Current Good Compounding and Manufacturing Practices

  1. Standards for cGMP?
    • Established by FDA
    • Domestic and foreign
  2. Quality control unit:
    Authority and responsibility for all functions that may affect product quality
  3. Organization and personnel for cGMP
    • Quality control unity
    • Education, training, and experience
    • Skill development, CE, and performance evaluation
    • Adequate laboratory facilities
    • Written procedures followed
    • Records maintained
  4. Building and Facilities for cGMP
    • Design, structural features, and functional aspects
    • Water quality standards
    • Plumbing
    • Sanitation
    • Ventilation, air filtration, air heating, cooling
    • Materials used for floors, walls, ceilings, lighting
    • Compliance with occupational safety and health adminstration
  5. Equipment for cGMP
    • Appropriate design and size
    • Suitable location
    • Standard operating procedures written and followed
    • Maintenance and cleaning of equipment
    • Appropriate logs and records maintained
    • Routinely calibrated, maintained, and validated for accuracy
  6. Components, Containers, and Closures for cGMP
    • Wirtten procedures: receipt, indentification, storage, handling, sampling, testing
    • Physical and chemical specifications
  7. Production and Process Controls for cGMP
    • Wirtten procedures: sample testing, process and equipment validation
    • Deviations recorded and justified
    • Distinctive labeling for all product ingredients, equipment, and containers
    • In-process sampling for product control
  8. Packaging and Labeling Control for cGMP
    • Written procedures: Receipt, identifcation, storage, handling, sampling, and testing of drug product and issuance of labeling and packaging materials
    • Labeling stored separately for variations in drug product
    • Products are visually and electronically inspected for correct labeling and packaging
    • Everything documented
  9. Labeling for cGMP
    • Labels on the immediate container and packaging
    • Inserts
    • Company literature
    • Advertising and promotional material (brochures, booklets, bulletins, sound recordings, etc)
    • Other materials related to the product
  10. Types of Labels for cGMP
    • All drug products distributed in US must meet labeling requirements: Investigational drugs, Manufaturer's prescription drugs, Controlled substances, dispensed prescription medication, OTC products, products for animals, medical devices
    • All labels include expiration date and lot number
  11. Laboratory controls for cGMP
    Requirements for establishment of and conformance to written specifications, standards, sampling plans and test procedures (sample size, test intervals, sample storage, stability testing, special testing requirements for certain dosage forms (parenterals, ophthalmic, CR products, and radioactive pharmaceuticals)
  12. Records and Reports for cGMP
    • Production, control, and distribution records (Maintained 1 yr following expiration date of proction batch)
    • writeen and oral complaintes (procut failure, adverse drug experience)
  13. Holding and Distribution cGMP
    • Finished pharmaceuticals quarantined in storage until released by the quality control unity
    • Stored and shipped as to not affect product quality
    • Normally, distribute oldest first
    • Distribution control system must enable a recall if necessary
  14. Other cGMP regulatory Requirements
    • Active pharmaceutical ingredients
    • Pharmaceutical excipients
    • Clincal trial materials
    • Biologics
    • Medical Devices
  15. Active ingredients and excipients
    • Guide to the Inspection of Bulk Pharmaceutical Chemicals
    • Inspection program for chemical components
    • All defining elements of chemical purity and quality
  16. What is the Guide to the Inspection of Bulk Pharmaceutical Chemicals?
    • FDA publication
    • For active ingredients
  17. Clinical Trial Materials
    • Production of pharmaceutical ingredients (subject to all requirements of bulk pharmaceutical chemicals)
    • Investigational drug products (same requirements for identity, purity, strength, and quality)
  18. Biologics
    • cGMP standards defined in the Code of Federal Regulations
    • Basic Regulation and additional items (Blood collection procedures, segregation of activities, cell bank and cell line characterization and testing, cell propagation and fermentation, inactivation of infectious agents, aseptic processing validation, bioassays, live vaccine work areas, evaluation, quantifcations, and validation of risk factors)
  19. Medical Devices
    • Similar FDA approval path as pharmaeuticals
    • Subject to repoarting of adverse even, to recall, and to termination of approval
    • Exaples: hearing aids, intraocular lenses, catheters, cardiac pacemakers, powered wheelchairs and many others
  20. Noncompliance with cGMP Regulations
    • Inspection for NDA (delay in approval)
    • Regularly scheduled inspection (Fines, Time given for corrective action, remove violative products from market, withdraw product approval, restrict further applications)
  21. Manufacuring in Pharmacies
    • Large-scale products for distribution and sale
    • Register with FDA as manufacurer or distributor
    • Subject to FDA inspections
  22. Current Good Compounding Practices
    Compounding-professional preparation of prescriptions for specific patients as a part of the traditional practice of pharmacy
  23. USPNF
    Chapter <795> Pharmacy Compounding
    • Compounding environment
    • Stability of compounded preparations
    • Ingredient selection and calculation
    • Checklist for acceptable strength, quality, and purity
    • Compounded preparations
    • Compounding process (with a template for compounding prescriptions)
    • Compounding records and documents (Formulation record, compounding record)
    • Quality control and patient counseling
  24. Compounding Environment
    • Specific design and maintenance of facilities
    • Selection of equipment (appropriate size and design)
  25. Stability of Compounded Preparations
    • Packaging
    • Sterility
    • Stability criteria
    • Beyond-use dates (non-sterile)
  26. Ingredient Selection
    • USP of NF grade substances is preferred
    • Drug of the highest quality reasonably available (must maintain material safety data sheets)
    • A manufactured drug product can be used as a source of a drug, excipient, or vehicle (presence of all excipients must be considered for overall acceptability
  27. National Association of Boards of Pharmacy
    • "The Good Compounding Practices Applicable to State-Licensed Pharmacist"
    • Organization and personnel
    • Facilities and Equipment
    • Control of componenets and drug product containers and closure (packaging requirements)
    • Drug compounding controls
    • Labeling control of excess product and records and reports
  28. Packaging and storage
    • Standards found in the cGMP section of the code of federal regulation
    • NDA (all specification for packaging, initial-adequate drug stability for duration of trials, ultimate-complete information for drug stability for entire shelf life)
  29. Contaiers for storage
    • Different specifications required depending on product
    • (Parenteral vs nonparenteral, Pressurized, Bulk containers, Glass, Plastic, Metal)
  30. Storage
    • Necessary to maintain stability
    • Labeling contains desired conditions (cold, cool, room temperature, warm, excessive heat, protection from freezing)
  31. Child-Resistant
    • Poison prevention Packaging Act 1970
    • Reduce accidental poisonings
    • Enforcement and adminstration now by consumer product safety commission
    • patient must request no-child-resistant closures
    • OTC exemptions premitted for one package size or specially marked package ("This package for households without young children" or "Package not child resistant"
  32. Tamper-Evident Packaging
    • FDA published initial regulations in 1982
    • Improve security and ensure safety and effectiveness
    • All retail sales OTC (except dentifrices, skin care products, insulin, and throat lozenges)
    • Request for exemption from Tamper evident rule
Card Set
Current Good Compounding and Manufacturing Practices
Dose Form Final