SOP for Validation of Autoclave with Biological Indicator for Sterilization Efficiency

Standard operating procedure to validate the Autoclave using Biological Indicators for sterilization efficiency. OBJECTIVE To describe the procedure to validate…

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Complaints And Recalls Handling In API Manufacturing Unit- Pharma

COMPLAINTS AND RECALLS All quality related complaints, whether received orally or in writing, should be recorded and investigated according to…

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Guideline for Buidlings & Facilities

BUILDINGS AND FACILITIES Design and Construction  Buildings and facilities used in the manufacture of intermediates and APIs should be located,…

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SOP on Cleaning Validation

OBJECTIVE  : The objectives of good manufacturing practices (GMP) include the prevention of possible contamination and cross-contamination of pharmaceutical starting…

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SOP on Analytical Report (AR) Numbering

OBJECTIVE: The purpose of this SOP to lay down the procedure for Analytical Report (AR) numbering. SCOPE: This SOP is…

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SOP ON Receipt, Issue & Control Of Lab Chemicals

SOP ON Receipt, Issue & Control Of Lab Chemicals OBJECTIVE: The purpose of this SOP is to lay down a…

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SOP On Safety In Quality Control Laboratory

SOP On Safety In Quality Control Laboratory OBJECTIVE: The purpose of this SOP is to lay down a procedure for…

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Out of Specification Investigation Phase II & III (MHRA)

Out of Specification Investigation Phase II (Unknown Cause / No Assignable  Cause ) & Phase III Phase II Investigation  –…

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Out Of Specification Investigation Phase II (MHRA)

Out Of Specification Investigation Phase II (MHRA) Conducted when the phase I investigations did not  reveal an assignable laboratory error. …

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Out Of Specification Investigation Phase Ia & Phase Ib (MHRA)

Out Of Specification Investigation Phase Ia & Phase Ib (MHRA) Phase Ia Investigation Definition: Out of Specification Investigation Phase la…

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