1.0 OBJECTIVE To confirm that the personnel performing the tests in IPQA and other documentations in Quality Assurance are adequately trained to produce reliable and accurate results within the specified parameters. 2.0 SCOPE This procedure is applicable to IPQA officers to assure that the analysts ...

1.0 OBJECTIVE To lay down a procedure for Technology Transfer of products from one site to another site. 2.0 SCOPE This SOP is applicable to the products to be transferred from Track-I/Sending unit to (Compnay Name). 3.0 RESPONSIBILITY 3.1 Concerned R&D/QA Head of Receiving Unit shall be responsible ...

Objective To provide a procedure to audit a new vendor or re-audit an existing vendor for the active / inactive ingredients and packaging materials. Scope This procedure is applicable for approval of all vendors (manufacturers) and suppliers of incoming Active Pharmaceuticals Ingredients (APIs), Inactive ...

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 ...

Objective: To provide the guidelines for compilation of data for process parameters, assay values for actives to establish that Process performs according to design and is under control. Trend analysis data can be used to apply reduced testing in non-regulatory specifications after having established ...

1. Purpose The purpose of this SOP is to provide a guideline about the disposal procedure of expired quality records of (Company Name), Bhaluka. 2. Scope This SOP is applicable for all expired quality records of (Company Name). 3. Responsibilities 3.1 SVP, Factory Operation is responsible to give authorization ...

Purpose: To ensure recall of products that are known or suspected to be defective or hazardous in accordance with a pre-determined plan promptly and effectively from the market. Scope: This SOP is applicable for all products marketed by (Company Name). Definitions: Product Recall: All complaints and ...

Objective: Change control is a formal system by which qualified representatives from appropriate disciplines including quality organization, review proposed changes that might affect validated status, regulatory compliance or in-house specifications. The representatives will define & approve appropriate ...

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