Professional Documents
Culture Documents
Introduction
An excipient
During systhesis
Background (1)
Background (2)
Scope
Purified Water
6
Potable Water
Purified Water
10
WFI
Highly Purified
Purified
Ammonium
---
---
Aluminium
---
NMT 10 ppb *
NMT 10 ppb *
Ca and Mg
Complies
---
---
---
Residue on evaporation
Complies
---
---
Particulate contamination
Complies
---
---
Complies
---
---
Heavy metals
Nitrates
Sterility
Bacterial endotoxin
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13
Parenteral
WFI
Ophthalmic
Purified
Haemofiltration Solutions
Haemodiafiltration Solutions
WFI
WFI
Irrigation Solutions
WFI
Nasal/Ear Preparations
Purified
Cutaneous Preparation
Purified
14
Oral Preparations
Purified
Nebuliser Solutions
Purified *
Cutaneous Preparations
Purified **
Nasal/Ear Preparations
Purified
Purified
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16
Product requirements
Minimum
acceptable
quality of water
Synthesis of all
intermediates of APIs
prior to final isolation
and purification steps
Potable water *
Fermentation media
Potable water *
Extraction of herbal
Potable water **
Potable water *
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Product requirements
Minimum
acceptable quality
of water
API is not sterile, but is intended for use in Purified Water with
a sterile, parenteral product
an endotoxin limit of
0.25EU/ml and
control of specified
organisms.
Purified Water
Purified Water should be used where there are technical requirement for greater chemical purity.
**
The Application would need to demonstrate that potential variations in the water quality, particularly with
respect to mineral composition, would not influence the composition of the extract.
18
Granulation
Purified *
Tablet coating
Purified
Purified
WFI
* For some veterinary premix products eg. granulated concentrates it may be acceptable
to use potable water where justified and authorised taking account of the API or used
as an excipient in a medicinal product.
19
Product type
Minimum Acceptable
quality of water
Initial rinse
Intermidiates and
API
Potable water
Final rinse
API
Potable water
Initial rinse including CIP* Pharmaceutical
of equipment, containers
products non-sterile
and closures, if applicable.
Purified Water or use same
Final rinse including CIP* Pharmaceutical
of equipment, containers
products non-sterile quality of water as used in
manufacture of medicinal
and closures, if applicable.
product, if highly quality than
Purified Water
21
Product type
Sterile products
Minimum Acceptable
quality of water
Purified Water
Final rinse*** including CIP* Sterile non-parenteral Purified Water or use same
quality of water as used in
of equipment, containers
products
manufacture of medicinal
and closures, if applicable.
product, if highly quality
than Purified Water
Final rinse*** including CIP* Sterile parenteral
products
of equipment, containers
and closures, if applicable.
WFI ****
22
**
*** If equipment is dried after rinsing with 70% alcohol, the alcohol
should be diluted in water of the same quality as the water used
for the final rinse.
**** Where a subsequent depyrogenisation step is employed the use
of Highly Purified Water may be acceptable subject to suitable
justification and validation data.
23
Annex 3
WHO Good Manufacturing Practices :
Water for pharmaceutical use
Polypropylene (PP)
Polyvinylidenedifluoride (PVDF)
Perfluoroalkoxy (PFA)
Other materials such as materials such as unplasticized polyvinylchloride (uPVC) may be used
for non-hygienic designed water treatment
equipment such as ion exchangers and softeners.
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26
(cont.)
27
(cont.)
(cont.)
29
at 30 35 C for 5 days.
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Purified Water
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Reference
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