PHARMACEUTICAL QUALITY
MANAGEMENT
Dr. Hajra Iqbal; RPh
Lecturer(Pharmaceutical Chemistry)
The University of Faisalabad
September, 2024
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unioffaisalabad
Quality Control
• The word “quality” relates to characteristics of a product from both a qualitative and
quantitative point of view.
• The word “ control” implies a procedure by which decision may be made regarding
whether production is proceeding according to plan and meeting standards established previously.
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Quality Control
• QC is the part of GMP.
• It is concerned with sampling, specifications, and testing , documentation and, release procedures.
• This ensures that
i. All the tests are properly carried out
ii. Materials are neither released for use
iii. Products are not used for sale and supply
Until their quality has not been satisfactory.
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Quality control in the pharmaceutical industry
• QC in the pharmaceutical industry is the effort to design required specifications and to
produce and assure the consistent attainment of those specifications in its finished products.
• These specific standards are established by design during the research and development phases.
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• Adequate facilities and approved procedures must be available for sampling , inspecting and testing of
starting materials, packaging materials and finished products.
• The type of testing including, organoleptic, chemical, physical, biological, and microbiological
• Environmental conditions for GMP purpose must also be monitored properly.
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Batch inspection and
Records sampling
Validation QC QC labs
Retained samples Analysis of finished
product
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Quality Assurance in pharmaceutical industry
Process control
• Provide continues surveillance of many phases of production so that the final product is of highest
quality.
• Its functions include monitoring records, procedures, system facilities, and labeling as well as
• performing tests.
QUALITY SYSTEM
Quality assurance
Quality control
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Dosage form control
• Product quality assurance is not complete with the release of the batch.
• The stability of the product in the marketed package should be repeatedly confirmed
by actual physical, chemical, and biological tests.
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Testing program and method
Quality assurance certifies that each manufactured batch of the product meets the established quality
standards.
1. Physical and chemical tests
Tests for appearance, odor, ,pH, viscosity, disintegration time, hardness, friability, weight variation,
Content uniformity, and moisture content.
2. Biological and microbiological tests
Tests for safety, toxicity, pyrogenicity, sterility, antiseptic action, and preservative action.
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Specifications
The main purpose of established specifications is to ensure that the characteristics of finished product
meet the appropriate standards of identity, purity, potency, quality, physiological availability and
therapeutic activity.
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Official standards for pharmaceutical products
Designed to set permissive limits of tolerance for the product at time it reaches the patients.
The primary consideration is that the product should be satisfactory clinically.
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Official methods of control
• Official monographs are available in the official books (U.S.P., N.F., B.P., and others).
• Official monographs for pharmaceutical chemicals generally include
1. Description of the drug
2. Physical constants
3. Quantitative assay of pure chemical assay
4. Limit tests to exclude contamination
5. Storage conditions
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Description of the drug
1. Pharmacological group
2. Usual dose and dose range
3. Strengths available
4. Dispensing information
5. Packaging and storage
6. Dissolution test
For injectable
1. Pyrogen test
2. Safety test
3. Sterility test
4. Clarity test
5. pH
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Assay
• An assay is an investigative or analytic procedure for assessing or measuring the presence,
amount, or functional activity of a drug.
• Assays play an important role in this process by determining the concentration of a drug
compared to its labeled amount.
• Assay for pure chemicals are comparatively simple.
• Assay for active drug in the finished dosage form is may follow one or two steps.
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Objectives of Quality Assurance
• The overall objectives of quality assurance is to ensure that each product leaving the plant for
consumer distribution has met every recommendation of the current good manufacturing Practices.
• The product has been maintained within the identity, purity, potency, and quality standards
throughout the manufacturing and packaging operations.
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Pharmaceutical guidelines for quality control
• Good manufacturing practices (GMP)
Provide comprehensive standards for the manufacturing, testing, and quality control
of pharmaceutical products. They cover facility design, staff training, documentation,
and quality assurance.
• Good Laboratory Practices (GLP)
Ensure that testing and analytical procedures are accurate and reliable.
• Pharmacopeial Standards
Establish standards for the quality of pharmaceutical ingredients and finished products.
• Validation Guidelines
Validation guidelines outline procedures for validating equipment, analytical methods, and processes.
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• Stability Testing Guidelines
Specify the requirements for conducting stability studies to determine pharmaceutical products' shelf-life
and storage conditions.
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Good laboratory practices
The good laboratory practice guideline promotes the development of quality test data, and provides a
tool to ensure the management of laboratory procedures for national pharmaceutical control
laboratories involved in the analysis of active pharmaceutical ingredients (APIs), exipients and
pharmaceutical products.
Validation
Action of proving, in accordance with the principles of good practice quality guidelines and regulations,
that any procedure, process, equipment, material, activity or system actually and consistently leads to
the expected results.
