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The control of water quality, including microbiological and chemical quality, throughout production, storage and distribution processes is a major concern. Unlike other product and process ingredients, water is usually drawn from an on-demand system and is not subject to testing and batch or lot release prior to use. The assurance of water quality to meet the on-demand expectation is, therefore, essential. WHO Document

The World Health Organization (WHO) this month issued guidance detailing its expectations and flexibilities during the coronavirus (COVID-19) pandemic for manufacturers, laboratories and contract research organizations taking part in the agency's prequalifications programs. Localized adjustments in processes and procedures may be necessary for manufacturing, clinical trial and testing organizations due to the coronavirus pandemic, but should aim to minimize the risk of harms to the product and individuals, according to guidance issued 14 May by the WHO Prequalification Unit – Inspection Team (PQT/INS). Recognizing that the impact of the coronavirus and associated governmental and public health measures vary by country and region, the guidance specifically addresses regulatory expectations and permitted flexibility during the pandemic. Inspections WHO PQT/INS will consider waiving or postponing a routine site inspection for organizations that have already been inspected, pro...

The US Food and Drug Administration (FDA) on Tuesday released a warning letter to sent to a Goa, India-based manufacturing site of pharmaceutical company Cipla. Following a more than week-long inspection last September, FDA uncovered cross-contamination of products, noting, “Your testing confirmed the presence of active ingredients from a previous product in batches of the next product.” And the firm’s “lack of a clear root cause casts doubt on whether you have fully resolved a serious cross-contamination problem,” FDA said. The agency acknowledged that the site has suspended production in several sterile units. The firm also failed to adequately investigate “excessive and atypical High Efficiency Particulate Air (HEPA) filters failures in a short period. More than 45 filters failed due to side leakages and media failures,” FDA said. The failures impacted about 80 batches of pharmaceuticals intended for the US market, the letter says. In resolving the issues identified, FDA called on C...

GSK Pharma has decided to sell its state-of-the-art tablet facility at Vemagal (Karnataka), taking a financial impairment of Rs 640 crore in the third quarter ended December 31. The decision was taken on account of the financial impact of voluntary recall of popular heartburn medicine ranitidine, Zinetac in India. The company had recalled the medicine in September last year, following investigations by USFDA which raised a global alarm over the presence of a cancer-causing substance—NDMA (N-Niteosodimethylamine) in certain ranitidine medicines. The decision is due to under-utilisation of GSK India’s manufacturing facilities, and Rs 97 crore on account of other related assets / costs, a company statement said. As part of this strategic review, GSK India will explore future options for the Vemgal facility including a potential sale of the site, it said. GSK had invested around Rs 1000 crore staggered over a period 2012-13 and 2017-18 in the facility, which was to be inaugurated this year...

Granules India said that it is voluntarily recalling ranitidine tablets used to treat ulcers of the stomach and intestines. "Ranitidine is being recalled by various producers from the US market, as they contain unacceptable levels of N — nitrosodimethylamine (NDMA). The voluntary ongoing recall is a class II recall," the company said in a BSE filing. "The company is in the process of recall from channel partners and the exact quantities are being estimated, " it added. The company believes that this will not have any material impact on its financials.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week released a new guideline explaining its pre-accession procedure for competent authorities wishing to join the inspection scheme. Membership in PIC/S is open to any competent authority “having the arrangements necessary to apply an inspection system comparable to that enforced by” existing members. “The scheme is primarily based on mutual confidence between participating authorities (PA). Such confidence can only be achieved on the basis of a thorough knowledge of each other’s inspection systems and inspection practice and standards,” PIC/S writes. In light of varying good manufacturing practice (GMP) regulations and quality systems (QS) applied by regulators, PIC/S has opted to split its initiation process into two phases: pre-accession and accession. PIC/S says the purpose of the pre-accession procedure is to allow interested regulators “to better understand what PIC/S is and what the expectations are for becoming...