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

Info iconThis preview shows page 1. Sign up to view the full content.

View Full Document Right Arrow Icon
This is the end of the preview. Sign up to access the rest of the document.

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 n n 5 ...
View Full Document

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.

Ask a homework question - tutors are online