Quality Assurance

SOP For Laboratory Incident

OBJECTIVE: The purpose of this SOP is to lay down the procedure for reporting, initiation, review, approval, compliance and closing of Laboratory incident.     SCOPE: This SOP is applicable for reporting, initiation, review, approval, compliance and closing of Laboratory incident Which occurs in Quality Control laboratory at the manufacturing facility.      RESPONSIBILITY: Quality …

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SOP For Operation of Water Purification System

OBJECTIVE: This procedure outlines the procedure for operation of Water Purification System. Make : ADRONA-SIA Model : Q-Front SCOPE:  This SOP is applicable to Quality Control Department at manufacturing facility. RESPONSIBILITY: Analyst / Section Head or his designee shall be responsible to follow the SOP. The Head of Quality Control Department or his designee shall …

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EU Guidelines For Computerized System Part- 2

Project Phase Validation4.1 The validation documentation and reports should cover the relevant steps of the life cycle. Manufacturers should be able to justify their standards, protocols, acceptance criteria, procedures and records based on their risk assessment. 4.2 Validation documentation should include change control records (if applicable) and reports on any deviations observed during the validation …

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EU Guidelines For Computerized System Part -1

PrincipleThis annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities.The application should be validated; IT infrastructure should be qualified.Where a computerised system replaces a manual operation, there should be no resultant decrease …

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Cleaning Validation Protocol Format

A cleaning validation protocol format shall be developed for the ‘worst case’ product selected for cleaning validation programme. Following information (but not limited to) the following included in the cleaning validation protocol. Numbering of protocol shall done through of respective SOP of Cleaning Validation Protocol Numbering. Cleaning Validation Protocol Format – Objective: A brief description …

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