Checklist

Safety work permit is a written record that authorizes specific work, at a specific location, for a specific time period.… Read More

Standard Operating Procedure (SOP) for Handling of Data Integrity Incident Investigation and compliance in Pharmaceutical Drug Manufacturing Plant. Handling of… Read More

Documents and Data Control is a function or department which keeps track of all documentation, specifications, and processes. The purpose… Read More

Standard Operating Procedure for Receipt, Issuance, Performance, Regeneration, Use, Cleaning, Storage and Rejection of GC Columns. GC Column Management 1.0 … Read More

Standard Operating Procedure (SOP) for Finished Drug Product (Finished Goods) Release for Sale and Distribution including the review of batch… Read More

Checklist / Check points of Laboratory preliminary Investigation (OOS Phase I) for find out the root cause for out of… Read More

Guideline for Handling of Out of Specification (OOS) results occurs during analysis of Raw Material and Pharmaceutical Drug Products (Different… Read More

Vendor Audit is an evaluation of vendor's manufacturing site, for product of interest(s), for the understanding and application of the… Read More

Standard Operating Procedure (SOP) for Failure Investigation (process failure as well as non-process failure) occurs during manufacturing or processing of… Read More

Guideline for Laboratory Standard Management (Preparation, Qualification and Handling of Analytical standards/Working Standard/Primary Standard etc.) Working Standard Management 1.0   Objective… Read More

Standard Operating Procedure (SOP) and Guideline for sampling of raw material (API and Excipient) / Starting material for analysis. Raw… Read More

Standard Operating Procedure and Guideline for New Product Introduction in existing set of product list and equipment trail and Quality… Read More

Standard Operating Procedure (SOP) & Guideline for Quality Risk Management (QRM) i.e. risk identification, analysis, evaluation, reduction/ mitigation, communication and… Read More

Standard Operating Procedure (SOP) for various investigation tools for finding the root causes that enables determination of corrective and preventive… Read More

Standard Operating Procedure (SOP) and Guideline for performing Cleaning Validation (CV) of drug product manufacturing equipments. Cleaning Validation (CV) 1.0 … Read More

Standard Operating Procedure for Annual Product Quality Review (APQR), also known as Product Quality Review (PQR) and Annual Product Review… Read More

Standard Operating Procedure (SOP) for Procedure, Process and Management of Change Control (temporary change or permanent change control) in the… Read More

Self Inspection (Internal Audit) Checklist for various departments/systems and functions of the pharmaceutical manufacturing plant. These checklists are applicable for… Read More