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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