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Quality Control in Pharma

The quality control department is responsible for sampling, specification preparation and testing to ensure quality standards are met before products are released. This includes documenting and validating test methods, monitoring stability, investigating complaints, and ensuring finished product specifications are met. Quality control personnel must have independent laboratories that meet Good Laboratory Practice standards for areas, equipment, environmental monitoring and documentation of testing reports, methods and equipment calibration. Laboratories are inspected every two years at minimum to evaluate compliance with Good Manufacturing Practices.

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175 views

Quality Control in Pharma

The quality control department is responsible for sampling, specification preparation and testing to ensure quality standards are met before products are released. This includes documenting and validating test methods, monitoring stability, investigating complaints, and ensuring finished product specifications are met. Quality control personnel must have independent laboratories that meet Good Laboratory Practice standards for areas, equipment, environmental monitoring and documentation of testing reports, methods and equipment calibration. Laboratories are inspected every two years at minimum to evaluate compliance with Good Manufacturing Practices.

Uploaded by

RainMan75
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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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 ) in Quality control.

 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 of Quality control Department.
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.
Laboratory Inspection

The specific objective will be spelled out prior to the inspection. The
laboratory inspection may be limited to specific issues, or the inspection
may encompass a comprehensive evaluation of the laboratory’s compliance
with CGMP’s. As a minimum, each pharmaceutical quality control
laboratory should receive a comprehensive GMP evaluation each two years
as part of the statutory inspection obligation.

In general these inspections may include

 the specific methodology which will be used to test a new


product
 a complete assessment of laboratory’s conformance with
GMP’s

 a specific aspect of laboratory operations

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