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Parmaceutical
(refers to man-made and natural drugs use to treat disease,…
Parmaceutical
(refers to man-made and natural drugs use to treat disease, disorder and illnesses)
Medication
(can be classified by chemicals properties, mode or route of administration, biological system affected or therapeutic effect)
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Preparations
Container
- Clean and suitable container
Tools needed
- Kinves, pilers, saw
- deep tube (sampling liquid)
- sampling scoop (solid material)
- sampling speers
[Disposable or reuseable]
- cross contamination is eliminated
- no cleaning is required before or after use
- save time and money
A) Types of samples
- starting materials
- in process, before and after packaging products
- primary and secondary packaging material
Condition
- aseptic (aviod the risk of loss of sterility)
Storage area
- ventilation, cold chain
- amber glass
- material to reclose (sealing tape)
Stability
- only allow a 5% signifcant change
Liquid
- bottles closed by screw tops with inert liners
- must have headspace
(to minimize any possible degradation)
Solid
- protected during transit
(total filling up the container with products, filling any resisdual space)
Operation
Sampler
(read health and safety infomation(SDS), wear appropriate PPE, respiratory equipment)
Physical inspection
(shape, size, colour, moist crust)
Sampling objective
a) Prequalification
- defining a product or service need
- seeking expressions of interest from enterprises to supply the product or service
- examing the product or service offered against the specification
- a facility where the product or service is prepared against common standards of good manufacturing practice (GMP)
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c) Batch release testing
- a given cycle of manufacture, stable and have no modification
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Standards
- starting materials
- packing materials
- finished products
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