asepsis 1

Question 1

what is the role of GMP in pharmaceutical manufacturing?

Answer 1

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

Question 2

what does GMP apply to?

Answer 2

Applies to both sterile and non-sterile pharmaceutials although the requirements differ

Question 3

what are the main 5 aspects that GMP covers?

Answer 3

• 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)

Question 4

why is documentation so important to GMP?

Answer 4

• Helps prevent errors associated with verbal communication
• Facilitates tracing of manufacturing history of pharmaceuticals
• Ensures reproducibility in all aspects of manufacturing

Question 5

what is hierarchical documentation?

Answer 5

documentation that underpins the drug manufacturing processes
–Legally binding documents containing approved pharmaceutical standards and assessment methods

Question 6

what is martindale?

Answer 6

The extra Pharmacopoeia”–Nota book of standards–Provides concise, unbiased information on drugs in clinical use taken from peer reviewed literature

Question 7

how does the specificity of the documentation differ ?

Answer 7

least specific to most specific:

quality manual, company policies, SOP’s, specifications, validation documents/ batch records/ log books

Question 8

what are quality manuals and company policies?

Answer 8

•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

Question 9

what are SOP’s?

Answer 9

• 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

Question 10

what do the SOPS’s allow for?

Answer 10

• Provides consistency
• Allows for errors to be tracked and identified
• Can be used as a reference by employees

Question 11

what are specifications, validation documents, batch records, log books?

Answer 11

• 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

Question 12

what is qualification?

Answer 12

it is a pre-requsite of validation. There are 4 stages to qualification

Question 13

what are the 4 stages of qualification?

Answer 13

• 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

Question 14

what is validation?

Answer 14

process of getting evidence that your procedure maintains compliance at all stages

Question 15

what are the 4 types of validation?

Answer 15

• 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)

Question 16

what are the different types of scale manufacturing?

Answer 16

• Terminally sterilised

* Aseptically manufactured

Question 17

what is terminal sterilization?

Answer 17

Product is manufactured and packaged then subjected to a sterilisation process

Question 18

what are the features of terminal sterilisation?

Answer 18

• 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

Question 19

what is aseptic preparation?

Answer 19

Separate components of a drug subjected to sterilisation prior to packaging

Question 20

what is a disadvantage of aseptic sterilisation?

Answer 20

Will have more variables than terminal sterilisation

•Each step of the process (including those after sterilisation) could introduce a contaminan

Question 21

why do we prepare aseptically?

Answer 21

terminal sterilisation preferred to filtration and aseptic preparation
•Actually kills microorganisms
•Reliable sterility assurance level can be calculated (with a safety margin)

Question 22

what are the benefits of aseptic prep?

Answer 22

drugs that are not amenable to terminal sterilization are sterilsed this way