QC & QA compliance requirement for final release Flashcards
Describe the Quality Management diagram
QA systems ensures that:
- Products are designed & developed to GMP
- Controls on the environment
- Controls on starting, intermediate & finished products
- Operators competent to perform functions
- Correct system for “release”
- Storage & distribution consistent with shelf life
- Pharmaceutical Quality System operates
What is the definition of ‘Quality Control’?
…concerned with:
- Sampling, specifications, and testing
- Organisation, documentation and release procedures
Which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use until their quality has been judged to be satisfactory
What are the main requirements of QC?
- Adequate facilities, trained personnel & approved procedures are available
- Samples are taken from all parts of the process and retained samples kept for future testing
- Test methods are validated
- Records made of sampling + deviations
- Qualitative and Quantitative tests comply
- Tests encompass product in container with label
- Participate in investigations of complaints
an Aseptically Prepared Product is…
- Sterile
- Particle Free
- Contamination Free
- Right Patient
- Right Drug
- Right Dose, Concentration & Frequency
- Right Label and Instructions
- Right Administration Device
- Appropriate Shelf Life
What are the requirements of each grade of cleanroom according to the Micro Testing Guidelines (Orange Guide 2015)
Describe ‘Air Monitoring’
- Air acts as a carrier of contamination
- Quantitative analysis
- Known volume of air
- Impaction/centrifugal forces used
- Physical stress to bacteria
- Do not interchange instrument design
Describe ‘Fallout methods - settle plate’
- Passive technique
- Settle out by gravity
- Simple to measure
- No physical stress to bacteria
- Represents <0.2% of working surface
- Consistent position required
Describe ‘Surface monitoring - contact plate’
- Contact Plates
- Plate overfilled with media
- Good surface contact
- Standardise technique
- Media should include neutraliser
- Wash surface after plating to remove agar residues
Describe ‘Finger Dabs - glover print’
- Monitor personnel
- Contamination through
-> Inadvertent contact with contaminated surface
-> Damaged glove
-> Excessive personnel shedding
Standardise technique
Clean gloves/change afterwards
Sterility testing takes around 14 days, why is this an issue?
Shelf-life 3 hours to 3 months
Sterility testing only tests container sampled, why is this an issue?
Batch size from 1 to 100s
Sterility testing is a poor indicator if low levels of contamination, why is this a problem?
Grade A
Staff validated
In-process testing usually consists of…
Quick testing methods performed prior to filling e.g.
Flame photometry
- Metal ion content
UV absorption
- Identification of drug
- Content
End-process testing usually consists of…
HPLC
Atomic absorption
What are the main risks associated with having air in the syringe?
Risk of air embolism in patient
- fatality dependant on volume and rate
Incorrect volume and solution (patient recieving low dose)
Implications for stability & infusion rate
What are the main risks associated with an incomplete bung seal?
Reduction in safety barriers to user
Risk of integrity of syringe being compromised
What are the main risks associated with drug in the bung?
Risk of contamination to user
Integrity of syringe has been compromised exposing the contents of the syringe to microbiological contamination
What are the main risks associated with drug in the hub?
Risk of exposure to cytotoxic drugs
Creates a fluid pathway for microbiological contamination into the solution
What can be done to try and ensure that the final product is contamination free?
Licensed starting material
CE marked devices & components
Appropriate segreation
Appropriate diluent
Appropritate shelf-life & stability studies
Validated cleaning procedures
Demonstrate cross-contamination not occurring
What should normally be checked during the final release process?
Good written communication
Documentation record complies with data integrity requirements
Checks on patient ID
Correct transcription of product requirements
Right administration device
Formula
Ingredient checks
Method
Equipment
Label
Process
What is the pharmacists responsibility in the final release process?
Release assured by familiarisation with QA processes:
- Starting material approval
- Accurate documentation
- Knowledge
- Supervision
- Trained staff
- Validation
- Monitoring
- Deviations
- Audit
