asepsis 1 Flashcards
what is the role of GMP in pharmaceutical manufacturing?
Regulatory agencies require that the principles of Good manufacturing practice (GMP or cGMP) are adhered to
•Falls within the wide ranging concept of Quality Assurance (QA)•These are the minimum standards a manufacturer must meet in their production
what does GMP apply to?
Applies to both sterile and non-sterile pharmaceutials although the requirements differ
what are the main 5 aspects that GMP covers?
- Quality management (i.e. are the right quality ingredients being used, are the ingredients contaminated)
- Personnel(i.e. are they properly trained)
- Sanitation (i.ehow to clean an area or equipment)
- Buildings, facilities and equipment (i.eare things stored properly, is the right equipment being used)
- Documentation(i.e. are appropriate records maintained)
why is documentation so important to GMP?
- Helps prevent errors associated with verbal communication
- Facilitates tracing of manufacturing history of pharmaceuticals
- Ensures reproducibility in all aspects of manufacturing
what is hierarchical documentation?
documentation that underpins the drug manufacturing processes
–Legally binding documents containing approved pharmaceutical standards and assessment methods
what is martindale?
The extra Pharmacopoeia”–Nota book of standards–Provides concise, unbiased information on drugs in clinical use taken from peer reviewed literature
how does the specificity of the documentation differ ?
least specific to most specific:
quality manual, company policies, SOP’s, specifications, validation documents/ batch records/ log books
what are quality manuals and company policies?
•Quality manuals serve as a guide to introduce GMP for medicinal products and devices
–Establishes criteria which guarantee consistent production of safe and effective drugs
•Company policies describe in general terms, how specific aspects of GMP will be implemented;–E.ghow staff will receive training to do their jobs properly
what are SOP’s?
- SOPs are a series of step by step instructions to help carry out complex routine operations
- Focus is on the repetition of a process with NO deviations
what do the SOPS’s allow for?
- Provides consistency
- Allows for errors to be tracked and identified
- Can be used as a reference by employees
what are specifications, validation documents, batch records, log books?
- Specifications–Exact requirements for raw materials, packing materials and final products
- Validation Documentation–Documentation that provides a high degree of assurance that a planned process will perform consistently •Batch Records–Records specifically what happens for each batch (who made it, when it was made, which equipment was used etc etc)
- Logbooks–Forms used to record operations
what is qualification?
it is a pre-requsite of validation. There are 4 stages to qualification
what are the 4 stages of qualification?
- Design qualification (DQ)
- Demonstrates that the proposed design will satisfy all the requirements is suitable (e.ga facility design)
- Installation Qualification(IQ)
- Ensuring equipment is installed, operates as per manufacturer’sspecifications and documentation needed for continued use in place
- Operation Qualification(OQ)
- Demonstrates that equipment/process works properly
- Establishes “worst case” conditions
- Performance Qualification(PQ)
- Demonstrates that process/equipment works properly over time
- Should maintain data to show performance over time
what is validation?
process of getting evidence that your procedure maintains compliance at all stages
what are the 4 types of validation?
- Prospective: Establishes documented evidence of what a system does based on a plan (new products)
- Concurrent: Establishes documented evidence of what a system does based a system that is implemented
- Retrospective: Establishes documented evidence of what a system does based on previously acquired data (not encouraged)
- Revalidation: Process which occurs after a change in the process takes place which could have an impact on efficacy or safety (i.e. when something goes wrong)
what are the different types of scale manufacturing?
- Terminally sterilised
* Aseptically manufactured
what is terminal sterilization?
Product is manufactured and packaged then subjected to a sterilisation process
what are the features of terminal sterilisation?
- Limited number of steps prior to sterilisation
- Filled and packed under a high quality environment to minimize bioburden
- Product will likely contain a low bioburden prior to sterilisation
- Process tightly controlled with SOPs and monitoring
what is aseptic preparation?
Separate components of a drug subjected to sterilisation prior to packaging
what is a disadvantage of aseptic sterilisation?
Will have more variables than terminal sterilisation
•Each step of the process (including those after sterilisation) could introduce a contaminan
why do we prepare aseptically?
terminal sterilisation preferred to filtration and aseptic preparation
•Actually kills microorganisms
•Reliable sterility assurance level can be calculated (with a safety margin)
what are the benefits of aseptic prep?
drugs that are not amenable to terminal sterilization are sterilsed this way
