Microbiology
Corrective and Preventive Action (CAPA)
Standard Operating Procedure (SOP) for various investigation tools for finding the root causes that enables determination of corrective and preventive… Read More
Cleaning Validation (CV) Procedure and Protocol
Standard Operating Procedure (SOP) and Guideline for performing Cleaning Validation (CV) of drug product manufacturing equipments. Cleaning Validation (CV) 1.0 … Read More
Deviation (Planned and Un-planned) Control System
Standard Operating Procedure (SOP) for identification, Investigation, approval, and trending of Deviation (s) which may occur during manufacturing, packaging, or… Read More
APQR – Annual Product Quality Review in Pharma
Standard Operating Procedure for Annual Product Quality Review (APQR), also known as Product Quality Review (PQR) and Annual Product Review… Read More
Change Control Process and Management in Pharma
Standard Operating Procedure (SOP) for Procedure, Process and Management of Change Control (temporary change or permanent change control) in the… Read More
Stability Study of Drug Product as per ICH Q1A(R2)
Standard Operating Procedure (SOP) for Stability Study of Drug Product as per ICH Q1A(R2). The term (Stability Study) with respect… Read More
Self Inspection & Internal Audit Procedure in Pharma
Standard Operating Procedure (SOP) for Self Inspection (Internal Audit) of various departments/sections and functions of the pharmaceutical drug manufacturing plant.… Read More
Self Inspection Checklist & Internal Audit Formats
Self Inspection (Internal Audit) Checklist for various departments/systems and functions of the pharmaceutical manufacturing plant. These checklists are applicable for… Read More
General Information – Pharmaceuticals Quality Control
Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations… Read More