Gap Analysis For Regulatory Complience
by Check the list of the documents of the respective department and identify the areas to be analyzed for gap, according to the criticality of the …
Category: Quality Assurance
SOP FOR DOSSIER
1.0 PURPOSE to lay down procedure for general guideline for the preparation of the dossier for various ROW markets. 2.0 SCOPE The SOP shall be …
Cleaning Validation Sampling in Pharmaceutical
The two main sampling techniques available for cleaning validation are rinse and swab sampling. FDA prefers swab sampling to rinse sampling (4, 5). In many pharmaceutical …
Worst Case Identification in Cleaning Validation
Cleaning is a crucial step in the manufacturing of pharmaceutical products, and it is essential to validate that the equipment is cleaned thoroughly. In identifying …
Quality Management System
A quality management system (QMS) is a collection of business processes and procedures which aims to ensure that the quality of products or services meets …
MACO and NOEL Calculation for Cleaning Validation
MACO and NOEL calculations have great importance in the pharmaceutical industries. NOEL refers to “No observed effect level” and MACO is a “Maximum allowable carryover”. …
Handling of samples between Laboratories
OBJECTIVE To lay down a procedure for handling of samples between QC Laboratory. SCOPE This procedure is applicable for the handling of samples between. RESPONSIBILITIES …
Standard Operating Procedure for Sampling of Packaging Materials
Objective To lay down a procedure for Sampling of Packaging Materials. Scope This SOP is applicable in Quality Control for sampling of Packaging Materials. Responsibility …
Standard Operating Procedure For Laboratory Safety
Objective To lay down a procedure for maintaining the laboratory safe. Scope This SOP is applicable in Quality Control during working in laboratory. Responsibility QC …
Resampling & Retesting of Materials
Objective To lay down procedure for resampling & retesting of materials. Scope This SOP is applicable in quality control for resampling & retesting of …