Current good manufacturing practice (cGMP) for finished pharmaceuticals falls under the schedule-M as per drug & cosmetic rule 1940 and refers to the Current Good Manufacturing Practice regulations enforced by the USFDA. cGMP provides for
1.0 PURPOSE: To lay down the procedure for reworking or reprocessing of pharmaceutical product. 2.0 SCOPE: This procedure for reworking or reprocessing of pharmaceutical product is applicable at Pharmaceutical Manufacturing Facility of (Company name). 3.0
1.0 PURPOSE: To describe the responsibilities of quality units. 2.0 SCOPE: This SOP describes the functions and responsibilities of quality units at (Company name). 3.0 DEFINITIONS: Nil 4.0 RESPONSIBILITY: 4.1 All personnel in Quality Unit
1.0 PURPOSE: To lay down the procedure for the Preparation, Review and Approval of Validation Master Plan. 2.0 SCOPE: This procedure applicable for preparation of Validation Master Plan at Pharmaceutical Manufacturing Facilities of (Company name).
1.0 PURPOSE: The purpose of the procedure is to have documented procedure for initiation, evaluation, approval and implementation of change control. 2.0 SCOPE: 2.1 This sop for change control programme is applicable to (Company name).
1.0 PURPOSE: To provide a procedure for conducting the Management Review Meeting (MRM). 2.0 SCOPE: This procedure is applicable to management review meeting (MRM). The meeting is conducted for assessing the quality management system and
Tablet compression machines are designed with consideration of the types of dies and punches they will use. The dies and punches and their setup on compression machine is called tablet tablet tooling , it is
Definition of Good laboratory practices (GLP): Good Laboratory Practices (GLP): Good Laboratory Practices is a quality system comprises with the organizational process and the conditions under which laboratory studies are planned, performed, monitored, recorded, reported
1.0 PURPOSE: To define the procedure of Job Responsibilities of Quality Assurance at Unit level. 2.0 SCOPE: This procedure is applicable to Quality Assurance department at (Company name). 3.0 DEFINITION: An order to effectively manage
Data integrity stands as a paramount concern for regulators globally. It is due to poor practices develop by the industry. Collection of various types of information and results collectively called as data. This data are
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