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 …
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 …
OBJECTIVE: The purpose of this SOP is to lay down a procedure for Operation and calibration of Dissolution Test Apparatus. SCOPE: This SOP is applicable for operation and calibration of Dissolution Test Apparatus at manufacturing site of XXX. …
SOP For Operation and calibration of Dissolution Test Apparatus. Read More »
OBJECTIVE: The purpose of this SOP is to lay down the procedure for cleaning & effective removal of previous product / batch residue from blister pack machine Rotovac 210S. SCOPE: This SOP is applicable for cleaning & removal of previous product / batch residue from blister pack machine Rotovac 210S at manufacturing facility of xxx. …
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 …
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 …
EU Guidelines For Outsourced Activities Any activity covered by the GMP Guide that is outsourced should be appropriately defined, agreed and controlled in order to avoid misunderstandings which could result in a product or operation of unsatisfactory quality. There must be a written Contract between the Contract Giver and the Contract Acceptor which clearly establishes …
Change management system – Innovation, continual improvement, the outputs of process performance and product quality monitoring and CAPA drive change. In order to evaluate, approve and implement these changes properly, a company should have an effective change management system. There is generally a difference in formality of change management processes prior to the initial regulatory …
MICROBIAL CONTAMINATION OF COMPRESSED AIR Compressed air systems can harbor the nutrients required for microbes to grow; namely water, oil, and warm temperatures. Maintaining a dry water level of -40°F can inhibit the growth of microbes but will not eliminate them. Bacterial spores can be resistant to U.V., desiccation or heat and can remain dormant …
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 …
