X

Checklist

Work Permit System (Safety)

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

Data Integrity Incident Handling Procedure

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 in Pharmaceuticals

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

GC Columns (Gas Chromatography) Management

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

Finished Product Release Procedure (SOP)

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

Laboratory Investigation Checklist – OOS Result

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

Out of Specification (OOS) Handling Procedure

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

Vendor Audit & Qualification Management Procedure

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

Failure Investigation Procedure and Tools

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

Working Standard Qualification Procedure

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