MDM: PO, SU, VAL Flashcards
1
Q
- What is process optimisation?
- What does it mean?
- What dose it lead to?
A
- Maximising number of batches which pass release specifications OR maximising number of doses per unit time passing release specifications
- Reduced quantity of materials used OR reduced production time
- Reduced waste OR making sure we get the same thing each time
2
Q
- What is validation?
- Why do we need it?
- What does it lead too?
A
- Formally doccumented, predetermined success criteria, part of the QA
- Reproducibilty and to be able to confidently state the system gives the expected results
- Quality product, wihtout full end of process testing
3
Q
- What is scale up?
- When does it occur?
- What need to happen at each stage?
A
- Transferring a process from one batch size to another because the compnay needs to increase number of production units
- Research (<1g), Development (1g -1000g), Clinical P1 (1kg - 2kg) P2/3 (10kg - 100kg), full scale (>100kg)
- Process optimisation needs to occur at each stage process and validation of the optimised process needs to occur
4
Q
How do we process optimisation?
A
- Once manufactuing method has been designed we identifiy critical processes - ones which if not controlled could have a detrimental effect on the product
- Time and temperature usually critical (max/ min temp?)
Repeat evlaution stage for each variable in the process
5
Q
When scaling up what needs to occur for CT productions?
A
- Increase batch size
- USe different equipement
- monitor manufactuing process carefully
- Make sure critical factor checked
- dissoluton drug sample after 10 minutes at 75C and carrry out assay
- monitor cooling stage
6
Q
When scaling up what needs to be done for larger scale or process transfers?
A
- Different equipment used
- increase batch size
- 1/10th of full scale
- incoperate more rigorous testing regimes
- validation bataches or piolet batches
- must be done triplicate
7
Q
What is optimisation of process flow and why is it important?
A
- Movement of batches costs money and problems (segregation)
- Facilities must be desgined in so to minimise movement of products
8
Q
What must process flows be?
A
- logical
- take into consideration people, processes, materials, products, waste
- Must have a production flow diagram
9
Q
What can be validated?
A
- Equipment
- cleaning
- processes
- systmes
- facilities
10
Q
Who can validate?
A
- Quality Assurance department
- Engineering staff
- production staff
- Validaition specialists
- doccumentation specialists
11
Q
How is validation done?
A
- Instalation qualification
- calibration qualification
- desgin qualification
- performance qualification
- operational qualification
12
Q
What is design quality?
A
- ensures quality built into the design
- suitable for use in GMP enviroment
- In accorance with desgin specifications and intentions
13
Q
What is installation qualification?
A
- Ensures the right thing has arrived
- ensures it meets specificatinos of DQ and GMP requirements
- Has been installed as directed
- Calibrations have been done, with certified, tracable standards used
14
Q
What is operational qualification?
A
- Checks equipment works under power
- performed without material or placebo
- Assess stability of equipment
15
Q
WHat is performance qualification?
A
- Testing actual production process
- each stage of process evaluated
- determine of critical factors
- assess effects of variability of critical factors
16
Q
What people are invoved in the scaling up process
A
- Research - pharmacologists, synthetic scientists
- development - analytical and development chemists
- production - manufacturing personel, technology transfer scientist
17
Q
What doccumentation is there for scaling up process?
A
- Master batch doccuments
- specifications
- validation doccuments
18
Q
What is a good process
A
- Reproducible
- product stable over full shelf life
- reproducable
- as simple as possible
19
Q
What liquid dosage forms is there?
A
- emulsion
- suspension
- simple liquid
- parental
20
Q
What solid dosage forms is there?
A
- tablet
- capsule
- pessaries
21
Q
Describe steps to make a supository
A
22
Q
Describe steps to make a granulation
A
23
Q
- What is change control?
- Why?
- How?
A
- A system to evalusate consequences of change before they are implemented
- to prevent mistakes or costly revalidation exercises
- Proposed changes doccumented and evalusated before implemention
24
Q
- Why revalidaiton?
- How often?
- What?
A
- To ensure system is maintained in a validated state
- depends on many factors
- Depends on what has happened to the equipment, system, process since last validated
25
What is calibration?
what are the instrament categories?
1. The set of opperations which establish the relationship between values indicated by a measuring instrament/system to the corresponding values of a known reference standard
* Critical - effect on both process and product (6 monthly)
* Major - effect on either Process or product (annualy)
* Reference - no effect on process or product (on instalment)
26
1. What is a VMP and what should it contain?
* A Validation Master Plan (VMP), a part of GMPs , is a document that outlines and defines the processes and equipment that are to be validated and the priority and order in which this will be don
The VMP or equivalent document should define the qualification/ validation system and include or reference information on at least the following:
* **Qualification and Validation policy**;
* The **organisational structure** including roles and responsibilities for qualification and validation activities;
* Summary of the facilities, equipment, systems, processes on site and the qualification and validation status;
* Change control and deviation management for qualification and validation; Guidance on developing acceptance criteria;
* References to existing documents; The qualification and validation strategy, including requalification, where applicable.
27
1. What are the three types of process validation which can be carried out and how do they differ?
* Traditional – a number of batches of finished products are manufactured under routine to conditions to confirm reproducibility
* Continuous – used where product has been developed by a quality by design approach
* Hybrid – hybrid of continuous and traditional approach. Used where there is substantial product and process knowledge
28
1. Why does cleaning validation need to be carried out?
Cleaning validation should be performed in order to confirm the effectiveness of any cleaning procedure for all product contact equipment.
