Sunday, January 20, 2019

Quality Audit: Introduction, Types and Procedure

Auditing in simple terms could be defined as inspection of a process or a system to make sure that it complies with the requirements...

SOP on Status Labeling System and Its Control

1.0 Objective: To lay down a procedure for the status labeling system and its control. 2.0 Scope: This Standard Operating Procedure is applicable for identification...

SOP on Handling of Non-Conformances

1.0 Objective To lay down a procedure for handling of non-conformances. 2.0 Scope This Standard Operating Procedure is applicable for handling of non-conformances associated with product (s)...

SOP on Quality Risk Management

1.0 Objective To describe the procedure for management of risks, arising from different operations, activities and discrepancies. 2.0 Scope This Standard Operating Procedure is applicable for the...

Sampling of Inprocess Materials and Finished Products

1.0 Objective To lay down a procedure for Sampling of Inprocess materials and Finished products. 2.0 Scope This standard operating procedure is applicable to pharmaceutical formulation plant...

Qualification of Water System

Earlier pharmaceutical industries used to rely on one time procedures that had a severe impact on the formulations resulting in product recalls often and...

Sop on Rejection and Destruction Policy of Drug Products and its Components

1.0 Objective To establish the guidelines for destruction of drug products and its components. Scope: This sop shall be applicable for rejection, collecting, accounting & safe destruction...

Acceptable Quality Level (AQL) in Pharmaceuticals

What is AQL AQL’ stands for ‘Acceptance Quality Limit’, and is defined as the “quality level that is the worst tolerable” in ISO 2859-1. It decides on...

In-Process Checks During Blister Packaging

During Blister packing of solid oral dosage followings are the In-process checkpoints: After running the machine in initial, a piece of blister foil to...

Technology Transfer Sample Protocol in Pharmaceuticals

In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to...