Validation Times articles from March 2003

Validation Times archives from March 2003

CDER enforcer advises firms to list Part 11 records and non-Part 11 documents; FDA saw firms reverting to paper. (Electronic records).
March 1, 2003... NEW YORK--Drug, device and biologics manufacturers should list the records their companies believe should meet requirements of FDA's electronic signature/records regulation (21 CFR Part 11) and those records that do not, but not keep two sets...

Lab controls, production records lead 2002 PAI 483 citings; validation leads list of withhold causes. (Process validation).
March 1, 2003... ATHENS, GA -- Laboratory controls and production record reviews tied as the leading citations on 483s for pre-approval inspections (PAIs) in fiscal 2002; and in terms of NDA and ANDA withholds, validation concerns were the leading items on...

'Validation Council,' manual seen used successfully at Pharmacia, other firms. (Process Validation).
March 1, 2003... PHILADELPHIA -- Pharmacia created an internal "Corporate Validation Council" and uniform manual to ensure process validation was consistent at all facilities worldwide, especially those it acquired from Upjohn in the 1990s merger. Richard...

Panel, FDA urge industry to adopt PAT now. (Process analytical technology).
March 1, 2003... ROCKVILLE, MD -- Now that FDA has unveiled its "Pharmaceutical GMPs for the 21st initiative," companies should expect to see a guidance document on Process Analytical Technology (PAT) very soon, but the agency and its Advisory Committee for...

To validate or revalidate--that is the question. (Revalidation).
March 1, 2003... PHILADELPHIA -- One of the bigger debates in recent discussions of validation is the practice of revalidation. If a process is validated, some industry leaders will argue, then the state of validation simply needs to be maintained through a...

Process development could be key for good validation. (Process development).
March 1, 2003... PHILADELPHIA -- One of the best ways to prepare for process validation is to have a proactive, involved process development that draws from the expertise of engineers and gathers ample documentation. Addressing a recent Barnett...

Broken bottle, glass contamination the focus of Amersham inspection. (Human drugs).
March 1, 2003... Amersham Mediphysics, Arlington Heights, IL, received a 10-item 483 from FDA following a June 2001 investigation of a broken bottle of thallous chloride that was later recycled and used in distributed product. The 483 noted that the "firm has...

FDA challenges King on validation, complaint handling. (Human drugs).
March 1, 2003... Investigator Edward Maticka of FDA's New Orleans District called into question the validation practices of King Pharmaceuticals following a June 24-July 2, 2002, audit of the company's Bristol, TN, manufacturing plant. According to the...

Repackager's legion of deficiencies cited for Medwatch reports, recalls. (Human drugs).
March 1, 2003... Investigators Paul Figarole and Leo Lagrotte of the Florida District inspected Tallahassee, FL-based TYA Pharmaceuticals Feb. 11-15 citing the firm for having insufficient process validation and cleaning equipment validation. According to...

Jomed gets 483 for CAPA unsupported by validation data. (Medical devices).
March 1, 2003... Stent maker Jomed, San Diego, CA, was hit with a two-item 483 for running inadequate risk analyses and failing to complete corrective and preventive action (CAPA) activities within a reasonable time frame following an inspection by Los Angeles...

Icon falls short on validation, stability testing. (Human drugs).
March 1, 2003... OTC drug maker Icon Laboratories failed to perform process validation studies on the manufacturing process of the bulk solution and equipment cleaning processes for P-K-Pain Relief Medication, according to a Feb. 4 warning letter. The...

Equipment problems net PureTek 11-item letter. (Human drugs).
March 1, 2003... San Fernando, CA-based PureTek Corp. came under fire from FDA for deficient written calibration procedures for instruments, apparatus, gauges and recording devices. The Feb. 10 warning letter stated the firm's procedures were deficient in...

Insulin injector maker's unvalidated package testing nets warning letter. (Medical Devices).
March 1, 2003... In its 18-item, Jan. 30 warning letter, FDA hit needleless insulin injector manufacturer Activa Brand Products with failure to adequately validate a packaging integrity testing process. Specifically, the agency stated that the Canadian firm...

Untested waters affect bioburden in surgical sponges. (Medical Devices).
March 1, 2003... Switching in-process water sources without revalidating manufacturing processes may have played heavily in Ultracell Medical Technologies' receipt of a Feb. 3 warning letter. FDA cited the manufacturer of ophthalmic surgical sponges for...