WATER SYSTEM VALIDATION GUIDANCE ON WATER SYSTEM VALIDATION

water is a main resource for many pharmaceutical formulations , it is a major exceipients in many pharmaceuticals it is also used as a medium for reconstitution for pharmaceuticals, during synthesis of all kind of pharmaceutical ingredients it is a main source.
Raw water contains all sorts of impurities and contamination’s ,impurities from soil mineral , chemical and microbial organisms ,to render water completely safe for use in pharmaceuticals it is subjected to rigorous steps of purification and there are very rigorous measures for preventing it from contamination after purification.

Water purification process:

De-ionisation de-mineralisation is carried out by process of ion exchange, reverse osmosis.
and distillation.

I have given in detail over this blog all aspects of a water purification system which is used for production and storage of purified water.

Water for injection:- Has to be of better quality water which should comply with stringent requirements as it comes directly with blood and body tissues.
water for injection should be sterile (free from microorganisms bacterias yeasts fungi ) and apart from this it has to be pyrogen free.

why water for injection should be pyrogen free :
Water for injection is used in formulations which are meant for injecting directly in to body or tissue fluid , blood , there are chances of direct inoculation of human body with contamination from water if water is not free from micro organisms.
If water is not free of pyrogens human body will respond by anaphylaxix or raise in temperature and sezers , to such water if it is injected or given intravenously in body.
why water has to be completely free from acidic moiety?
why water should be free from base?
why water should be free from calcium ,magnesium and iron , etc , all bivalent cations and chlorine sodium sulfate etc.
Pharmaceuticals are intended to render its pharmacological actions on body by its active molecule , and the activity of active ingredient or molecule greatly depend on stability , stability of active molecule , it is very important to protect this molecule from degradation, if the active molecule is hydrophilic and is soluble in water its stability is greatly affected if water is having bi valent cations( Ca++ fe ++ etc) as the process of degradation of active molecules are catalysed by these ions , presence of these ions enhances the degradation of active molecules ,where degradation reactions are of first order kinetics(Rate of degradation is dependant on only concentration of one reactant) .
Anions like chlorine ,sulfate actually participate in degradation reaction of active ingredients and the degradation reactions are second order kinetics.
Hence the water for pharmaceutical is very important ingredient with respect to stability of a dosage form or a medicine is concerned.
Hence for final rinsing after washing of all equipments which come directly in contact with active ingredients in process of manufacturing purified water is used.
To maintain the standard of water used in pharmaceutical manufacturing water purification system is required to be validated for its performance.(DQ.IQ.PQ).
validation results should be reproducible and should determine and establish at any given time that the water for pharmaceuticals , purified water ,water for injection comply with all pharmacopoeia standards.

I have given a sample document for validation of waters purification storage system a water system validation master plan actual retro respective validation sample document for your reference over this blog.

Apart from this i have given sample SOP’S for microbiology department,
pharmaceutical product validation sample document whoguidelines who-gmp guideline questions and answers for training for workers for GMP(good manufacturing practice).

I have given documents over this blog for who gmp guideline for sterile aseptic process for pharmaceutical dosage form.

Keep reading this blog for cGMP and WHO GMP requirements SOP Validations Master Manufacturing documents sample Change control procedure and format water purification system and its validations cleaning validations ,personnel hygiene and guidelines for gmp microbiological procedure SOPS and manufacturing procedures for pharmaceutical dosage forms Master validation plan sample copy and for your WHO GMP requirements
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good manufacturing practice guide for pharmaceuticals manufacturing
Quality assuarance guide for pharmaceuticals manufacturing