CGMP Regulations in Pharmaceuticals

CGMP for Finished Pharmaceuticals

• CGMP regulations were established by the Food and Drug Administration (FDA)
• These regulations ensure premium standards for drug product quality.

Definitions

• Active Pharmaceutical Ingredient (API): Any ingredient intended to furnish pharmacological activity or other direct effects in the diagnosis, mitigation, prevention, or cure of a disease.
• Component: Any ingredient used in a drug product.
• Drug Products: Finished form that contains active drug & inactive ingredients.
• Quality Control: The regulatory process through which the industry measures and compares the actual industry performance with the set standards.
• Quality Control Unit: A department in the industry made to ensure the quality of the drug formed.
• Quarantine Area: A specified area for ingredients to be placed/stored before acceptance testing and qualification for use.

Organization & Personnel

• The personnel section deals with the responsibilities of quality control.
• Employees and consultants in the quality control unit have the authority to accept or reject a drug product formed.
• Packaging and labeling may affect drug product quality.

Buildings & Facilities

• Regulations in this section include design, structural features, and functional aspects of buildings and facilities for drug manufacturing.
• The place for drug manufacturing must be clean.
• Other factors to consider include water quality standards, security, materials used in ceilings, and floors, lighting and walls.
• Production storage, handling of waste, heat, humidity, and ventilation must be present in the building.

Equipment

• Each piece of equipment must be appropriate size and at the appropriate position for its intended use.
• Standard operating procedures must be written for cleaning each piece of equipment.
• Automated equipment must be calibrated daily.

Production & Process Control

• Written procedures are required to control production processes to ensure the drug product has correct identity, strength, and quality and purity.
• Any deviation from the written procedures must be recorded and justified.
• Automated equipment should be controlled and validated / calibrated regularly.

Packaging & Labeling Control

• Procedures are required to receive, identify, package, and label drug products.
• Labeling for each drug variation (strength, dosage form, or quantity of contents) must be separated.
• Materials must be stored only by authorized personnel.
• Labeling and packaging must be withheld for use until the packaging is approved and released by the quality control unit.
• The quantities issued must be reconciled and investigated.
• Each label must meet the requirements for the product batch number and expiration date.

Expiration Dating

• To ensure that the drug product meets the applicable standards of purity, strength, and quality at the time of use, it must have an expiration date.

Laboratory Controls

• Laboratory controls are the requirements for the establishment of standards, sampling plans, test procedures, and other mechanisms for the specification of the drug product which applies to each batch.
• The specifications include provision for sample testing intervals, sample storage, stability testing, and special testing requirements for certain dosage forms, including parenterals, ophthalmics, and controlled-release products.

Records & Reports

• Control and distribution records for production must be maintained for at least one year.
• This includes equipment cleaning, maintenance logs, raw materials, and product containers and closures and labels.
• Complete master production control records for each batch must be kept.

Manufacturing of Sterile Products

• Sterilization is the process of killing bacteria, all other forms of living organisms, and their spores.
• Sterilization methods include physical methods (dry heat, moist heat, radiation) and chemical methods (ethylene oxide, formaldehyde, hydrogen peroxide).

Physical Methods of Sterilization

• Dry Heat: Used to sterilize items, but requires more time and high temperature.
• Substances Sterilized: Liquid paraffin, fixed oils, petroleum, propylene glycol, and powders.
• Moist Heat: Most reliable method for sterilization. Bacteria are destroyed at relatively low temperatures.
• Used for sterilization of equipment and instruments.
• Mechanism: Destroys microbes by denaturation and coagulation of proteins.

Methods for Dry Sterilization

• Flaming: A simple method for sterilization using a hot part of a bunsen burner flame for short periods.
• Hot Air Oven: Sterilization in a chamber of metal, heated electrically, and controlled by a thermostat

Incineration

• A method to dispose of contaminated materials to ash.
• Used to dispose of biohazard and medical waste.

Moist Heat Sterilization

• The most reliable method of sterilization, using moist heat (boiling water).
• The mechanism kills microorganisms by coagulation and protein denaturation.
• Microorganisms are killed at relatively low temperatures.
• Methods include Autoclaving (pressure steam sterilization)

Methods for Moist Sterilization (autoclaving)

• Autoclaving uses steam under pressure to sterilize items.

Heating with Bactericide

• A method of sterilization where bactericide is added to the suspension and the sealed containers are heated for a controlled time.

Sterilization by Radiation

• A method of cold sterilization, using radiation to kill microorganisms.
• A widely used method of sterilization for medical equipment and items.

Gamma Rays

• Very penetrating radiation.
• Used to sterilize disposable medical equipment, syringes, and needles.

UV Light

• Used for sterilization of surfaces and transparent objects.
• Effective for sterilizing biological safety cabinets.

Electron Beam Processing

• A high-dose radiation method used for medical devices.

Chemical Sterilization

• Chemicals are used when heat is not suitable.
• Examples include ethylene oxide, ozone, formaldehyde, hydrogen peroxide, and chlorine bleach.
• Ethylene oxide is highly flammable and takes longer than heat sterilization.

Preservatives

• Agents used to inhibit the growth of microorganisms in foods.
• They should be non-toxic if consumed.

Antimicrobial Agents

• Chemicals that kill or inhibit the growth of microorganisms.
• Antiseptics are applied to the skin and mucous membranes, while disinfectants are applied to inanimate objects.

Prions

• Highly resistant to chemical sterilization.
• Treatment with aldehyde increases prion resistance.

Control of Microbial Contamination

• Steps to prevent microbial contamination including risk assessment and hazard analysis of critical control points (HACCP)
• Environmental cleanliness and hygiene
• Quality of starting materials
• Water quality and storage processes

Explore the essential concepts surrounding CGMP regulations for pharmaceutical products. This quiz covers topics including Quality Control Units, facility design, and the importance of maintaining a clean environment in drug manufacturing. Test your understanding of compliance and operational standards critical to ensuring drug safety and effectiveness.