Management of Clinical Supplies
Management of Clinical Supplies Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to take part in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioral …
Read More »Assigning Manufacturing and Expiry date to the Finished Products
Assigning Manufacturing and Expiry date to the Finished Products Objective To lay down a procedure for assigning manufacturing and expiry date to the finished products manufactured. Scope This procedure shall be applicable to all products manufactured. Responsibility Executive / Officer Production shall be responsible for assigning manufacturing and expiry date …
Read More »Internal Audit and Self Inspection
Internal Audit and Self Inspection Internal Audit: An onsite verification of activity used to determine effective implementation of documented quality systems. Self-Inspection : Verification of departmental activity used to determine effective implementation of documented quality systems. Objective To lay down a procedure for periodic internal audit and self inspection, to …
Read More »Preparation, Approval and Control of Specifications and Standard Test Procedures for Raw Materials, Packaging Materials, In-process Materials and Finished Products
Preparation, Approval and Control of Specifications and Standard Test Procedures Objective To lay down a procedure for the preparation, approval and control of Specifications and Standard Test Procedures for raw materials, packaging materials, in-process materials and finished products. Scope This Standard Operating Procedure is applicable for the preparation and implementation …
Read More »Preparation, Approval, Review and Control of Technical Directions for Manufacture of Drug Products
Preparation, Approval, Review and Control of Technical Directions for Manufacture of Drug Products Objective To lay down a procedure for the Preparation, Approval, Review and Control of Technical Directions for Manufacture of Drug Products. Scope This Standard Operating Procedure is applicable for preparation and implementation of Technical Directions for all …
Read More »Production Quiz 03
Production Quiz 03
Read More »HOLD TIME STUDY FOR DISPENSED MATERIAL, INTERMEDIATES AND FINISHED PRODUCTS
HOLD TIME FOR DISPENSED MATERIAL, INTERMEDIATES AND FINISHED PRODUCTS The purpose of this SOP is to describe the systematic procedure to establish the hold time of Dispensed materials, intermediate and bulk product prior to final packing. This SOP is applicable for Dispensed materials, intermediate as well as bulk product hold …
Read More »Operation, cleaning & calibration of pH meter
Operation, cleaning & calibration of pH meter 1.0 PURPOSE: To lay down the procedure for operation & calibration of pH meter. 2.0. SCOPE : This SOP shall be applicable for operation & calibration of pH meter of SVP manufacturing facility Equipment Name Make & Model No. Equipment ID pH …
Read More »VISUAL INSPECTION TABLE
CLEANING, OPERATION, MONITORING & PRECAUTIONS OF MANUAL VISUAL INSPECTION TABLE & PROCESS FOR MANUAL INSPECTION OF SVP CONTAINERS. 1.0 PURPOSE To lay down the procedure for cleaning, operation, monitoring & precautions of visual Inspection table & process for manual visual inspection of filled & sealed SVP containers. 2.0 SCOPE …
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