cgmp-outline - 9/6/2010 1 2 3 4 5 6 7 8 Current Good...

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Unformatted text preview: 9/6/2010 1 2 3 4 5 6 7 8 Current Good Compounding and Manufacturing Practices Standards for cGMP n Established by FDA n Domestic and foreign n Definitions found on pg 69 n n cGMP Overview n Organization and Personnel n Buildings and Facilities n Equipment n Components, Containers, and Closures n Production and Process Control n Packaging and Labeling Control n Laboratory Controls n Records and Reports n Holding and Distribution Organization and Personnel n Quality control unit ¨Authority and responsibility for all functions that may affect product quality n Education, training, and experience n Skill development, CE, and performance evaluations n Adequate laboratory facilities n Written procedures followed n Records maintained Buildings and Facilities n Design, structural features, and functional aspects n Water quality standards n Plumbing n Sanitation n Ventilation, air filtration, air heating, cooling n Materials used for floors, walls, ceilings, lighting n Compliance with Occupational Safety and Health Administration ¨ Equipment n Appropriate design and size n Suitable location n Standard operating procedures written and followed n Maintenance and cleaning of equipment n Appropriate logs and records maintained n Routinely calibrated, maintained, and validated for accuracy Components, Containers, and Closures n Written procedures ¨Receipt ¨Identification ¨Storage ¨Handling ¨Sampling ¨Testing n Physical and chemical specifications Production and Process Controls 1 9/6/2010 9 10 11 12 13 14 15 n Written procedures ¨Sample testing ¨Process and equipment validation n Deviations recorded and justified n Distinctive labeling for all product ingredients, equipment, and containers n In-process sampling for product control Packaging and Labeling Control n Written procedures ¨Receipt, identification, storage, handling, sampling, and testing of drug product and issuance of labeling and packaging materials n Labeling stored separately for variations in drug product n Products are visually and electronically inspected for correct labeling and packaging n Everything documented Labeling n Labels on the immediate container and packaging n Inserts n Company literature n Advertising and promotional material (brochures, booklets, bulletins, sound recordings, etc.) n Other materials related to the product Types of Labels n All drug products distributed in US must meet labeling requirements ¨Investigational drugs ¨Manufacturer’s prescription drugs ¨Controlled substances ¨Dispensed prescription medication ¨OTC products ¨Products for animals ¨Medical devices n All labels include expiration date and lot number Laboratory Controls n 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) Records and Reports n Production, control, and distribution records ¨Maintained 1 yr following expiration date of product batch n Written and oral complaints (product failure, adverse drug experience) n Holding and Distribution n Finished pharmaceuticals quarantined in storage until released by the quality control unit n Stored and shipped as to not affect product quality n Normally, distribute oldest first n Distribution control system must enable a recall if necessary Other cGMP Regulatory Requirements n Active pharmaceutical ingredients n Pharmaceutical excipients 2 9/6/2010 16 17 18 19 20 21 22 n n Clinical trial materials n Biologics n Medical Devices n Active ingredients and excipients n FDA publication Guide to the Inspection of Bulk Pharmaceutical Chemicals (for active ingredients) n Inspection program for chemical components n All defining elements of chemical purity and quality n n n Clinical Trial Materials n Production of pharmaceutical ingredients ¨Subject to all requirements of bulk pharmaceutical chemicals n Investigational drug products ¨Same requirements for identity, purity, strength, and quality Biologics n cGMP standards defined in the Code of Federal Regulations n 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, quantification, and validation of risk factors Medical Devices n Similar FDA approval path as pharmaceuticals n Subject to reporting of adverse events, to recall, and to termination of approval n Examples: hearing aids, intraocular lenses, catheters, cardiac pacemakers, powered wheelchairs and many others n n Noncompliance with cGMP Regulations n Inspection for NDA ¨Delay in approval n Regularly scheduled inspection ¨Fines ¨Time given for corrective action ¨Remove violative products from market ¨Withdraw product approval ¨Restrict further applications ¨ Manufacturing in Pharmacies n Large-scale production of drugs or drug products for distribution and sale n Register with FDA as manufacturer or distributor n Subject to FDA inspections n Current Good Compounding Practices 3 9/6/2010 23 24 25 26 27 28 29 n Compounding- professional preparation of prescriptions for specific patients as a part of the traditional practice of pharmacy n Examples of reasons for patient-specific medications? n USP-NF n Chapter <795>, “Pharmacy Compounding” ¨Compounding environment ¨Stability of compounded preparations ¨Ingredient selection and calculations ¨Checklist for acceptable strength, quality, and purity ¨Compounded preparations ¨Compounding process (with a template for compounding prescriptions) ¨Compounding records and documents nFormulation record nCompounding record ¨Quality control and Patient counseling Compounding Environment n Specific design and maintenance of facilities n Selection of equipment ¨Appropriate size and design n Stability of Compounded Preparations n Packaging n Sterility n Stability criteria n Beyond-use dates (non-sterile) ¨ Ingredient Selection n USP or NF grade substance is preferred n Drug of the highest quality reasonably available ¨Must maintain material safety data sheets n 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 National Association of Boards of Pharmacy n “The Good Compounding Practices Applicable to State-Licensed Pharmacist” ¨Organization and personnel ¨Facilities and Equipment ¨Control of components and drug product containers and closures (packaging requirements) ¨Drug compounding controls ¨Labeling control of excess products and records and reports Packaging and Storage n Standards found in the cGMP section of the Code of Federal Regulations n NDA ¨All specifications for packaging nInitial: adequate drug stability for duration of trials nUltimate: complete information for drug stability for entire shelf life Containers for Storage n Different specifications required depending on product ¨Parenteral versus nonparenteral 4 9/6/2010 30 31 32 33 ¨ ¨Pressurized ¨Bulk containers ¨Glass ¨Plastic ¨Metal ¨ Storage n Necessary to maintain stability n Labeling contains desired conditions ¨Labeling contains desired conditions ¨Cold ¨Cool ¨Room Temperature ¨Warm ¨Excessive Heat ¨Protection from Freezing n ¨ n Child-Resistant n Poison Prevention Packaging Act (1970) n Reduce accidental poisonings n Enforcement and administration now by Consumer Product Safety Commission n Patient must request non-child-resistant closures n OTC exemptions permitted for one package size or specially marked package ¨“This package for households without young children” or “Package not child-resistant” n Tamper-Evident Packaging n FDA published initial regulations in 1982 n Improve security and ensure safety and effectiveness n All retail sale OTC (except dentifrices, skin care products, insulin, and throat lozenges) n Request for Exemption From Tamper Evident Rule n Extra References n http://www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg460-200.html n http://www.nabp.net/ftpfiles/task_force_reports/2002_2003_reports/LELReport2003.PDF n http://pharmacyboard.state.wy.us/laws/Chapter_13_Pharmacy_Act.pdf 5 ...
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This note was uploaded on 10/15/2010 for the course PHCY 6100 taught by Professor Teixeira during the Fall '10 term at Univeristy of Wyoming- Laramie.

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