Quality Control

HPLC Calibration- A Complete Guide Part 1

Calibration of an instrument is the demonstration that the instrument or device produces results within specified limits by comparison with those produced by reference or traceable standard over an appropriate range of measurement. HPLC Calibration is the most critical activity in the laboratory, HPLC is the most sophisticated instrument in the Pharmaceutical Laboratory. This article …

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General Safety Rules of Quality Control Laboratory

General and specific safety Rules & instructions reflecting identified risk, should be made available to each staff member and supplemented regularly as appropriate. (e.g. with written material, poster displays, audiovisual material and occasional seminars). General Safety rules for safe working in accordance with national regulations and SOPs normally include the following requirements: safety data sheets …

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Premises – Good Practices for Pharmaceutical Quality Control Laboratories

The laboratory Premises are to be of a suitable size, construction and location. These Premises are to be designed to suit the functions and operations to be conducted in them. Rest and refreshment rooms should be separate from laboratory areas. Changing areas and toilets should be easily accessible and appropriate for the number of users. …

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Personnel – Good Practices for Pharmaceutical Quality Control Laboratories

The laboratory should have sufficient personnel with the necessary education, training, technical knowledge and experience for their assigned functions. The technical management should ensure the competence of all personnel operating specific equipment, instruments or other devices, who are performing tests and/or calibrations, validations or verifications. Their duties also involve the evaluation of results as well …

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Records Maintenance in Quality Control Laboratory

The Quality Control laboratory should establish and maintain procedures for the identification, collection, indexing, retrieval, storage, maintenance and disposal of and access to all quality and technical/scientific records.All original observations, including calculations and derived data, calibration, validation and verification records and final results, should be retained on record for an appropriate period of time in …

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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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