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PH3114 > Solid Oral Dosage Forms 7 > Flashcards

Solid Oral Dosage Forms 7 Flashcards

1
Q

What are samples taken for?

A

Test on raw materials- identity, assay, contamination/adulteration
In process tests- mix quality, validation of equipment or process

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2
Q

Sampling solid raw materials

A

Best method is to take from moving stream
Possible to sample limited number of containers if supplied from approved reliable audited source
If more than 1 take samples from either √N + 1 or
10 + (N/10) containers
Take number of samples, test identity of each one then combine for assay

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3
Q

Sampling thief

A

Simple tube with chamber in end, opened by twisting
Get sample of material that flows best
Depends upon operator, need training in technique

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4
Q

Sample size reduction- representative sample

A 
Scoop 7%
Mix and quarter 4%
Chute splitter 2%
Spinning Riffler 0.5%
Smaller samples use sampling thief
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5
Q

Spinning riffler parts

A

Mass flow hopper
Vibrating chute
Rotating carousel
Sample containers

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6
Q

Sampling for verification

A

Looking for homogeneity

Take samples from various positions in drum/mixer

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7
Q

Sampling theory for inspection

A

Medicines manufactured in millions of units
100% sampling possible
Test on samples are destructive
Based on probability theory

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8
Q

Quality assessment: inspection plans

A

Conformity and non-conformity
Attributes- visual: large samples, robust, not affected by distribution shape
Variables- dimension: smaller samples, affected by distribution shape, takes more time, gives process average

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9
Q

Finished product: inspection by sampling

A

Problem, if fault levels low, how to estimate quality of lot from sample
Producer’s risk- chance of rejecting acceptable batch
Consumer’s risk- chance of approving rejectable batch

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10
Q

Inspection by sampling: BS6001

A

Acceptable quality levels: maximum percent defective that can be considered satisfactory as process average
Acceptable outgoing quality level: maximum average outgoing quality for given acceptance plan

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11
Q

Inspection plan: visual quality

A

Major faults- stop process or product working correctly
Minor faults- cosmetic in nature
Major faults accept 0.015%
Minor faults accept 0.4%

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12
Q

Inspection plans: criteria

A

Measurements are subjective, not a precise value
Can only compare data if method is strictly controlled- lighting, time, viewing conditions
Operators must be trained in inspection

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13
Q

Validation and qualification

A

Validation: act of proving in accordance with GMP that any procedure, process, equipment, material, activity or system leads to the expected results
Qualification: act of proving that any equipment works correctly and actually leads to expected results, sometimes widened to incorporate concept of validation

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14
Q

Validation

A 
Set objectives and acceptance criteria
Write protocol
Organise team
Assess results
Final report, including information for future production e.g. specifications and limits
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15
Q

Agitator mixer

A

Ribbon blender
Main mechanism- convection
Good for mixer poorly flowing materials, less likely to cause segregation
Problem- elimination of dead spots

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16
Q

Cleaning

A

Equipment and area
Cross contamination- active ingredients, inactive materials
Microbiological- non-sterile products, sterile product

17
Q

Cleaning validation active ingredients

A 
Potency
Precision of assay
Properties of all materials
Process, detergents
Determination of contamination
18
Q

Cleaning and contamination

A

Equipment logs- products, people, tasks
Area logs- product, people, tasks
Environmental monitoring- bio-burden, indicator before problem occurs

19
Q

Factory design

A

Control of people and product flow
Use gravity to transfer bulk materials
Restrict access to clean manufacturing areas
Minimise contamination of non-clean areas with active materials
Supply services, electricity, water, compressed air, vacuum, outside of clean area, supply through walls directly to machines

20
Q

Dry products factory

A

All services to clean area accessed from technical area

Through the floor feeding from supply to manufacturing to delivery

21
Q

IBC docking station

A

Powders delivered from sealed containers through floor to tabletting/capsule filling machine on floor below

22
Q

Environmental monitoring- physical

A

Pressure
Non-viable particle count
Air flow velocity
Air change rate

23
Q

Environmental monitoring-microbiological

A

Active air sampling- known volume drawn through filter
Settle plates- 90mm diameter, for 4 hours
Contact plate- 55mm diameter
Glove print, 5 fingers

24
Q

Printed packaging

A

Fixed information- pre-printed, labels, cartons, leaflets
Variable information- lot number, expiry date
Most frequent cause of product recall- product in wrongly labelled package

25
Q

Complaints and product recalls

A

Designated person for each
Written up to date procedures
Actions- identify problem, lots involved, every step documented, notify authorities, records of supply, system to alert supply chain, system for returning, investigation and destruction

26
Q

MHRA

A

Manufacturer needs to show- right facilities and equipment with properly trained and qualified people
Medicines inspectors- ensure compliance with GMP, carry out inspections of factories and make constructive audits

27
Q

Harmonisation

A

Pharmaceutical Inspection Co-operation Scheme- mutual acceptance of inspections, exchange of reports, training of GMP inspectors promoting international harmonisation
EU/FDA mutual recognition agreement

28
Q

International Standards Organisation 9000

A

Applies to companies that manufacture and sell
Certification by approved independent bodies
Advantages- partnerships in quality e.g. on time delivery, customer confidence, less testing

29
Q

Post registration changes

A

Formulation and manufacturing process is that used for batches on which product was approved
Problems in changing this to improve process

30
Q

Initiatives in quality systems

A

Process Analytical Technology- significant improvements in instrument technology, miniaturisation and portability. Enables measurement of key properties in real time during manufacture
Quality by Design- applies techniques used in other industries to better understand how processes work and the variables to design a system that will always produce the correct product

31
Q

USA FDA: quality by design

A

Define desired product performance upfront; identify product CQAs
Design formulation and process to meet product CQAs
Understand impact of material attributes and process parameters on product CQAs
Identify and control sources of variability in material and process
Continually monitor and update process to assure consistent quality

32
Q

Process capability

A

A statistical measure of inherent process variability for a given characteristic
Process capability index = upper limit - lower limit/ 6 standard deviation
Robust process if CpK significantly >1

33
Q

EMA FDA cooperation

A

Pilot program for parallel assessment of quality by design applications to ensure consistent implementation of ICH Q8, 9 and 10 guidelines and share regulatory decisions on new concepts
Share knowledge and further collaboration
Better defined interaction

34
Q

Variations during manufacture

A

Materials- different suppliers or within lot variations
Machines- different equipment, different adjustments, poor maintenance
Methods- inexact, inadequate procedures
People- training, team work, motivation

35
Q

Package functions

A

Contain
Protect- damage, contamination, tampering
Identify- batch number, manufacturer
Provide information- usage, warnings, storage

36
Q

Self inspection

A

Check implementation and compliance with GMP
Trained people and external experts
records- observations, corrective measures, actions

37
Q

Packaging security

A 
Secure storage
Security for issue
Security in transfer
Counting and reconciliation
Line clearance checks
Code readers- on-line, bar codes

PH3114 (28 decks)

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