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 Function of Quality control unit 

1- Receipt of raw materials 2- Sampling
3- Pharmaceutical analysis 4- Documentations
5- Total analytical validation 6- Drug stability and stability indication
1- Receipt of raw materials
- Sources of Pharmaceutical Products:
Multi-source • Well-established products, long history of use, no longer subject to patent
protection
Single source • It's the innovator manufacturer , newer products , still subject to patent protection
 Drug Standards
• Standard of quality of drug are defined in term of chemical , physical characteristic +
pharmacological and microbiological characteristic.
• Official drug has its characteristic stated by pharmacopeia
• Non-official drug are specified by health authority
 Drugs fail to conform to the required standards due to:
1- Inadequate product development lead to unstable product
2- Improper storage and exposure to humidity
3- Defective packaging lead to deterioration of drug
4- Violation of GMP-guideline
5- Manufacturer may reduce API in products to increase his profit margin
6- Drug may be produced on unlicensed premises
 Prequalification (Random Testing of Samples)
• Undertaken to verify compliance, with standard and references provided in dossier.
• Test samples should be from supplies, not from pre-supply batches.
• Verification of compliance with GMP.
2- Sampling
- Sampling is the process of extracting small portion from large quantity of material which is truly
representative of composition of the whole material .
- Sampling is one of the most common sources of analytical error :
a) In mixed lots of goods or
b) in lots where analyte is not homogenously dispersed or present in low conc
- Glossary
Batch - Quantity of any drug produced during a given cycle of manufacture
Lot - Very similar to batch but is subset of batch
- there can be many lots in single batch
- single lot contain only one batch

Dr.Baher 01222578887
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Sample - Portion of material collected according to defined sampling procedure
- size of any sample should be sufficient to allows all test procedures including
all repetitions and retention samples
Random sample - sample in which the different fractions of material have equal probability of
being represented
Homogeneity - Material is homogeneous when it is all of the same origin (from same batch )
- Material is non- homogeneous when it is of differing origins
Uniformity - Starting material is considered uniform when samples drawn from different
layers → do not show significant differences in quality control tests .
Consignment - The quantity of bulk starting material or of drug product and supplied at one
time in response to particular request or order
 Sampling plans :
The n plan - Material to be sampled is uniform , supplied from recognized source
- Drawn from any part of container (usually from top layer )
- The formula n = 1+ N (N is the number of sampling units in consignment )
- The value of n is obtained by simple rounding
The p plan - Material is uniform , supplied from recognized source
- The main purpose is to test for identity
- P = 0.4 N (N is the number of sampling units )
- P are obtained by rounding up to next highest integer
The r Plan - Material is suspected to be non-uniform → received from not well known source
- May also be used for herbal medicinal products used as starting materials
- r = 1.5 N (N is the number of sampling units )
- r are obtained by rounding up to next highest integer
 Analytical sampling techniques:
1- Composite sample 2- Multiple individual units ( either one of them or sometimes both )
Composite Sample Multiple unit sampling
Definition - The individual units or representative portions - analysis of individual units or
of units → mixed to form uniform mixture samples each separately
(each unit is sample)
Used a) homogeneity is not significant problem a) range of values in individual units
when (variability) is large or
b)variability among units is of no great
importance b) it is desirable to establish
variability in lot under investigation
Advantage a) save analytical time b) More representative - more accurate and specific
c) In acceptance testing it is procedure of
choice or the specified

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 Notes:
- Prepared sample should achieve homogeneity , treated → to prevent change from original
composition
- For homogeneous liquids → sampling present minor problems
- for solid mixture → it is necessary to combine number of portions to ensure that representative
sample is finally selected for analysis
- Bulk material → increments → gross sample → sub sample → particle size reduction → test
sample → analysis
 The sampling procedures
A- The cone and quarter technique
- reduction in size of gross sample without bias is possible
- It involves arranging total material into pile (cone) → then drawing two vertical lines through the
pile at right angles to each other → producing 4 identical quarters
- two opposite quarter are combined and retained
- other two quarter are discarded
- the mass has been halved without bias
- Sampling tools or facilities: range from simple spatula
and spoon to large scoops and measuring buckets

B- Zone powder sampler

- it is used for proper sampling of powder and other friable materials that become non homogenous
in bags
- it extract samples at 3 levels from one container
- The T handle is turned → close sample cells and steel points is inserted through bag wall
- when sampler is deep enough to cover 3 cells → half turn of handle allows samples to enter
- then return it to original position → remove sampler into analysis container
 Dip tubes :
- used for sampling liquid and topical products
- should be made of inert material such as
propylene or stainless steel

Dr.Baher 01222578887