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QA/QC

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IPEC calls for excipient GMP standard implementation plans to be in place by Q4

07-Apr-2015 - IPEC-Americas (International Pharmaceutical Excipient Council) stopped short of recommending a specific date for implementation of a new GMP standard for excipient manufacturers, but the group is calling on manufacturers to have an implementation plan in place by the end of Q3 of this year.

Calling all QA/QC whizzes: US FDA 'super' office hunts quality leader

07-Apr-2015 - The Director of the new 'super' Office of Pharmaceutical Quality must address issues surrounding increasing globalisation and manufacturing complexity, the FDA says as it begins the recruitment process.

FDA looks to incentivize abuse-deterrent opioid development with final guidance

02-Apr-2015 - Although the abuse-deterrent technology is still relatively new, the FDA has released final guidance explaining to manufacturers how to conduct studies to demonstrate that an opioid formulation has abuse-deterrent properties.

Hamburg exits US FDA calling on increased international co-operation

01-Apr-2015 - Margaret Hamburg has called for increased regulatory co-operation to tackle the issues raised by globalisation of the drug industry as she steps down as Commissioner of the US FDA.

EMA: TTIP and inspection databases a way of improving global manufacturing standards

31-Mar-2015 - Ensuring drugs, APIs and excipients are safe will be a focus for the EMA, which says it will explore supplier inspection databases and using trade deals like TTIP to promote GMP standards globally.

No more waiting for the Sun: FTC approves $4bn Ranbaxy acquisition

30-Mar-2015 - Sun Pharmaceutical Industries has completed its $4bn (€3.7bn) acquisition of Ranbaxy after receiving the thumbs up from the US Federal Trade Commission (FTC).

Aarti says US FDA has not detailed GMP problems that earned it an import ban

27-Mar-2015 - Aarti Drugs says the US FDA has not provided details of observations that earned its E-22 facility in Tarapur, India an import ban.

‘Game changer’: latest GDP rules spell full traceability for APIs

26-Mar-2015 - Makers and distributors of APIs (active pharmaceutical ingredients) will have to track their products throughout the supply chain and meet rules on cold chain transport and outsourcing under revised guidance from the European Commission.

GMP for excipients: new EU rules on raw materials, packaging, tracking

25-Mar-2015 - The European Commission has published guidelines on GMP excipients after a two-year consultation.

FDA plans new approach to manufacturer inspections in India

24-Mar-2015 - Several FDA officials are currently visiting India and meeting with manufacturer CEOs and government officials to discuss the way the agency’s inspections are expected to change over time.

WHO calls for proactive strategies to combat falsified, substandard medicines

23-Mar-2015 - The WHO’s latest report on substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products has the organization divvying up certain responsibilities for controlling the fraudulent products between countries.

Dispatches from DCAT

Message is clear: Europe is in trouble in terms of pharma growth, experts say

17-Mar-2015 - The European pharma market isn’t likely to deliver much growth over the next five years as generic markets commoditize, IMS Health VP Graham Lewis warned participants at the DCAT (Drug, Chemical and Associated Technologies) conference on Monday.

NSF publishes first US standard for pharmaceutical excipients

17-Mar-2015 - NSF International has published a new standard and developed an auditing program that can help pharma companies verify regulatory compliance and strengthen safety and quality across their excipient supply chain.

Endotoxin and microbial testing to become portable

16-Mar-2015 - Bacterial testing is moving from the lab to the manufacturing floor, says an expert at CRO Charles River.

FDA wins Ranbaxy ANDA approval suit as judge raises ‘grave concerns’ over FDA actions

13-Mar-2015 - Despite slamming the US FDA for tentatively approving two Ranbaxy ANDAs (abbreviated new drug applications) for the first Nexium and Valcyte generics, US District Judge Beryl Howell said last week the agency can revoke the approvals because of manufacturing concerns.

Speciality Compounding banned after contaminated shots cause blood infections

12-Mar-2015 - Speciality Compounding has been ordered to cease production by the US Courts after tests confirmed injectable drugs made at its facility in Texas were contaminated by bacteria. 

Novacyl’s acetyl salicylic acid plant in Thailand hit with FDA warning letter

11-Mar-2015 - For the second time this year, the FDA has issued a warning letter to API (active pharmaceutical ingredient) and intermediate manufacturer Novacyl and this time it’s for the company’s manufacturing site in Thailand.

J&J pleads guilty, pays $25m over manufacturing adulterated infants’, children’s OTC medicines

10-Mar-2015 - J&J unit McNeil-PPC has admitted breaking US law by selling contaminated liquid medications, including Infants’ Tylenol and Children’s Motrin, deemed adulterated under the federal Food, Drug and Cosmetic Act (FDCA).

Slew of recalls, Form 483 shake Hospira

09-Mar-2015 - Quality troubles for Hospira continue as the company announced on Friday recalls of two injections, in addition to the recall of two infusion pumps, as well as a Form 483 for an Indian manufacturing site.

Health Canada looks to crack down further on noncompliant manufacturers

04-Mar-2015 - Health Canada is telling drug and API manufacturers that it’s going to ramp up announced and unannounced inspections due to concerns raised around APIs and data integrity, and the findings will be published online beginning next month.

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