Quality Management System

Quality management system for Laboratory Management in Pharma

The laboratory or Quality organization management should establish, implement and maintain a quality management system appropriate to the scope of its activities, including the type, range and volume of testing and/or calibration, validation and verification activities it undertakes. The laboratory management should ensure that its policies, systems, programmes, procedures and instructions are described to the …

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Handling of Pharmaceutical Market Complaint

Principle. All complaints and other information concerning potentially defective products should be carefully reviewed according to written procedures and the corrective action should be taken. A person responsible for handling the complaints and deciding the measures to be taken should be designated, together with sufficient supporting staff to assist him or her. If this person …

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SOP For Risk Management

SOP For Risk Management. Objective :- The purpose of this SOP is to lay out the procedure for Risk Management (risk identification, analysis, evaluation, reduction / mitigation, communication and conclusion of risk in order to ensure the quality, safety, integrity and purity of the drug product by using FMEA (Failure Mode Effect Analysis). Scope:-  The …

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