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 […]
Working Procedure for Incoming Samples received by a laboratory may be for compliance testing or for investigative testing. Samples for compliance testing include routine samples for control, samples suspected of not complying with the specifications or samples submitted in connection with a marketing authorization process. Close collaboration with the providers of the samples is important.
Calibration, Verification of Performance and Qualification of Equipment, Instruments and other devices in Quality Control
Calibration, Verification of Performance and Qualification of Equipment, Instruments and other devices in Quality Control. Each item of equipment, instrument or other device used for testing, verification and/or calibration should, when practicable, be uniquely identified. All equipment, instruments and other devices (e.g. volumetric glassware and automatic dispensers) requiring calibration should be labelled, coded or otherwise
Reference substances (primary reference substances or secondary reference substances (8)) are used for the testing of a sample. Note: Pharmacopoeial reference substances should be employed when available and appropriate for the analysis. When a pharmacopoeia reference substance has not been established then the manufacturer should use its own reference substance. Reference materials may be necessary
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.
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
Data Processing of Quality Control Lab Equipment. Detailed recommendations are provided in Appendix 5 to Annex 4 of the Fortieth report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations: Supplementary guidelines in good manufacturing practice: validation. Validation of computerized systems (12). For computers, automated tests or calibration equipment, and the collection, processing, recording,
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
Documentation is an essential part of the quality management system. The laboratory should establish and maintain procedures to control and review all documents (both internally generated and from external sources) that form part of the quality documentation. A master list identifying the current version status and distribution of documents should be established and readily available.
At EU-level there are not fixed rules about how risk assessments should be undertaken (you should check the specific legislation relating to risk assessment in your country). However, there are two principles which should always be borne in mind when approaching a risk assessment: to structure the assessment to ensure that all relevant hazards and