Quality Control / In-Process Quality Control

Quality Control / In-Process Quality Control

The term quality control refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical product. Such procedures may range from the performance of simple chemical experiments which determine the identity and screening for the presence of particular pharmaceutical substance to more complicated requirements of pharmacopoeial monographs.

The quality of a product may deviate from the standard required, hence, carrying out analysis is important in order to determine the quality.

Counterfeit medicines as defined by the World Health Organization (WHO) is a drug product that is with intent and illegally mislabeled with respect to its identity and/or source. Counterfeiting of medicinal products, active pharmaceutical ingredients or product labels are criminal offenses, which may endanger patient health.

Counterfeit medicines may:

  • Contain no active ingredient
  • Contain the wrong active ingredient (e.g. a cheap antibiotic instead of an expensive antibiotic)
  • Contain an incorrect (usually low) quantity of the active ingredient.
  • Manufactured using low-quality active ingredient or excipient.
  • Manufactured under poor standards of good manufacturing practice (GMP) compliance.

Counterfeit products that contain no active ingredient and those that contain the wrong active ingredient or the correct active ingredient in the wrong amount can be detected by carrying out appropriate identification and quantitative tests. In situations where resources for accurate and precise quantitative testing are limited, including semi-quantitative tests, may be sufficient to detect these types of counterfeit medicines.

It may also be possible to identify products as being counterfeit by their general appearance (color, markings, etc.); particularly when the appearance differs from a genuine batch of the product.

Laboratories that regularly undertake checks for counterfeit medicines maintain a stock of genuine reference products for comparison. Examination of the labelling should also be carried out to check the accuracy of the information presented.

Analytical Process

  1. Standard Methods: This may be the national standard procedures, or international guidelines (e.g. American Society for Testing and Material (ASTM), International Organization for Standardization (ISO), International Union of Pure and Applied Chemistry (IUPAC), etc.) and standards, or procedures described by legal regulations.
  2. Laboratory Procedures: Quantitative analytical process which vary in procedure from standard methods, but are verified as equivalence against standard methods.
  3. Analytical procedures which have various used and objectives in the laboratory outside of governmentally regulated areas. These also include the latest analytical procedures for which standards have not yet been established.
  4. Field methods: Analytical processes which can be performed outside the laboratory. With the aid of objective measurement methods, field methods can bring quantitative or semi-quantitative results depending on the previous handling of the sample and quality assurance procedures.

The objective of analytical work is the achievement of reliable analytical results of a defined quality. Quality characteristics of analytical process are therefore:

  1. Specificity - the ability of the analytical process to register only the desired analyte, while other components or characteristics present in the sample (known as the matrix) do not influence the results.
  2. Sensitivity - the change in measured value per change in analyte.
  3. Accuracy - is the sense of both trueness (lack of systematic errors) and precision (measurement of differences between results, as obtained by the repeated use of an established analytical process on the same sample). Imprecision is caused by random errors.

The chronology of quality assurance characteristics is reflected in a 4-phase model of analytical quality assurance using statistical method:

Phase I: The quality characteristics of a new analytical process in need of calibration are determined and if necessary, the process is improved and documented.

Phase II: Preperative Quality Control. An analytical process whose quality characteristics have already been documented and is made operational for routine analysis. This includes achieving and maintaining sufficient analytical test before routine analysis begins.

Phase III: Performance of all internal laboratory quality assurance measures of routine analysis.

Phase IV: External laboratory quality assurance in the form of inter laboratory tests and external audits.

In the pharmaceutical industry, quality control and assessment (QC and QA) are required to monitor production and assess the quality, safety, and efficacy of its products. In clinical analysis, QC and QA is vital to the quality and safety of patient care, to the diagnosis, and control of therapy for the individual patient, and for research and public health purposes.

For toxicologists and pathologists, QC and QA help to distinguish between therapeutic and overdose levels and to determine the cause of death. In law enforcement, it is used to provide information to link drugs offenses, to identify drug distribution networks, and to provide evidence of possession or misuse for the courts. It is also essential for monitoring individuals on drug rehabilitation programmers.

Medicinal products should be safe and efficacious. Manufacturers of medicinal products are required by law to possess marketing authorizations from government regulatory agencies in countries in which their products are marketed and to manufacture their products in compliance with cGMP standards. These requirements involve conducting appropriate quality control tests to check that the product conforms to a specification that assures its safety and efficacy.

Typical specifications include tests to verify the chemical composition and physical properties of the medicine and to ensure that the medicine is not contaminated by microorganisms or other substances.

Although medicinal products are subjected to quality-control testing by the manufacturer, they may also have to be checked independently to:

  1. Determine or confirm their composition
  2. Assess their suitability for use
  3. Investigate defects
  4. Identify unknown medicinal products
  5. Identify contaminants
  6. Determine if the products have been adulterated
  7. Establish id the products are counterfeit

In the absence of a pharmacopoeial monograph, alternative approaches are required to obtain as much as information as possible about the quality of the medicinal product.

This requires the development of a valid test methods to measure relevant quality parameters and the application of generally accepted criteria to assess the quality. However, If the laboratory uses different analytical techniques to those used by the manufacturer (e.g. a High Performance Liquid Chromatography (HPLC) technique instead of an Ultraviolet (UV) spectrophotometric technique), the results may differ significantly from those obtained by the manufacturer, particularly of high levels of impurities are present.

Testing Flow

Raw Materials/Packaging Materials

Raw Materials/Packaging Materials

Finished Good Testing

Finished Good Testing

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