Good Manufacturing Practice (PT-5110)

Quality and Quality Assurance

• Quality refers to the total features and characteristics of a medicinal product meeting stated needs.
• Quality management involves determining and implementing a formalized quality policy authorized by top management.
• Basic elements of quality management include a quality system incorporating organizational structure, procedures, and resources.

Quality Assurance (QA)

• QA ensures that pharmaceutical products meet the necessary quality for intended use, requiring competent personnel and adequate facilities.
• Objectives of QA include:
  • Designing products according to GMP requirements.
  • Specifying production and control operations in written form.
  • Clearly defining management responsibilities in job descriptions.
  • Controlling starting materials, intermediate products, and finished products.
  • Certifying each batch of products before sale by authorized personnel.
  • Implementing self-inspection procedures and regular product quality evaluations.

Good Manufacturing Practice (GMP)

• GMP is a segment of quality assurance ensuring products are produced and controlled according to quality standards for intended use.
• Covered aspects of GMP include collection, transportation, processing, storage, quality control (QC), and delivery of finished products.
• Violations of GMP can lead to product adulteration, facility shutdowns, product seizures, recalls, and competitive disadvantages.

Quality Control (QC)

• QC is part of GMP focused on the sampling, specification, testing, documentation, and release procedures to ensure product quality.
• Differentiates QA from QC: QA pertains to process testing, while QC involves material testing.

Objectives of GMP

• Definition and systematic review of all manufacturing processes.
• Performing qualifications and validations for all processes.
• Providing necessary resources, including:
  • Qualified personnel.
  • Adequate facilities and equipment.
  • Appropriate materials, containers, and approved instructions.
• Ensuring clarity in written instructions and proper training for operators.
• Implementing proper record-keeping for manufacturing and distribution to reproduce batches.
• Addressing consumer complaints and investigating quality defects to prevent recurrence.

Ten Principles of GMP

• Facility and equipment design must be appropriate.
• Adherence to written procedures and instructions.
• Comprehensive documentation of processes.
• Validation of processes to ensure effectiveness.
• Planned and periodic audits of facilities and equipment.
• Detailed operating procedures and work instructions.
• Ensuring job competence and protection against contamination.
• Control of components and related processes.
• Avoiding costs from quality failures, such as waste, rework, and recalls.

Industrial Benefits of GMP/QA

• Improved plant layouts and workflows contribute to enhanced operational efficiency.
• Efficient documentation systems lead to better quality control processes.
• Prevention of quality issues avoids costs associated with waste and loss of reputation.

Clinical Benefits of GMP

• Ensures product safety for human use and minimizes potency variations.
• Guarantees reproducible physiological activity.
• Prevents side effects and toxicity due to inconsistent drug content.