Pharma GMP Newsletter


WHO: Updated Edition of the GMP Compendium for Medical Products

The World Health Organization (WHO) has published the 10th edition of the "Quality Assurance of Pharmaceuticals: a Compendium of Guidelines and Related Materials, Volum


ICMR issues extensive guidance on ethical prerequisites for laboratory validation testing

The Indian Council of Medical Research (ICMR) has recently issued detailed guidelines titled "Ethical Requirements for Laboratory Validation Testing" to uphold ethical


FDA Revision to the Guidelines on Quality Considerations for Ophthalmic Drug Products

FDA has updated its guidance on Quality Considerations for Ophthalmic Drug Products in response to recent incidents of microbial contamination and safety recalls. The r


New FDA Warning Letter for inadequate Quality Oversight

The FDA issued a Warning Letter to a pharmaceutical company in Thailand for breaching current Good Manufacturing Practice (CGMP) regulations. The letter cited numerous


India's Health Ministry modifies GMP Rules - and replaces the 'GMP' Term.

The Indian pharmaceutical industry, a major exporter of generic drugs, faces scrutiny for occasional lapses in quality. In response, the Ministry of Health has issued r