US FDA (United States Food and Drug
Administration) has recently released Establishment Inspection Report (EIR ) on recent Pre Approval Inspection (PAI ) to Square Pharmaceuticals Ltd. Based
on the report, the report states that Square had a satisfactory cGMP inspection
covering manufacturing of solid dosage form. Square has taken necessary
preparations to manufacture launched quantity of the product.
For
the first time in Bangladesh US FDA (United States Food and Drug
Administration) conducted cGMP (Current Good Manufacturing Practices) audit of
Bangladesh Pharmaceutical manufacturing facilities in January 2015.
Manufacturing and Quality Assurance system of the oral solid dosage facilities
of Square Pharma located at Gazipur was audited in accordance with the Code of
Federal Regulations (21 CFR : Food & Drugs) of United Stated of America.
The audit ended without issuing any 483 form. Square Pharma facilities have the
track record of complying with the most stringent cGMP audits of highly regulated
agencies like UK and Australia. (Source: Press Release)
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