Good Manufacturing Practices Flashcards
Ensuring quality offers….?
- Offers the assurance that a healthcare professional prescribing or administering the drug is confident of each unit’s efficacy
- Protects the public against potential hazards caused by accidental manufacturing and design defects, or instructions for product usage/storage
Quality determined by?
- Identity: Active ingredient
- Purity: Not contaminated with potentially harmful substances
- Potency: Usually 90–110% of the labeled amount
- Uniformity: Consistency of color, shape, size
- Bioavailability
- Stability: Ensuring medicine activity for stated period
Importance of cGMP?
• Assures proper design, monitoring, and control of manufacturing processes and facilities
• Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that drug manufacturers adequately control manufacturing operations
• Establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories
• Helps to prevent instances of contamination, mix-ups, deviations, failures, and errors
• Assures that drug products meet their quality standards
Impacts of poor-quality meds
• Poor efficacy which may result in prolonged illnesses and/or death
• High Health Bills
• Toxicity, severe adverse effects
• Loss of credibility
• Wastage of materials
• Wastage of finances
Good Manufacturing Practice
- Set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods
• Part of quality assurance ensuring that products are:
- consistently produced
- controlled to the quality standards appropriate to their intended use and as required by the marketing authorization
Objectives of cGMP
• Guarantee high quality products
• Products safe and free of contamination
• Efficient and stable products
Components of GMP
• GMP is a part of Q.A
•GMP’s main function is to produce quality products consistently
• GMP must meet legal requirements of country
• GMP must meet both production and Q.C. related issues
-WHO further comments that the main function of GMP is to avoid mix-ups
Areas covered by cGMP
- General considerations
- Personnel
- Premises
- Equipment
- Sanitation
- SOP’s
- Raw Materials
- Self Inspection And Audit
- Master Formula Records
- Batch Manufacturing Records
- Warehousing Area
- Labels And Other Printed Materials
- QA
warehousing areas
- Should be designed and adapted to ensure good storage conditions
- Should be clean, dry and maintained with acceptable temperature limits
- Should have appropriate house-keeping and rodents, pests and vermin control
- Separate sampling area for active raw material and excipients
- Receiving bay separate from outgoing bay
- Every material stored should be labeled properly
- Fire Prevention
Potential Risks in Manufacturing
- Contamination of products (microbial, particulate or other)
- Incorrect labels on containers
- Insufficient active ingredient
- Excess active ingredient
- Poor quality raw materials
- Poor formulation practices
Calibration
The set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (especially weighing), recording, and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard
Design features
- Minimize risks of errors
- Permit effective cleaning
- Permit effective maintenance
- Avoid cross-contamination, build-up of dirt and dust
- Maximum protection against entry of insects, birds and animals
- Separate facilities for other products such as some antibiotics, hormones, cytotoxic substances
- Finishing floors, walls, and Ceilings should be smooth, impervious, hard-wearing, easy to clean
- Specific Areas: Production areas, Quality control areas, Weighing areas, Storage areas, Ancillary areas, Hygiene
Validation
Action of proving (in accordance with principles of GMP) that any procedure, process, equipment, material, activity, or system actually leads to expected results
General considerations
- Compliance with GMP
- Consistent uniform batches
- Location And surroundings
- Water system
- Disposal Of Waste
Design and construction features
- Any building used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance
- The orderly placement of equipment and materials to prevent mix-ups between different components, drug product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination
- Lighting: Adequate lighting shall be provided in all areas
- Ventilation, air filtration, air heating and cooling
- Equipment for adequate control over air pressure, micro-organisms, dust, humidity
Qualification
Action of proving that any premises, system, and items of equipment work correctly and actually lead to expected results
