Validation Times articles from May 2006

Validation Times archives from May 2006

Team approach advised to selecting CMOs, not relying only on phones, networking.(Selecting CMOs)
May 1, 2006... SAN DIEGO -- Selecting a contract manufacturing organization (CMO) requires careful planning, a strong, cross-functional team and multiple steps, a pharmaceutical manufacturing site selection expert told the IQPC [International Quality and...

'Answer-based Submissions' touted for working with CDER's 'Question-based Review' for generics.(CMC/Design space)
May 1, 2006... Generic drug makers seeking ways to fathom FDA's new "Question-based Review" (QbR) of ANDAs should consider a concept that one executive is calling "Answer-based Submissions" as a means of providing a good "quality overall summary" (QOS) and...

Comprehensive agreements needed to withstand FDA scrutiny, ensure CMOs instill quality.(Quality agreements)
May 1, 2006... SAN DIEGO -- The development and implementation of comprehensive quality agreements (QA) is a critical component of the relationship between pharmaceutical product owners and CMOs, and one that FDA may seek to examine during an audit, speakers...

ASTM standard, defining shipments with NDA or ANDA number advised.(Shipping)
May 1, 2006... SAN DIEGO -- Conducting performance testing on shipping containers via an ASTM standard, and doing simple things, such as, including the NDA or ANDA number on shipments bound for the U.S., will go a long way toward minimizing hassles with the...

Sponsors should have own personnel working with contractors, speakers advise.(Drug development)
May 1, 2006... SAN DIEGO -- A sponsor who relies on CMOs in the pre-approval stages should expend staff to work on site with the contractor, whether during the development stage that readies a product for regulatory approval, or during a scale-up for a...

Validation flaws and lack of instrument calibration net 9-item 483.(Human/animal drugs)
May 1, 2006... Alwyn, an OTC drugs and cosmetics manufacturer in Lake Crystal, MN, received a nine-item 483 because of flaws in its validation of manufacturing processes, and for instruments that were not calibrated at suitable intervals. The inspection,...

483 lists poor cleaning records, contaminated equipment, no SOPs for out-of-spec results.(Human/animal drugs)
May 1, 2006... Ameri-Pac, an animal nutritional supplement manufacturer based in Saint Joseph, MO, was hit with an 11-item 483 because cleaning and maintenance records for equipment was not kept, and its equipment and utensils were not cleaned to prevent...

Cassidy receives 7-item 483 for not testing to spec, no stability-testing program.(Human/animal drugs)
May 1, 2006... St. Paul, MN-based cosmetic manufacturer Cassidy received a seven-item 483 for testing and release of drug products for distribution that did not include appropriate laboratory determination of conformance to final specifications prior to...

Pharmaceutical Specialties clears audit, but Part 11 issues are noted in EIR.(Human/animal drugs)
May 1, 2006... Pharmaceutical Specialties, Rochester, MN, avoided a 483 following a recent FDA audit, but several observations were noted in the EIR regarding electronic records and computer-validation requirements, validation of methods not listed in the...

Cody Labs slapped with letter for multiple GMP violations.(Human drugs)
May 1, 2006... An FDA investigation March 7-17, 2005, of Cody Labs, Cody, WY, found deviations from the current GMP requirements that caused API product hydromorphone HCI and finished drug product morphine sulfate concentrate oral solution to be adulterated...

Dirty equipment and poor building maintenance nets letter for Pliva.(Human drugs)
May 1, 2006... An FDA investigation of Pliva Croatia Ltd., Zagreb, Croatia, Jan. 23-Feb. 8 indicated significant deviations from current GMP Regulations in the manufacture of drug products. Violations in the April 28 warning letter included buildings used...

Wockhardt fails to establish production and process controls.(Human drugs)
May 1, 2006... A review of Wockhardt, Ltd., Aurangabad, India, by FDA investigator Alicia Mozzachio, microbiologist Raymond Oji and chemist Felix Maldonado, Nov. 8-11, 2005, revealed significant deviations from current GMPs in the manufacture of...

Lack of investigations cited for Advanced Imaging Research.(Medical devices)
May 1, 2006... A Feb. 6-9, and 13, FDA investigation of Advanced Imaging Research, Cleveland, OH, determined the manufacturer of head and body coils, which are used in MRI systems, and the initial importer and marketer for the MR-Diagnostic Neonatal...

Carolina Liquid fails to establish quality plan.(Medical devices)
May 1, 2006... An Oct. 26-Nov. 28, 2005, FDA investigation of Carolina Liquid Chemistries, Brea, CA, determined that the manufacturer and repackager of in vitro diagnostic devices was not in conformance with the current GMP requirements for medical devices....

Design-change flaws trip up EM Innovations.(Medical devices)
May 1, 2006... During a Feb. 10 inspection of EM Innovations, Galloway, OH, FDA investigators determined the specification developer for medical sharps containers was not in conformance with QS regulations. Violations, included, but were not limited to, the...

Ferno-Washington fails to investigate complaints.(Medical devices)
May 1, 2006... An FDA investigation Sept. 26-30, 2005, of Ferno-Washington, Wilmington, OH, determined the manufacturer of emergency medical devices--including ambulance transporters, wheeled stretchers and cots--was not in conformance with the current GMP...

Lack of design-control procedures nets warning letter for Neurotone.(Medical devices)
May 1, 2006... An FDA investigation conducted Sept. 19-Oct. 7, 2005, of Neurotone Systems, Garland, TX--the manufacturer of the RelaxPak, Neurotone III and the Neurotone III D Cranial Electrotherapy Stimulator (CES)--indicated nonconformance with the current...

Orthohelix fails to report removal of device to reduce risk to health.(Medical devices)
May 1, 2006... FDA conducted an inspection of Orthohelix Surgical Designs, Akron, OH, Jan. 10-31, and documented serious deficiencies from the Correction and Removal Regulation and QS Regulations, in regards to the company's MaxLock Driver system. The...