Validation Times articles from June 2007

Validation Times archives from June 2007

Lack of sterility assurance and non-sterility top drug recall reasons for FY '06: Famulare.(Sterile drugs)
June 1, 2007... ARLINGTON, VA -- The top reasons for drug recalls in FY 2006 were lack of assurance of sterility, non-sterility sub-potency, defective container, impurities/degradation, and GMP deviations, the deputy director of the Center for Drugs Office of...

PQLI project by ISPE to tackle implementation of QbD, creation of reference materials.(Quality-by-design)
June 1, 2007... ARLINGTON, VA -- ISPE is undertaking a project entitled Product Quality Life Cycle Implementation (PQLI) in collaboration with regulatory authorities and industry as a practical approach to implementing quality-by-design (QbD), a senior Ortho...

CDER inspector says firms must manufacture non-pencillin beta-lactam drugs in separate facility.(APIs/sterile drugs)
June 1, 2007... ARLINGTON, VA -- GMP regulations specifically require the separation of penicillin production, and FDA expects non-penicillin betalactam drugs to be produced in separate manufacturing facilities from other drug products, according to a Center...

Dirty equipment holding time high risk with water left on equipment: Pfizer exec.(Cleaning validation)
June 1, 2007... ARLINGTON, VA -- Dirty equipment holding time (DEHT) may considered to be high risk to cleaning when water residues are left on equipment, or if the material to be cleaned is hygroscopic (sticky), susceptible to microbial growth, has high...

PQLI design space session recommends determining critical quality attributes first.(Design space)
June 1, 2007... ARLINGTON, VA -- An API design space session team of PQLI participants recommended here that when creating a "design space," you first determine expected critical quality attributes. Next, use prior knowledge and risk assessment to determine an...

Corwood Labs cited for failure to validation software.(Human drugs)
June 1, 2007... Corwood Labs, Hauppauge, NY, received a six-item 483 because it did not validate its visual manufacturing software. Investigator Kevin Gonzalez from the Jamaica, NY, District Office wrote the report. He noted in the EIR that Corwood is a...

Nelco nets 5-item 483 due to contamination issues.(Human drugs)
June 1, 2007... Nelco Laboratories, Deer Park, NY, was written up in a five-item 483 because several mold lots were not free of contamination prior to harvest. FDA investigator Prabhu Raju conducted the audit for the Center for Drugs. The EIR was not...

Equipment cleaning records trip up 3M.(Human drugs)
June 1, 2007... 3M Company, Northridge, CA, netted a two-item 483 in a recent audit because it did not keep records during cleaning of equipment used in pharmaceutical manufacturing. Investigators Uttaniti Limchumroon, Sarah Hassas and Kelvin Sanders from...

Validation deficiencies, CAPAs net device firm 8-item 483.(Medical devices)
June 1, 2007... Minntech Corp., Plymouth, MN, netted an eight-item 483 in a 2006 inspection because process validation was not performed according to established procedures. Investigators Jocelyn Muggli and Billi Jo Johnson conducted the inspection from the...

MedImmune written up for disburden-related inadequacies.(Human drugs)
June 1, 2007... MedImmune, Gaithersburg, MD, received a warning letter for violations of the FD&C Act related to its BLA for its influenza virus vaccine live, intranasal. According to the May 24 warning letter, the firm agreed in the BLA to interim...

CuraScript warned for failure to validate, ensure products meet specifications.(Medical devices)
June 1, 2007... CuraScript SD, Lake Mary, FL, was warned in a May 10 letter for its surgical trays, packs and kits not meeting FD&C requirements of the Quality System regulation. Specifically, the company failed toestablish and implement procedures to...

TOSOH AIA receives warning for design verification flaws, Part 11.
June 1, 2007... TOSOH AIA, Toyama City, Japan, was cited in a May 9 warning letter because of not being in compliance with the Quality System regulation in the following areas: The firm was cited for failure to perform design verification to confirm that...