Future vacations reviews

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India is a land of color, which offers different shades with every changing season and changing terrain. It is a nation, which exemplifies a wonderful blend of rich art and culture.

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In the month of February 2014 US Food and Drug Administration Commissioner Margaret Hamburg visited India to discuss issues of drug quality with her counterparts in the Indian Government. The FDA has imposed a rash of regulatory sanctions on Indian generic makers in the last year, triggering concerns about the quality of the medicines supplied by the $14 billion industry to countries including the United States, the biggest market. India is second only to Canada as a drug exporter to the United States, where it supplies about 40 percent of generic and over-the-counter drugs.There were comments made about the US and Indian GMP Standards. Drug Regulations has now compared the GMP standards of US and India. The comparison is given in the presentation here.

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This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations. Several approaches to software validation exist and may be appropriate for a specific project. The scope of any validation effort depends upon a number of factors Size and complexity of the software, Origin of the software (custom vs. off-the-shelf) and Whether the functions are critical or non-critical in nature. By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.

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En vedette (18)

Ácidos nucleicos ARN

DevOps, Development and Operations, Tina McGinley

Project report on dancing light

Comparision of US & Indian GMP's

Application of Q R M in Manufacturing Operations

Process Validation of Legacy Products

Correlation of FDA-EU-PICS-WHO Requirement for Computer System Validation

Guias de remision_tratamiento_normativo_y_operativo

Content Uniformity and Blend Uniformity : Why FDA Withdrew the 2002 Guidance

Digisuunnistus - kohtaamisia johtamisessa

2. Design, Trust & Control of Sterile Manufacturing (Particles)

Reforma e contra reforma

1. Design, Trust & Control of Sterile Manufacturing (Opening Note)

Computer System Validation

Kế hoạch kinh doanh thực phẩm chức năng ( tpcn )

Process Failure Modes & Effects Analysis (PFMEA)

FMEA Introduction.ppt

Good documentation practice

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