Validation Times articles from September 2005

Validation Times archives from September 2005

Data collected for future implementation of PAT protected from investigator scrutiny, except 'gray areas'.(Process analytical technology)
September 1, 2005... WASHINGTON -- If a company is in the process of gathering research data on an existing product for the future implementation of process analytical technology (PAT), the data is most likely in a "safe harbor" where FDA will not view it from a...

Data to back up design processes is key to FDA okay on aseptic processing, Friedman says.(Aseptic processing)
September 1, 2005... WASHINGTON -- It is FDA's policy to "let your data lead the way" on the implementation of advanced aseptic processing systems, including Restricted Access Barrier Systems (RABS) and isolators, so the design concepts described in the 2004...

Q8 needs way to demonstrate process understanding to minimize need for supplemental applications.(ICH Q8)
September 1, 2005... WASHINGTON -- Within ICH Q8 guidance on pharmaceutical development, "there should be a way to demonstrate process understanding so the need for supplemental applications is minimized. If a change can improve the assurance of product quality,...

Concerns raised on whether Q9 is mandatory for quality risk management.(ICH Q9)
September 1, 2005... WASHINGTON -- On ICH Q9, the scope of which covers principles and examples of tools for quality risk management, implementation in Europe needs to be considered, and there is concern among industry that Q9 guidance may become mandatory if...

Road to greater regulatory flexibility at EMEA on Q10 a bumpy one, says Pfizer exec.(ICH Q10)
September 1, 2005... WASHINGTON -- One of the primary obstacles to the full implementation of ICH Q10 on quality systems in Europe has been the unwillingness of the European Agency for the Evaluation of Medicinal Products (EMEA) to provide greater regulatory...

Millipore, Talecris report successes in implementing PAT.(PAT)
September 1, 2005... WASHINGTON -- Two biopharmaceutical firms--Millipore Corporation, Billerica, MA, and Talecris Biotherapeutics, Clayton, NC--reported at the PDA/FDA Joint Regulatory Conference Sept. 12 on successful implementations of PAT at their respective...

Able Labs sunk by QC flaws, primarily, OOS handling, poor lab controls.(Human drugs)
September 1, 2005... Out-of-specification (OOS) results and laboratory controls appeared to be the lead reasons that Able Laboratories, Cranbury, NJ, in May suspended operations and issued a voluntary recall of all its pharmaceutical products, according to the...

Improper design and process validation nets 23-item 483 for Medsep.(Medical devices/biologics)
September 1, 2005... A 23-item 483 was issued to Medsep Corp., Covina, CA, for design validation that "did not ensure that devices conform to defined user/patient needs," as well as for a lack of process validation. The inspection of the biological medical device...

Similasan AG warned for improper equipment, lack of heat penetration studies.(Human drugs)
September 1, 2005... An April 4-8 inspection of Similasan AG, Jonen, Switzerland, determined the drug manufacturer was not in compliance with GMPs, including deficiencies found in facilities and equipment, production, quality, laboratory control, and packaging and...

Acceptance / rejection procedures, DHRs cited for Alpha Omega.(Medical devices)
September 1, 2005... An Aug. 25 warning letter was issued to Alpha Omega Manufacturing, Grapeland, TX, because a July 12-28 inspection of the specification developer revealed deviations involving the Dua12 Cooler-Heater cardiopulmonary bypass temperature...

AM2 PAT tripped up for validation failures.
September 1, 2005... A June 2-17 inspection of AM2 PAT (dba Salient Health Care Technology), Raleigh, NC, found several violations of the current GMP requirements of the QS regulation. For example, the Aug. 11 warning letter stated that the manufacturer of...

Custom Ultrasonics short on QS procedures and design changes.
September 1, 2005... During a Jan. 18-Feb. 15 inspection of Custom Ultrasonics, Ivyland, PA, FDA investigators determined that the manufacturer of washer/disinfectors for endoscopes, was not in conformance with the current GMP requirements of the QS regulation. ...

Complaint handling and design procedures net letter for Estill Medical.
September 1, 2005... After a July 5-28 investigation of Estill Medical Technologies, Dallas, the specification developer of the TA-200 Thermal Angel Blood and IV Fluid Infusion Warmer received an Aug. 23 warning letter because FDA determined that the product did...

Georgia Biomedical lacks adequate quality systems.
September 1, 2005... A June 24 warning letter was issued to Georgia Biomedical, Macon, GA, because a May 2-12 inspection found that the specifications developer and label distributor of the C02 Guard-an insufflations tubing and filter assembly was in violation of...

Validation reports and lack of conformance tests for Haidylena.
September 1, 2005... After an April 18-April 21 inspection of Haidylena for Advanced Medical Industries, Nasr City, Cairo, Egypt, FDA determined that the manufacturer of dialyzers and bloodline sets was not in conformance with the current GMP requirements of the QS...

Southern Implants lacks appropriate validation protocols and quality audits.
September 1, 2005... An Aug. 25 warning letter was sent to Southern Implants, Irene, South Africa, stemming from an April 11-14 inspection, which found that the firm was not in conformance with the current GMP requirements of the QS regulation. Southern...

Tyco fails to establish, maintain validation procedures for design changes.
September 1, 2005... During an inspection of Tyco Healthcare Group's Galway, Ireland, manufacturing site Feb. 28-March 3, FDA determined the manufacturer of ventilator, pulse oximetry and oxygen therapy products was not in conformance with current GMP requirements...