Quality Assurance

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 …

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 …

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 …

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 …

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 …

QUALITY AGREEMENT OF MANUFACTURE AND SUPPLY  This Manufacture and Supply Agreement is made and executed on this ___ day of _________ 202__ (“Effective Date”) By and Between First Part , a company incorporated under the Companies Act, 1956 having its registered office at __________________________________________ and its corporate office at ___________________________________________ or …

Guideline for Process Validation  To define the procedure for exhibit batch monitoring and process validation of drug products for meeting all the predefined attributes and the process is capable of consistently delivering quality products. This involves the collection and evaluation of data from the process design stage through commercial production …

GxP in Pharmaceuticals: Ensuring Quality, Safety, and Compliance In the complex and dynamic world of pharmaceuticals, ensuring the quality, safety, and compliance of products is of paramount importance. GxP, a set of regulations and guidelines that govern various aspects of pharmaceutical manufacturing, plays a critical role in maintaining industry standards. …

Stability (ICH) Quiz 7

Stability (ICH) Quiz 6