Institute of Good Manufacturing Practices India

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IGMPI Approvals & Accreditation : Approved by Quality Council of India (QCI) & Accredited Vocational Institution of Ministry of HRD, Government of India, Approved Training Institute of Food Safety and Standards Authority of India (FSSAI), Recognized by Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India, An ISO 9001:2015 Certified Organisation registered under The Societies Registration Act,1860 Government of India Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh, Affiliated with Life Sciences and Food Industry Sector Skills Council (SSC)
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GMP Non-compliance Reports available in EudraGMDP

A GMP Non-Compliance Report has come from the Bulgarian Authority for Vetprom AD regarding finished medicinal products particularly those which involve sterile manufacturing.

The British Medicines Authority MHRA has issued a GMP Non-Compliance Report for the sterile manufacturer Yung Shin Pharmaceutical Ind Co Ltd in Taiwan.During the inspection, a lack of GMP control of moist heat sterilization processes was identified. The wide-ranging problems include both the validation and the technical implementation with regard to the equipment.

Besides, the Spanish Authority has also published a GMP Non-Compliance Report for Renown Pharmaceuticals Pvt. Ltd. in India. This was the first inspection of the site which intended to manufacture products for the EU market. 'In Inspection, critical GMP deficiencies were observed like for example 'Defective performance of cleaning', 'Inappropriate validation of cleaning procedures', 'Failures in line clearance', as well as 'Lack of mechanisms to ensure integrity of analytical data. The inspection was triggered by a marketing authorization filed in Ireland.

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