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Quality Control

Quality Control Is most Important part of Quality Team. Quality Control Department is deal with Sampling, Specification & Analytical Procedure preparation & appropriate execution.Quality Control department is also documentation and release procedures which ensure that the necessary and relevant tests are carried out, and that materials are not released for use, nor products released for sale or supply, until their quality has been judged satisfactory.

As per EudraLex – Volume 4 – Good Manufacturing Practice ( GMP ) Guideline.

  • Each holder of a manufacturing authorisation should have a Quality Control Department. This department should be independent from other departments, and under the authority of a person with appropriate qualifications and experience, who has one or several control laboratories at his disposal. Adequate resources must be available to ensure that all the Quality Control arrangements are effectively and reliably carried out.
  • The principal duties of the head of Quality Control are summarised in Chapter 2. The Quality Control Department as a whole will also have other duties, such as to establish, validate and implement all quality control procedures, oversee the control of the reference and/or retention samples of materials and products when applicable, ensure the correct labelling of containers of materials and products, ensure the monitoring of the stability of the products, participate in the investigation of complaints related to the quality of the product, etc. All these operations should be carried out in accordance with written procedures and, where necessary, recorded.
  • Finished product assessment should embrace all relevant factors, including production conditions, results of in-process testing, a review of manufacturing (including packaging) documentation, compliance with Finished Product Specification and examination of the final finished pack.
  • Quality Control personnel should have access to production areas for sampling and investigation as appropriate.

GLP (Good Laboratory Practice )

  • Quality Control Laboratory Area & equipment should meet the general & Specific Requirements for Quality Control Areas given in Chapter 3. Laboratory equipment should not be routinely  moved between high risk areas to avoid accidental Cross-Contamination.
  • In particular the microbiological laboratory should be arranged so as to minimise risk of Cross-Contamination.
  • the personnel  premises, and equipment in the laboratories should be appropriate to the tasks imposed by the nature and the scale of the manufacturing operations. The use of outside laboratories, in conformity with the principles detailed in Chapter 7, Contract Analysis, can be accepted for particular reasons, but this should be stated in the Quality Control records.

Documentation

Minimum Availability in of Documents In Quality control department as per given below ;

  • Specifications.
  • SOP for Sampling, Testing, Records ( Including test worksheets & Laboratory  notebooks format ), Recording and verifying ;
  • SOP for calibration/qualification of instruments and Maintenance of Equipment also department should maintain Records of the same.
  • SOP of investigation of out of specification and out of Trend results.
  • testing reports and/or certificates of analysis.
  • Data from environmental (air,water & other utilities ) monitoring, where required;
  • validation records of test methods where is applicable.