Lecture 3 Review Flashcards
Who does the standards and manufacturing group consist of?
Quality control unit, employees and consultants
What is important to know about the buildings and facilities?
The structure, space, design, and placement of equipment must be such to enable through cleaning, inspection and safe use for the designated operations. All work must be logged, inspected by supervisor and signed off (accountability).
What is important about the equipment for standards and manufacturing?
It must be the appropriate design and size. Must be suitably located to facilitate intended use, cleaning and maintenance. Standard operating procedures followed
What do you need to know about control of components, containers, and closures?
There need to be written procedures. They include a receipt, identification, storage, handling, sampling, testing, and approval or rejection of all drug components, product containers and closures.
What is included in production and process controls?
Need to ensure correct identity, strength, quality and purity. Any deviation must be recorded and justified. All product ingredients, equipment, and drums or other containers must be distinctly identified.
What is important to know about packaging and labeling control?
There needs to be an expiration date and tamper-evidence packaging
What is there to know about holding and distribution?
There are written procedures on holding, distribution and quarantine. Has to be stored and shipped under appropriate conditions.
What are laboratory controls?
Establishment of and conformance to specifications, standards, sampling plans, test procedures and other mechanisms
What kinds of records and reports are kept and how long?
Records for production, control and distribution are kept and maintained for not less than 1 year after expiration date
What happens with returned and salvaged drug products?
They are identified by lot number, quality is determined through appropriate testing, salvage or processing is allowed if specifications met and through records must be kept.
What is important to know about the NECC FDA inspection?
In October of 2012, 50 people died and 800 were sickened from injecting methylprednisolone acetate made in a compounding pharmacy. 2 pharmacists were indicted for murder and there were many lawsuits to follow.
What did the NECC FDA inspectors find?
83/321 vials had a greenish-black foreign matter, tarnish and discoloration on inside of the autoclave, the firm was right next to a recycling facility, large equipment producing airborne particles, rooftop units 100 ft from recycling facility, raw materials were nonsterile, many surfaces of the site had bacteria and mold, air samples had bacteria and mold and no evidence of a quality assurance system.
What are the ICH Q10 objectives?
Achieve product realization, establish and maintain a state of control and facilitate continuous improvement.
What is important to know about the QOS diagram?
Controlling critical quality attributes helps ensure quality.
