GMP and Documentation
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What does the GMP stand for ?
Good manufacturing practise
What is point of GMP ?
It ensures every tablet and liquid is made safely , consistently and to the same standard
What do you need for pharmaceutics ??
Physical chemistry Human body and drug kinetics Formulation science Manufacturing processes Microbial contamination control
What does PQS stand for ?
Pharmaceutical Quality system
Why is PQS important?
Ensures medicines are consistently made to required quality standards Introduces the regulatory framework for GMP in the UK and EU
Who is PQS lead by ?
It’s led by senior management , commitment from all staff essential
What does PQS integrate ?
GMP principles and Quality risk management
What are the 4 key requirements for goid manufacturing practise ?
Requires qualified staff , proper facilities and suitable equipment Processes must be clearly defined and validated All steps have to be documented with clear procedures and records Deviations must be investigated and addressed through the CAPA
What does the CAPA stand for ?
Corrective and preventive actions
What is the point of quality control ?
No product can be released without testing All results must be recorded Samples are kept for review
What is the point of product quality review ?
Annual product quality reviews assess consistency Supports ongoing improvement and revalidation
What must the risk assessment for GMP be ?
Based on scientific based evidence Focus on patients safety They have more documentation for high risk processes
List types of GMP documentation?
Specification for materials Manufacturing formula and process instructions Packaging instructions Batch processing and packaging records Standard operating procedures for recipt , sampling and testing
Why are GMP documentaries principles important?
They are critical for demonstrating GMP compliance and traceability
What are the 3 good documentation practices ?
Documents must be clear, accurate and available at point of use Corrections should not obscure original entries Records should be retained for a specific period of time until it becomes expired
What are the 2 manufacturers long scales ?
Small scale manufacturing Large scale manufacturing
What are 3 ways to describe large scale manufacturing?
Industrial , controlled, automated
What are 2 words to describe small scale manufacturing?
Less automated , pharmacy based as it’s done by people
What type of packaging does large scale manufacturing use?
Use this packaging designed to maintain product stability
What does a large scale of manufacturing implement?
Rigourous quality control and testing procedures
What kind of equipment does large scale manufacturing use?
Uses large scale specialised equipment, which is both sterile and non-sterile
What type of products do large scale manufacturing produce?
Produces licensed , approved products which are not individualised so mass production
What type of environment does small scale manufacturing happen in pharmacies?
Community settings Hospital settings Specials manufacturing
When is small scale manufacturing used?
It’s generally less precise and only used when there is no alternative