OBJECTIVE : The purpose of this SOP to describe the procedure for the operation of fluidized bed dryer (FBD). SCOPE …
Objective To provide detail procedure for Analyst qualification of Quality control analyst for the performance verification. SCOPE: This SOP…
Objective: The purpose of this SOP is to lay down a procedure the guidelines regarding storage and handling of volumetric…
Validation Master Plan A manufacturer should have a VMP which reflects the key elements of validation. It should be concise…
MLT (Microbial Limit Test) Validation Learn how to validate the Microbial Limit Test for Pharmaceutical products using Bacillus subtilis and…
Standard operating procedure to validate the Autoclave using Biological Indicators for sterilization efficiency. OBJECTIVE To describe the procedure to validate…
COMPLAINTS AND RECALLS All quality related complaints, whether received orally or in writing, should be recorded and investigated according to…
BUILDINGS AND FACILITIES Design and Construction Buildings and facilities used in the manufacture of intermediates and APIs should be located,…
OBJECTIVE : The objectives of good manufacturing practices (GMP) include the prevention of possible contamination and cross-contamination of pharmaceutical starting…
OBJECTIVE: The purpose of this SOP to lay down the procedure for Analytical Report (AR) numbering. SCOPE: This SOP is…