cgmp-outline - 1 2 3 4 5 6 7 Current Good Compounding and...

Info icon This preview shows pages 1–3. Sign up to view the full content.

View Full Document Right Arrow Icon
9/6/2010 1 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 2 3 4 5 6 7 8
Image of page 1

Info iconThis preview has intentionally blurred sections. Sign up to view the full version.

View Full Document Right Arrow Icon
9/6/2010 2 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
Image of page 2
Image of page 3
This is the end of the preview. Sign up to access the rest of the document.

{[ snackBarMessage ]}

What students are saying

  • Left Quote Icon

    As a current student on this bumpy collegiate pathway, I stumbled upon Course Hero, where I can find study resources for nearly all my courses, get online help from tutors 24/7, and even share my old projects, papers, and lecture notes with other students.

    Student Picture

    Kiran Temple University Fox School of Business ‘17, Course Hero Intern

  • Left Quote Icon

    I cannot even describe how much Course Hero helped me this summer. It’s truly become something I can always rely on and help me. In the end, I was not only able to survive summer classes, but I was able to thrive thanks to Course Hero.

    Student Picture

    Dana University of Pennsylvania ‘17, Course Hero Intern

  • Left Quote Icon

    The ability to access any university’s resources through Course Hero proved invaluable in my case. I was behind on Tulane coursework and actually used UCLA’s materials to help me move forward and get everything together on time.

    Student Picture

    Jill Tulane University ‘16, Course Hero Intern