Validation Times articles from November 2004

Validation Times archives from November 2004

Office of New Drug Chemistry to become 'Office of New Drug Quality Assessment' by April; reviewers to join inspections.(CMC)
November 1, 2004... BALTIMORE -- FDA's Office of New Drug Chemistry (ONDC) is being restructured into the Office of New Drug Quality Assessment to facilitate the implementation of the agency's new quality assessment system and to allow reviewers to team up with...

Balloting progress noted on several ASTM Committee E55 PAT work items; others to be voted on by December.(Process analytical technology)
November 1, 2004... WASHINGTON -- ASTM International's first draft of the "Standard Practice for PAT [Process Analytical Technology] Data Management" was "well-received" in balloting that closed Sept. 9, with 75% of ballots in favor of the document, industry...

ICH Q8 expected to be published by early 2005.(Drug development)
November 1, 2004... BALTIMORE -- International Conference on Harmonization (ICH) guideline Q8, a proposed guideline on pharmaceuticals, was expected to reach Step 2 of the ICH process in November 2004, meaning publication could be at hand by early 2005. The...

PAT seen facilitating quality by design, right-first-time manufacturing.(Manufacturing)
November 1, 2004... BALTIMORE -- Process analytical technology is viewed by some in industry as an enabling tool to accomplish the key strategic manufacturing objective of Quality by Design (QbD), which is the new paradigm in pharmaceutical manufacturing, and also...

PQRI developing PAT implementation protocol.
November 1, 2004... PARSIPPANY, NJ -- The Product Quality Research Institute (PQRI) is developing a PAT-implementation protocol for introducing the technology into manufacturing. PQRI representatives described the protocol at a recent Consumer Healthcare...

Process flow, segregation of functions among first CBER will audit in multi-use facilities.(Process validation/design)
November 1, 2004... SAN DIEGO--Concerned mostly with cross-contamination in multi-use facilities, FDA's Center for Biologics' top priority in a pre-licensing inspection will be to ensure there is no chance for mix-ups, meaning the agency will look closely at flows...

Biotech firms can validate buildings even before completion, and equipment; VMP suggested.(Equipment validation)
November 1, 2004... SAN DIEGO -- A biopharmaceutical manufacturing facility manager and consultant advised a conference here Nov. 1 how to control and document the CBER validation process, beginning well before the building is open for business. Addressing...

Abbott slapped with 483, warning letter for process control, software, cleaning and sanitation violations.(Human drugs)
November 1, 2004... Failure to have adequate process control procedures and software validation procedures resulted in an eight-item 483 and a subsequent warning letter for Abbott Laboratories, Rocky Mount, NC. The company was cited in the 483 because...

Aldrich Chemical receives 483 for inadequate laboratory records; analysis of OOS results reveals training faults.(Human drugs)
November 1, 2004... An inspection of Aldrich Chemical in Sheboygan Falls, WI, resulted in a two-item 483 for deficient laboratory records; and analysis of OOS results showed deficiencies in the firm's training records. Aldrich Chemical, an active...

Parkedale gets 483 for lab control mechanisms; validation and stability of Tigan injection cited.(Human drugs)
November 1, 2004... A GMP inspection covering quality and production systems revealed that Parkedale Pharmaceuticals, Rochester, MI, did not follow established laboratory control mechanisms, netting a two-item 483 for the company. Detroit District Office...

Process validation flaws result in 6-item 483 for AppTec Labs.(Biologics)
November 1, 2004... "Failure to prepare, validate and follow written procedures for prevention of infectious disease contamination and cross-contamination during processing" netted a six-item 483 for AppTec Laboratory Services in St. Paul, MN. A June 14 warning...

C.R. Canfield lacked procedures to prevent contamination.(Human drugs)
November 1, 2004... C.R. Canfield, Edina, MN, failed to establish and follow written procedures designed to prevent contamination of its drug products and failed to have appropriate laboratory testing to determine conformance to such requirements for each batch of...

Guardian's computer, software and protocol validation draws warning letter.(Human drugs)
November 1, 2004... Failure to test viscosity on certain validation lots and computer validation were among citations in a warning letter to Guardian Drug Co., Dayton, NJ. In addition, the Sept. 15 letter stated that the company failed to follow the...

Medical Energy used sterilizers that were never validated, FDA says.(Human drugs)
November 1, 2004... According to an Aug. 20 warning letter, Medical Energy, Inc., Pensacola, FL, used optical fiber laser delivery systems with sterilizers that had never been validated; the cleaning and resterilization operations were not validated, either. ...

Patient lift system design not validated.(Human drugs)
November 1, 2004... In Sept. 28 warning letter, FDA stated that Penner Manufacturing, Inc., Aurora, NE, had not established, defined or documented procedures for validating the device design of its patient lift system. An FDA audit performed April 22-May 14...

Roche clinical workstations cited for lack of FDA approval, CAPA faults, design control issues; agency audits workstations maker.(Human drugs)
November 1, 2004... FDA reviewed Roche Diagnostic Corp., Indianapolis, the marketer of Tecan Clinical Workstations, and determined the devices did not have a PMA application or an IDE for the devices, nor did Roche have various design controls in place (see...

Software validation, CAPA and quality audit faults cited at Tecan.(Human drugs)
November 1, 2004... A May 10-27 inspection of Tecan US, Durham, NC, the manufacturer and distributor of the Tecan Clinical Workstation, revealed a number of QS violations, including failure to validate their software program, failure to establish or maintain...

Soule cited for CAPA, audit and quality policy/plan faults.(Human drugs)
November 1, 2004... The Soule Co., Inc., Lutz, FL, was found to be in violation of QS regulations, including not establishing or implementing CAPA [corrective and preventive action] procedures; quality audit procedures; a quality policy and plan; management review...

Sugih Instrumendo's aneroid sphygmomanometers cited for validation problems.(Human drugs)
November 1, 2004... During an inspection May 31-June 3, FDA found Sugih Instrumendo Abadi, Pt., Padalarang, Jawa Barat, Indonesia did not conform to current GMPs in that they failed to validate a process where the results could not be fully verified by subsequent...

Sterex high-frequency needles, packaging equipment, inspection system not validated.(Human drugs)
November 1, 2004... An Oct. 8 warning letter cited Sterex International, Tyseley, Birmingham, U.K., for failure to validate its manufacturing process for its epilator high-frequency needles, its needle production machines, its packaging equipment and a...

Blood center failed to give notification of fatality due to transfusion.(Blood/biologics)
November 1, 2004... Mary Greeley Medical Center, Ames, IA, failed to notify the Center for Biologics when a complication of blood collection or transfusion was confirmed to be fatal, according to a Sept. 21 warning letter. During an inspection of the blood...