Documentos de Académico
Documentos de Profesional
Documentos de Cultura
cGMP
Biotech companies coming to GMP like large pharma difficult transition Problems due to:
tight budgets limited (trained) personnel R & D scientists only
Types of Documentation
Early on, scope and project goals
timeline or Gantt chart http://www.netmba.com/operations/project/ gantt http://searchcio.techtarget.com/sDefinition/0, ,sid19_gci331397,00.html
Gantt chart
Planning tool timelines showing duration stages of the project in chronological order interrelationship between various stages of the project responsible parties for each phase of the project Figure 3.1, Page 29
Areas of Documentation
Process overview
explain major process steps detail sufficient so personnel at each step knows how the product is made and what their role is blueprint of project process targets
GLP documentation
Preclinical operations user-friendly document numbering system (needs to accommodate many doc types) index should contain 3 parts:
functional group (testing vs. processing) stage of process (scale-up, purification) type (general item, specific procedure, etc.)
GMP documentation
Extension of docs begun in preclinical lab includes prompts were information needs to be entered need QA tested raw materials (remember, the product is now going into a person!) record expiration date- cannot use 1 day past that date (not so in a research lab)
GMP documents
Contain process limits (maintains control of process) limits include process parameters
pH temperature volume concentration WHAT are some other limits?
GMP documents
Steps after a process is complete:
technician verifies and signs that process is complete supervisor reviews and signs documents independent reviewer QAs the documents (and the process) Therefore, each document is reviewed 3 times have review document for this process (GETTING the picture about how much writing goes on!)
Validation Chapter 4
Validation
Document that a manufacturing process is under control Capable of consistent production of a biopharmaceutical Begins with product specifications
Validation
Cant test for quality, so validate Therefore, each step of manufacturing process validated so you have assurance of quality product
Cell Seed
aliquot of cells derived from single tissue
Certification
review and approval process (final step)
Drug Product
a finished dosage that contains active ingredient (s)
HVAC
Heating, ventilation, and air conditioning
Prospective Validation
written evidence, prior to carrying out a process, that the process will do as suggested
Qualification
separate validation- shows system is suitable to carry out designated process
Regulatory requirements
FDA - safety and efficacy of drug supply See quote page 48 under section 4.1.3 Parts 210 and 211 of GMPs - if FDA thinks drug is tampered they may take action against the producer highly trained FDA personnel to carry out inspections of drug makers
Process Development
IF process development weak or absent, inconsistent results will appear during manufacturing runs
Involves personnel from validation, QA, QC, manufacturing and engineering Section under change control (page 49)
MWCB
History and morphology of cell line, plasmid, and transfection into host cell storage, maintenance and propagation of cell line cell markers tumorigenicity studies expression of endogenous retroviruses test for presence of virus, fungi, bacteria or
MWCB contd
Bacterial production systems check for:
carbohydrate use antibiotic resistance contamination sequence and restriction map of plasmid growth rate of host SDS-PAGE of product profile
Validation