Overview of Good Manufacturing Practices (GMP)

What is GMP

• GMP is a quality assurance system for pharmaceutical production ensure that drug products meet rigorous quality and regulatory standards
• GMP primarily aims to diminish the risks of:
  • Cross-contamination
  • Mix-ups caused by incorrect labeling
• GMP is a set of principles and procedures that manufacturers follow to ensure the required quality of therapeutic products.
• cGMP emphasizes promoting continual advancement to keep up with industry developments

GMP Evolution

• The first GMP text was published by WHO during 1967-69
• The FDA adopted the term cGMP in 1978 to emphasize that guidelines are constantly evolving
• GMP guidelines were revised and expanded during 1989-90
• WHO published GMP guidelines in 1996 for the validation of manufacturing processes.

Importance of GMP

• Poor quality medicine can contain harmful substances that have been added unintentionally
• Medicines with insufficient active ingredients will not have the intended therapeutic effect
• GMP boosts pharmaceutical export opportunities:
  • Most countries only accept medicine manufactured according to internationally recognized GMP standards
  • Countries that require GMP for pharmaceutical production and train inspectors on GMP requirements increase their export potential

Specific GMP Requirements

• All manufacturing processes must be clear defined, systematically reviewed and consistently manufacture products that meet quality specifications
• Qualification and validation must be performed
• Necessary resources must be provided, including:
  • Qualified and trained personnel
  • Adequate premises and space
  • Suitable equipment and services
  • Appropriate materials, containers, and labels
  • Approved procedures and instructions
  • Suitable storage and transport
  • Adequate personnel, laboratories, and equipment for in-process controls
• Operators are trained to follow correct procedures

Specific GMP Requirements continued

• Instructions and procedures must be clear and specifically applicable to the facilities
• Records are made manually or electronically during manufacturing to show that the required procedures are followed. When significant deviations are reported they must be fully recorded and investigated
• Records for manufacturing and distribution that provide a history of each batch must be retained in an accessible and understandable form
• Proper storage and distribution must minimize risk to product quality
• A system must be in place to recall batches of product from sale
• Complaints about marketed products must be examined, causes investigated, and appropriate measures taken to prevent recurrence

Glossary of Terms

• Pharmaceutical product: A material or product intended for human or veterinary use, presented in its finished dosage form and subject to pharmaceutical legislation.
• Active pharmaceutical ingredient (API): Any substance or mixture intended to be used in the manufacture of a pharmaceutical dosage form and becomes an active ingredient.
• Starting material: Any substance used in the production of a pharmaceutical product (excluding packaging).
• Intermediate product: A partly-processed product requiring further processing stages.
• Bulk product: Any product that has completed all processing stages, excluding final packaging.
• Finished product: A finished dosage form that has completed all manufacturing stages, including final container packaging and labeling.
• Quarantine: The status of starting or packaging materials, unfinished products, or bulk or finished products that are isolated while awaiting release, rejection or reprocessing.
• Batch: A defined quantity of a material or product processed in one or more steps to ensure homogeneity.
• Batch records: All documents associated with manufacturing a batch of bulk or finished products.
• Batch number: A combination of numbers and/or letters that uniquely identifies a batch on the labels, records, and certificates of analysis.
• Master record: A document used as a basis for batch documentation.
• In-process control: Checks during production that monitor and adjust the process to ensure product conformance with specifications.
• Specification: A list of detailed requirements for materials or products used or obtained during manufacture.

Glossary of Terms continued

• Reconciliation: A comparison between theoretical and actual quantities
• Standard operating procedure (SOP): Written instructions for performing operations not specific to a given product or material.
• Validation: The process of proving that a procedure, process, equipment, material, activity, or system has produced the expected results.
• Calibration: Establishing a relationship between values indicated by an instrument, and the corresponding known values of a reference standard.
• Reprocessing: Subjecting all or part of a batch or lot of a drug to a previous validated step in the manufacturing process if specifications are not met.
• Reworking: Subjecting an in-process or bulk product to an alternate manufacturing process if specifications are not met.
• Packaging: All operations (including filling and labeling) that a bulk product undergoes to become a finished product.
• Packaging material: Any material (including printed material) employed in the packaging of a pharmaceutical.
• Large-volume parenterals: Sterile solutions intended for parenteral administration with a volume of 100 ml or more.

Quality Assurance (QA)

• Quality assurance: A wide-ranging concept covering all matters that influence the quality of a product.
• QA system: Ensures that:
  • Pharmaceutical products are designed and developed in a way that complies with GMP requirements and other associated codes (GLP, GCP)
  • Production and control operations are specified in writing and GMP requirements are adopted.
  • Managerial responsibilities are specified in job descriptions
  • Correct starting and packaging materials are used
  • All necessary controls are performed on starting materials, intermediates, bulk products, and finished products
  • The finished product is processed and checked correctly according to defined procedures
  • Pharmaceutical products are not sold or supplied before authorized personnel confirm that each production batch has been produced and controlled according to the marketing authorization and relevant regulations.
  • Deviations are reported, investigated, and recorded
  • There is a procedure for self-inspection and/or quality audit that regularly appraises the quality assurance system.

This quiz covers the fundamentals of Good Manufacturing Practices (GMP) in pharmaceutical production, including its evolution, principles, and importance in ensuring drug quality and safety. Test your understanding of GMP guidelines and their impact on the industry.