Study Set Content:
• Not part of the cGMP requirements, but when used effectively they can enhance process developments, production efficiency, product quality and compliance
Information Technology and Automation
• The quality of all components affects the quality of the finished pharmaceutical product
• The quality of all components affects the quality of the finished pharmaceutical product
must comply to cGMP standards since it is critical in the FDA’s preapproval inspection program for NDAs and ANDAs
APIs and excipients
Must be produced under cGMP standards
Clinical Trial Materials
Flexibility in the regulations is applicable during the preclinical testing and in the earlier part of the clinical tests
Clinical Trial Materials
Additional mandates specific for blood, bacterial, and viral products are found in the regulations due to their nature
Biologics
• Approval process similar to pharmaceuticals.
Medical Devices
Result to FDA Regulatory actions
Noncompliance with cGMP Regulations
Similar standards in place.
Medical Devices
Thousands of medical devices are covered.
Thousands of medical devices are covered.
Intraocular lenses, hearing aids, intrauterine devices, cardiac pacemakers, clinical chemistry analyzers, catheters, bypass machines, dental x-ray equipment, surgical gloves, condoms, prosthetic hip joints, traction equipment, and powered wheelchairs
Medical Devices
• Good Compounding Practices Applicable to State
Licensed Pharmacies—Model Act
Eight recommendations
National Association of Boards of Pharmacy
Compounding vs Manufacturing
National Association of Boards of Pharmacy
that which holds the article and is or may be in direct contact with the article
USP
that which is in direct contact with the article at all times
Immediate container
Must be clean and dry before it is filled, and must not physically or chemically interact with the drug
Containers
Minimally acceptable container; Protects the contents from extraneous solids and from loss of the article under the ordinary or customary conditions of handling, shipment, storage, and distribution
Well-closed:
Protects the contents from contamination by extraneous liquids, solids, or vapors, from loss of the article, and from efflorescence, deliquescence, or evaporation under the ordinary or customary conditions of handling, shipment, storage and distribution, and is capable of tight reclosure
Tight:
Impervious to air or any other gas under ordinary conditions
Hermetic
