Quality Assurance

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 ensure current Good Manufacturing Practices … Read more

Preparation, Approval, Review, and Control of Technical Directions for the 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 the preparation and implementation of Technical Directions for all products manufactured at … Read more

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 time study. REFERENCE(S) & ATTACHMENT(S) … Read more

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 meaning thereof be deemed to … Read more

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 to establish scientific evidence that … Read more

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. This blog explores the significance … Read more

Good Manufacturing Practice for Medicinal Products Good Manufacturing Practice is that part of Quality Management which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation, Clinical Trial Authorisation or product specification. Good Manufacturing Practice is concerned with both production and … Read more

Product Quality Review Regular periodic or rolling quality reviews of all authorised medicinal products, including export only products, should be conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product, to highlight any trends and to identify product and process improvements. … Read more

QMS Document Review QMS Document Review refers to the systematic examination and evaluation of key documents that govern quality management processes within an organization. It ensures compliance with regulatory requirements, internal policies, and industry standards. The primary objectives of document review are to maintain document accuracy, effectiveness, and alignment with the organization’s quality objectives. QMS … Read more