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Showing posts from November, 2016

Process qualification during compression stage ׀ Process validation sampling protocol during compression

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Process validation sampling plan during compression: Fig: Sampling during process validation

Effective sampling during process validation ׀ Process qualification sampling plan

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Sampling procedure during process validation : For qualification of a process sampling stages & locations are critical parameters. Actually, effective sampling is ultimate part of process validation. During validation of a wet granulation drug product, following stages as well as locations must be consider to qualify the process. At granulation phase, sample should be collected as follow- Premixing Wet mixing Dry mixing 

Methodology of process validation

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Process validation may be sub-categories into three phases: 1. process design 2. process qualification 3. Continuous process verification Fig: Cycle of process validation

Methodology of process validation

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Process validation may be sub-categories into three phases: 1. process design 2. process qualification 3. Continuous process verification Fig: Cycle of process validation

Determine sampling interval from a process validation batch during compression

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Calculating sampling interval during compression from a process validation batch

Line clearance before compression ׀ Area & equipment clearance before compression

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Fig: Quality 

Critical parts of tablet press machine ׀ Pictorial illustration of tablet press machine

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Tablet press: A  tablet press  is a mechanical device that compresses  powder  into  tablets  of uniform size and weight. A press can be used to manufacture tablets of a wide variety of materials, including  pharmaceuticals , illicit drugs such as  MDMA , cleaning products, and  cosmetics .