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Slovenian regulators slam Polydrug API plant in India

17-Jun-2015 - Polydrug Laboratories chose not to log customer complaints about APIs made at its plants in Maharashtra according to Slovenian regulators.

Hospira hit with Canada import ban over data integrity concerns

16-Jun-2015 - Health Canada has issued Hospira with an import ban over concerns about a testing lab at its manufacturing facility in Liscate, Italy.

US FDA upgrades Jubilant's troubled Washington plant to VAI

12-Jun-2015 - A Jubilant HollisterStier sterile manufacturing facility hit with a warning letter in 2013 has been upgraded following inspections by the US FDA last year.

CSIRO tells of sea shells that protect sensitive cures

09-Jun-2015 - A capsule inspired by the porous structure of seashells has been developed to protect drugs from extreme temperatures and could be used in controlled delivery.

Indian manufacturers struggling to stay on top of data integrity issues, EY survey finds

08-Jun-2015 - Despite increased scrutiny from regulators, one third of Indian pharma manufacturers and CMOs have yet to conduct a review to assess potential gaps in the assurance of data integrity, according to a new EY survey.

US preference for ANSI 363 excipient standards will change, says EXCiPACT

03-Jun-2015 - Multinational excipient-makers will drive US interest in EXCiPACT, the industry-led certification scheme says as a UK Colorcon plant becomes the eighteenth site to receive accreditation.

US FDA issues guidance on DNA-mutating pharma impurities

03-Jun-2015 - The US FDA has issued guidance to manufacturers on impurities in finished drugs which can change human DNA and cause cancer.

Czech API manufacturer hit with FDA warning letter over contamination, data issues

03-Jun-2015 - The US FDA has issued a warning letter to Czech API manufacturer VUAB Pharma for failing to properly respond to microbiological contamination and data integrity issues.

Lonza set to get commercial Adva-27a contract if cancer drug is approved

27-May-2015 - Lonza shipped a sample batch of a drug for resistant cancers this week and is set produce commercial supplies if the Phase I candidate goes on to be approved says Sunshine Biopharma. 

Intertek opens new drug stability testing facility citing demand and bigger med devices

26-May-2015 - Intertek has opened a new stability facility citing demand for bespoke drug and device services like abuse potential assessments and stress testing.

Draft guidance stresses need for quality in development of gene therapies

25-May-2015 - The EMA has released draft guidelines to aid the gene therapy developers, many of which it says are small companies not familiar with the regulatory environment.

Industry calls for global alignment of qualification and validation guidelines

21-May-2015 - EFPIA and EGA say European Commission GMP guidance should be more closely aligned with guidelines elsewhere to help international drugmakers understand the recently updated requirements.

Home-brew morphine: Is opiate production about to get way too easy?

21-May-2015 - Access to yeast strains modified to produce opiates for cheaper, more effective pain meds must be strictly controlled according to researchers who warn that stopping criminals using such API manufacturing routes to make illegal narcotics is vital.

Update

Hospira to lay off 100 following closure of Clayton, NC plant

07-May-2015 - Hospira’s closure of its manufacturing facility in Clayton, North Carolina, which it says is a cost rather than a quality issue , will result in the laying off of 100 employees, according to a WARN notice  posted Wednesday.

FDA needs to conduct all generic manufacturing inspections requested by reviewers, report says

07-May-2015 - Although the US FDA has drastically increased its preapproval inspections of generic drug makers worldwide, the agency failed to conduct all of the inspections requested by its own generic application reviewers, according to a report from the HHS Office of the Inspector General (OIG).

Three-way collaboration to offer packaging serialisation ahead of EU Directive

06-May-2015 - Schott, Heuft and GEA have teamed up to offer drugmakers a serialisation service for primary packaging to help with EU anti-counterfeiting requirements.

IPEC says confusion around FDA review of excipients could delay ANDA review cycles

05-May-2015 - Inaccurate and incomplete information on excipients referenced in the US FDA Inactive Ingredient Database (IID), as well as other agency policies and guidance on the review of inactive ingredients in ANDAs (Abbreviated New Drug Applications) “continue to create confusion for the pharmaceutical industry,” according to a position paper from IPEC-Americas (International Pharmaceutical Excipients Council). 

Indian API and generics firms want a bigger share of the Japanese market

04-May-2015 - Indian generics firms see opportunities in the Japanese drug market according to a trade delegation that visited Tokyo last week seeking supply contracts.

FDA calls on manufacturers to begin switch from batch to continuous production

01-May-2015 - Though making the switch from batch to continuous manufacturing may be difficult, costly and time consuming, pharma manufacturers and CMOs should begin to consider the switch as in the long-run it will end up saving companies time, money and space, FDA’s CDER Director Janet Woodcock told congressmen in a hearing Thursday. 

IBEF: India still attractive for Japanese pharma despite Daiichi Sankyo's Ranbaxy experience

30-Apr-2015 - Japanese drug firms eyeing international investments should not be put off by Daiichi Sankyo’s turbulent ownership of Ranbaxy according to an Indian delegation in Tokyo last week to seek collaborations.

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