SOP for Qualification of Quality Control analyst

   Objective To provide detail procedure for Analyst qualification of Quality control analyst for the performance verification.     SCOPE:             This SOP…

Continue Reading →

SOP for Volumetric Glassware

Objective: The purpose of this SOP is to lay down a procedure the guidelines regarding storage and handling of volumetric…

Continue Reading →

Validation Master Plan

Validation Master Plan A manufacturer should have a VMP which reflects the key elements of validation. It should be concise…

Continue Reading →

MLT (Microbial Limit Test) Validation

MLT (Microbial Limit Test) Validation Learn how to validate the Microbial Limit Test for Pharmaceutical products using Bacillus subtilis and…

Continue Reading →

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…

Continue Reading →

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…

Continue Reading →

Guideline for Buidlings & Facilities

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

Continue Reading →

SOP on Cleaning Validation

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

Continue Reading →

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…

Continue Reading →

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…

Continue Reading →