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Month: February 2014

Start Clean Room Qualification

1 Comment
| Quality Assurance, Validation

Clean room practice is one of the toughest task in sterile pharmaceuticals. Now a days advanced HVAC system was designed to provide human comfort at working area and to maintain clean room requirement as per guidelines. Major regulatory guidelines now a days available with well define limits of viable and non viable for different grades (A,B,C,D). But […]

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THE TEN GOLDEN RULES OF GMP

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| News Updates, Quality Assurance

1    Get the facility design right from the start 2    Validate processes 3    Write good procedures and follow them 4    Identify who does what 5    Keep good records 6    Train and develop staff 7    Practice good hygiene 8    Maintain facilities and equipment 9    Build quality into the whole product lifecycle 10  Perform self audits

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Water System Design In Pharmaceutical Industry In Sterile Injectable Facility

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| Quality Assurance, Validation

1. PW Generation, Storage and Distribution System2. WFI Generation, Storage and Distribution System3. PSG Generation and Distribution System

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