OBJECTIVE : To describe a procedure to ensure an all-time audit preparedness, so that every audit is managed successfully and all post audit actions are completed effectively to close audit observations, if any. SCOPE : This SOP shall be applicable to all departments of (Company Name). RESPONSIBILITY Functional ...

1.0 OBJECTIVE To ensure that Beximco products are manufactured by the contractor using facilities and operations that conforms to cGMP requirements. 2.0 SCOPE The SOP is applicable for all products of (Company Name) manufactured & packed in a third party contract manufacturer. 3.0 RESPONSIBILITY 3.1 ...

1.0 OBJECTIVE To ensure that all batches of product manufactured at third party contract manufacturer undergo a formal agreement and evaluation of suitability for use prior to release to the market. 2.0 SCOPE The SOP is applicable for contract manufacture and release the product batches manufactured ...

1.0 OBJECTIVE To provide guidelines for preparation, approval & maintenance of new artwork or for changing the existing one, incorporating necessary requirements of Local Drugs Authority or any other regulatory authority, pharmacopoeia or marketing requirements. 2.0 SCOPE This procedure is applicable ...

1. Objective: To ensure continuous consistent product quality, the quality of raw & packaging material from reliable vendors is essential. The purpose of this procedure is to describe the various activities and system for the approval of vendors for the active / inactive ingredients and packaging ...

1.0 OBJECTIVE To set up a guideline for the operation, calibration and cleaning of Water Bath (Model:1004) 2.0 SCOPE This SOP is applicable for operation, calibration and cleaning of Water bath (Model: 1004) installed in IPQA Room of OSD facility under Quality Assurance Department of (Company Name). ...

1.0 OBJECTIVE To describe a procedure for handling market complaints and take appropriate corrective action to address the complaint as well as to prevent a recurrence. 2.0 SCOPE This procedure is applicable to all types of market complaints that are related to quality, packing, and/or shortage of ...

1.0 OBJECTIVE To describe the procedure for activities involved in the preparation, control, retrieval and archiving of quality related documents. 2.0 SCOPE This procedure covers all the documents issued by Quality Assurance and it also includes documents related to regulatory, calibration, qualification ...

1.0 OBJECTIVE To provide guidelines and a framework for the preparation of technical terms of supply (TTS) between supplying and receiving organization (Company Name). A TTS document will provide a clear understanding of all technical and quality requirements, and agreement on the division of responsibilities ...

1.0 OBJECTIVE To set up a procedure for the operation and cleaning of Tablet Friability Tester (Model: TA/TAR). 2.0 SCOPE This SOP is applicable for the operation and cleaning of Tablet Friability Tester (Model: TA/TAR) at Quality Assurance Department of (Compnay Name). 3.0 RESPONSIBILITY 3.1 Operating ...