor/service provider approval or rejection procedure. Vendor qualification is required to evaluate the product quality, vendor capability, consistency, reproducibility etc. SOP on Supplier or Vendor Qualification / Vendor Management / Vendor … Read more

Most commonly used Root Cause Investigation / Root cause Analysis tools with examples, 5 why analysis, Ishikawa diagram.

  Most commonly used Root Cause Investigation / Root cause Analysis tools with examples, 5 why analysis, Ishikawa diagram, etc. The root cause is the very common procedure adopted by most of the industry to identify the issue/problem. Most of the industry follow the standard procedure to identify the root cause. Some of the common … Read more

SOP for Root Cause Analysis (RCA) / Root cause investigation procedure with template, Commonly used Root cause investigation tools

SOP for Root Cause Analysis (RCA) / Root cause investigation procedure with template, Commonly used Root cause investigation tools This SOP is describing the investigation process of the nonconformity to identify the main reason behind the occurrence of that nonconformity. This root cause investigation process is helpful to find the corrective action and preventive action … Read more

SOP for Corrective Action and Preventive Action (CAPA) , Difference between corrective and preventive action, Corrective Action and Preventive Action plan and CAPA template in Pharmaceuticals

  SOP for Corrective Action and Preventive Action (CAPA) , Difference between corrective and preventive action, Corrective Action and Preventive Action plan and CAPA template in Pharmaceuticals SOP for Corrective and preventive action (CAPA) is the concept used within cGMP to correct and prevent the occurrence of nonconformances. CAPA is helpful to enhance consistency in … Read more

SOP for Handling of Deviation Control /Non-conformance report (NCR) management with example and template in Pharmaceuticals

SOP for Handling of Deviation Control /Non-conformance report (NCR) management with example and template in Pharmaceuticals Deviation control /Non-conformance report (NCR) is the quality management system (QMS) tool is used pharmaceutical industry. This SOP is helpful to understand what the importance of the Deviation control/Non-conformance report (NCR), why Deviation control/Non-conformance report (NCR) is required, what … Read more

Importance of username/ID and password in data integrity, importance of access control in the pharma industry, Risk of sharing ID and password in pharma industry

What is the importance of user ID and password in data integrity? Why access control is important in the pharmaceutical industry? Data integrity is a very popular concept in the pharmaceutical industry. All regulatory bodies required authentic, accurate, complete and trustworthy data. FDA’s general requirement is that, keep data in an unaltered and secure manner. So, … Read more

SOP for Entry and Exit Procedure in pharma industry and Manufacturing Area of all employee/workers/visitors

SOP for Entry and Exit Procedure in the pharma industry and Manufacturing Area of all employee/workers/visitors Each pharmaceutical industry has its own entry and exit procedure in the plant and manufacturing area. The pharmaceutical industry designs its entry and exit procedure in such a way to prevent contamination. Human is a major source of contamination. … Read more

SOP on Self-Inspection/Internal Audit, what is Self-Inspection/Internal Audit, Self-Inspection/Internal Audit Checklist/Checkpoints and Self-Inspection/Internal Audit Guidelines

  SOP on Self-Inspection/Internal Audit, what is Self-Inspection/Internal Audit, Self-Inspection/Internal Audit Checklist/Checkpoints and Self-Inspection/Internal Audit Guideline SOP on the Self-Inspection/Internal Audit in the pharmaceutical industry. One of the best quality tool for Quality improvement which helps to identify the gap between the existing procedure and cGMP. Also, check for the compliance of regulatory guidelines. We … Read more

SOP for Good Laboratory Practices (GLP), What are Good Laboratory Practices (GLP), Good laboratory practices (GLP) as per guideline (USFDA) ,Good Laboratory practices (GLP) examples and principles, Schedule L1 requirements

SOP for Good Laboratory Practices (GLP), What are Good Laboratory Practices (GLP), Good laboratory practices (GLP) as per guideline (USFDA), Good Laboratory practices (GLP) examples and principles, Schedule L1 requirements This SOP is introducing what practices need to be performed in the laboratory for consistent, reliable analytical results, Good Laboratory Practices (GLP) guidelines (USFDA), Examples … Read more

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